Total knee replacement (TKR) is a reliable treatment for end-stage arthritis of the knee, resulting in pain relief and return of function. While surgeons have historically focused on surgical technique and implant selection as important factors on the path to a successful outcome, additional care elements may play similarly important roles. As hospital length of stay continues to decrease, more of the patient’s postoperative care occurs in a postacute setting, with home care becoming a more important component of a well-designed care path. Early experience suggests that this shift toward home care has resulted in a more cost-effective approach with improved outcomes.^1–4

Although TKR has traditionally been viewed as a surgical procedure, an important shift in thinking has increased recognition that TKR is best viewed as part of a spectrum of care required to obtain an end result. Viewing the procedure as an episode of care is gaining significant traction. In this approach, the surgical procedure and its attendant features and factors remain paramount and central in driving outcomes, but the care that precedes and follows the procedure can have a significant impact on important measures of success. From the patient’s perspective, this view is intuitive; ie, the outcome of the intervention can only be assessed when complete healing has occurred and the patient has returned to routine activities of daily living (ADL). As such, a more holistic or global view of the episode is warranted and is receiving increasing attention.^5–8

INNOVATIVE PAYMENT METHODS AND RESOURCE ALLOCATION

Recently, the Center for Medicare & Medicaid Services (CMS) launched a call for innovative payment methods for episodes of care. Traditionally, CMS has paid for each component of care separately; the new approach, represented in this call for proposals and driven by the Patient Protection and Affordable Care Act (PPACA), is to pay for care based on defined episodes. This method of payment is sometimes referred to as “bundling,” in that the payment for a group of services is linked into a single payment. Although the details and definitions of the episodes may vary, the conceptual framework supports the integration of care along a continuum. By paying for care based on the entire episode, CMS believes it can encourage more rational allocation of resources along the care path.⁹

It is widely recognized that one area where care can be better managed is during the transitions that occur at many points along the care path—for example, transition from operating theater to postoperative unit and then to the acute care hospital setting, and transition from acute care hospital to a postacute setting.^1,4,10

When a patient no longer requires hospital services but needs the benefits of continued care, the transition to postacute care must be managed carefully. Optimizing this transition and choosing among postacute care venues can significantly affect cost and outcomes of the procedure. In fact, there is increasing evidence that the transition from hospitalization to postacute care has been significantly undermanaged, with deferral of some important considerations until after the process has already begun.^1,4,10 Neglecting this important transition results in unwarranted variation in process and outcomes. For example, physicians often delegate decisions regarding the location and intensity of postacute services to other team members. Patient preferences and, at times, misconceptions can drive the choices for postacute care, with patients erroneously believing that one venue is inherently better than another or that more is somehow better than less. Such patterns can lead to over- or underutilization, with care unmatched to individual need or circumstance. Careful scrutiny by an engaged team of the resources necessary for patients as they transition to the postacute component of the episode is likely to result in a more rational, cost-effective approach to care. It is also likely to increase patient satisfaction and improve patient outcome measures.^5,10–13

MEETING THE CHALLENGE OF INCREASED DEMAND WITH HOME CARE

With the rising incidence of knee arthritis, the demand for TKR is expected to more than double in the coming years.¹⁴ This increased utilization is driven by an aging population that desires to remain active, as well as by evidence suggesting health benefits associated with increased activity levels. Along with these demographic and utilization trends, another evolution in joint replacement derives from patients’ expectation of continuously improving results. Patients measure the success of TKR not only by relative reduction in pain, but also by other outcome metrics, including, importantly, return to sport or work.^5,7 The tandem challenge posed by increased demand for services and increased patient expectations regarding outcomes is testing health care providers as they consider the resources that will be required to meet the demand.

Health care systems, payers, and physicians are looking for ways to more efficiently meet this growing need for TKR services in the context of finite health care resources subject to competing demand from several clinical entities. Regardless of TKR’s record of clinical success, the resources applied to this orthopedic intervention come at the expense of the same resources being applied to other health care needs. As demand is unlikely to wane, the only rational approach is to redesign care delivery in favor of a more efficient model. In order to meet the demand with the available resources, several goals need to be achieved: fewer inpatient hospital and postacute bed days consumed by joint replacement services, better streamlined care paths, and improved engagement of the patient and his or her home-based support network. Key to this process is driving care to the home environment, provided that quality is at least comparable and cost is significantly less.^3,15–17

Postoperative rehabilitation and physical therapy is essential to restoration of function after TKR. It is therefore no surprise that rehabilitation and physical therapy make up a significant proportion of the home care services for this patient population.^8,17,18 Among its advantages, therapy in the home environment gives the therapist the opportunity to identify and address the patient’s unique needs in his or her own home. In addition, family and other support personnel often feel more comfortable assuming responsibility for assisting with care in a familiar setting. Tailored therapy in the home setting can improve safety and satisfaction and speed the resumption of ADL; it is increasingly seen as an essential component of the care path.^4,11

Recently, care path designs have been subject to careful analyses that compare in-home rehabilitation outcomes with outcomes achieved in an inpatient environment. Observational, retrospective, and prospective study designs have confirmed that the in-home rehabilitation model of care delivery is not only viable, but in many circumstances preferable.^{5,10,12,17,19} The quality is comparable to inpatient care for most TKR patient populations and the cost and resource utilization intensity are considerably reduced. Such reports have lent credence to the movement to incorporate home care services into successful post–joint replacement care paths. The approach appears to have a large potential for benefit with very little risk. Strategies that aim to more rationally deliver needed rehabilitation services at home promise to keep TKR services within the reach of our strained health care resources.

THE HOME CARE CLINICAL PATH

The underlying principle of a home care clinical path is that the patient remains at the center of the program and shares in decisions about care strategies (Table). One of the greatest concerns patients have about a pending knee replacement is the duration of their expected recovery. To meet this concern, a Rapid Recovery Care Path has been developed that incorporates an integrated approach to acute and postacute care, with increased emphasis on discharging patients to their home environment as early as it appears safe to do so. The goals of a rapid recovery home-centered care program following routine TKR include reduced postoperative pain and early return to function.^2,15,16 Meeting these goals minimizes the development of a vicious cycle of pain and stiffness that may lead to chronic pain and fibrosis. As a result, the patient can pursue more aggressive rehabilitation, which maintains joint range of motion, permits earlier hospital discharge and discharge to home rather than another health care facility, and improves patient satisfaction.

The Cleveland Clinic Total Knee Care Path effectively incorporates the rapid recovery approach, with home care taking the lead in discharge planning and transition of care management. Education is essential and should start early, at the time of informed consent; involve the patient and family; and continue throughout the care path.

The key to a successful outcome is patient engagement with agreed-upon principles of care, which form the basis for the care path. In the Cleveland Clinic program, patients are engaged to embrace the following goals:

• Shared decision-making
• A home care environment that includes support of family and friends
• Patient and family education to enhance shared decision-making
• Return to the home environment as soon as it is deemed safe
• Elimination of unnecessary or duplicative treatments, tests, or interventions
• Acceptance of multiple plans or paths in response to changing clinical conditions

All patients undergo a preoperative evaluation, during which they are introduced to and educated about the Rapid Recovery Total Knee Care Path. The Rapid Recovery Path accommodates planned interventions and contingencies depending on clinical course. Every patient envisions a safe return home as a primary goal, with as short an exposure to inpatient acute and postacute settings as is necessary. No fixed length of stay or discharge destination is mandated. Rather, patients are encouraged to articulate their goals, drive their discharge, and return home. Such shared decision-making empowers patients and improves satisfaction.

Factors that affect recovery are assessed through a detailed perioperative history and physical examination. The patient’s readiness for an intervention such as TKR is assessed in three phases:

• The preoperative history, physical examination, and radiographic parameters establish that appropriate indications exist in terms of diagnosis and level of disability.
• The assessment team identifies conditions that affect risk and devises plans for their perioperative management—for example, control of blood glucose or decolonization of methicillin-resistant Staphylococcus Taurus carriers. Plans are made for the perioperative as well as seamless postdischarge management of chronic conditions such as atrial fibrillation requiring anticoagulation or hypertension.
• Psychosocial factors are evaluated for their potential impact on discharge planning and postacute management. Patients must establish their ability to participate actively in their care and consider their access to family, friends, and neighbors who can assist with care management in the home. Successful management of the care episode depends on an effective and reliable advocate. If the patient is unable to perform this function, then a surrogate advocate must be identified. If this role cannot be filled, the patient will require transfer to an inpatient rehabilitation facility.

POSITIVE RESULTS, BUT REGULATORY CHALLENGES

Since our 2006 incorporation of an active postacute home care program into our rapid recovery protocol, we have observed several improved outcome metrics:

• Average acute care hospital length of stay has been reduced by an average of 0.9 days.
• Our discharge to home rate has risen from 32% to 74%. In fact, among surgeons who have fully embraced the rapid recovery protocol, the discharge to home rate is 74% compared with 45% among the remaining surgeons. The difference is statistically (P < .05) and clinically significant.
• The readmission rate for patients discharged to home using this protocol is significantly lower compared with the rate before the protocol was implemented and with the rate of a control cohort discharged to a skilled nursing facility. Patients discharged to home consume significantly fewer resources and cost the system about one-third as much as those sent to an inpatient postacute facility.

Despite these gains, the regulatory environment is not structured to reward good stewardship of health care resources. For example, current payment rules penalize institutions that achieve early discharge (less than 3 days) from an acute care hospital when the patient will be transferred to another care venue. In addition, requirements for home care can be stringent, limiting the beneficial application of therapy in the home if alternatives, such as outpatient or subacute care, exist. Fortunately, PPACA and the request for bundled pricing of episodes of care gives providers the opportunity to apply for exceptions to rules that hinder cost containment. As such, relief may be in sight.

OUTLOOK

The future is bright for care path development and incorporation of better methods to manage care episodes.^20,21 Although the concept of outpatient joint replacement has been considered by some, questions remain regarding the lower limit of resources that should be applied to a given episode and how best to predict which patients can benefit from even less inpatient care. Predictive modeling based on patient-specific factors might assist in this, but prudence suggests that flexibility in care path management will always be the most important element of protection for patients. Specifically, early detection of significant clinical deviation requiring a change in venue is paramount and is routinely incorporated into any well-designed care path. The goal is not to minimize resource utilization, but rather to ensure appropriate and rational distribution of health care resources to meet the clinical needs of each patient. Refining our approaches to achieving this balance will require ongoing work and monitoring of metrics of success.

Total knee replacement (TKR) is a reliable treatment for end-stage arthritis of the knee, resulting in pain relief and return of function. While surgeons have historically focused on surgical technique and implant selection as important factors on the path to a successful outcome, additional care elements may play similarly important roles. As hospital length of stay continues to decrease, more of the patient’s postoperative care occurs in a postacute setting, with home care becoming a more important component of a well-designed care path. Early experience suggests that this shift toward home care has resulted in a more cost-effective approach with improved outcomes.^1–4

Although TKR has traditionally been viewed as a surgical procedure, an important shift in thinking has increased recognition that TKR is best viewed as part of a spectrum of care required to obtain an end result. Viewing the procedure as an episode of care is gaining significant traction. In this approach, the surgical procedure and its attendant features and factors remain paramount and central in driving outcomes, but the care that precedes and follows the procedure can have a significant impact on important measures of success. From the patient’s perspective, this view is intuitive; ie, the outcome of the intervention can only be assessed when complete healing has occurred and the patient has returned to routine activities of daily living (ADL). As such, a more holistic or global view of the episode is warranted and is receiving increasing attention.^5–8

INNOVATIVE PAYMENT METHODS AND RESOURCE ALLOCATION

Recently, the Center for Medicare & Medicaid Services (CMS) launched a call for innovative payment methods for episodes of care. Traditionally, CMS has paid for each component of care separately; the new approach, represented in this call for proposals and driven by the Patient Protection and Affordable Care Act (PPACA), is to pay for care based on defined episodes. This method of payment is sometimes referred to as “bundling,” in that the payment for a group of services is linked into a single payment. Although the details and definitions of the episodes may vary, the conceptual framework supports the integration of care along a continuum. By paying for care based on the entire episode, CMS believes it can encourage more rational allocation of resources along the care path.⁹

It is widely recognized that one area where care can be better managed is during the transitions that occur at many points along the care path—for example, transition from operating theater to postoperative unit and then to the acute care hospital setting, and transition from acute care hospital to a postacute setting.^1,4,10

When a patient no longer requires hospital services but needs the benefits of continued care, the transition to postacute care must be managed carefully. Optimizing this transition and choosing among postacute care venues can significantly affect cost and outcomes of the procedure. In fact, there is increasing evidence that the transition from hospitalization to postacute care has been significantly undermanaged, with deferral of some important considerations until after the process has already begun.^1,4,10 Neglecting this important transition results in unwarranted variation in process and outcomes. For example, physicians often delegate decisions regarding the location and intensity of postacute services to other team members. Patient preferences and, at times, misconceptions can drive the choices for postacute care, with patients erroneously believing that one venue is inherently better than another or that more is somehow better than less. Such patterns can lead to over- or underutilization, with care unmatched to individual need or circumstance. Careful scrutiny by an engaged team of the resources necessary for patients as they transition to the postacute component of the episode is likely to result in a more rational, cost-effective approach to care. It is also likely to increase patient satisfaction and improve patient outcome measures.^5,10–13

MEETING THE CHALLENGE OF INCREASED DEMAND WITH HOME CARE

With the rising incidence of knee arthritis, the demand for TKR is expected to more than double in the coming years.¹⁴ This increased utilization is driven by an aging population that desires to remain active, as well as by evidence suggesting health benefits associated with increased activity levels. Along with these demographic and utilization trends, another evolution in joint replacement derives from patients’ expectation of continuously improving results. Patients measure the success of TKR not only by relative reduction in pain, but also by other outcome metrics, including, importantly, return to sport or work.^5,7 The tandem challenge posed by increased demand for services and increased patient expectations regarding outcomes is testing health care providers as they consider the resources that will be required to meet the demand.

Health care systems, payers, and physicians are looking for ways to more efficiently meet this growing need for TKR services in the context of finite health care resources subject to competing demand from several clinical entities. Regardless of TKR’s record of clinical success, the resources applied to this orthopedic intervention come at the expense of the same resources being applied to other health care needs. As demand is unlikely to wane, the only rational approach is to redesign care delivery in favor of a more efficient model. In order to meet the demand with the available resources, several goals need to be achieved: fewer inpatient hospital and postacute bed days consumed by joint replacement services, better streamlined care paths, and improved engagement of the patient and his or her home-based support network. Key to this process is driving care to the home environment, provided that quality is at least comparable and cost is significantly less.^3,15–17

Postoperative rehabilitation and physical therapy is essential to restoration of function after TKR. It is therefore no surprise that rehabilitation and physical therapy make up a significant proportion of the home care services for this patient population.^8,17,18 Among its advantages, therapy in the home environment gives the therapist the opportunity to identify and address the patient’s unique needs in his or her own home. In addition, family and other support personnel often feel more comfortable assuming responsibility for assisting with care in a familiar setting. Tailored therapy in the home setting can improve safety and satisfaction and speed the resumption of ADL; it is increasingly seen as an essential component of the care path.^4,11

Recently, care path designs have been subject to careful analyses that compare in-home rehabilitation outcomes with outcomes achieved in an inpatient environment. Observational, retrospective, and prospective study designs have confirmed that the in-home rehabilitation model of care delivery is not only viable, but in many circumstances preferable.^{5,10,12,17,19} The quality is comparable to inpatient care for most TKR patient populations and the cost and resource utilization intensity are considerably reduced. Such reports have lent credence to the movement to incorporate home care services into successful post–joint replacement care paths. The approach appears to have a large potential for benefit with very little risk. Strategies that aim to more rationally deliver needed rehabilitation services at home promise to keep TKR services within the reach of our strained health care resources.

THE HOME CARE CLINICAL PATH

The underlying principle of a home care clinical path is that the patient remains at the center of the program and shares in decisions about care strategies (Table). One of the greatest concerns patients have about a pending knee replacement is the duration of their expected recovery. To meet this concern, a Rapid Recovery Care Path has been developed that incorporates an integrated approach to acute and postacute care, with increased emphasis on discharging patients to their home environment as early as it appears safe to do so. The goals of a rapid recovery home-centered care program following routine TKR include reduced postoperative pain and early return to function.^2,15,16 Meeting these goals minimizes the development of a vicious cycle of pain and stiffness that may lead to chronic pain and fibrosis. As a result, the patient can pursue more aggressive rehabilitation, which maintains joint range of motion, permits earlier hospital discharge and discharge to home rather than another health care facility, and improves patient satisfaction.

The Cleveland Clinic Total Knee Care Path effectively incorporates the rapid recovery approach, with home care taking the lead in discharge planning and transition of care management. Education is essential and should start early, at the time of informed consent; involve the patient and family; and continue throughout the care path.

The key to a successful outcome is patient engagement with agreed-upon principles of care, which form the basis for the care path. In the Cleveland Clinic program, patients are engaged to embrace the following goals:

• Shared decision-making
• A home care environment that includes support of family and friends
• Patient and family education to enhance shared decision-making
• Return to the home environment as soon as it is deemed safe
• Elimination of unnecessary or duplicative treatments, tests, or interventions
• Acceptance of multiple plans or paths in response to changing clinical conditions

All patients undergo a preoperative evaluation, during which they are introduced to and educated about the Rapid Recovery Total Knee Care Path. The Rapid Recovery Path accommodates planned interventions and contingencies depending on clinical course. Every patient envisions a safe return home as a primary goal, with as short an exposure to inpatient acute and postacute settings as is necessary. No fixed length of stay or discharge destination is mandated. Rather, patients are encouraged to articulate their goals, drive their discharge, and return home. Such shared decision-making empowers patients and improves satisfaction.

Factors that affect recovery are assessed through a detailed perioperative history and physical examination. The patient’s readiness for an intervention such as TKR is assessed in three phases:

• The preoperative history, physical examination, and radiographic parameters establish that appropriate indications exist in terms of diagnosis and level of disability.
• The assessment team identifies conditions that affect risk and devises plans for their perioperative management—for example, control of blood glucose or decolonization of methicillin-resistant Staphylococcus Taurus carriers. Plans are made for the perioperative as well as seamless postdischarge management of chronic conditions such as atrial fibrillation requiring anticoagulation or hypertension.
• Psychosocial factors are evaluated for their potential impact on discharge planning and postacute management. Patients must establish their ability to participate actively in their care and consider their access to family, friends, and neighbors who can assist with care management in the home. Successful management of the care episode depends on an effective and reliable advocate. If the patient is unable to perform this function, then a surrogate advocate must be identified. If this role cannot be filled, the patient will require transfer to an inpatient rehabilitation facility.

POSITIVE RESULTS, BUT REGULATORY CHALLENGES

Since our 2006 incorporation of an active postacute home care program into our rapid recovery protocol, we have observed several improved outcome metrics:

• Average acute care hospital length of stay has been reduced by an average of 0.9 days.
• Our discharge to home rate has risen from 32% to 74%. In fact, among surgeons who have fully embraced the rapid recovery protocol, the discharge to home rate is 74% compared with 45% among the remaining surgeons. The difference is statistically (P < .05) and clinically significant.
• The readmission rate for patients discharged to home using this protocol is significantly lower compared with the rate before the protocol was implemented and with the rate of a control cohort discharged to a skilled nursing facility. Patients discharged to home consume significantly fewer resources and cost the system about one-third as much as those sent to an inpatient postacute facility.

Despite these gains, the regulatory environment is not structured to reward good stewardship of health care resources. For example, current payment rules penalize institutions that achieve early discharge (less than 3 days) from an acute care hospital when the patient will be transferred to another care venue. In addition, requirements for home care can be stringent, limiting the beneficial application of therapy in the home if alternatives, such as outpatient or subacute care, exist. Fortunately, PPACA and the request for bundled pricing of episodes of care gives providers the opportunity to apply for exceptions to rules that hinder cost containment. As such, relief may be in sight.

OUTLOOK

The future is bright for care path development and incorporation of better methods to manage care episodes.^20,21 Although the concept of outpatient joint replacement has been considered by some, questions remain regarding the lower limit of resources that should be applied to a given episode and how best to predict which patients can benefit from even less inpatient care. Predictive modeling based on patient-specific factors might assist in this, but prudence suggests that flexibility in care path management will always be the most important element of protection for patients. Specifically, early detection of significant clinical deviation requiring a change in venue is paramount and is routinely incorporated into any well-designed care path. The goal is not to minimize resource utilization, but rather to ensure appropriate and rational distribution of health care resources to meet the clinical needs of each patient. Refining our approaches to achieving this balance will require ongoing work and monitoring of metrics of success.

Total knee replacement (TKR) is a reliable treatment for end-stage arthritis of the knee, resulting in pain relief and return of function. While surgeons have historically focused on surgical technique and implant selection as important factors on the path to a successful outcome, additional care elements may play similarly important roles. As hospital length of stay continues to decrease, more of the patient’s postoperative care occurs in a postacute setting, with home care becoming a more important component of a well-designed care path. Early experience suggests that this shift toward home care has resulted in a more cost-effective approach with improved outcomes.^1–4

Although TKR has traditionally been viewed as a surgical procedure, an important shift in thinking has increased recognition that TKR is best viewed as part of a spectrum of care required to obtain an end result. Viewing the procedure as an episode of care is gaining significant traction. In this approach, the surgical procedure and its attendant features and factors remain paramount and central in driving outcomes, but the care that precedes and follows the procedure can have a significant impact on important measures of success. From the patient’s perspective, this view is intuitive; ie, the outcome of the intervention can only be assessed when complete healing has occurred and the patient has returned to routine activities of daily living (ADL). As such, a more holistic or global view of the episode is warranted and is receiving increasing attention.^5–8

INNOVATIVE PAYMENT METHODS AND RESOURCE ALLOCATION

Recently, the Center for Medicare & Medicaid Services (CMS) launched a call for innovative payment methods for episodes of care. Traditionally, CMS has paid for each component of care separately; the new approach, represented in this call for proposals and driven by the Patient Protection and Affordable Care Act (PPACA), is to pay for care based on defined episodes. This method of payment is sometimes referred to as “bundling,” in that the payment for a group of services is linked into a single payment. Although the details and definitions of the episodes may vary, the conceptual framework supports the integration of care along a continuum. By paying for care based on the entire episode, CMS believes it can encourage more rational allocation of resources along the care path.⁹

It is widely recognized that one area where care can be better managed is during the transitions that occur at many points along the care path—for example, transition from operating theater to postoperative unit and then to the acute care hospital setting, and transition from acute care hospital to a postacute setting.^1,4,10

When a patient no longer requires hospital services but needs the benefits of continued care, the transition to postacute care must be managed carefully. Optimizing this transition and choosing among postacute care venues can significantly affect cost and outcomes of the procedure. In fact, there is increasing evidence that the transition from hospitalization to postacute care has been significantly undermanaged, with deferral of some important considerations until after the process has already begun.^1,4,10 Neglecting this important transition results in unwarranted variation in process and outcomes. For example, physicians often delegate decisions regarding the location and intensity of postacute services to other team members. Patient preferences and, at times, misconceptions can drive the choices for postacute care, with patients erroneously believing that one venue is inherently better than another or that more is somehow better than less. Such patterns can lead to over- or underutilization, with care unmatched to individual need or circumstance. Careful scrutiny by an engaged team of the resources necessary for patients as they transition to the postacute component of the episode is likely to result in a more rational, cost-effective approach to care. It is also likely to increase patient satisfaction and improve patient outcome measures.^5,10–13

MEETING THE CHALLENGE OF INCREASED DEMAND WITH HOME CARE

With the rising incidence of knee arthritis, the demand for TKR is expected to more than double in the coming years.¹⁴ This increased utilization is driven by an aging population that desires to remain active, as well as by evidence suggesting health benefits associated with increased activity levels. Along with these demographic and utilization trends, another evolution in joint replacement derives from patients’ expectation of continuously improving results. Patients measure the success of TKR not only by relative reduction in pain, but also by other outcome metrics, including, importantly, return to sport or work.^5,7 The tandem challenge posed by increased demand for services and increased patient expectations regarding outcomes is testing health care providers as they consider the resources that will be required to meet the demand.

Health care systems, payers, and physicians are looking for ways to more efficiently meet this growing need for TKR services in the context of finite health care resources subject to competing demand from several clinical entities. Regardless of TKR’s record of clinical success, the resources applied to this orthopedic intervention come at the expense of the same resources being applied to other health care needs. As demand is unlikely to wane, the only rational approach is to redesign care delivery in favor of a more efficient model. In order to meet the demand with the available resources, several goals need to be achieved: fewer inpatient hospital and postacute bed days consumed by joint replacement services, better streamlined care paths, and improved engagement of the patient and his or her home-based support network. Key to this process is driving care to the home environment, provided that quality is at least comparable and cost is significantly less.^3,15–17

Postoperative rehabilitation and physical therapy is essential to restoration of function after TKR. It is therefore no surprise that rehabilitation and physical therapy make up a significant proportion of the home care services for this patient population.^8,17,18 Among its advantages, therapy in the home environment gives the therapist the opportunity to identify and address the patient’s unique needs in his or her own home. In addition, family and other support personnel often feel more comfortable assuming responsibility for assisting with care in a familiar setting. Tailored therapy in the home setting can improve safety and satisfaction and speed the resumption of ADL; it is increasingly seen as an essential component of the care path.^4,11

Recently, care path designs have been subject to careful analyses that compare in-home rehabilitation outcomes with outcomes achieved in an inpatient environment. Observational, retrospective, and prospective study designs have confirmed that the in-home rehabilitation model of care delivery is not only viable, but in many circumstances preferable.^{5,10,12,17,19} The quality is comparable to inpatient care for most TKR patient populations and the cost and resource utilization intensity are considerably reduced. Such reports have lent credence to the movement to incorporate home care services into successful post–joint replacement care paths. The approach appears to have a large potential for benefit with very little risk. Strategies that aim to more rationally deliver needed rehabilitation services at home promise to keep TKR services within the reach of our strained health care resources.

THE HOME CARE CLINICAL PATH

The underlying principle of a home care clinical path is that the patient remains at the center of the program and shares in decisions about care strategies (Table). One of the greatest concerns patients have about a pending knee replacement is the duration of their expected recovery. To meet this concern, a Rapid Recovery Care Path has been developed that incorporates an integrated approach to acute and postacute care, with increased emphasis on discharging patients to their home environment as early as it appears safe to do so. The goals of a rapid recovery home-centered care program following routine TKR include reduced postoperative pain and early return to function.^2,15,16 Meeting these goals minimizes the development of a vicious cycle of pain and stiffness that may lead to chronic pain and fibrosis. As a result, the patient can pursue more aggressive rehabilitation, which maintains joint range of motion, permits earlier hospital discharge and discharge to home rather than another health care facility, and improves patient satisfaction.

The Cleveland Clinic Total Knee Care Path effectively incorporates the rapid recovery approach, with home care taking the lead in discharge planning and transition of care management. Education is essential and should start early, at the time of informed consent; involve the patient and family; and continue throughout the care path.

The key to a successful outcome is patient engagement with agreed-upon principles of care, which form the basis for the care path. In the Cleveland Clinic program, patients are engaged to embrace the following goals:

• Shared decision-making
• A home care environment that includes support of family and friends
• Patient and family education to enhance shared decision-making
• Return to the home environment as soon as it is deemed safe
• Elimination of unnecessary or duplicative treatments, tests, or interventions
• Acceptance of multiple plans or paths in response to changing clinical conditions

All patients undergo a preoperative evaluation, during which they are introduced to and educated about the Rapid Recovery Total Knee Care Path. The Rapid Recovery Path accommodates planned interventions and contingencies depending on clinical course. Every patient envisions a safe return home as a primary goal, with as short an exposure to inpatient acute and postacute settings as is necessary. No fixed length of stay or discharge destination is mandated. Rather, patients are encouraged to articulate their goals, drive their discharge, and return home. Such shared decision-making empowers patients and improves satisfaction.

Factors that affect recovery are assessed through a detailed perioperative history and physical examination. The patient’s readiness for an intervention such as TKR is assessed in three phases:

• The preoperative history, physical examination, and radiographic parameters establish that appropriate indications exist in terms of diagnosis and level of disability.
• The assessment team identifies conditions that affect risk and devises plans for their perioperative management—for example, control of blood glucose or decolonization of methicillin-resistant Staphylococcus Taurus carriers. Plans are made for the perioperative as well as seamless postdischarge management of chronic conditions such as atrial fibrillation requiring anticoagulation or hypertension.
• Psychosocial factors are evaluated for their potential impact on discharge planning and postacute management. Patients must establish their ability to participate actively in their care and consider their access to family, friends, and neighbors who can assist with care management in the home. Successful management of the care episode depends on an effective and reliable advocate. If the patient is unable to perform this function, then a surrogate advocate must be identified. If this role cannot be filled, the patient will require transfer to an inpatient rehabilitation facility.

POSITIVE RESULTS, BUT REGULATORY CHALLENGES

Since our 2006 incorporation of an active postacute home care program into our rapid recovery protocol, we have observed several improved outcome metrics:

• Average acute care hospital length of stay has been reduced by an average of 0.9 days.
• Our discharge to home rate has risen from 32% to 74%. In fact, among surgeons who have fully embraced the rapid recovery protocol, the discharge to home rate is 74% compared with 45% among the remaining surgeons. The difference is statistically (P < .05) and clinically significant.
• The readmission rate for patients discharged to home using this protocol is significantly lower compared with the rate before the protocol was implemented and with the rate of a control cohort discharged to a skilled nursing facility. Patients discharged to home consume significantly fewer resources and cost the system about one-third as much as those sent to an inpatient postacute facility.

Despite these gains, the regulatory environment is not structured to reward good stewardship of health care resources. For example, current payment rules penalize institutions that achieve early discharge (less than 3 days) from an acute care hospital when the patient will be transferred to another care venue. In addition, requirements for home care can be stringent, limiting the beneficial application of therapy in the home if alternatives, such as outpatient or subacute care, exist. Fortunately, PPACA and the request for bundled pricing of episodes of care gives providers the opportunity to apply for exceptions to rules that hinder cost containment. As such, relief may be in sight.

OUTLOOK

The future is bright for care path development and incorporation of better methods to manage care episodes.^20,21 Although the concept of outpatient joint replacement has been considered by some, questions remain regarding the lower limit of resources that should be applied to a given episode and how best to predict which patients can benefit from even less inpatient care. Predictive modeling based on patient-specific factors might assist in this, but prudence suggests that flexibility in care path management will always be the most important element of protection for patients. Specifically, early detection of significant clinical deviation requiring a change in venue is paramount and is routinely incorporated into any well-designed care path. The goal is not to minimize resource utilization, but rather to ensure appropriate and rational distribution of health care resources to meet the clinical needs of each patient. Refining our approaches to achieving this balance will require ongoing work and monitoring of metrics of success.

The home is the most important context of care for individuals with chronic heart failure and yet it is the least accessible to caregivers. Patients often struggle to manage a complex regimen of medications, follow an unfamiliar diet, monitor weight and vital signs, and work to coordinate care among various providers who, in some cases, fail to communicate effectively. Heart failure patients do all this while making difficult decisions about their livelihoods, social condition, and future direction. With progression of the disease and comorbidity, these patients often experience a downward cycle of repeat hospitalization and worsening functional capacity (Figure 1). Each subsequent transition from acute care to home becomes incrementally more difficult to manage.

According to the latest American College of Cardiology/American Heart Association Guidelines for the Diagnosis and Management of Heart Failure in Adults, appropriate care for patients with heart failure should include:

• Intensive patient education
• Encouragement of patients to be more aggressive participants in their care
• Close monitoring of patients through telephone follow-up or home nursing
• Careful review of medications to improve adherence to evidence-based guidelines
• Multidisciplinary care with nurse case management directed by a physician¹

Beyond these general suggestions, recommendations about specific approaches and models of care in the home are lacking.

Contemporary research suggests that postacute, home-based care of heart failure patients may yield outcomes similar to those of clinic-based outpatient care. Results of the Which Heart Failure Intervention is Most Cost-Effective & Consumer-Friendly in Reducing Hospital Care (WHICH?) trial support this hypothesis. This multicenter, randomized clinical trial (n = 280) compared home- with clinic-based multidisciplinary management for postacute heart failure patients.² Investigators compared outcomes in patients managed at a heart failure clinic with those managed at home. They found that postdischarge home visits by heart failure nurses did not significantly alter the primary composite end point of death or unplanned rehospitalization from any cause over 18 months (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.73–1.30, P = .8621). The rate of unplanned and total hospitalization was also similar in the two groups. However, the average length of hospital stay was significantly lower in the home care group (4 days) than in the clinic-based group (6 days); P = .004. A cost-effectiveness analysis is planned but has not yet been presented.

HEART CARE AT HOME

At Cleveland Clinic, our group of physicians (geriatrics and cardiology), nurses, nurse practitioners, and hospital administrators founded a primarily home-based postacute transitional care program in 2010 called “Heart Care at Home.” The design of our program was influenced by Coleman et al’s care transitions interventions program,³ Naylor et al’s transitional care intervention,⁴ and the contemporary remote monitoring literature.⁵ The program focuses primarily on older adults hospitalized for heart failure who are transitioning from hospital to home. In our model:

• Inpatient care advocates identify candidates during the index inpatient stay, introduce a model of care, and begin a coaching intervention.
• After discharge, home liaisons visit the patient at home, continue coaching intervention, and teach the patient to use the newly installed remote monitoring equipment.
• For 30 to 40 days after discharge, a team of telehealth nurses monitors the patient, makes contact with him or her weekly in order to reinforce coaching intervention, coordinates care, and tracks outcomes.
• Nurse practitioners experienced both in home care and heart failure provide clinical oversight and leadership and visit the highest-acuity patients at home.

To date, the program has provided care in more than 2,100 patient encounters, with approximately 50 to 80 patients actively enrolled at any time. We identified potential program candidates using a digital list tool embedded in Cleveland Clinic’s electronic medical record (EMR) system. This tool was developed by our team together with an internal business intelligence team. We have been approximately 65% successful in identifying eligible inpatients. Patients enrolled in our transitional care program tend to be older, have longer hospital stays, and have more comorbidities than other older adults hospitalized at Cleveland Clinic for similar reasons.

Following index hospital discharge, our home liaisons have been able to make an initial home visit after a median of 2 days (25th to 75th percentile: 1 to 3 days). Patients thought to be at higher risk for hospital readmissions have been seen at home by our nurse practitioners within the first week of discharge. The most common challenge that our at-home team members have faced relates to patients’ medications (for example, unfilled prescriptions and errors in utilization). On many occasions our at-home team has succeeded in transitioning patients not benefiting from care at home to nonhospital venues (skilled nursing facilities, chronic care facilities, inpatient hospice) or to higher levels of at-home care (at-home physician visits, home-care nursing and therapy, at-home hospice).

To date, patients have been enrolled in our program for a median of 30 days (25th to 75th percentile: 20 to 35 days). We have observed an increased level of patient satisfaction. Among heart failure patients enrolled in our program for the first time, we have observed a lower readmission rate compared with publicly reported Cleveland Clinic rates (24.5% vs 28.2%). However, there are several ongoing challenges in the care of heart failure patients in the home environment. These relate to longitudinal care across venues, cross training of providers, and home monitoring.

 

 

Longitudinal care across venues

Our program aims to address the lack of integrated care over time and between care venues. This problem lies at the intersection of health care reimbursement policy and clinical practice. Currently, the hospital reimbursement system does not encourage care coordination across settings. The system has, in fact, evolved into a string of disconnected care providers who act as “toll booths” providing services for a fee in isolation from other providers. Coleman and colleagues have documented the complexity of the transitions among these care providers for older patients with chronic disease, noting the implications for patient safety and cost.⁶

Hospitals receive a fixed payment for an inpatient admission, which increases the financial incentive to discharge patients faster to other venues of care. The study by Bueno et al of a Medicare population treated between 1993 and 2006 confirms that such a trend exists for heart failure patients.⁷ The authors found a steady decrease in the mean length of hospital stay from 8.81 days to 6.33 days over the study period (28% relative reduction, P < .001). During this same period, the 30-day all-cause readmission rate increased from 17.2% to 20.1% (a 17% relative increase, P < .001) with an associated 10% relative reduction in the proportion of patients discharged to home.⁷ Experience in other populations with heart failure, such as patients in the Veterans Affairs health care system, has shown similar trends in length of hospital stay and readmissions.⁸

During these transitions, information is often lost in the handoff from the discharging hospital to the next venue of care. Medication management is the most common problem area with the potential for patient noncompliance with prescriptions,^9,10 which can have serious deleterious effects on quality and safety. Forster et al found that 66% of untoward outcomes in discharged patients were due to adverse drug events.¹¹ Similarly, Gray et al identified adverse drug events in 20% of patients discharged from hospital to home with home health care services.¹²

In the Cleveland Clinic Health System, we are coupling our “Heart Care at Home” transitional care program with an aggressive plan to develop a more comprehensive cross-venue EMR. Connecting the hospital EMR with our health system–owned home health agency will enable a consistent medication record and communication system for patients transitioning from our hospitals to Cleveland Clinic home care services (nearly 20,000 patients per year).

Despite these issues, several care transition interventions have shown promising clinical and economic results. Coleman and colleagues conducted a randomized, controlled trial of a transition coaching model in which patients and caregivers were encouraged to take a more active role in care transitions. Results of this trial showed a significant decrease in 30- and 90-day rehospitalizations (the 90-day read-mission rate in the treatment group was 16.7 vs 22.5 in the control group, P = .04) with associated cost savings.³ Voss et al showed similar results in reduction of readmissions in a nonintegrated delivery system.¹³ Additionally, telephone-based chronic disease management programs have been shown to be cost-effective in chronically ill Medicare patients.¹⁴

When will the clinical evidence behind care transitions and financial incentives converge to create an atmosphere conducive to more optimal care coordination? Today, this question remains unanswered. Health care reform, with the passage of the Patient Protection and Affordable Care Act (PPACA) (http://housedocs.house.gov/energycommerce/ppacacon.pdf), may spur the creation of programs to increase incentives for care coordination. These include a move to episodic reimbursement that would bundle payments for acute and postacute care, thus creating more incentives for coordinating care across settings. The “Bundled Payments for Care Improvement” project run by the Center for Medicare & Medicaid Innovation will test different models and approaches to bundled payments (http://innovations.cms.gov/initiatives/bundled-payments). Additionally, beginning in fiscal year 2013, Medicare will penalize hospitals that have high readmission rates for heart failure, acute myocardial infarction, and pneumonia with a financial risk of up to 3% of total hospital Medicare payments by year 3 of the program.

The PPACA will have a significant effect on home-based care for older adults with chronic conditions. The PPACA reforms will likely lead to more patients being treated at home (the lower-cost care setting), ideally under the care of highly skilled teams. Payment reforms will also create new incentives for providers to better coordinate care, keep patients healthy at home, and avoid the “toll-booth” description entirely, enabling providers to focus on patient care. However, more research and experimentation are required to streamline the elements on the transitions spectrum in order to create the most value for specific patient populations. New infrastructure, use of technology, changing culture, and dedicated clinical teams will be necessary to deliver on the hopes of more integrated longitudinal care across venues.

Cross training of providers

Older community-dwelling adults with heart failure exhibit more health instability; take more medications; have more comorbidities; and receive more nursing, homemaking, and meal services than do other home care clients.¹⁵ Nurses thus have a unique opportunity to improve outcomes for home-based heart failure patients,^16,17 but are often insufficiently trained to do so. Delaney et al administered a validated 20-item heart failure knowledge questionnaire to 94 home care nurses from four different home care agencies.¹⁸ The investigators found a 79% knowledge level in overall heart failure education principles, with lowest scores related to issues of asymptomatic hypotension (25% answered correctly), daily weight monitoring (27%), and transient dizziness (31%). Nurses with poorer heart failure–related knowledge may partially explain worse process and outcome measures among this patient population.¹⁹

The home-based nursing workforce of the future, and specifically nurses who care for heart failure patients at home, will need to be better trained and specialized in issues relating both to home-based nursing and medical heart failure. These “hybrid nurses” should be allowed a central clinical leadership role among their peers, as they will need to be empowered to make medical and care coordination decisions.

At our center, hybrid-trained home care/heart failure nurse practitioners make home visits for higher-acuity home-based patients and provide clinical leadership and support for other home care nurses. These nurse practitioners have been instrumental in identifying and correcting heart failure medication–related problems, as well as effectively coordinating care. Examples include: independently prescribing and coordinating administration of intravenous diuretics at home for patients who have difficulty managing volume overload, avoiding hospital readmissions by transitioning ill patients to a skilled nursing facility or an at-home hospice, and effectively educating patients and families about appropriate heart failure self-care.

Home monitoring

From The New England Journal of Medicine (Desai AS, et al. Connecting the circle from home to heart-failure disease management. N Engl J Med 2010; 363:2364–2367). Copyright © 2010 Massachusetts Medical Society (MMS). Reprinted with permission from MMS.

Home monitoring of selected physiologic parameters and patient-reported health status measures among heart failure patients may facilitate early detection of clinical deterioration and direct timely intervention to prevent adverse outcomes.²⁰ Desai and Stevenson have previously proposed the “circle from home to heart-failure disease management,” a concept illustrating how home monitoring can be embedded in a comprehensive heart failure management approach (Figure 2).²⁰ This concept emphasizes the following:

• Home monitoring should facilitate early detection of clinical deterioration.²⁰
• Home monitoring data will most directly lead to action if the data can be used by the patient to improve self-care.
• In the setting of multidisciplinary care, data should be remotely transmitted to a midlevel team, preferably one empowered to make therapeutic decisions.
• Further engagement of physicians or other clinical providers may be beneficial but will delay the clinical response.

The most commonly monitored physiologic parameter of heart failure patients is daily weight. While nearly universally used, this parameter is in fact a poor surrogate for subclinical hemodynamic congestion and has poor diagnostic performance for clinical decompensation. Results are conflicting from studies evaluating the utility of daily body weight measurements in patients with heart failure who are being cared for in the home environment.

In one study, an increase in body weight of > 2 kg over 24 to 72 hours had a 9% sensitivity for detecting clinical deterioration.²¹ In another study, Chaudhry et al performed a nested case-control trial in 134 patients with heart failure and 134 matched controls referred to a home monitoring system by managed care organizations. The researchers found that increases in body weight were associated with hospitalization for heart failure and that the increases began at least 1 week before admission.²² However, they did not investigate whether the use of this information by clinicians altered outcomes. In a prior randomized clinical trial of symptom monitoring versus transtelephonic body weight monitoring in patients with symptomatic heart failure, the Weight Monitoring in Heart Failure trial (n = 280), weight monitoring did not result in improvement in the primary outcome of hospitalizations for heart failure over a 6-month period.²³

The ideal monitoring parameters in heart failure patients may include direct hemodynamic measurements from the right ventricular outflow tract,²⁴ pulmonary artery,²⁵ or left atrium,²⁶ using implantable devices. For example, the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial (n = 550) was a randomized, single-blind, industry-sponsored trial of heart failure management guided by physiologic hemodynamic data derived from a percutaneously inserted pulmonary artery hemodynamic monitor (Champion HF Monitoring System; CardioMEMS, Atlanta, Georgia). The researchers found that monitoring these parameters was associated with a 28% reduction in heart failure–related hospitalizations during the first 6 months (rate 0.32 vs 0.44, HR 0.72, 95% CI 0.60–0.85, P = .0002) compared with usual care.²⁵ At 6 months, the freedom from device- or system-related complications was 98.6%.

Despite success in the trial, the US Food and Drug Administration Circulatory System Devices Panel voted against approving the device. The panel was concerned that the e-mail–alert and care systems built into the intervention arm of the trial created bias in favor of the device, and that in a real-world situation it may not be as effective. This demonstrates the ongoing challenges and barriers to adoption of invasive hemodynamic monitoring.

At our center, we are conducting an institutional review board–approved investigation of an entirely noninvasive under-the-mattress piezoelectric monitor in a cohort of postacute heart failure patients. Piezoelectricity is the charge that accumulates in certain solid materials in response to mechanical stress. Common applications of piezoelectricity include microphones, push-start propane barbecues, and cigarette lighters. The device under investigation (EverOn; EarlySense, Ramat-Gan, Israel) detects heart rate, respiratory rate, and movement rate through vibrations of the mattress. Case examples are shown in Figure 3. Whether such monitoring technology will play a future role in the home environment remains to be seen.

SUMMARY

At the time of this writing, the Supreme Court of the United States has reaffirmed the constitutionality of the PPACA, clearing the way for implementation of significant changes in the US health care delivery system. The implications for in-home care for older adults with chronic conditions, including heart failure, are significant. The home will become an increasingly common venue of postacute care. Today is the time to investigate beneficial models of care and optimal uses of technology, and to develop a specialized mobile workforce that will confidently care for individuals with heart failure at home, responsibly and at lower cost.

The home is the most important context of care for individuals with chronic heart failure and yet it is the least accessible to caregivers. Patients often struggle to manage a complex regimen of medications, follow an unfamiliar diet, monitor weight and vital signs, and work to coordinate care among various providers who, in some cases, fail to communicate effectively. Heart failure patients do all this while making difficult decisions about their livelihoods, social condition, and future direction. With progression of the disease and comorbidity, these patients often experience a downward cycle of repeat hospitalization and worsening functional capacity (Figure 1). Each subsequent transition from acute care to home becomes incrementally more difficult to manage.

According to the latest American College of Cardiology/American Heart Association Guidelines for the Diagnosis and Management of Heart Failure in Adults, appropriate care for patients with heart failure should include:

• Intensive patient education
• Encouragement of patients to be more aggressive participants in their care
• Close monitoring of patients through telephone follow-up or home nursing
• Careful review of medications to improve adherence to evidence-based guidelines
• Multidisciplinary care with nurse case management directed by a physician¹

Beyond these general suggestions, recommendations about specific approaches and models of care in the home are lacking.

Contemporary research suggests that postacute, home-based care of heart failure patients may yield outcomes similar to those of clinic-based outpatient care. Results of the Which Heart Failure Intervention is Most Cost-Effective & Consumer-Friendly in Reducing Hospital Care (WHICH?) trial support this hypothesis. This multicenter, randomized clinical trial (n = 280) compared home- with clinic-based multidisciplinary management for postacute heart failure patients.² Investigators compared outcomes in patients managed at a heart failure clinic with those managed at home. They found that postdischarge home visits by heart failure nurses did not significantly alter the primary composite end point of death or unplanned rehospitalization from any cause over 18 months (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.73–1.30, P = .8621). The rate of unplanned and total hospitalization was also similar in the two groups. However, the average length of hospital stay was significantly lower in the home care group (4 days) than in the clinic-based group (6 days); P = .004. A cost-effectiveness analysis is planned but has not yet been presented.

HEART CARE AT HOME

At Cleveland Clinic, our group of physicians (geriatrics and cardiology), nurses, nurse practitioners, and hospital administrators founded a primarily home-based postacute transitional care program in 2010 called “Heart Care at Home.” The design of our program was influenced by Coleman et al’s care transitions interventions program,³ Naylor et al’s transitional care intervention,⁴ and the contemporary remote monitoring literature.⁵ The program focuses primarily on older adults hospitalized for heart failure who are transitioning from hospital to home. In our model:

• Inpatient care advocates identify candidates during the index inpatient stay, introduce a model of care, and begin a coaching intervention.
• After discharge, home liaisons visit the patient at home, continue coaching intervention, and teach the patient to use the newly installed remote monitoring equipment.
• For 30 to 40 days after discharge, a team of telehealth nurses monitors the patient, makes contact with him or her weekly in order to reinforce coaching intervention, coordinates care, and tracks outcomes.
• Nurse practitioners experienced both in home care and heart failure provide clinical oversight and leadership and visit the highest-acuity patients at home.

To date, the program has provided care in more than 2,100 patient encounters, with approximately 50 to 80 patients actively enrolled at any time. We identified potential program candidates using a digital list tool embedded in Cleveland Clinic’s electronic medical record (EMR) system. This tool was developed by our team together with an internal business intelligence team. We have been approximately 65% successful in identifying eligible inpatients. Patients enrolled in our transitional care program tend to be older, have longer hospital stays, and have more comorbidities than other older adults hospitalized at Cleveland Clinic for similar reasons.

Following index hospital discharge, our home liaisons have been able to make an initial home visit after a median of 2 days (25th to 75th percentile: 1 to 3 days). Patients thought to be at higher risk for hospital readmissions have been seen at home by our nurse practitioners within the first week of discharge. The most common challenge that our at-home team members have faced relates to patients’ medications (for example, unfilled prescriptions and errors in utilization). On many occasions our at-home team has succeeded in transitioning patients not benefiting from care at home to nonhospital venues (skilled nursing facilities, chronic care facilities, inpatient hospice) or to higher levels of at-home care (at-home physician visits, home-care nursing and therapy, at-home hospice).

To date, patients have been enrolled in our program for a median of 30 days (25th to 75th percentile: 20 to 35 days). We have observed an increased level of patient satisfaction. Among heart failure patients enrolled in our program for the first time, we have observed a lower readmission rate compared with publicly reported Cleveland Clinic rates (24.5% vs 28.2%). However, there are several ongoing challenges in the care of heart failure patients in the home environment. These relate to longitudinal care across venues, cross training of providers, and home monitoring.

 

 

Longitudinal care across venues

Our program aims to address the lack of integrated care over time and between care venues. This problem lies at the intersection of health care reimbursement policy and clinical practice. Currently, the hospital reimbursement system does not encourage care coordination across settings. The system has, in fact, evolved into a string of disconnected care providers who act as “toll booths” providing services for a fee in isolation from other providers. Coleman and colleagues have documented the complexity of the transitions among these care providers for older patients with chronic disease, noting the implications for patient safety and cost.⁶

Hospitals receive a fixed payment for an inpatient admission, which increases the financial incentive to discharge patients faster to other venues of care. The study by Bueno et al of a Medicare population treated between 1993 and 2006 confirms that such a trend exists for heart failure patients.⁷ The authors found a steady decrease in the mean length of hospital stay from 8.81 days to 6.33 days over the study period (28% relative reduction, P < .001). During this same period, the 30-day all-cause readmission rate increased from 17.2% to 20.1% (a 17% relative increase, P < .001) with an associated 10% relative reduction in the proportion of patients discharged to home.⁷ Experience in other populations with heart failure, such as patients in the Veterans Affairs health care system, has shown similar trends in length of hospital stay and readmissions.⁸

During these transitions, information is often lost in the handoff from the discharging hospital to the next venue of care. Medication management is the most common problem area with the potential for patient noncompliance with prescriptions,^9,10 which can have serious deleterious effects on quality and safety. Forster et al found that 66% of untoward outcomes in discharged patients were due to adverse drug events.¹¹ Similarly, Gray et al identified adverse drug events in 20% of patients discharged from hospital to home with home health care services.¹²

In the Cleveland Clinic Health System, we are coupling our “Heart Care at Home” transitional care program with an aggressive plan to develop a more comprehensive cross-venue EMR. Connecting the hospital EMR with our health system–owned home health agency will enable a consistent medication record and communication system for patients transitioning from our hospitals to Cleveland Clinic home care services (nearly 20,000 patients per year).

Despite these issues, several care transition interventions have shown promising clinical and economic results. Coleman and colleagues conducted a randomized, controlled trial of a transition coaching model in which patients and caregivers were encouraged to take a more active role in care transitions. Results of this trial showed a significant decrease in 30- and 90-day rehospitalizations (the 90-day read-mission rate in the treatment group was 16.7 vs 22.5 in the control group, P = .04) with associated cost savings.³ Voss et al showed similar results in reduction of readmissions in a nonintegrated delivery system.¹³ Additionally, telephone-based chronic disease management programs have been shown to be cost-effective in chronically ill Medicare patients.¹⁴

When will the clinical evidence behind care transitions and financial incentives converge to create an atmosphere conducive to more optimal care coordination? Today, this question remains unanswered. Health care reform, with the passage of the Patient Protection and Affordable Care Act (PPACA) (http://housedocs.house.gov/energycommerce/ppacacon.pdf), may spur the creation of programs to increase incentives for care coordination. These include a move to episodic reimbursement that would bundle payments for acute and postacute care, thus creating more incentives for coordinating care across settings. The “Bundled Payments for Care Improvement” project run by the Center for Medicare & Medicaid Innovation will test different models and approaches to bundled payments (http://innovations.cms.gov/initiatives/bundled-payments). Additionally, beginning in fiscal year 2013, Medicare will penalize hospitals that have high readmission rates for heart failure, acute myocardial infarction, and pneumonia with a financial risk of up to 3% of total hospital Medicare payments by year 3 of the program.

The PPACA will have a significant effect on home-based care for older adults with chronic conditions. The PPACA reforms will likely lead to more patients being treated at home (the lower-cost care setting), ideally under the care of highly skilled teams. Payment reforms will also create new incentives for providers to better coordinate care, keep patients healthy at home, and avoid the “toll-booth” description entirely, enabling providers to focus on patient care. However, more research and experimentation are required to streamline the elements on the transitions spectrum in order to create the most value for specific patient populations. New infrastructure, use of technology, changing culture, and dedicated clinical teams will be necessary to deliver on the hopes of more integrated longitudinal care across venues.

Cross training of providers

Older community-dwelling adults with heart failure exhibit more health instability; take more medications; have more comorbidities; and receive more nursing, homemaking, and meal services than do other home care clients.¹⁵ Nurses thus have a unique opportunity to improve outcomes for home-based heart failure patients,^16,17 but are often insufficiently trained to do so. Delaney et al administered a validated 20-item heart failure knowledge questionnaire to 94 home care nurses from four different home care agencies.¹⁸ The investigators found a 79% knowledge level in overall heart failure education principles, with lowest scores related to issues of asymptomatic hypotension (25% answered correctly), daily weight monitoring (27%), and transient dizziness (31%). Nurses with poorer heart failure–related knowledge may partially explain worse process and outcome measures among this patient population.¹⁹

The home-based nursing workforce of the future, and specifically nurses who care for heart failure patients at home, will need to be better trained and specialized in issues relating both to home-based nursing and medical heart failure. These “hybrid nurses” should be allowed a central clinical leadership role among their peers, as they will need to be empowered to make medical and care coordination decisions.

At our center, hybrid-trained home care/heart failure nurse practitioners make home visits for higher-acuity home-based patients and provide clinical leadership and support for other home care nurses. These nurse practitioners have been instrumental in identifying and correcting heart failure medication–related problems, as well as effectively coordinating care. Examples include: independently prescribing and coordinating administration of intravenous diuretics at home for patients who have difficulty managing volume overload, avoiding hospital readmissions by transitioning ill patients to a skilled nursing facility or an at-home hospice, and effectively educating patients and families about appropriate heart failure self-care.

Home monitoring

From The New England Journal of Medicine (Desai AS, et al. Connecting the circle from home to heart-failure disease management. N Engl J Med 2010; 363:2364–2367). Copyright © 2010 Massachusetts Medical Society (MMS). Reprinted with permission from MMS.

Home monitoring of selected physiologic parameters and patient-reported health status measures among heart failure patients may facilitate early detection of clinical deterioration and direct timely intervention to prevent adverse outcomes.²⁰ Desai and Stevenson have previously proposed the “circle from home to heart-failure disease management,” a concept illustrating how home monitoring can be embedded in a comprehensive heart failure management approach (Figure 2).²⁰ This concept emphasizes the following:

• Home monitoring should facilitate early detection of clinical deterioration.²⁰
• Home monitoring data will most directly lead to action if the data can be used by the patient to improve self-care.
• In the setting of multidisciplinary care, data should be remotely transmitted to a midlevel team, preferably one empowered to make therapeutic decisions.
• Further engagement of physicians or other clinical providers may be beneficial but will delay the clinical response.

The most commonly monitored physiologic parameter of heart failure patients is daily weight. While nearly universally used, this parameter is in fact a poor surrogate for subclinical hemodynamic congestion and has poor diagnostic performance for clinical decompensation. Results are conflicting from studies evaluating the utility of daily body weight measurements in patients with heart failure who are being cared for in the home environment.

In one study, an increase in body weight of > 2 kg over 24 to 72 hours had a 9% sensitivity for detecting clinical deterioration.²¹ In another study, Chaudhry et al performed a nested case-control trial in 134 patients with heart failure and 134 matched controls referred to a home monitoring system by managed care organizations. The researchers found that increases in body weight were associated with hospitalization for heart failure and that the increases began at least 1 week before admission.²² However, they did not investigate whether the use of this information by clinicians altered outcomes. In a prior randomized clinical trial of symptom monitoring versus transtelephonic body weight monitoring in patients with symptomatic heart failure, the Weight Monitoring in Heart Failure trial (n = 280), weight monitoring did not result in improvement in the primary outcome of hospitalizations for heart failure over a 6-month period.²³

The ideal monitoring parameters in heart failure patients may include direct hemodynamic measurements from the right ventricular outflow tract,²⁴ pulmonary artery,²⁵ or left atrium,²⁶ using implantable devices. For example, the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial (n = 550) was a randomized, single-blind, industry-sponsored trial of heart failure management guided by physiologic hemodynamic data derived from a percutaneously inserted pulmonary artery hemodynamic monitor (Champion HF Monitoring System; CardioMEMS, Atlanta, Georgia). The researchers found that monitoring these parameters was associated with a 28% reduction in heart failure–related hospitalizations during the first 6 months (rate 0.32 vs 0.44, HR 0.72, 95% CI 0.60–0.85, P = .0002) compared with usual care.²⁵ At 6 months, the freedom from device- or system-related complications was 98.6%.

Despite success in the trial, the US Food and Drug Administration Circulatory System Devices Panel voted against approving the device. The panel was concerned that the e-mail–alert and care systems built into the intervention arm of the trial created bias in favor of the device, and that in a real-world situation it may not be as effective. This demonstrates the ongoing challenges and barriers to adoption of invasive hemodynamic monitoring.

At our center, we are conducting an institutional review board–approved investigation of an entirely noninvasive under-the-mattress piezoelectric monitor in a cohort of postacute heart failure patients. Piezoelectricity is the charge that accumulates in certain solid materials in response to mechanical stress. Common applications of piezoelectricity include microphones, push-start propane barbecues, and cigarette lighters. The device under investigation (EverOn; EarlySense, Ramat-Gan, Israel) detects heart rate, respiratory rate, and movement rate through vibrations of the mattress. Case examples are shown in Figure 3. Whether such monitoring technology will play a future role in the home environment remains to be seen.

SUMMARY

At the time of this writing, the Supreme Court of the United States has reaffirmed the constitutionality of the PPACA, clearing the way for implementation of significant changes in the US health care delivery system. The implications for in-home care for older adults with chronic conditions, including heart failure, are significant. The home will become an increasingly common venue of postacute care. Today is the time to investigate beneficial models of care and optimal uses of technology, and to develop a specialized mobile workforce that will confidently care for individuals with heart failure at home, responsibly and at lower cost.

The home is the most important context of care for individuals with chronic heart failure and yet it is the least accessible to caregivers. Patients often struggle to manage a complex regimen of medications, follow an unfamiliar diet, monitor weight and vital signs, and work to coordinate care among various providers who, in some cases, fail to communicate effectively. Heart failure patients do all this while making difficult decisions about their livelihoods, social condition, and future direction. With progression of the disease and comorbidity, these patients often experience a downward cycle of repeat hospitalization and worsening functional capacity (Figure 1). Each subsequent transition from acute care to home becomes incrementally more difficult to manage.

According to the latest American College of Cardiology/American Heart Association Guidelines for the Diagnosis and Management of Heart Failure in Adults, appropriate care for patients with heart failure should include:

• Intensive patient education
• Encouragement of patients to be more aggressive participants in their care
• Close monitoring of patients through telephone follow-up or home nursing
• Careful review of medications to improve adherence to evidence-based guidelines
• Multidisciplinary care with nurse case management directed by a physician¹

Beyond these general suggestions, recommendations about specific approaches and models of care in the home are lacking.

Contemporary research suggests that postacute, home-based care of heart failure patients may yield outcomes similar to those of clinic-based outpatient care. Results of the Which Heart Failure Intervention is Most Cost-Effective & Consumer-Friendly in Reducing Hospital Care (WHICH?) trial support this hypothesis. This multicenter, randomized clinical trial (n = 280) compared home- with clinic-based multidisciplinary management for postacute heart failure patients.² Investigators compared outcomes in patients managed at a heart failure clinic with those managed at home. They found that postdischarge home visits by heart failure nurses did not significantly alter the primary composite end point of death or unplanned rehospitalization from any cause over 18 months (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.73–1.30, P = .8621). The rate of unplanned and total hospitalization was also similar in the two groups. However, the average length of hospital stay was significantly lower in the home care group (4 days) than in the clinic-based group (6 days); P = .004. A cost-effectiveness analysis is planned but has not yet been presented.

HEART CARE AT HOME

At Cleveland Clinic, our group of physicians (geriatrics and cardiology), nurses, nurse practitioners, and hospital administrators founded a primarily home-based postacute transitional care program in 2010 called “Heart Care at Home.” The design of our program was influenced by Coleman et al’s care transitions interventions program,³ Naylor et al’s transitional care intervention,⁴ and the contemporary remote monitoring literature.⁵ The program focuses primarily on older adults hospitalized for heart failure who are transitioning from hospital to home. In our model:

• Inpatient care advocates identify candidates during the index inpatient stay, introduce a model of care, and begin a coaching intervention.
• After discharge, home liaisons visit the patient at home, continue coaching intervention, and teach the patient to use the newly installed remote monitoring equipment.
• For 30 to 40 days after discharge, a team of telehealth nurses monitors the patient, makes contact with him or her weekly in order to reinforce coaching intervention, coordinates care, and tracks outcomes.
• Nurse practitioners experienced both in home care and heart failure provide clinical oversight and leadership and visit the highest-acuity patients at home.

To date, the program has provided care in more than 2,100 patient encounters, with approximately 50 to 80 patients actively enrolled at any time. We identified potential program candidates using a digital list tool embedded in Cleveland Clinic’s electronic medical record (EMR) system. This tool was developed by our team together with an internal business intelligence team. We have been approximately 65% successful in identifying eligible inpatients. Patients enrolled in our transitional care program tend to be older, have longer hospital stays, and have more comorbidities than other older adults hospitalized at Cleveland Clinic for similar reasons.

Following index hospital discharge, our home liaisons have been able to make an initial home visit after a median of 2 days (25th to 75th percentile: 1 to 3 days). Patients thought to be at higher risk for hospital readmissions have been seen at home by our nurse practitioners within the first week of discharge. The most common challenge that our at-home team members have faced relates to patients’ medications (for example, unfilled prescriptions and errors in utilization). On many occasions our at-home team has succeeded in transitioning patients not benefiting from care at home to nonhospital venues (skilled nursing facilities, chronic care facilities, inpatient hospice) or to higher levels of at-home care (at-home physician visits, home-care nursing and therapy, at-home hospice).

To date, patients have been enrolled in our program for a median of 30 days (25th to 75th percentile: 20 to 35 days). We have observed an increased level of patient satisfaction. Among heart failure patients enrolled in our program for the first time, we have observed a lower readmission rate compared with publicly reported Cleveland Clinic rates (24.5% vs 28.2%). However, there are several ongoing challenges in the care of heart failure patients in the home environment. These relate to longitudinal care across venues, cross training of providers, and home monitoring.

 

 

Longitudinal care across venues

Our program aims to address the lack of integrated care over time and between care venues. This problem lies at the intersection of health care reimbursement policy and clinical practice. Currently, the hospital reimbursement system does not encourage care coordination across settings. The system has, in fact, evolved into a string of disconnected care providers who act as “toll booths” providing services for a fee in isolation from other providers. Coleman and colleagues have documented the complexity of the transitions among these care providers for older patients with chronic disease, noting the implications for patient safety and cost.⁶

Hospitals receive a fixed payment for an inpatient admission, which increases the financial incentive to discharge patients faster to other venues of care. The study by Bueno et al of a Medicare population treated between 1993 and 2006 confirms that such a trend exists for heart failure patients.⁷ The authors found a steady decrease in the mean length of hospital stay from 8.81 days to 6.33 days over the study period (28% relative reduction, P < .001). During this same period, the 30-day all-cause readmission rate increased from 17.2% to 20.1% (a 17% relative increase, P < .001) with an associated 10% relative reduction in the proportion of patients discharged to home.⁷ Experience in other populations with heart failure, such as patients in the Veterans Affairs health care system, has shown similar trends in length of hospital stay and readmissions.⁸

During these transitions, information is often lost in the handoff from the discharging hospital to the next venue of care. Medication management is the most common problem area with the potential for patient noncompliance with prescriptions,^9,10 which can have serious deleterious effects on quality and safety. Forster et al found that 66% of untoward outcomes in discharged patients were due to adverse drug events.¹¹ Similarly, Gray et al identified adverse drug events in 20% of patients discharged from hospital to home with home health care services.¹²

In the Cleveland Clinic Health System, we are coupling our “Heart Care at Home” transitional care program with an aggressive plan to develop a more comprehensive cross-venue EMR. Connecting the hospital EMR with our health system–owned home health agency will enable a consistent medication record and communication system for patients transitioning from our hospitals to Cleveland Clinic home care services (nearly 20,000 patients per year).

Despite these issues, several care transition interventions have shown promising clinical and economic results. Coleman and colleagues conducted a randomized, controlled trial of a transition coaching model in which patients and caregivers were encouraged to take a more active role in care transitions. Results of this trial showed a significant decrease in 30- and 90-day rehospitalizations (the 90-day read-mission rate in the treatment group was 16.7 vs 22.5 in the control group, P = .04) with associated cost savings.³ Voss et al showed similar results in reduction of readmissions in a nonintegrated delivery system.¹³ Additionally, telephone-based chronic disease management programs have been shown to be cost-effective in chronically ill Medicare patients.¹⁴

When will the clinical evidence behind care transitions and financial incentives converge to create an atmosphere conducive to more optimal care coordination? Today, this question remains unanswered. Health care reform, with the passage of the Patient Protection and Affordable Care Act (PPACA) (http://housedocs.house.gov/energycommerce/ppacacon.pdf), may spur the creation of programs to increase incentives for care coordination. These include a move to episodic reimbursement that would bundle payments for acute and postacute care, thus creating more incentives for coordinating care across settings. The “Bundled Payments for Care Improvement” project run by the Center for Medicare & Medicaid Innovation will test different models and approaches to bundled payments (http://innovations.cms.gov/initiatives/bundled-payments). Additionally, beginning in fiscal year 2013, Medicare will penalize hospitals that have high readmission rates for heart failure, acute myocardial infarction, and pneumonia with a financial risk of up to 3% of total hospital Medicare payments by year 3 of the program.

The PPACA will have a significant effect on home-based care for older adults with chronic conditions. The PPACA reforms will likely lead to more patients being treated at home (the lower-cost care setting), ideally under the care of highly skilled teams. Payment reforms will also create new incentives for providers to better coordinate care, keep patients healthy at home, and avoid the “toll-booth” description entirely, enabling providers to focus on patient care. However, more research and experimentation are required to streamline the elements on the transitions spectrum in order to create the most value for specific patient populations. New infrastructure, use of technology, changing culture, and dedicated clinical teams will be necessary to deliver on the hopes of more integrated longitudinal care across venues.

Cross training of providers

Older community-dwelling adults with heart failure exhibit more health instability; take more medications; have more comorbidities; and receive more nursing, homemaking, and meal services than do other home care clients.¹⁵ Nurses thus have a unique opportunity to improve outcomes for home-based heart failure patients,^16,17 but are often insufficiently trained to do so. Delaney et al administered a validated 20-item heart failure knowledge questionnaire to 94 home care nurses from four different home care agencies.¹⁸ The investigators found a 79% knowledge level in overall heart failure education principles, with lowest scores related to issues of asymptomatic hypotension (25% answered correctly), daily weight monitoring (27%), and transient dizziness (31%). Nurses with poorer heart failure–related knowledge may partially explain worse process and outcome measures among this patient population.¹⁹

The home-based nursing workforce of the future, and specifically nurses who care for heart failure patients at home, will need to be better trained and specialized in issues relating both to home-based nursing and medical heart failure. These “hybrid nurses” should be allowed a central clinical leadership role among their peers, as they will need to be empowered to make medical and care coordination decisions.

At our center, hybrid-trained home care/heart failure nurse practitioners make home visits for higher-acuity home-based patients and provide clinical leadership and support for other home care nurses. These nurse practitioners have been instrumental in identifying and correcting heart failure medication–related problems, as well as effectively coordinating care. Examples include: independently prescribing and coordinating administration of intravenous diuretics at home for patients who have difficulty managing volume overload, avoiding hospital readmissions by transitioning ill patients to a skilled nursing facility or an at-home hospice, and effectively educating patients and families about appropriate heart failure self-care.

Home monitoring

From The New England Journal of Medicine (Desai AS, et al. Connecting the circle from home to heart-failure disease management. N Engl J Med 2010; 363:2364–2367). Copyright © 2010 Massachusetts Medical Society (MMS). Reprinted with permission from MMS.

Home monitoring of selected physiologic parameters and patient-reported health status measures among heart failure patients may facilitate early detection of clinical deterioration and direct timely intervention to prevent adverse outcomes.²⁰ Desai and Stevenson have previously proposed the “circle from home to heart-failure disease management,” a concept illustrating how home monitoring can be embedded in a comprehensive heart failure management approach (Figure 2).²⁰ This concept emphasizes the following:

• Home monitoring should facilitate early detection of clinical deterioration.²⁰
• Home monitoring data will most directly lead to action if the data can be used by the patient to improve self-care.
• In the setting of multidisciplinary care, data should be remotely transmitted to a midlevel team, preferably one empowered to make therapeutic decisions.
• Further engagement of physicians or other clinical providers may be beneficial but will delay the clinical response.

The most commonly monitored physiologic parameter of heart failure patients is daily weight. While nearly universally used, this parameter is in fact a poor surrogate for subclinical hemodynamic congestion and has poor diagnostic performance for clinical decompensation. Results are conflicting from studies evaluating the utility of daily body weight measurements in patients with heart failure who are being cared for in the home environment.

In one study, an increase in body weight of > 2 kg over 24 to 72 hours had a 9% sensitivity for detecting clinical deterioration.²¹ In another study, Chaudhry et al performed a nested case-control trial in 134 patients with heart failure and 134 matched controls referred to a home monitoring system by managed care organizations. The researchers found that increases in body weight were associated with hospitalization for heart failure and that the increases began at least 1 week before admission.²² However, they did not investigate whether the use of this information by clinicians altered outcomes. In a prior randomized clinical trial of symptom monitoring versus transtelephonic body weight monitoring in patients with symptomatic heart failure, the Weight Monitoring in Heart Failure trial (n = 280), weight monitoring did not result in improvement in the primary outcome of hospitalizations for heart failure over a 6-month period.²³

The ideal monitoring parameters in heart failure patients may include direct hemodynamic measurements from the right ventricular outflow tract,²⁴ pulmonary artery,²⁵ or left atrium,²⁶ using implantable devices. For example, the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial (n = 550) was a randomized, single-blind, industry-sponsored trial of heart failure management guided by physiologic hemodynamic data derived from a percutaneously inserted pulmonary artery hemodynamic monitor (Champion HF Monitoring System; CardioMEMS, Atlanta, Georgia). The researchers found that monitoring these parameters was associated with a 28% reduction in heart failure–related hospitalizations during the first 6 months (rate 0.32 vs 0.44, HR 0.72, 95% CI 0.60–0.85, P = .0002) compared with usual care.²⁵ At 6 months, the freedom from device- or system-related complications was 98.6%.

Despite success in the trial, the US Food and Drug Administration Circulatory System Devices Panel voted against approving the device. The panel was concerned that the e-mail–alert and care systems built into the intervention arm of the trial created bias in favor of the device, and that in a real-world situation it may not be as effective. This demonstrates the ongoing challenges and barriers to adoption of invasive hemodynamic monitoring.

At our center, we are conducting an institutional review board–approved investigation of an entirely noninvasive under-the-mattress piezoelectric monitor in a cohort of postacute heart failure patients. Piezoelectricity is the charge that accumulates in certain solid materials in response to mechanical stress. Common applications of piezoelectricity include microphones, push-start propane barbecues, and cigarette lighters. The device under investigation (EverOn; EarlySense, Ramat-Gan, Israel) detects heart rate, respiratory rate, and movement rate through vibrations of the mattress. Case examples are shown in Figure 3. Whether such monitoring technology will play a future role in the home environment remains to be seen.

SUMMARY

At the time of this writing, the Supreme Court of the United States has reaffirmed the constitutionality of the PPACA, clearing the way for implementation of significant changes in the US health care delivery system. The implications for in-home care for older adults with chronic conditions, including heart failure, are significant. The home will become an increasingly common venue of postacute care. Today is the time to investigate beneficial models of care and optimal uses of technology, and to develop a specialized mobile workforce that will confidently care for individuals with heart failure at home, responsibly and at lower cost.

Many technologies have emerged to monitor, interact with, and support patients at home and change home health care delivery.^1–5 This trend coincides with the explosion of consumer digital and mobile products such as “smartphones” and has brought with it many different names, such as telehealth, telemedicine, e-medicine, remote monitoring, “virtual” care, digital health, mobile medicine, interactive health, and distance health. Many of these terms and concepts raise concerns for those who value traditional expressions of caring, physical diagnosis, touch, and presence in health care. However, these new technologies may present opportunities to find ways to enhance humanism in home health care. This potential may be most evident among patients with serious chronic illness and their families, who often struggle 168 hours a week but find their access to help limited to brief visits at times convenient for the provider.

While our health care system offers heroic acute-care treatments for hundreds of life-threatening maladies, we seem to fall short in helping those with serious ongoing needs whose care must be coordinated over time and across health care venues. Thinking in terms of “connected health” may provide a more holistic nomenclature that suggests the bond between technology and the opportunity for closer personal relationships.^6–8

OPPORTUNITIES

Can technology better connect our home health patients and families to care during the “white space,”⁹ between our visits? Can we use new mobile and digital technologies to improve care for the seriously chronically ill? We have the technology to turn many challenges into opportunities in the next decade. For example:

1. Can we change our visit-based model of home health care to a model that provides 24/7 “inbound” multichannel access to home health care teams along with proactive “outbound” support between visits in the form of multimedia health education and virtual encounters? Can this free up time for longer visits targeted toward higher-risk and higher-complexity scenarios that require extensive team leadership and care coordination?
2. Can “smart” home monitoring be integrated into home-based long-term care for patients who have dementia, fall risks, other safety issues, or unaddressed limitations in activities of daily living to increase independence and quality of life and reduce institutionalization while decreasing cost of care and accommodating workforce constraints?¹⁰
3. How do we apply clinician-to-clinician and clinician-to-patient videoconferencing and other connected health approaches to increase home health patient access to specialized, but hard-to-find, clinicians for consultative and direct-care services?
4. Can emerging technologies accelerate the shift in care whereby most acute care for exacerbations of chronic illness and other common acute scenarios move from hospitals into home-based models of acute care, such as “Hospital at home”?¹¹
5. To what extent can apps and other technologies provide self-management support to truly deliver the home health care version of the automatic teller machine? For example, diabetes self-management support tools provide patients feedback about their disease based on information input into mobile devices.¹² Can this be expanded in a way that dramatically increases access, especially for vulnerable groups that have been hard to reach, while also decreasing costs?
6. Can we improve the home health care experience by using connected health concepts to improve transparency, minimize common scheduling delays and annoyances, and empower patients while they are receiving care?

REAL-WORLD BARRIERS

Despite the opportunities, barriers remain for innovative providers. With few exceptions, there is no direct third-party reimbursement for care that comes through a device rather than the front door. Medicare does not reimburse home health providers for services outside of a visit, but specific guidance has been issued that clarifies some of the opportunities:

An HHA (Home Health Agency) may adopt telehealth technologies that it believes promote efficiencies or improve quality of care…. An HHA may not substitute telehealth services for Medicare-covered services ordered by a physician. However, if an HHA has telehealth services available to its clients, a doctor may take their availability into account when he or she prepares a plan…. If a physician intends that telehealth services be furnished while a patient is under a home health plan of care, the services should be recorded in the plan of care along with the Medicare covered home health services to be furnished.¹³

Thus, there is no reimbursement for telehealth services, but if telehealth is part of a physician-directed plan of care, it may be included if it promotes home health quality and efficiency. Beyond reimbursement, there are other regulatory barriers. If monitoring or other digital or virtual services are provided across state lines, the clinicians involved in a regional or national “command center” likely must meet the licensure requirements (or obtain waivers) for every jurisdiction in which their patients reside. Providers should seek counsel regarding the extent to which new devices and software need to be approved by the US Food and Drug Administration before being deployed. And, as with all health-related communication, it is essential that information transmitted in nontraditional ways be secure, private, and compliant with all mandated standards for privacy. Finally, if the technology or service is rolled out in a fashion that could be construed as a “gift” or “freebie” for marketing purposes rather than a tool to improve clinical outcomes and health care value, then there may be a risk that the approach runs afoul of laws to prevent undue inducements.

In addition to reimbursement and regulatory concerns, there are technical barriers to fully realizing the connected health opportunities in home care. Even if patients are provided with devices, there is variability in internet connectivity or bandwidth in any given home. Providing devices with built-in cellular capabilities can reduce these barriers, but cellular data coverage varies across different geographies. High-quality health care videoconferencing tends to require more bandwidth than that provided in the typical “3G” connection. Use of existing cable television connections, which are almost ubiquitous, is another option, but it typically requires a more customized set-up than consumer mobile devices with cellular and wireless capabilities. If the services were delivered or coordinated by the cable provider, some of these inconveniences might be resolved.

As with most innovation, there is no “cookbook,” and there is limited and conflicting evidence in the clinical sciences literature to guide best practices. Organizations that commit to using technology to improve the quality and efficiency of care will experience fits and starts before they find the right types and “doses” of technology in their new care models. The home health community should beware of these frustrations leading to undue skepticism, like that of Newsweek author Clifford Stoll, who in 1995 infamously wrote about the developing internet:

…today, I’m uneasy about this [trend]…. Visionaries see a future of telecommuting workers, interactive libraries and multimedia classrooms. They speak of electronic town meetings and virtual communities. Commerce and business will shift from offices and malls to networks and modems. And the freedom of digital networks will make government more democratic. Baloney. Do our computer pundits lack all common sense? The truth is no online database will replace your daily newspaper … no computer network will change the way government works.¹⁴

Like the internet of 15 years ago, mobile and digital technologies are now changing how people live and relate to one another and how businesses function. It is unlikely that the impact of these technologies on health care will be fully elucidated by controlled trials that consider incremental changes to existing care models and workflows. Rather, innovative providers and the next generation of clinicians that “grew up,” with mobile devices as part of their lives will create new home care workflows and care realities. Home health providers can use these technologies to better connect their patients and find new ways to reduce suffering, increase health and independence, and improve the care experience while lowering costs and increasing value. The individuals and organizations that seize the moment and “answer” these key questions in connected health with successful new approaches to care will be the winners of the future. There is such an opportunity to make a difference.

Many technologies have emerged to monitor, interact with, and support patients at home and change home health care delivery.^1–5 This trend coincides with the explosion of consumer digital and mobile products such as “smartphones” and has brought with it many different names, such as telehealth, telemedicine, e-medicine, remote monitoring, “virtual” care, digital health, mobile medicine, interactive health, and distance health. Many of these terms and concepts raise concerns for those who value traditional expressions of caring, physical diagnosis, touch, and presence in health care. However, these new technologies may present opportunities to find ways to enhance humanism in home health care. This potential may be most evident among patients with serious chronic illness and their families, who often struggle 168 hours a week but find their access to help limited to brief visits at times convenient for the provider.

While our health care system offers heroic acute-care treatments for hundreds of life-threatening maladies, we seem to fall short in helping those with serious ongoing needs whose care must be coordinated over time and across health care venues. Thinking in terms of “connected health” may provide a more holistic nomenclature that suggests the bond between technology and the opportunity for closer personal relationships.^6–8

OPPORTUNITIES

Can technology better connect our home health patients and families to care during the “white space,”⁹ between our visits? Can we use new mobile and digital technologies to improve care for the seriously chronically ill? We have the technology to turn many challenges into opportunities in the next decade. For example:

1. Can we change our visit-based model of home health care to a model that provides 24/7 “inbound” multichannel access to home health care teams along with proactive “outbound” support between visits in the form of multimedia health education and virtual encounters? Can this free up time for longer visits targeted toward higher-risk and higher-complexity scenarios that require extensive team leadership and care coordination?
2. Can “smart” home monitoring be integrated into home-based long-term care for patients who have dementia, fall risks, other safety issues, or unaddressed limitations in activities of daily living to increase independence and quality of life and reduce institutionalization while decreasing cost of care and accommodating workforce constraints?¹⁰
3. How do we apply clinician-to-clinician and clinician-to-patient videoconferencing and other connected health approaches to increase home health patient access to specialized, but hard-to-find, clinicians for consultative and direct-care services?
4. Can emerging technologies accelerate the shift in care whereby most acute care for exacerbations of chronic illness and other common acute scenarios move from hospitals into home-based models of acute care, such as “Hospital at home”?¹¹
5. To what extent can apps and other technologies provide self-management support to truly deliver the home health care version of the automatic teller machine? For example, diabetes self-management support tools provide patients feedback about their disease based on information input into mobile devices.¹² Can this be expanded in a way that dramatically increases access, especially for vulnerable groups that have been hard to reach, while also decreasing costs?
6. Can we improve the home health care experience by using connected health concepts to improve transparency, minimize common scheduling delays and annoyances, and empower patients while they are receiving care?

REAL-WORLD BARRIERS

Despite the opportunities, barriers remain for innovative providers. With few exceptions, there is no direct third-party reimbursement for care that comes through a device rather than the front door. Medicare does not reimburse home health providers for services outside of a visit, but specific guidance has been issued that clarifies some of the opportunities:

An HHA (Home Health Agency) may adopt telehealth technologies that it believes promote efficiencies or improve quality of care…. An HHA may not substitute telehealth services for Medicare-covered services ordered by a physician. However, if an HHA has telehealth services available to its clients, a doctor may take their availability into account when he or she prepares a plan…. If a physician intends that telehealth services be furnished while a patient is under a home health plan of care, the services should be recorded in the plan of care along with the Medicare covered home health services to be furnished.¹³

Thus, there is no reimbursement for telehealth services, but if telehealth is part of a physician-directed plan of care, it may be included if it promotes home health quality and efficiency. Beyond reimbursement, there are other regulatory barriers. If monitoring or other digital or virtual services are provided across state lines, the clinicians involved in a regional or national “command center” likely must meet the licensure requirements (or obtain waivers) for every jurisdiction in which their patients reside. Providers should seek counsel regarding the extent to which new devices and software need to be approved by the US Food and Drug Administration before being deployed. And, as with all health-related communication, it is essential that information transmitted in nontraditional ways be secure, private, and compliant with all mandated standards for privacy. Finally, if the technology or service is rolled out in a fashion that could be construed as a “gift” or “freebie” for marketing purposes rather than a tool to improve clinical outcomes and health care value, then there may be a risk that the approach runs afoul of laws to prevent undue inducements.

In addition to reimbursement and regulatory concerns, there are technical barriers to fully realizing the connected health opportunities in home care. Even if patients are provided with devices, there is variability in internet connectivity or bandwidth in any given home. Providing devices with built-in cellular capabilities can reduce these barriers, but cellular data coverage varies across different geographies. High-quality health care videoconferencing tends to require more bandwidth than that provided in the typical “3G” connection. Use of existing cable television connections, which are almost ubiquitous, is another option, but it typically requires a more customized set-up than consumer mobile devices with cellular and wireless capabilities. If the services were delivered or coordinated by the cable provider, some of these inconveniences might be resolved.

As with most innovation, there is no “cookbook,” and there is limited and conflicting evidence in the clinical sciences literature to guide best practices. Organizations that commit to using technology to improve the quality and efficiency of care will experience fits and starts before they find the right types and “doses” of technology in their new care models. The home health community should beware of these frustrations leading to undue skepticism, like that of Newsweek author Clifford Stoll, who in 1995 infamously wrote about the developing internet:

…today, I’m uneasy about this [trend]…. Visionaries see a future of telecommuting workers, interactive libraries and multimedia classrooms. They speak of electronic town meetings and virtual communities. Commerce and business will shift from offices and malls to networks and modems. And the freedom of digital networks will make government more democratic. Baloney. Do our computer pundits lack all common sense? The truth is no online database will replace your daily newspaper … no computer network will change the way government works.¹⁴

Like the internet of 15 years ago, mobile and digital technologies are now changing how people live and relate to one another and how businesses function. It is unlikely that the impact of these technologies on health care will be fully elucidated by controlled trials that consider incremental changes to existing care models and workflows. Rather, innovative providers and the next generation of clinicians that “grew up,” with mobile devices as part of their lives will create new home care workflows and care realities. Home health providers can use these technologies to better connect their patients and find new ways to reduce suffering, increase health and independence, and improve the care experience while lowering costs and increasing value. The individuals and organizations that seize the moment and “answer” these key questions in connected health with successful new approaches to care will be the winners of the future. There is such an opportunity to make a difference.

Many technologies have emerged to monitor, interact with, and support patients at home and change home health care delivery.^1–5 This trend coincides with the explosion of consumer digital and mobile products such as “smartphones” and has brought with it many different names, such as telehealth, telemedicine, e-medicine, remote monitoring, “virtual” care, digital health, mobile medicine, interactive health, and distance health. Many of these terms and concepts raise concerns for those who value traditional expressions of caring, physical diagnosis, touch, and presence in health care. However, these new technologies may present opportunities to find ways to enhance humanism in home health care. This potential may be most evident among patients with serious chronic illness and their families, who often struggle 168 hours a week but find their access to help limited to brief visits at times convenient for the provider.

While our health care system offers heroic acute-care treatments for hundreds of life-threatening maladies, we seem to fall short in helping those with serious ongoing needs whose care must be coordinated over time and across health care venues. Thinking in terms of “connected health” may provide a more holistic nomenclature that suggests the bond between technology and the opportunity for closer personal relationships.^6–8

OPPORTUNITIES

Can technology better connect our home health patients and families to care during the “white space,”⁹ between our visits? Can we use new mobile and digital technologies to improve care for the seriously chronically ill? We have the technology to turn many challenges into opportunities in the next decade. For example:

1. Can we change our visit-based model of home health care to a model that provides 24/7 “inbound” multichannel access to home health care teams along with proactive “outbound” support between visits in the form of multimedia health education and virtual encounters? Can this free up time for longer visits targeted toward higher-risk and higher-complexity scenarios that require extensive team leadership and care coordination?
2. Can “smart” home monitoring be integrated into home-based long-term care for patients who have dementia, fall risks, other safety issues, or unaddressed limitations in activities of daily living to increase independence and quality of life and reduce institutionalization while decreasing cost of care and accommodating workforce constraints?¹⁰
3. How do we apply clinician-to-clinician and clinician-to-patient videoconferencing and other connected health approaches to increase home health patient access to specialized, but hard-to-find, clinicians for consultative and direct-care services?
4. Can emerging technologies accelerate the shift in care whereby most acute care for exacerbations of chronic illness and other common acute scenarios move from hospitals into home-based models of acute care, such as “Hospital at home”?¹¹
5. To what extent can apps and other technologies provide self-management support to truly deliver the home health care version of the automatic teller machine? For example, diabetes self-management support tools provide patients feedback about their disease based on information input into mobile devices.¹² Can this be expanded in a way that dramatically increases access, especially for vulnerable groups that have been hard to reach, while also decreasing costs?
6. Can we improve the home health care experience by using connected health concepts to improve transparency, minimize common scheduling delays and annoyances, and empower patients while they are receiving care?

REAL-WORLD BARRIERS

Despite the opportunities, barriers remain for innovative providers. With few exceptions, there is no direct third-party reimbursement for care that comes through a device rather than the front door. Medicare does not reimburse home health providers for services outside of a visit, but specific guidance has been issued that clarifies some of the opportunities:

An HHA (Home Health Agency) may adopt telehealth technologies that it believes promote efficiencies or improve quality of care…. An HHA may not substitute telehealth services for Medicare-covered services ordered by a physician. However, if an HHA has telehealth services available to its clients, a doctor may take their availability into account when he or she prepares a plan…. If a physician intends that telehealth services be furnished while a patient is under a home health plan of care, the services should be recorded in the plan of care along with the Medicare covered home health services to be furnished.¹³

Thus, there is no reimbursement for telehealth services, but if telehealth is part of a physician-directed plan of care, it may be included if it promotes home health quality and efficiency. Beyond reimbursement, there are other regulatory barriers. If monitoring or other digital or virtual services are provided across state lines, the clinicians involved in a regional or national “command center” likely must meet the licensure requirements (or obtain waivers) for every jurisdiction in which their patients reside. Providers should seek counsel regarding the extent to which new devices and software need to be approved by the US Food and Drug Administration before being deployed. And, as with all health-related communication, it is essential that information transmitted in nontraditional ways be secure, private, and compliant with all mandated standards for privacy. Finally, if the technology or service is rolled out in a fashion that could be construed as a “gift” or “freebie” for marketing purposes rather than a tool to improve clinical outcomes and health care value, then there may be a risk that the approach runs afoul of laws to prevent undue inducements.

In addition to reimbursement and regulatory concerns, there are technical barriers to fully realizing the connected health opportunities in home care. Even if patients are provided with devices, there is variability in internet connectivity or bandwidth in any given home. Providing devices with built-in cellular capabilities can reduce these barriers, but cellular data coverage varies across different geographies. High-quality health care videoconferencing tends to require more bandwidth than that provided in the typical “3G” connection. Use of existing cable television connections, which are almost ubiquitous, is another option, but it typically requires a more customized set-up than consumer mobile devices with cellular and wireless capabilities. If the services were delivered or coordinated by the cable provider, some of these inconveniences might be resolved.

As with most innovation, there is no “cookbook,” and there is limited and conflicting evidence in the clinical sciences literature to guide best practices. Organizations that commit to using technology to improve the quality and efficiency of care will experience fits and starts before they find the right types and “doses” of technology in their new care models. The home health community should beware of these frustrations leading to undue skepticism, like that of Newsweek author Clifford Stoll, who in 1995 infamously wrote about the developing internet:

…today, I’m uneasy about this [trend]…. Visionaries see a future of telecommuting workers, interactive libraries and multimedia classrooms. They speak of electronic town meetings and virtual communities. Commerce and business will shift from offices and malls to networks and modems. And the freedom of digital networks will make government more democratic. Baloney. Do our computer pundits lack all common sense? The truth is no online database will replace your daily newspaper … no computer network will change the way government works.¹⁴

Like the internet of 15 years ago, mobile and digital technologies are now changing how people live and relate to one another and how businesses function. It is unlikely that the impact of these technologies on health care will be fully elucidated by controlled trials that consider incremental changes to existing care models and workflows. Rather, innovative providers and the next generation of clinicians that “grew up,” with mobile devices as part of their lives will create new home care workflows and care realities. Home health providers can use these technologies to better connect their patients and find new ways to reduce suffering, increase health and independence, and improve the care experience while lowering costs and increasing value. The individuals and organizations that seize the moment and “answer” these key questions in connected health with successful new approaches to care will be the winners of the future. There is such an opportunity to make a difference.

As the prevalence of serious illness among the elderly population has increased, interest in palliative care has grown as an approach to care management that is patient-centered and focused on quality of life. Case management that employs palliative care has the potential to alleviate unnecessary pain and suffering for patients while they concurrently pursue life-prolonging therapy. Palliative care can be provided across the continuum of care, involving multiple health care providers and practitioners.

Home health care, while often used as a postacute care provider, also can provide longitudinal care to elderly patients without a preceding hospitalization. Home health providers often act as central liaisons to coordinate care while patients are at home, particularly chronically ill patients with multiple physician providers, complex medication regimens, and ongoing concerns with independence and safety in the home.

Home health care can play a critical role in providing palliative care and, through innovative programs, can improve access to it. This article provides context and background on the provision of palliative care and explores how home health can work seamlessly in coordination with other health care stakeholders in providing palliative care.

WHAT IS PALLIATIVE CARE?

Palliative care means patient- and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and [facilitating] patient autonomy, access to information, and choice.¹

At its core, palliative care is a field of medicine aimed at alleviating the suffering of patients. As a “philosophy of care,” palliative care is appropriate for various sites of care at various stages of disease and all ages of patients. While hospice care is defined by the provision of palliative care for patients at the end of life, not all palliative care is hospice care. Rather, palliative care is an approach to care for any patient diagnosed with a serious illness that leverages expertise from multidisciplinary teams of health professionals and addresses pain and symptoms.

Palliative care addresses suffering by incorporating psychosocial and spiritual care with consideration of patient and family needs, preferences, values, beliefs and cultures. Palliative care can be provided throughout the continuum of care for patients with chronic, serious, and even life-threatening illnesses.¹ To a degree, all aspects of health care can potentially address some palliative issues in that health care providers ideally combine a desire to cure the patient with a need to alleviate the patient’s pain and suffering.

Although the Medicare program recognizes the potential breadth of palliative care, the hospice benefit is relatively narrow. Consistent with the depiction in the Figure,² the Medicare hospice benefit is limited to care that is focused on “comfort, not on curing an illness”³ (emphasis added). The Medicare hospice benefit is available to Medicare beneficiaries who: (1) are eligible for Medicare Part A; (2) have a doctor and hospice medical director certifying that they are terminally ill and have 6 months or less to live if their illness runs its normal course; (3) sign a statement choosing hospice care instead of other Medicare-covered benefits to treat their terminal illness (although Medicare will still pay for covered benefits for any health problems that are not related to the terminal illness); and (4) get care from a Medicare-certified hospice program.³

There are, however, clear benefits to providing palliative care outside of the Medicare hospice benefit. In particular, patients with serious illnesses may have more than 6 months to live if their illness runs its normal course. Patients who may die within 1 year due to serious illness can benefit from palliative care. Furthermore, some patients would like to continue to pursue curative treatment of their illnesses, but would benefit from a palliative care approach. By providing palliative care in the context of a plan of care with the patient’s physician, the patient and family can comprehensively make decisions and obtain support that enables access to appropriate treatments while allowing enhanced quality of life through symptom management.

WHO CAN PROVIDE PALLIATIVE CARE?

Palliative care can be provided in any care setting that has been accredited or certified to provide care, including those that are upstream from hospice along the continuum of care. Hospitals, nursing homes, and home health agencies can provide palliative care.

The Joint Commission, a nonprofit accrediting organization, currently accredits or certifies more than 17,000 organizations or programs across the care continuum, including hospitals, nursing homes, home health agencies, and hospices. Within the scope of the home care accreditation program, hospices and home health agencies are evaluated by certified field representatives to determine the extent to which their services meet the standards established by The Joint Commission. These standards are developed with input from health care professionals, providers, subject matter experts, consumers, government agencies (including the Centers for Medicare & Medicaid Services [CMS]) and employers. They are informed by scientific literature and expert consensus and approved by the board of commissioners.

The Joint Commission also has a certification program for palliative care services provided in hospitals and has certified 21 palliative care programs at various hospitals in the United States.

The Joint Commission’s Advanced Certification Program for Palliative Care recognizes hospital inpatient programs that demonstrate exceptional patient-and family-centered care and optimize quality of life for patients (both adult and pediatric) with serious illness. Certification standards emphasize:

• A formal, organized, palliative care program led by an interdisciplinary team whose members are experts in palliative care
• Leadership endorsement and support of the program’s goals for providing care, treatment and services
• Special focus on patient and family engagement
• Processes that support the coordination of care and communication among all care settings and providers
• The use of evidence-based national guidelines or expert consensus to guide patient care

The certification standards cover program management, provision of care, information management, and performance improvement. The standards are built on the National Consensus Project’s Clinical Practice Guidelines for Quality Palliative Care² and the National Quality Forum’s National Framework and Preferred Practices for Palliative and Hospice Care Quality.⁴ Many of the concepts contained in the standards for inpatient palliative care have their origins in hospice care.

In addition to palliative care accreditation programs, certification in palliative care for clinicians is also possible. The American Board of Medical Specialties approved the creation of hospice and palliative medicine as a subspecialty in 2006. The National Board of Certification of Hospice and Palliative Nurses offers specialty certification for all levels of hospice and palliative care nursing. The National Association of Social Workers also offers an advanced certified hospice and palliative social worker (ACHP-SW) certifcation for MSW-level clinicians. These certification programs establish qualifications and standards for the members of a palliative care team.

Subject to federal and state requirements that regulate the way health care is provided, hospitals, nursing homes, home health agencies, and hospices are able to provide palliative care to patients who need such care.^5,6

WHAT IS HOME HEALTH’S ROLE IN PROVIDING PALLIATIVE CARE?

Many Medicare-certified home health agencies also operate Medicare-approved hospice programs. Home health agencies have a heightened perspective on patients’ palliative care needs. Because of the limited nature of the Medicare hospice benefit, home health agencies have built palliative care programs to fill unmet patient needs. Home health agencies often provide palliative care to patients who may be ineligible for the hospice benefit or have chosen not to enroll in it. These programs are particularly attractive to patients who would like to pursue curative treatment for their serious illnesses or who are expected to live longer than 6 months.

Home health patients with advancing or serious illness or chronic illness are candidates for a palliative care service. For these patients, the burden of their illness continues to grow as distressing symptoms begin to more regularly impact their quality of life. As they continue curative treatment of their illness, they would benefit from palliative care services that provide greater relief of their symptoms and support advanced care planning. Palliative care interventions become an integrated part of the care plan for these patients. Home health agencies serving patients with chronic or advancing illnesses will see care benefits from incorporating palliative care into their team’s skill set.

Two innovative examples of home health–based programs that include a palliative care component have been reported in peer-reviewed literature to date: Kaiser Permanente’s In-Home Palliative Care program and Sutter Health’s Advanced Illness Management (AIM) program.^7–10

Kaiser Permanente’s In-Home Palliative Care Program

Kaiser Permanente (KP) established the TriCentral Palliative Care Program in 1998 to achieve balance for seriously ill patients facing the end of life who were caught between “the extremes of too little care and too much.”¹¹ KP began the program after discovering that patients were underusing their existing hospice program. The TriCentral Palliative Care program is an outpatient service, housed in the KP home health department and modeled after the KP hospice program with three key modifications designed to encourage timely referrals to the program:

• Physicians are asked to refer a patient if they “would not be surprised if this patient died in the next year.” Palliative care patients with a prognosis of 12 months or less to live are accepted into the program.
• Improved pain control and symptom management are emphasized, but patients do not need to forgo curative care as they do in hospice programs.
• Patients are assigned a palliative care physician who coordinates care from a variety of health care providers, preventing fragmentation.

The program has five core components that are geared toward enhanced quality of care and patient quality of life. These core components are:

• An interdisciplinary team approach, focused on patient and family, with care provided by a core team consisting of a physician, nurse, and social worker, all with expertise in pain control, other symptom management, and psychosocial intervention
• Home visits by all team members, including physicians, to provide medical care, support, and education as needed by patients and their caregivers
• Ongoing care management to fill gaps in care and ensure that the patient’s medical, social, and spiritual needs are being met
• Telephone support via a toll-free number and after-hours home visits available 24 hours a day, 7 days a week as needed by the patient
• Advanced-care planning that empowers patients and their families to make informed decisions and choices about end-of-life care¹¹

Assessments of the program’s results in a randomized controlled trial⁸ and a comparative study⁹ showed that patient satisfaction increased; patients were more likely to die at home in accordance with their wishes; and emergency department (ED) visits, inpatient admissions, and costs were reduced (Table 1).

Sutter Health AIM Program

Sutter Health in northern California, in collaboration with its home care and hospice affiliate, Sutter Care at Home, initiated a home health–based program, Advanced Illness Management (AIM), in 2000 in response to the growing population of patients with advanced illness who needed enhanced care planning and symptom management. This program served patients who met the Medicare eligibility criteria for home health, had a prognosis of 1 year or less, and were continuing to seek treatment or cure for their illness. These patients frequently lacked awareness of their health status, particularly as it related to choices and decisions connected to the progression and management of their conditions. They also were frequently receiving uncoordinated care through various health channels, resulting in substandard symptom management. As a result, patients tended to experience more acute episodes that required frequent use of “unwanted and inappropriate care at the end of life, and they, their families, and their providers were dissatisfied.”¹²

As the AIM program matured, it incorporated a broader care management model, including principles of patient/caregiver engagement and goal setting, self-management techniques, ongoing advanced care planning, symptom management, and other evidence-based practices related to care transitions and care management. The program connects with the patient’s network of care providers and coordinates the exchange of realtime information about the current status of care plans and medication, as well as the patient’s defined goals. This more comprehensive model of care for persons with advanced illness has achieved improved adherence to patient wishes and goals, reductions in unnecessary hospital and ED utilization, and higher patient/caregiver and provider satisfaction than usual care.

Today, AIM is not primarily a palliative care program. Rather, it provides a comprehensive approach to care management that moves the focus of care for advanced illness out of the hospital and into the home/community setting. AIM achieves this through integrating the patient’s “health system.”

This integration occurs through formation of an interdisciplinary team comprised of the home care team, representative clinicians connected to the hospital, and providers of care for the patient. This expanded team, then, becomes the AIM care management team that is trained on the principles of AIM and its interventions. With this enhanced level of care coordination and unified focus on supporting the patient’s personal health goals, the AIM program serves as a “health system integrator” for the vulnerable and costly population of people with advanced chronic illness.

Inpatient palliative care is a separate and distinct systemwide priority at Sutter Health and, because of this, AIM collaborates closely with the inpatient palliative care teams to ensure that patients experience a seamless transition from hospital to home. There, AIM staff work with patients and families over time to clarify and document their personal values and goals, then use these to develop and drive the care plan. Armed with clearer appreciation of the natural progression of illness, both clinically and practically, coupled with improved understanding of available options for care, most choose to stay in the safety and comfort of their homes and out of the hospital. These avoided hospitalizations are the primary source of AIM’s considerable cost savings.

Patients eligible for AIM are those with clinical, functional, or nutritional decline; with multiple hospitalizations, ED visits, or both within the past 12 months; and who are clinically eligible for hospice but have chosen to continue treatment or have not otherwise made the decision to use a hospice model of care. Once the patient is enrolled, the AIM team works with the patient, the family, and the physician on a preference-driven plan of care. That plan is shared with all providers supporting the patient and is regularly updated to reflect changes in the patient’s evolving choices as illness advances. This tracking of goals and preferences over time as illness progresses has been a critical factor in improving outcomes, especially those related to adherence or honoring a patient’s personal goals.

The AIM program started as a symptom management and care planning intervention for Medicare-eligible home health patients. The program has evolved over time into a pivotal fulcrum by which to engage or create an interdisciplinary focus and skill set across sites and providers of care in an effort to improve the overall outcomes for patients with advancing illness. In 2009, the AIM program began geographically expanding its home health–based AIM teams across 12 counties surrounding the San Francisco Bay area and the greater Sacramento region in northern California. The program now coordinates care with more than 17 hospitals and all of the large Sutter-affiliated medical groups, and it serves approximately 800 patients per day.

The AIM program has yielded significant results in terms of both quality of care and cost savings. Preliminary data on more than 300 AIM patients surveyed from November 2009 through September 2010 showed significant reductions in unnecessary hospitalizations and inpatient direct care costs (Table 2).¹² Survey data also showed significant improvements in patient, family, and physician satisfaction when late-stage patients were served through AIM rather than through home care by itself.¹²

The Sutter Health AIM program recently received a Health Care Innovation Award from the Center for Medicare & Medicaid Innovation (CMMI) because of the program’s ability to “improve care and patient quality of life, increase physician, caregiver, and patient satisfaction, and reduce Medicare costs associated with avoidable hospital stays, ED visits, and days spent in intensive care units and skilled nursing facilities.”¹³ The $13 million CMMI grant will help expand AIM to the entire Sutter Health system. It is estimated that the program will save $29,388,894 over 3 years.¹³

CONCLUSION: CHALLENGES AND OPPORTUNITIES FOR THE US HEALTH CARE SYSTEM

The basic objective of AIM and programs like it is to move the focus of care for people with advanced illness out of the hospital and into home and community. This fulfills the Triple Aim vision set forth in 2008 by former CMS Administrator Don Berwick¹⁴:

• Improving health by reducing inpatient care that does not achieve person-centered goals or reduce overall mortality
• Improving care by basing it on the values and goals of people dealing with serious chronic illness
• Reducing costs by preventing unwanted hospital care

Sutter Health, a system that is on its way to becoming fully clinically integrated, was a logical choice for launching AIM because its hospitals are forming relationships with physician groups and home care providers. This integration process is supported nationally by CMS and CMMI, which are promoting new models of care and reimbursement such as accountable care organizations (ACOs) and bundled payments.

Nonintegrated hospitals and other provider groups can move in this same direction. AIM establishes key care coordination roles in each setting of care such as in hospitals and physician offices, as well as in the home care–based team and providers. The AIM care model emphasizes close coordination of clinical activities and communications, and integrates these with hospital and medical group operations. These provider groups can move strategically toward becoming “virtual ACOs” by coordinating care for people with advanced illness, who comprise the most vulnerable and costly segment of the US population and increasingly impact Medicare expenditures.

Changes in federal policy will be needed to facilitate national implementation of AIM-like programs. If ACOs and bundled payments were to be implemented overnight, the person-centered, cost-saving advantages of AIM would be obvious. However, until shared risk/shared savings models replace fee-for-service reimbursement, new payment policies will be needed on an interim basis to cover the costs of currently nonreimbursed care management services. This could be arranged through a per-enrollee-per-month payment or shared savings models tied to specific quality and utilization outcomes.

Simplification of regulatory requirements to better serve persons with advancing illness and to reduce the burden on providers operating such programs would be valuable. The pattern or progression of advancing chronic illness requires ongoing coordination in order to maintain a higher quality of life and symptom management. Current regulations and requirements foster an episodic focus in the home, as well in the hospital and physician’s office, which is not in alignment with the experience of persons living with advancing illness.

As the prevalence of serious illness among the elderly population has increased, interest in palliative care has grown as an approach to care management that is patient-centered and focused on quality of life. Case management that employs palliative care has the potential to alleviate unnecessary pain and suffering for patients while they concurrently pursue life-prolonging therapy. Palliative care can be provided across the continuum of care, involving multiple health care providers and practitioners.

Home health care, while often used as a postacute care provider, also can provide longitudinal care to elderly patients without a preceding hospitalization. Home health providers often act as central liaisons to coordinate care while patients are at home, particularly chronically ill patients with multiple physician providers, complex medication regimens, and ongoing concerns with independence and safety in the home.

Home health care can play a critical role in providing palliative care and, through innovative programs, can improve access to it. This article provides context and background on the provision of palliative care and explores how home health can work seamlessly in coordination with other health care stakeholders in providing palliative care.

WHAT IS PALLIATIVE CARE?

Palliative care means patient- and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and [facilitating] patient autonomy, access to information, and choice.¹

At its core, palliative care is a field of medicine aimed at alleviating the suffering of patients. As a “philosophy of care,” palliative care is appropriate for various sites of care at various stages of disease and all ages of patients. While hospice care is defined by the provision of palliative care for patients at the end of life, not all palliative care is hospice care. Rather, palliative care is an approach to care for any patient diagnosed with a serious illness that leverages expertise from multidisciplinary teams of health professionals and addresses pain and symptoms.

Palliative care addresses suffering by incorporating psychosocial and spiritual care with consideration of patient and family needs, preferences, values, beliefs and cultures. Palliative care can be provided throughout the continuum of care for patients with chronic, serious, and even life-threatening illnesses.¹ To a degree, all aspects of health care can potentially address some palliative issues in that health care providers ideally combine a desire to cure the patient with a need to alleviate the patient’s pain and suffering.

Although the Medicare program recognizes the potential breadth of palliative care, the hospice benefit is relatively narrow. Consistent with the depiction in the Figure,² the Medicare hospice benefit is limited to care that is focused on “comfort, not on curing an illness”³ (emphasis added). The Medicare hospice benefit is available to Medicare beneficiaries who: (1) are eligible for Medicare Part A; (2) have a doctor and hospice medical director certifying that they are terminally ill and have 6 months or less to live if their illness runs its normal course; (3) sign a statement choosing hospice care instead of other Medicare-covered benefits to treat their terminal illness (although Medicare will still pay for covered benefits for any health problems that are not related to the terminal illness); and (4) get care from a Medicare-certified hospice program.³

There are, however, clear benefits to providing palliative care outside of the Medicare hospice benefit. In particular, patients with serious illnesses may have more than 6 months to live if their illness runs its normal course. Patients who may die within 1 year due to serious illness can benefit from palliative care. Furthermore, some patients would like to continue to pursue curative treatment of their illnesses, but would benefit from a palliative care approach. By providing palliative care in the context of a plan of care with the patient’s physician, the patient and family can comprehensively make decisions and obtain support that enables access to appropriate treatments while allowing enhanced quality of life through symptom management.

WHO CAN PROVIDE PALLIATIVE CARE?

Palliative care can be provided in any care setting that has been accredited or certified to provide care, including those that are upstream from hospice along the continuum of care. Hospitals, nursing homes, and home health agencies can provide palliative care.

The Joint Commission, a nonprofit accrediting organization, currently accredits or certifies more than 17,000 organizations or programs across the care continuum, including hospitals, nursing homes, home health agencies, and hospices. Within the scope of the home care accreditation program, hospices and home health agencies are evaluated by certified field representatives to determine the extent to which their services meet the standards established by The Joint Commission. These standards are developed with input from health care professionals, providers, subject matter experts, consumers, government agencies (including the Centers for Medicare & Medicaid Services [CMS]) and employers. They are informed by scientific literature and expert consensus and approved by the board of commissioners.

The Joint Commission also has a certification program for palliative care services provided in hospitals and has certified 21 palliative care programs at various hospitals in the United States.

The Joint Commission’s Advanced Certification Program for Palliative Care recognizes hospital inpatient programs that demonstrate exceptional patient-and family-centered care and optimize quality of life for patients (both adult and pediatric) with serious illness. Certification standards emphasize:

• A formal, organized, palliative care program led by an interdisciplinary team whose members are experts in palliative care
• Leadership endorsement and support of the program’s goals for providing care, treatment and services
• Special focus on patient and family engagement
• Processes that support the coordination of care and communication among all care settings and providers
• The use of evidence-based national guidelines or expert consensus to guide patient care

The certification standards cover program management, provision of care, information management, and performance improvement. The standards are built on the National Consensus Project’s Clinical Practice Guidelines for Quality Palliative Care² and the National Quality Forum’s National Framework and Preferred Practices for Palliative and Hospice Care Quality.⁴ Many of the concepts contained in the standards for inpatient palliative care have their origins in hospice care.

In addition to palliative care accreditation programs, certification in palliative care for clinicians is also possible. The American Board of Medical Specialties approved the creation of hospice and palliative medicine as a subspecialty in 2006. The National Board of Certification of Hospice and Palliative Nurses offers specialty certification for all levels of hospice and palliative care nursing. The National Association of Social Workers also offers an advanced certified hospice and palliative social worker (ACHP-SW) certifcation for MSW-level clinicians. These certification programs establish qualifications and standards for the members of a palliative care team.

Subject to federal and state requirements that regulate the way health care is provided, hospitals, nursing homes, home health agencies, and hospices are able to provide palliative care to patients who need such care.^5,6

WHAT IS HOME HEALTH’S ROLE IN PROVIDING PALLIATIVE CARE?

Many Medicare-certified home health agencies also operate Medicare-approved hospice programs. Home health agencies have a heightened perspective on patients’ palliative care needs. Because of the limited nature of the Medicare hospice benefit, home health agencies have built palliative care programs to fill unmet patient needs. Home health agencies often provide palliative care to patients who may be ineligible for the hospice benefit or have chosen not to enroll in it. These programs are particularly attractive to patients who would like to pursue curative treatment for their serious illnesses or who are expected to live longer than 6 months.

Home health patients with advancing or serious illness or chronic illness are candidates for a palliative care service. For these patients, the burden of their illness continues to grow as distressing symptoms begin to more regularly impact their quality of life. As they continue curative treatment of their illness, they would benefit from palliative care services that provide greater relief of their symptoms and support advanced care planning. Palliative care interventions become an integrated part of the care plan for these patients. Home health agencies serving patients with chronic or advancing illnesses will see care benefits from incorporating palliative care into their team’s skill set.

Two innovative examples of home health–based programs that include a palliative care component have been reported in peer-reviewed literature to date: Kaiser Permanente’s In-Home Palliative Care program and Sutter Health’s Advanced Illness Management (AIM) program.^7–10

Kaiser Permanente’s In-Home Palliative Care Program

Kaiser Permanente (KP) established the TriCentral Palliative Care Program in 1998 to achieve balance for seriously ill patients facing the end of life who were caught between “the extremes of too little care and too much.”¹¹ KP began the program after discovering that patients were underusing their existing hospice program. The TriCentral Palliative Care program is an outpatient service, housed in the KP home health department and modeled after the KP hospice program with three key modifications designed to encourage timely referrals to the program:

• Physicians are asked to refer a patient if they “would not be surprised if this patient died in the next year.” Palliative care patients with a prognosis of 12 months or less to live are accepted into the program.
• Improved pain control and symptom management are emphasized, but patients do not need to forgo curative care as they do in hospice programs.
• Patients are assigned a palliative care physician who coordinates care from a variety of health care providers, preventing fragmentation.

The program has five core components that are geared toward enhanced quality of care and patient quality of life. These core components are:

• An interdisciplinary team approach, focused on patient and family, with care provided by a core team consisting of a physician, nurse, and social worker, all with expertise in pain control, other symptom management, and psychosocial intervention
• Home visits by all team members, including physicians, to provide medical care, support, and education as needed by patients and their caregivers
• Ongoing care management to fill gaps in care and ensure that the patient’s medical, social, and spiritual needs are being met
• Telephone support via a toll-free number and after-hours home visits available 24 hours a day, 7 days a week as needed by the patient
• Advanced-care planning that empowers patients and their families to make informed decisions and choices about end-of-life care¹¹

Assessments of the program’s results in a randomized controlled trial⁸ and a comparative study⁹ showed that patient satisfaction increased; patients were more likely to die at home in accordance with their wishes; and emergency department (ED) visits, inpatient admissions, and costs were reduced (Table 1).

Sutter Health AIM Program

Sutter Health in northern California, in collaboration with its home care and hospice affiliate, Sutter Care at Home, initiated a home health–based program, Advanced Illness Management (AIM), in 2000 in response to the growing population of patients with advanced illness who needed enhanced care planning and symptom management. This program served patients who met the Medicare eligibility criteria for home health, had a prognosis of 1 year or less, and were continuing to seek treatment or cure for their illness. These patients frequently lacked awareness of their health status, particularly as it related to choices and decisions connected to the progression and management of their conditions. They also were frequently receiving uncoordinated care through various health channels, resulting in substandard symptom management. As a result, patients tended to experience more acute episodes that required frequent use of “unwanted and inappropriate care at the end of life, and they, their families, and their providers were dissatisfied.”¹²

As the AIM program matured, it incorporated a broader care management model, including principles of patient/caregiver engagement and goal setting, self-management techniques, ongoing advanced care planning, symptom management, and other evidence-based practices related to care transitions and care management. The program connects with the patient’s network of care providers and coordinates the exchange of realtime information about the current status of care plans and medication, as well as the patient’s defined goals. This more comprehensive model of care for persons with advanced illness has achieved improved adherence to patient wishes and goals, reductions in unnecessary hospital and ED utilization, and higher patient/caregiver and provider satisfaction than usual care.

Today, AIM is not primarily a palliative care program. Rather, it provides a comprehensive approach to care management that moves the focus of care for advanced illness out of the hospital and into the home/community setting. AIM achieves this through integrating the patient’s “health system.”

This integration occurs through formation of an interdisciplinary team comprised of the home care team, representative clinicians connected to the hospital, and providers of care for the patient. This expanded team, then, becomes the AIM care management team that is trained on the principles of AIM and its interventions. With this enhanced level of care coordination and unified focus on supporting the patient’s personal health goals, the AIM program serves as a “health system integrator” for the vulnerable and costly population of people with advanced chronic illness.

Inpatient palliative care is a separate and distinct systemwide priority at Sutter Health and, because of this, AIM collaborates closely with the inpatient palliative care teams to ensure that patients experience a seamless transition from hospital to home. There, AIM staff work with patients and families over time to clarify and document their personal values and goals, then use these to develop and drive the care plan. Armed with clearer appreciation of the natural progression of illness, both clinically and practically, coupled with improved understanding of available options for care, most choose to stay in the safety and comfort of their homes and out of the hospital. These avoided hospitalizations are the primary source of AIM’s considerable cost savings.

Patients eligible for AIM are those with clinical, functional, or nutritional decline; with multiple hospitalizations, ED visits, or both within the past 12 months; and who are clinically eligible for hospice but have chosen to continue treatment or have not otherwise made the decision to use a hospice model of care. Once the patient is enrolled, the AIM team works with the patient, the family, and the physician on a preference-driven plan of care. That plan is shared with all providers supporting the patient and is regularly updated to reflect changes in the patient’s evolving choices as illness advances. This tracking of goals and preferences over time as illness progresses has been a critical factor in improving outcomes, especially those related to adherence or honoring a patient’s personal goals.

The AIM program started as a symptom management and care planning intervention for Medicare-eligible home health patients. The program has evolved over time into a pivotal fulcrum by which to engage or create an interdisciplinary focus and skill set across sites and providers of care in an effort to improve the overall outcomes for patients with advancing illness. In 2009, the AIM program began geographically expanding its home health–based AIM teams across 12 counties surrounding the San Francisco Bay area and the greater Sacramento region in northern California. The program now coordinates care with more than 17 hospitals and all of the large Sutter-affiliated medical groups, and it serves approximately 800 patients per day.

The AIM program has yielded significant results in terms of both quality of care and cost savings. Preliminary data on more than 300 AIM patients surveyed from November 2009 through September 2010 showed significant reductions in unnecessary hospitalizations and inpatient direct care costs (Table 2).¹² Survey data also showed significant improvements in patient, family, and physician satisfaction when late-stage patients were served through AIM rather than through home care by itself.¹²

The Sutter Health AIM program recently received a Health Care Innovation Award from the Center for Medicare & Medicaid Innovation (CMMI) because of the program’s ability to “improve care and patient quality of life, increase physician, caregiver, and patient satisfaction, and reduce Medicare costs associated with avoidable hospital stays, ED visits, and days spent in intensive care units and skilled nursing facilities.”¹³ The $13 million CMMI grant will help expand AIM to the entire Sutter Health system. It is estimated that the program will save $29,388,894 over 3 years.¹³

CONCLUSION: CHALLENGES AND OPPORTUNITIES FOR THE US HEALTH CARE SYSTEM

The basic objective of AIM and programs like it is to move the focus of care for people with advanced illness out of the hospital and into home and community. This fulfills the Triple Aim vision set forth in 2008 by former CMS Administrator Don Berwick¹⁴:

• Improving health by reducing inpatient care that does not achieve person-centered goals or reduce overall mortality
• Improving care by basing it on the values and goals of people dealing with serious chronic illness
• Reducing costs by preventing unwanted hospital care

Sutter Health, a system that is on its way to becoming fully clinically integrated, was a logical choice for launching AIM because its hospitals are forming relationships with physician groups and home care providers. This integration process is supported nationally by CMS and CMMI, which are promoting new models of care and reimbursement such as accountable care organizations (ACOs) and bundled payments.

Nonintegrated hospitals and other provider groups can move in this same direction. AIM establishes key care coordination roles in each setting of care such as in hospitals and physician offices, as well as in the home care–based team and providers. The AIM care model emphasizes close coordination of clinical activities and communications, and integrates these with hospital and medical group operations. These provider groups can move strategically toward becoming “virtual ACOs” by coordinating care for people with advanced illness, who comprise the most vulnerable and costly segment of the US population and increasingly impact Medicare expenditures.

Changes in federal policy will be needed to facilitate national implementation of AIM-like programs. If ACOs and bundled payments were to be implemented overnight, the person-centered, cost-saving advantages of AIM would be obvious. However, until shared risk/shared savings models replace fee-for-service reimbursement, new payment policies will be needed on an interim basis to cover the costs of currently nonreimbursed care management services. This could be arranged through a per-enrollee-per-month payment or shared savings models tied to specific quality and utilization outcomes.

Simplification of regulatory requirements to better serve persons with advancing illness and to reduce the burden on providers operating such programs would be valuable. The pattern or progression of advancing chronic illness requires ongoing coordination in order to maintain a higher quality of life and symptom management. Current regulations and requirements foster an episodic focus in the home, as well in the hospital and physician’s office, which is not in alignment with the experience of persons living with advancing illness.

As the prevalence of serious illness among the elderly population has increased, interest in palliative care has grown as an approach to care management that is patient-centered and focused on quality of life. Case management that employs palliative care has the potential to alleviate unnecessary pain and suffering for patients while they concurrently pursue life-prolonging therapy. Palliative care can be provided across the continuum of care, involving multiple health care providers and practitioners.

Home health care, while often used as a postacute care provider, also can provide longitudinal care to elderly patients without a preceding hospitalization. Home health providers often act as central liaisons to coordinate care while patients are at home, particularly chronically ill patients with multiple physician providers, complex medication regimens, and ongoing concerns with independence and safety in the home.

Home health care can play a critical role in providing palliative care and, through innovative programs, can improve access to it. This article provides context and background on the provision of palliative care and explores how home health can work seamlessly in coordination with other health care stakeholders in providing palliative care.

WHAT IS PALLIATIVE CARE?

Palliative care means patient- and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and [facilitating] patient autonomy, access to information, and choice.¹

At its core, palliative care is a field of medicine aimed at alleviating the suffering of patients. As a “philosophy of care,” palliative care is appropriate for various sites of care at various stages of disease and all ages of patients. While hospice care is defined by the provision of palliative care for patients at the end of life, not all palliative care is hospice care. Rather, palliative care is an approach to care for any patient diagnosed with a serious illness that leverages expertise from multidisciplinary teams of health professionals and addresses pain and symptoms.

Palliative care addresses suffering by incorporating psychosocial and spiritual care with consideration of patient and family needs, preferences, values, beliefs and cultures. Palliative care can be provided throughout the continuum of care for patients with chronic, serious, and even life-threatening illnesses.¹ To a degree, all aspects of health care can potentially address some palliative issues in that health care providers ideally combine a desire to cure the patient with a need to alleviate the patient’s pain and suffering.

Although the Medicare program recognizes the potential breadth of palliative care, the hospice benefit is relatively narrow. Consistent with the depiction in the Figure,² the Medicare hospice benefit is limited to care that is focused on “comfort, not on curing an illness”³ (emphasis added). The Medicare hospice benefit is available to Medicare beneficiaries who: (1) are eligible for Medicare Part A; (2) have a doctor and hospice medical director certifying that they are terminally ill and have 6 months or less to live if their illness runs its normal course; (3) sign a statement choosing hospice care instead of other Medicare-covered benefits to treat their terminal illness (although Medicare will still pay for covered benefits for any health problems that are not related to the terminal illness); and (4) get care from a Medicare-certified hospice program.³

There are, however, clear benefits to providing palliative care outside of the Medicare hospice benefit. In particular, patients with serious illnesses may have more than 6 months to live if their illness runs its normal course. Patients who may die within 1 year due to serious illness can benefit from palliative care. Furthermore, some patients would like to continue to pursue curative treatment of their illnesses, but would benefit from a palliative care approach. By providing palliative care in the context of a plan of care with the patient’s physician, the patient and family can comprehensively make decisions and obtain support that enables access to appropriate treatments while allowing enhanced quality of life through symptom management.

WHO CAN PROVIDE PALLIATIVE CARE?

Palliative care can be provided in any care setting that has been accredited or certified to provide care, including those that are upstream from hospice along the continuum of care. Hospitals, nursing homes, and home health agencies can provide palliative care.

The Joint Commission, a nonprofit accrediting organization, currently accredits or certifies more than 17,000 organizations or programs across the care continuum, including hospitals, nursing homes, home health agencies, and hospices. Within the scope of the home care accreditation program, hospices and home health agencies are evaluated by certified field representatives to determine the extent to which their services meet the standards established by The Joint Commission. These standards are developed with input from health care professionals, providers, subject matter experts, consumers, government agencies (including the Centers for Medicare & Medicaid Services [CMS]) and employers. They are informed by scientific literature and expert consensus and approved by the board of commissioners.

The Joint Commission also has a certification program for palliative care services provided in hospitals and has certified 21 palliative care programs at various hospitals in the United States.

The Joint Commission’s Advanced Certification Program for Palliative Care recognizes hospital inpatient programs that demonstrate exceptional patient-and family-centered care and optimize quality of life for patients (both adult and pediatric) with serious illness. Certification standards emphasize:

• A formal, organized, palliative care program led by an interdisciplinary team whose members are experts in palliative care
• Leadership endorsement and support of the program’s goals for providing care, treatment and services
• Special focus on patient and family engagement
• Processes that support the coordination of care and communication among all care settings and providers
• The use of evidence-based national guidelines or expert consensus to guide patient care

The certification standards cover program management, provision of care, information management, and performance improvement. The standards are built on the National Consensus Project’s Clinical Practice Guidelines for Quality Palliative Care² and the National Quality Forum’s National Framework and Preferred Practices for Palliative and Hospice Care Quality.⁴ Many of the concepts contained in the standards for inpatient palliative care have their origins in hospice care.

In addition to palliative care accreditation programs, certification in palliative care for clinicians is also possible. The American Board of Medical Specialties approved the creation of hospice and palliative medicine as a subspecialty in 2006. The National Board of Certification of Hospice and Palliative Nurses offers specialty certification for all levels of hospice and palliative care nursing. The National Association of Social Workers also offers an advanced certified hospice and palliative social worker (ACHP-SW) certifcation for MSW-level clinicians. These certification programs establish qualifications and standards for the members of a palliative care team.

Subject to federal and state requirements that regulate the way health care is provided, hospitals, nursing homes, home health agencies, and hospices are able to provide palliative care to patients who need such care.^5,6

WHAT IS HOME HEALTH’S ROLE IN PROVIDING PALLIATIVE CARE?

Many Medicare-certified home health agencies also operate Medicare-approved hospice programs. Home health agencies have a heightened perspective on patients’ palliative care needs. Because of the limited nature of the Medicare hospice benefit, home health agencies have built palliative care programs to fill unmet patient needs. Home health agencies often provide palliative care to patients who may be ineligible for the hospice benefit or have chosen not to enroll in it. These programs are particularly attractive to patients who would like to pursue curative treatment for their serious illnesses or who are expected to live longer than 6 months.

Home health patients with advancing or serious illness or chronic illness are candidates for a palliative care service. For these patients, the burden of their illness continues to grow as distressing symptoms begin to more regularly impact their quality of life. As they continue curative treatment of their illness, they would benefit from palliative care services that provide greater relief of their symptoms and support advanced care planning. Palliative care interventions become an integrated part of the care plan for these patients. Home health agencies serving patients with chronic or advancing illnesses will see care benefits from incorporating palliative care into their team’s skill set.

Two innovative examples of home health–based programs that include a palliative care component have been reported in peer-reviewed literature to date: Kaiser Permanente’s In-Home Palliative Care program and Sutter Health’s Advanced Illness Management (AIM) program.^7–10

Kaiser Permanente’s In-Home Palliative Care Program

Kaiser Permanente (KP) established the TriCentral Palliative Care Program in 1998 to achieve balance for seriously ill patients facing the end of life who were caught between “the extremes of too little care and too much.”¹¹ KP began the program after discovering that patients were underusing their existing hospice program. The TriCentral Palliative Care program is an outpatient service, housed in the KP home health department and modeled after the KP hospice program with three key modifications designed to encourage timely referrals to the program:

• Physicians are asked to refer a patient if they “would not be surprised if this patient died in the next year.” Palliative care patients with a prognosis of 12 months or less to live are accepted into the program.
• Improved pain control and symptom management are emphasized, but patients do not need to forgo curative care as they do in hospice programs.
• Patients are assigned a palliative care physician who coordinates care from a variety of health care providers, preventing fragmentation.

The program has five core components that are geared toward enhanced quality of care and patient quality of life. These core components are:

• An interdisciplinary team approach, focused on patient and family, with care provided by a core team consisting of a physician, nurse, and social worker, all with expertise in pain control, other symptom management, and psychosocial intervention
• Home visits by all team members, including physicians, to provide medical care, support, and education as needed by patients and their caregivers
• Ongoing care management to fill gaps in care and ensure that the patient’s medical, social, and spiritual needs are being met
• Telephone support via a toll-free number and after-hours home visits available 24 hours a day, 7 days a week as needed by the patient
• Advanced-care planning that empowers patients and their families to make informed decisions and choices about end-of-life care¹¹

Assessments of the program’s results in a randomized controlled trial⁸ and a comparative study⁹ showed that patient satisfaction increased; patients were more likely to die at home in accordance with their wishes; and emergency department (ED) visits, inpatient admissions, and costs were reduced (Table 1).

Sutter Health AIM Program

Sutter Health in northern California, in collaboration with its home care and hospice affiliate, Sutter Care at Home, initiated a home health–based program, Advanced Illness Management (AIM), in 2000 in response to the growing population of patients with advanced illness who needed enhanced care planning and symptom management. This program served patients who met the Medicare eligibility criteria for home health, had a prognosis of 1 year or less, and were continuing to seek treatment or cure for their illness. These patients frequently lacked awareness of their health status, particularly as it related to choices and decisions connected to the progression and management of their conditions. They also were frequently receiving uncoordinated care through various health channels, resulting in substandard symptom management. As a result, patients tended to experience more acute episodes that required frequent use of “unwanted and inappropriate care at the end of life, and they, their families, and their providers were dissatisfied.”¹²

As the AIM program matured, it incorporated a broader care management model, including principles of patient/caregiver engagement and goal setting, self-management techniques, ongoing advanced care planning, symptom management, and other evidence-based practices related to care transitions and care management. The program connects with the patient’s network of care providers and coordinates the exchange of realtime information about the current status of care plans and medication, as well as the patient’s defined goals. This more comprehensive model of care for persons with advanced illness has achieved improved adherence to patient wishes and goals, reductions in unnecessary hospital and ED utilization, and higher patient/caregiver and provider satisfaction than usual care.

Today, AIM is not primarily a palliative care program. Rather, it provides a comprehensive approach to care management that moves the focus of care for advanced illness out of the hospital and into the home/community setting. AIM achieves this through integrating the patient’s “health system.”

This integration occurs through formation of an interdisciplinary team comprised of the home care team, representative clinicians connected to the hospital, and providers of care for the patient. This expanded team, then, becomes the AIM care management team that is trained on the principles of AIM and its interventions. With this enhanced level of care coordination and unified focus on supporting the patient’s personal health goals, the AIM program serves as a “health system integrator” for the vulnerable and costly population of people with advanced chronic illness.

Inpatient palliative care is a separate and distinct systemwide priority at Sutter Health and, because of this, AIM collaborates closely with the inpatient palliative care teams to ensure that patients experience a seamless transition from hospital to home. There, AIM staff work with patients and families over time to clarify and document their personal values and goals, then use these to develop and drive the care plan. Armed with clearer appreciation of the natural progression of illness, both clinically and practically, coupled with improved understanding of available options for care, most choose to stay in the safety and comfort of their homes and out of the hospital. These avoided hospitalizations are the primary source of AIM’s considerable cost savings.

Patients eligible for AIM are those with clinical, functional, or nutritional decline; with multiple hospitalizations, ED visits, or both within the past 12 months; and who are clinically eligible for hospice but have chosen to continue treatment or have not otherwise made the decision to use a hospice model of care. Once the patient is enrolled, the AIM team works with the patient, the family, and the physician on a preference-driven plan of care. That plan is shared with all providers supporting the patient and is regularly updated to reflect changes in the patient’s evolving choices as illness advances. This tracking of goals and preferences over time as illness progresses has been a critical factor in improving outcomes, especially those related to adherence or honoring a patient’s personal goals.

The AIM program started as a symptom management and care planning intervention for Medicare-eligible home health patients. The program has evolved over time into a pivotal fulcrum by which to engage or create an interdisciplinary focus and skill set across sites and providers of care in an effort to improve the overall outcomes for patients with advancing illness. In 2009, the AIM program began geographically expanding its home health–based AIM teams across 12 counties surrounding the San Francisco Bay area and the greater Sacramento region in northern California. The program now coordinates care with more than 17 hospitals and all of the large Sutter-affiliated medical groups, and it serves approximately 800 patients per day.

The AIM program has yielded significant results in terms of both quality of care and cost savings. Preliminary data on more than 300 AIM patients surveyed from November 2009 through September 2010 showed significant reductions in unnecessary hospitalizations and inpatient direct care costs (Table 2).¹² Survey data also showed significant improvements in patient, family, and physician satisfaction when late-stage patients were served through AIM rather than through home care by itself.¹²

The Sutter Health AIM program recently received a Health Care Innovation Award from the Center for Medicare & Medicaid Innovation (CMMI) because of the program’s ability to “improve care and patient quality of life, increase physician, caregiver, and patient satisfaction, and reduce Medicare costs associated with avoidable hospital stays, ED visits, and days spent in intensive care units and skilled nursing facilities.”¹³ The $13 million CMMI grant will help expand AIM to the entire Sutter Health system. It is estimated that the program will save $29,388,894 over 3 years.¹³

CONCLUSION: CHALLENGES AND OPPORTUNITIES FOR THE US HEALTH CARE SYSTEM

The basic objective of AIM and programs like it is to move the focus of care for people with advanced illness out of the hospital and into home and community. This fulfills the Triple Aim vision set forth in 2008 by former CMS Administrator Don Berwick¹⁴:

• Improving health by reducing inpatient care that does not achieve person-centered goals or reduce overall mortality
• Improving care by basing it on the values and goals of people dealing with serious chronic illness
• Reducing costs by preventing unwanted hospital care

Sutter Health, a system that is on its way to becoming fully clinically integrated, was a logical choice for launching AIM because its hospitals are forming relationships with physician groups and home care providers. This integration process is supported nationally by CMS and CMMI, which are promoting new models of care and reimbursement such as accountable care organizations (ACOs) and bundled payments.

Nonintegrated hospitals and other provider groups can move in this same direction. AIM establishes key care coordination roles in each setting of care such as in hospitals and physician offices, as well as in the home care–based team and providers. The AIM care model emphasizes close coordination of clinical activities and communications, and integrates these with hospital and medical group operations. These provider groups can move strategically toward becoming “virtual ACOs” by coordinating care for people with advanced illness, who comprise the most vulnerable and costly segment of the US population and increasingly impact Medicare expenditures.

Changes in federal policy will be needed to facilitate national implementation of AIM-like programs. If ACOs and bundled payments were to be implemented overnight, the person-centered, cost-saving advantages of AIM would be obvious. However, until shared risk/shared savings models replace fee-for-service reimbursement, new payment policies will be needed on an interim basis to cover the costs of currently nonreimbursed care management services. This could be arranged through a per-enrollee-per-month payment or shared savings models tied to specific quality and utilization outcomes.

Simplification of regulatory requirements to better serve persons with advancing illness and to reduce the burden on providers operating such programs would be valuable. The pattern or progression of advancing chronic illness requires ongoing coordination in order to maintain a higher quality of life and symptom management. Current regulations and requirements foster an episodic focus in the home, as well in the hospital and physician’s office, which is not in alignment with the experience of persons living with advancing illness.

The passage of the Patient Protection and Affordable Care Act will profoundly affect the way physicians—particularly those engaged in primary care—practice medicine. Clinicians and their colleagues will be obliged to meet government-mandated performance quality measures while achieving cost efficiencies. Two concepts are central to the implementation of reform in the US health care system: accountable care organizations (ACOs) and the patient-centered medical home (PCMH). To get some perspective on what these changes mean for the practicing clinician, Cleveland Clinic Journal of Medicine (CCJM) interviewed David Longworth, MD, who chairs the Cleveland Clinic Medicine Institute and directs strategy and implementation of Cleveland Clinic ACO-related activities.

CCJM: Please explain briefly the concept of PCMH.

Dr. Longworth: PCMH is not a new concept; first advanced by the American Academy of Pediatrics in 1967,¹ it represents a model of care in which an individual patient has a primary relationship with one provider who manages and coordinates the different aspects of the patient’s health care. The provider collaborates with a team of health care professionals. The concept caught on about a decade ago when a consortium of family medicine organizations and ultimately industry, including IBM, endorsed the concept. IBM and others created the Primary Care Consortium and began to drive the concept of PCMH.

Increasingly, care delivered through PCMH is team-based. The team coordinates the patient’s care and, when appropriate, enlists specialists or subspecialists to provide necessary components of care, all while maintaining responsibility for care coordination across the continuum of care. The medical home model provides an opportunity for enhanced access and care coordination utilizing care outside of the office walls, such as through retail clinics, eVisits, online diagnostic services, phone and electronic communication, and house call services.

Patient-centered medical homes are springing up across the country. In 2008, the National Committee for Quality Assurance (NCQA) developed criteria for recognition of PCMHs.² It scored the sophistication of medical homes at three levels, level 1 being the lowest and level 3 the highest. Between 2008 and the end of 2010, NCQA had recognized more than 1,500 PCMHs. According to the latest figures, more than 3,000 practices have now earned PCMH recognition from the NCQA.³

At Cleveland Clinic, pilot projects at three family health centers that cover 60,000 persons have recently been rolled out with the goal of determining the model of team care that yields the highest value, with value defined by the equation of quality over cost. Ideally, higher quality is delivered at lower cost to increase value.

CCJM: What are the goals of ACOs?

Dr. Longworth: The term “accountable care,” first used in 2006 by Elliot Fisher, Dartmouth Institute of Health Policy and Clinical Practice,⁶ expresses the idea that health care organizations be accountable for the care they deliver, with the three-part aim of better health for populations, better care for individuals, and reduced cost inefficiencies without compromised care.

With accountable care, institutions take on risk with the expectation that they will improve quality but reduce costs, and if they reduce costs and achieve certain quality targets for populations of patients, they will share in the savings accrued. The Affordable Care Act laid the groundwork for creation of ACOs. The regulation for ACOs released by the Centers for Medicare & Medicaid Services (CMS) became effective in January 2012.^7,8 Many health care organizations opposed the rule for reasons related to complexity, prescriptiveness, onerous detail around governance and marketing, and shared savings arrangements, among others. The final rule addressed many of these concerns and enabled the creation of the first wave of ACOs.⁸ At present, 153 ACOs have been approved by CMS.⁹ Other ACOs funded by commercial payers are also being formed in many locations.

For ACOs to be effective, I believe that the cornerstone of management has to be PCMHs.

CCJM: You mentioned that institutions will take on risk. What kind of risk are you referring to?

Dr. Longworth: Added value must be rewarded with sustainable payment models. There are two payment models in the final ACO rule from CMS. Both models require 3-year commitments and both require involvement of primary care physicians. One model for organizations that want to stick a toe in the water has no downside risk and modest potential for gain if they hit certain quality and cost targets. For those organizations that are further along and want to assume risk, the second option is a shared savings/risk payment model, which creates greater incentives for efficiency and quality. In the shared savings/risk model, the ACO can retain a portion of savings if it meets performance and expenditure benchmarks based on its performance during the previous 3 years. It is also at risk for loss if expenditures are greater than a certain amount compared with benchmark expenditures. Ultimately, the final destination for ACOs will be a risk of loss if they don’t perform.

CCJM: How can these two structures—PCMHs and ACOs—optimize the use of home health?

Dr. Longworth: Home health, which is part of the postacute care continuum, will be vitally important for managing individuals and populations of patients as we move toward PCMHs and ACOs. Coordination of care will require communication between home health services and the primary care physicians who are integral to PCMHs. There will have to be an emphasis on transitions of care, from the hospital to home, from skilled nursing facilities to home, and so forth.

Accountable care organizations are responsible for a population of patients, and ACOs receive a fixed amount of money per year to cover an individual life in that population. Thus, managing quality and controlling cost is the name of the game no matter where the patient is in the health care continuum— the office, the emergency room, the hospital, a skilled nursing facility, or a home health setting. For some chronic diseases, managing patients in the home health setting may be vitally important to prevent unnecessary trips to the emergency room and hospital readmissions, thereby reducing expenditures while providing quality care.

CCJM: Do you expect an increase in the number of PCMHs and ACOs to increase the demand for home health services?

Dr. Longworth: Given the necessity of optimizing quality at lower cost, I anticipate a push to deliver as much care as we can in the least expensive “right” setting, which might be the home in some situations. Certainly, we don’t want to send patients home prematurely only to have them return to emergency departments or hospitals, but I think the demand for home health will increase as we try to decrease the number of days in skilled nursing facilities, which are expensive, and to move care from skilled nursing facilities to the home setting.

CCJM: Is there evidence that integrated delivery models such as PCMHs deliver value?

Dr. Longworth: The Patient-Centered Primary Care Collaborative demonstrated quality improvements in selected outcomes domains while also realizing savings through reductions in admissions, emergency department visits, skilled nursing facility days, and pharmacy costs.¹⁰

CCJM: What challenges do PCMHs and ACOs present to home health agencies and the way they provide services, and how will these challenges affect patients and clinicians?

Dr. Longworth: One challenge will be communication between home health services and primary care providers during transitions of care. A second will be managing costs for home health, which entails leveraging new technologies such as in-home devices and telemedicine to provide optimal and ideal monitoring of patients at the lowest potential cost. Home health, like other players along the care continuum, will face increasing scrutiny regarding quality metrics. Home health agencies will likely need to distinguish themselves from one another on the basis of performance measures such as emergency department utilization, unnecessary hospital readmissions, medication errors, and quality of service to patients as well as to primary care providers.

CCJM: How does personalized health care fit into the PCMH model?

Dr. Longworth: Personalized health care, which includes the use of genetic testing in certain situations, is an emerging field that is still in its infancy. Like PCMHs, personalized health care is proactive rather than reactive. Application of personalized health care can help deliver value with better prediction of disease and appropriate use of targeted therapies to improve outcomes for certain individuals. Such individualized treatment not only enables higher quality of care but wiser use of resources. For instance, genetic markers can be used to predict drug metabolism and adverse drug events for certain medications. In the field of oncology, the expression of genetic mutations in certain tumor types can help identify patients most likely to respond to specific targeted therapies. In these ways, personalized health care is patient-centered health care. As part of its proactive nature, personalized health care, beyond genetic testing, also implies advance planning of appointments with a focus on chronic care and keeping patients in the care system.

CCJM: How does participation in a PCMH or an ACO benefit the primary care provider? Are there any disadvantages to participation?

Dr. Longworth: In the current fee-for-service world, primary care physicians and all providers are paid on a widget-by-widget basis. Some primary care physicians and other specialists fear moving to this new world in which they will ultimately be accountable for quality and cost. Not everyone has embraced the concept, but I do think it is inevitable. Primary care physicians especially will be under increasing pressure to care for populations as opposed to individual patients. They will need to redesign the care delivery model to provide team-based, proactive care focusing on the highest-risk patients to try to keep them out of the emergency department and hospital. There will also be a greater emphasis on wellness moving forward, in an attempt to prevent the development of chronic diseases such as diabetes and obesity in individual patients and populations. All of these changes represent a different paradigm for the delivery of care, compared with the present model.

The benefit of participation for a primary care physician depends on the structure of an ACO, particularly the amount of personal financial liability an individual practitioner might have. In a staff-model, fixed-salary institution, primary care physicians would probably be more immune to financial liability than they would in other markets or other compensation models in which salary can fluctuate.

CCJM: What are some of the barriers to ACO implementation that are relevant to office-based practice, and how can they be overcome?

Dr. Longworth: There are a number of barriers to ACOs and true PCMHs. The barriers revolve around redefining workflows and moving away from reactive care—a physician-centric model in which a patient comes into the office with a problem and the physician reacts—to proactive care with the goal being to recognize how the patient is doing over time to prevent unnecessary trips to the emergency department and, ultimately, hospitalization. It is a fundamentally different mindset that involves proactive outreach targeted at high-risk patients whose chronic diseases are managed through a team-based approach. An essential feature of primary care practice will be care coordinators who will manage and proactively anticipate the needs of medically complex, high-risk patients who use a disproportionately large share of services.

In addition, a greater emphasis on wellness will be necessary to prevent the development of chronic diseases such as diabetes, obesity, and hypertension in the large segment of the population that is reasonably healthy.

CCJM: What steps can a clinician take to prepare his or her practice for ACO implementation?

Dr. Longworth: Small practices will be challenged. It is difficult to imagine accountable care without an electronic health record. To understand the population, the practitioner will need to do continuous performance management, which can’t be done without access to data from a population of patients. An increasing number of physicians are aligning with organizations that have the necessary infrastructure to provide the myriad data required to measure quality, to enable continuous improvement in performance, and to enhance the patient experience. Small practices may not have the resources to complete the administrative work necessary to become part of an ACO.

There are ways to align with an ACO that do not constitute full employment; for example, the Cleveland (Ohio) Quality Alliance has aligned with community-based physicians to provide informatics support. Linking with larger organizations that have the resources to provide quality measurement and contracting support will permit smaller community-based physicians’ practices to be part of the game.

CCJM: What steps should PCMHs and ACOs take to leverage and optimize home health services among other parts of the medical neighborhood?

Dr. Longworth: Frankly, the postacute continuum is a challenge for most systems across the country because postacute care is fragmented. Our strategy at Cleveland Clinic is to identify and align with preferred providers of home health services. The criteria that I look for are commitment to quality and transparency, service that is oriented to both patients and PCMHs, and openness to innovation for leveraging health care technology to deliver care at the best value. Home health providers need to think about how to best accomplish these results to position themselves to partner with ACOs.

CCJM: How do PCMHs and ACOs apply to special patient populations and their needs? Is there a population that’s best suited for the medical home model?

Dr. Longworth: Certain populations of higher-risk patients are ideally suited to home health coupled with chronic disease management using care coordinators. Some examples are children with asthma and children with intellectual and developmental disabilities (eg, autism) who have high utilization of emergency services. Another population is patients with heart failure who are often in and out of the emergency department and hospital; there has been a concerted effort to reduce 30-day readmission rates, which are as high as 30%, for this group. (Also see “Home-based care for heart failure: Cleveland Clinic’s ‘Heart Care at Home’ transitional care program”)

CCJM: What are the specific expectations for patient involvement in the PCMH setting?

Dr. Longworth: Our challenge lies in how best to motivate patients and engage them in their own care, especially patients who have chronic diseases. We all struggle to resolve the engagement question. Coaching and patient engagement are functions of PCMHs and at every point along the care continuum. Home health providers can serve as health coaches to promote adherence to medications, healthy lifestyles, and follow-up visits with patients’ doctors—these all need to happen to better engage patients. How to engage patients and motivate them to be more involved in their health is a basic challenge.

CCJM: Along similar lines, how can home health providers work with physicians to achieve patient-centered care?

Dr. Longworth: They can communicate early when they think that things are amiss, serve as health coaches, create technologic solutions that enhance efficiency of communication, and anticipate care needs of patients in the home setting.

CCJM: How might bundling affect the financial picture of PCMHs and patient care?

Dr. Longworth: When one talks about bundling, the devil is in the definition. In bundling, one gets paid for an episode of service. So, for example, a total knee replacement might be compensated by a 30-day bundle that covers only the surgery and the immediate postoperative period. Or it might be a 90-day bundle that includes hospitalization and perhaps some days in skilled nursing facility, but ideally transitioning from hospital to home. In the latter example, the bundle, or the total payment, will be split between the hospital and the home care services. If home health is included in a bundle, there will be tremendous pressure on the home health service to prevent readmission and emergency room visits and to eliminate waste of care. Home health’s vulnerability will depend upon how a bundle is defined for specific service.

CCJM: Who defines the terms of the bundle?

Dr. Longworth: Whoever is applying for the bundle—usually, a health care system, hospital, or ACO. It may be that home health services will subcontract for a fat fee in order to immunize themselves against risk, and shift all of the risk to the contracting organization. If I were a home health provider, I might try to minimize my own risk, but still offer my services at a price that is financially viable.

The passage of the Patient Protection and Affordable Care Act will profoundly affect the way physicians—particularly those engaged in primary care—practice medicine. Clinicians and their colleagues will be obliged to meet government-mandated performance quality measures while achieving cost efficiencies. Two concepts are central to the implementation of reform in the US health care system: accountable care organizations (ACOs) and the patient-centered medical home (PCMH). To get some perspective on what these changes mean for the practicing clinician, Cleveland Clinic Journal of Medicine (CCJM) interviewed David Longworth, MD, who chairs the Cleveland Clinic Medicine Institute and directs strategy and implementation of Cleveland Clinic ACO-related activities.

CCJM: Please explain briefly the concept of PCMH.

Dr. Longworth: PCMH is not a new concept; first advanced by the American Academy of Pediatrics in 1967,¹ it represents a model of care in which an individual patient has a primary relationship with one provider who manages and coordinates the different aspects of the patient’s health care. The provider collaborates with a team of health care professionals. The concept caught on about a decade ago when a consortium of family medicine organizations and ultimately industry, including IBM, endorsed the concept. IBM and others created the Primary Care Consortium and began to drive the concept of PCMH.

Increasingly, care delivered through PCMH is team-based. The team coordinates the patient’s care and, when appropriate, enlists specialists or subspecialists to provide necessary components of care, all while maintaining responsibility for care coordination across the continuum of care. The medical home model provides an opportunity for enhanced access and care coordination utilizing care outside of the office walls, such as through retail clinics, eVisits, online diagnostic services, phone and electronic communication, and house call services.

Patient-centered medical homes are springing up across the country. In 2008, the National Committee for Quality Assurance (NCQA) developed criteria for recognition of PCMHs.² It scored the sophistication of medical homes at three levels, level 1 being the lowest and level 3 the highest. Between 2008 and the end of 2010, NCQA had recognized more than 1,500 PCMHs. According to the latest figures, more than 3,000 practices have now earned PCMH recognition from the NCQA.³

At Cleveland Clinic, pilot projects at three family health centers that cover 60,000 persons have recently been rolled out with the goal of determining the model of team care that yields the highest value, with value defined by the equation of quality over cost. Ideally, higher quality is delivered at lower cost to increase value.

CCJM: What are the goals of ACOs?

Dr. Longworth: The term “accountable care,” first used in 2006 by Elliot Fisher, Dartmouth Institute of Health Policy and Clinical Practice,⁶ expresses the idea that health care organizations be accountable for the care they deliver, with the three-part aim of better health for populations, better care for individuals, and reduced cost inefficiencies without compromised care.

With accountable care, institutions take on risk with the expectation that they will improve quality but reduce costs, and if they reduce costs and achieve certain quality targets for populations of patients, they will share in the savings accrued. The Affordable Care Act laid the groundwork for creation of ACOs. The regulation for ACOs released by the Centers for Medicare & Medicaid Services (CMS) became effective in January 2012.^7,8 Many health care organizations opposed the rule for reasons related to complexity, prescriptiveness, onerous detail around governance and marketing, and shared savings arrangements, among others. The final rule addressed many of these concerns and enabled the creation of the first wave of ACOs.⁸ At present, 153 ACOs have been approved by CMS.⁹ Other ACOs funded by commercial payers are also being formed in many locations.

For ACOs to be effective, I believe that the cornerstone of management has to be PCMHs.

CCJM: You mentioned that institutions will take on risk. What kind of risk are you referring to?

Dr. Longworth: Added value must be rewarded with sustainable payment models. There are two payment models in the final ACO rule from CMS. Both models require 3-year commitments and both require involvement of primary care physicians. One model for organizations that want to stick a toe in the water has no downside risk and modest potential for gain if they hit certain quality and cost targets. For those organizations that are further along and want to assume risk, the second option is a shared savings/risk payment model, which creates greater incentives for efficiency and quality. In the shared savings/risk model, the ACO can retain a portion of savings if it meets performance and expenditure benchmarks based on its performance during the previous 3 years. It is also at risk for loss if expenditures are greater than a certain amount compared with benchmark expenditures. Ultimately, the final destination for ACOs will be a risk of loss if they don’t perform.

CCJM: How can these two structures—PCMHs and ACOs—optimize the use of home health?

Dr. Longworth: Home health, which is part of the postacute care continuum, will be vitally important for managing individuals and populations of patients as we move toward PCMHs and ACOs. Coordination of care will require communication between home health services and the primary care physicians who are integral to PCMHs. There will have to be an emphasis on transitions of care, from the hospital to home, from skilled nursing facilities to home, and so forth.

Accountable care organizations are responsible for a population of patients, and ACOs receive a fixed amount of money per year to cover an individual life in that population. Thus, managing quality and controlling cost is the name of the game no matter where the patient is in the health care continuum— the office, the emergency room, the hospital, a skilled nursing facility, or a home health setting. For some chronic diseases, managing patients in the home health setting may be vitally important to prevent unnecessary trips to the emergency room and hospital readmissions, thereby reducing expenditures while providing quality care.

CCJM: Do you expect an increase in the number of PCMHs and ACOs to increase the demand for home health services?

Dr. Longworth: Given the necessity of optimizing quality at lower cost, I anticipate a push to deliver as much care as we can in the least expensive “right” setting, which might be the home in some situations. Certainly, we don’t want to send patients home prematurely only to have them return to emergency departments or hospitals, but I think the demand for home health will increase as we try to decrease the number of days in skilled nursing facilities, which are expensive, and to move care from skilled nursing facilities to the home setting.

CCJM: Is there evidence that integrated delivery models such as PCMHs deliver value?

Dr. Longworth: The Patient-Centered Primary Care Collaborative demonstrated quality improvements in selected outcomes domains while also realizing savings through reductions in admissions, emergency department visits, skilled nursing facility days, and pharmacy costs.¹⁰

CCJM: What challenges do PCMHs and ACOs present to home health agencies and the way they provide services, and how will these challenges affect patients and clinicians?

Dr. Longworth: One challenge will be communication between home health services and primary care providers during transitions of care. A second will be managing costs for home health, which entails leveraging new technologies such as in-home devices and telemedicine to provide optimal and ideal monitoring of patients at the lowest potential cost. Home health, like other players along the care continuum, will face increasing scrutiny regarding quality metrics. Home health agencies will likely need to distinguish themselves from one another on the basis of performance measures such as emergency department utilization, unnecessary hospital readmissions, medication errors, and quality of service to patients as well as to primary care providers.

CCJM: How does personalized health care fit into the PCMH model?

Dr. Longworth: Personalized health care, which includes the use of genetic testing in certain situations, is an emerging field that is still in its infancy. Like PCMHs, personalized health care is proactive rather than reactive. Application of personalized health care can help deliver value with better prediction of disease and appropriate use of targeted therapies to improve outcomes for certain individuals. Such individualized treatment not only enables higher quality of care but wiser use of resources. For instance, genetic markers can be used to predict drug metabolism and adverse drug events for certain medications. In the field of oncology, the expression of genetic mutations in certain tumor types can help identify patients most likely to respond to specific targeted therapies. In these ways, personalized health care is patient-centered health care. As part of its proactive nature, personalized health care, beyond genetic testing, also implies advance planning of appointments with a focus on chronic care and keeping patients in the care system.

CCJM: How does participation in a PCMH or an ACO benefit the primary care provider? Are there any disadvantages to participation?

Dr. Longworth: In the current fee-for-service world, primary care physicians and all providers are paid on a widget-by-widget basis. Some primary care physicians and other specialists fear moving to this new world in which they will ultimately be accountable for quality and cost. Not everyone has embraced the concept, but I do think it is inevitable. Primary care physicians especially will be under increasing pressure to care for populations as opposed to individual patients. They will need to redesign the care delivery model to provide team-based, proactive care focusing on the highest-risk patients to try to keep them out of the emergency department and hospital. There will also be a greater emphasis on wellness moving forward, in an attempt to prevent the development of chronic diseases such as diabetes and obesity in individual patients and populations. All of these changes represent a different paradigm for the delivery of care, compared with the present model.

The benefit of participation for a primary care physician depends on the structure of an ACO, particularly the amount of personal financial liability an individual practitioner might have. In a staff-model, fixed-salary institution, primary care physicians would probably be more immune to financial liability than they would in other markets or other compensation models in which salary can fluctuate.

CCJM: What are some of the barriers to ACO implementation that are relevant to office-based practice, and how can they be overcome?

Dr. Longworth: There are a number of barriers to ACOs and true PCMHs. The barriers revolve around redefining workflows and moving away from reactive care—a physician-centric model in which a patient comes into the office with a problem and the physician reacts—to proactive care with the goal being to recognize how the patient is doing over time to prevent unnecessary trips to the emergency department and, ultimately, hospitalization. It is a fundamentally different mindset that involves proactive outreach targeted at high-risk patients whose chronic diseases are managed through a team-based approach. An essential feature of primary care practice will be care coordinators who will manage and proactively anticipate the needs of medically complex, high-risk patients who use a disproportionately large share of services.

In addition, a greater emphasis on wellness will be necessary to prevent the development of chronic diseases such as diabetes, obesity, and hypertension in the large segment of the population that is reasonably healthy.

CCJM: What steps can a clinician take to prepare his or her practice for ACO implementation?

Dr. Longworth: Small practices will be challenged. It is difficult to imagine accountable care without an electronic health record. To understand the population, the practitioner will need to do continuous performance management, which can’t be done without access to data from a population of patients. An increasing number of physicians are aligning with organizations that have the necessary infrastructure to provide the myriad data required to measure quality, to enable continuous improvement in performance, and to enhance the patient experience. Small practices may not have the resources to complete the administrative work necessary to become part of an ACO.

There are ways to align with an ACO that do not constitute full employment; for example, the Cleveland (Ohio) Quality Alliance has aligned with community-based physicians to provide informatics support. Linking with larger organizations that have the resources to provide quality measurement and contracting support will permit smaller community-based physicians’ practices to be part of the game.

CCJM: What steps should PCMHs and ACOs take to leverage and optimize home health services among other parts of the medical neighborhood?

Dr. Longworth: Frankly, the postacute continuum is a challenge for most systems across the country because postacute care is fragmented. Our strategy at Cleveland Clinic is to identify and align with preferred providers of home health services. The criteria that I look for are commitment to quality and transparency, service that is oriented to both patients and PCMHs, and openness to innovation for leveraging health care technology to deliver care at the best value. Home health providers need to think about how to best accomplish these results to position themselves to partner with ACOs.

CCJM: How do PCMHs and ACOs apply to special patient populations and their needs? Is there a population that’s best suited for the medical home model?

Dr. Longworth: Certain populations of higher-risk patients are ideally suited to home health coupled with chronic disease management using care coordinators. Some examples are children with asthma and children with intellectual and developmental disabilities (eg, autism) who have high utilization of emergency services. Another population is patients with heart failure who are often in and out of the emergency department and hospital; there has been a concerted effort to reduce 30-day readmission rates, which are as high as 30%, for this group. (Also see “Home-based care for heart failure: Cleveland Clinic’s ‘Heart Care at Home’ transitional care program”)

CCJM: What are the specific expectations for patient involvement in the PCMH setting?

Dr. Longworth: Our challenge lies in how best to motivate patients and engage them in their own care, especially patients who have chronic diseases. We all struggle to resolve the engagement question. Coaching and patient engagement are functions of PCMHs and at every point along the care continuum. Home health providers can serve as health coaches to promote adherence to medications, healthy lifestyles, and follow-up visits with patients’ doctors—these all need to happen to better engage patients. How to engage patients and motivate them to be more involved in their health is a basic challenge.

CCJM: Along similar lines, how can home health providers work with physicians to achieve patient-centered care?

Dr. Longworth: They can communicate early when they think that things are amiss, serve as health coaches, create technologic solutions that enhance efficiency of communication, and anticipate care needs of patients in the home setting.

CCJM: How might bundling affect the financial picture of PCMHs and patient care?

Dr. Longworth: When one talks about bundling, the devil is in the definition. In bundling, one gets paid for an episode of service. So, for example, a total knee replacement might be compensated by a 30-day bundle that covers only the surgery and the immediate postoperative period. Or it might be a 90-day bundle that includes hospitalization and perhaps some days in skilled nursing facility, but ideally transitioning from hospital to home. In the latter example, the bundle, or the total payment, will be split between the hospital and the home care services. If home health is included in a bundle, there will be tremendous pressure on the home health service to prevent readmission and emergency room visits and to eliminate waste of care. Home health’s vulnerability will depend upon how a bundle is defined for specific service.

CCJM: Who defines the terms of the bundle?

Dr. Longworth: Whoever is applying for the bundle—usually, a health care system, hospital, or ACO. It may be that home health services will subcontract for a fat fee in order to immunize themselves against risk, and shift all of the risk to the contracting organization. If I were a home health provider, I might try to minimize my own risk, but still offer my services at a price that is financially viable.

The passage of the Patient Protection and Affordable Care Act will profoundly affect the way physicians—particularly those engaged in primary care—practice medicine. Clinicians and their colleagues will be obliged to meet government-mandated performance quality measures while achieving cost efficiencies. Two concepts are central to the implementation of reform in the US health care system: accountable care organizations (ACOs) and the patient-centered medical home (PCMH). To get some perspective on what these changes mean for the practicing clinician, Cleveland Clinic Journal of Medicine (CCJM) interviewed David Longworth, MD, who chairs the Cleveland Clinic Medicine Institute and directs strategy and implementation of Cleveland Clinic ACO-related activities.

CCJM: Please explain briefly the concept of PCMH.

Dr. Longworth: PCMH is not a new concept; first advanced by the American Academy of Pediatrics in 1967,¹ it represents a model of care in which an individual patient has a primary relationship with one provider who manages and coordinates the different aspects of the patient’s health care. The provider collaborates with a team of health care professionals. The concept caught on about a decade ago when a consortium of family medicine organizations and ultimately industry, including IBM, endorsed the concept. IBM and others created the Primary Care Consortium and began to drive the concept of PCMH.

Increasingly, care delivered through PCMH is team-based. The team coordinates the patient’s care and, when appropriate, enlists specialists or subspecialists to provide necessary components of care, all while maintaining responsibility for care coordination across the continuum of care. The medical home model provides an opportunity for enhanced access and care coordination utilizing care outside of the office walls, such as through retail clinics, eVisits, online diagnostic services, phone and electronic communication, and house call services.

Patient-centered medical homes are springing up across the country. In 2008, the National Committee for Quality Assurance (NCQA) developed criteria for recognition of PCMHs.² It scored the sophistication of medical homes at three levels, level 1 being the lowest and level 3 the highest. Between 2008 and the end of 2010, NCQA had recognized more than 1,500 PCMHs. According to the latest figures, more than 3,000 practices have now earned PCMH recognition from the NCQA.³

At Cleveland Clinic, pilot projects at three family health centers that cover 60,000 persons have recently been rolled out with the goal of determining the model of team care that yields the highest value, with value defined by the equation of quality over cost. Ideally, higher quality is delivered at lower cost to increase value.

CCJM: What are the goals of ACOs?

Dr. Longworth: The term “accountable care,” first used in 2006 by Elliot Fisher, Dartmouth Institute of Health Policy and Clinical Practice,⁶ expresses the idea that health care organizations be accountable for the care they deliver, with the three-part aim of better health for populations, better care for individuals, and reduced cost inefficiencies without compromised care.

With accountable care, institutions take on risk with the expectation that they will improve quality but reduce costs, and if they reduce costs and achieve certain quality targets for populations of patients, they will share in the savings accrued. The Affordable Care Act laid the groundwork for creation of ACOs. The regulation for ACOs released by the Centers for Medicare & Medicaid Services (CMS) became effective in January 2012.^7,8 Many health care organizations opposed the rule for reasons related to complexity, prescriptiveness, onerous detail around governance and marketing, and shared savings arrangements, among others. The final rule addressed many of these concerns and enabled the creation of the first wave of ACOs.⁸ At present, 153 ACOs have been approved by CMS.⁹ Other ACOs funded by commercial payers are also being formed in many locations.

For ACOs to be effective, I believe that the cornerstone of management has to be PCMHs.

CCJM: You mentioned that institutions will take on risk. What kind of risk are you referring to?

Dr. Longworth: Added value must be rewarded with sustainable payment models. There are two payment models in the final ACO rule from CMS. Both models require 3-year commitments and both require involvement of primary care physicians. One model for organizations that want to stick a toe in the water has no downside risk and modest potential for gain if they hit certain quality and cost targets. For those organizations that are further along and want to assume risk, the second option is a shared savings/risk payment model, which creates greater incentives for efficiency and quality. In the shared savings/risk model, the ACO can retain a portion of savings if it meets performance and expenditure benchmarks based on its performance during the previous 3 years. It is also at risk for loss if expenditures are greater than a certain amount compared with benchmark expenditures. Ultimately, the final destination for ACOs will be a risk of loss if they don’t perform.

CCJM: How can these two structures—PCMHs and ACOs—optimize the use of home health?

Dr. Longworth: Home health, which is part of the postacute care continuum, will be vitally important for managing individuals and populations of patients as we move toward PCMHs and ACOs. Coordination of care will require communication between home health services and the primary care physicians who are integral to PCMHs. There will have to be an emphasis on transitions of care, from the hospital to home, from skilled nursing facilities to home, and so forth.

Accountable care organizations are responsible for a population of patients, and ACOs receive a fixed amount of money per year to cover an individual life in that population. Thus, managing quality and controlling cost is the name of the game no matter where the patient is in the health care continuum— the office, the emergency room, the hospital, a skilled nursing facility, or a home health setting. For some chronic diseases, managing patients in the home health setting may be vitally important to prevent unnecessary trips to the emergency room and hospital readmissions, thereby reducing expenditures while providing quality care.

CCJM: Do you expect an increase in the number of PCMHs and ACOs to increase the demand for home health services?

Dr. Longworth: Given the necessity of optimizing quality at lower cost, I anticipate a push to deliver as much care as we can in the least expensive “right” setting, which might be the home in some situations. Certainly, we don’t want to send patients home prematurely only to have them return to emergency departments or hospitals, but I think the demand for home health will increase as we try to decrease the number of days in skilled nursing facilities, which are expensive, and to move care from skilled nursing facilities to the home setting.

CCJM: Is there evidence that integrated delivery models such as PCMHs deliver value?

Dr. Longworth: The Patient-Centered Primary Care Collaborative demonstrated quality improvements in selected outcomes domains while also realizing savings through reductions in admissions, emergency department visits, skilled nursing facility days, and pharmacy costs.¹⁰

CCJM: What challenges do PCMHs and ACOs present to home health agencies and the way they provide services, and how will these challenges affect patients and clinicians?

Dr. Longworth: One challenge will be communication between home health services and primary care providers during transitions of care. A second will be managing costs for home health, which entails leveraging new technologies such as in-home devices and telemedicine to provide optimal and ideal monitoring of patients at the lowest potential cost. Home health, like other players along the care continuum, will face increasing scrutiny regarding quality metrics. Home health agencies will likely need to distinguish themselves from one another on the basis of performance measures such as emergency department utilization, unnecessary hospital readmissions, medication errors, and quality of service to patients as well as to primary care providers.

CCJM: How does personalized health care fit into the PCMH model?

Dr. Longworth: Personalized health care, which includes the use of genetic testing in certain situations, is an emerging field that is still in its infancy. Like PCMHs, personalized health care is proactive rather than reactive. Application of personalized health care can help deliver value with better prediction of disease and appropriate use of targeted therapies to improve outcomes for certain individuals. Such individualized treatment not only enables higher quality of care but wiser use of resources. For instance, genetic markers can be used to predict drug metabolism and adverse drug events for certain medications. In the field of oncology, the expression of genetic mutations in certain tumor types can help identify patients most likely to respond to specific targeted therapies. In these ways, personalized health care is patient-centered health care. As part of its proactive nature, personalized health care, beyond genetic testing, also implies advance planning of appointments with a focus on chronic care and keeping patients in the care system.

CCJM: How does participation in a PCMH or an ACO benefit the primary care provider? Are there any disadvantages to participation?

Dr. Longworth: In the current fee-for-service world, primary care physicians and all providers are paid on a widget-by-widget basis. Some primary care physicians and other specialists fear moving to this new world in which they will ultimately be accountable for quality and cost. Not everyone has embraced the concept, but I do think it is inevitable. Primary care physicians especially will be under increasing pressure to care for populations as opposed to individual patients. They will need to redesign the care delivery model to provide team-based, proactive care focusing on the highest-risk patients to try to keep them out of the emergency department and hospital. There will also be a greater emphasis on wellness moving forward, in an attempt to prevent the development of chronic diseases such as diabetes and obesity in individual patients and populations. All of these changes represent a different paradigm for the delivery of care, compared with the present model.

The benefit of participation for a primary care physician depends on the structure of an ACO, particularly the amount of personal financial liability an individual practitioner might have. In a staff-model, fixed-salary institution, primary care physicians would probably be more immune to financial liability than they would in other markets or other compensation models in which salary can fluctuate.

CCJM: What are some of the barriers to ACO implementation that are relevant to office-based practice, and how can they be overcome?

Dr. Longworth: There are a number of barriers to ACOs and true PCMHs. The barriers revolve around redefining workflows and moving away from reactive care—a physician-centric model in which a patient comes into the office with a problem and the physician reacts—to proactive care with the goal being to recognize how the patient is doing over time to prevent unnecessary trips to the emergency department and, ultimately, hospitalization. It is a fundamentally different mindset that involves proactive outreach targeted at high-risk patients whose chronic diseases are managed through a team-based approach. An essential feature of primary care practice will be care coordinators who will manage and proactively anticipate the needs of medically complex, high-risk patients who use a disproportionately large share of services.

In addition, a greater emphasis on wellness will be necessary to prevent the development of chronic diseases such as diabetes, obesity, and hypertension in the large segment of the population that is reasonably healthy.

CCJM: What steps can a clinician take to prepare his or her practice for ACO implementation?

Dr. Longworth: Small practices will be challenged. It is difficult to imagine accountable care without an electronic health record. To understand the population, the practitioner will need to do continuous performance management, which can’t be done without access to data from a population of patients. An increasing number of physicians are aligning with organizations that have the necessary infrastructure to provide the myriad data required to measure quality, to enable continuous improvement in performance, and to enhance the patient experience. Small practices may not have the resources to complete the administrative work necessary to become part of an ACO.

There are ways to align with an ACO that do not constitute full employment; for example, the Cleveland (Ohio) Quality Alliance has aligned with community-based physicians to provide informatics support. Linking with larger organizations that have the resources to provide quality measurement and contracting support will permit smaller community-based physicians’ practices to be part of the game.

CCJM: What steps should PCMHs and ACOs take to leverage and optimize home health services among other parts of the medical neighborhood?

Dr. Longworth: Frankly, the postacute continuum is a challenge for most systems across the country because postacute care is fragmented. Our strategy at Cleveland Clinic is to identify and align with preferred providers of home health services. The criteria that I look for are commitment to quality and transparency, service that is oriented to both patients and PCMHs, and openness to innovation for leveraging health care technology to deliver care at the best value. Home health providers need to think about how to best accomplish these results to position themselves to partner with ACOs.

CCJM: How do PCMHs and ACOs apply to special patient populations and their needs? Is there a population that’s best suited for the medical home model?

Dr. Longworth: Certain populations of higher-risk patients are ideally suited to home health coupled with chronic disease management using care coordinators. Some examples are children with asthma and children with intellectual and developmental disabilities (eg, autism) who have high utilization of emergency services. Another population is patients with heart failure who are often in and out of the emergency department and hospital; there has been a concerted effort to reduce 30-day readmission rates, which are as high as 30%, for this group. (Also see “Home-based care for heart failure: Cleveland Clinic’s ‘Heart Care at Home’ transitional care program”)

CCJM: What are the specific expectations for patient involvement in the PCMH setting?

Dr. Longworth: Our challenge lies in how best to motivate patients and engage them in their own care, especially patients who have chronic diseases. We all struggle to resolve the engagement question. Coaching and patient engagement are functions of PCMHs and at every point along the care continuum. Home health providers can serve as health coaches to promote adherence to medications, healthy lifestyles, and follow-up visits with patients’ doctors—these all need to happen to better engage patients. How to engage patients and motivate them to be more involved in their health is a basic challenge.

CCJM: Along similar lines, how can home health providers work with physicians to achieve patient-centered care?

Dr. Longworth: They can communicate early when they think that things are amiss, serve as health coaches, create technologic solutions that enhance efficiency of communication, and anticipate care needs of patients in the home setting.

CCJM: How might bundling affect the financial picture of PCMHs and patient care?

Dr. Longworth: When one talks about bundling, the devil is in the definition. In bundling, one gets paid for an episode of service. So, for example, a total knee replacement might be compensated by a 30-day bundle that covers only the surgery and the immediate postoperative period. Or it might be a 90-day bundle that includes hospitalization and perhaps some days in skilled nursing facility, but ideally transitioning from hospital to home. In the latter example, the bundle, or the total payment, will be split between the hospital and the home care services. If home health is included in a bundle, there will be tremendous pressure on the home health service to prevent readmission and emergency room visits and to eliminate waste of care. Home health’s vulnerability will depend upon how a bundle is defined for specific service.

CCJM: Who defines the terms of the bundle?

Dr. Longworth: Whoever is applying for the bundle—usually, a health care system, hospital, or ACO. It may be that home health services will subcontract for a fat fee in order to immunize themselves against risk, and shift all of the risk to the contracting organization. If I were a home health provider, I might try to minimize my own risk, but still offer my services at a price that is financially viable.

Assessment of colonic transit in a patient presenting with constipation is recommended only after excluding a defecatory disorder and after treatment with laxatives and first-line pharmacologic agents fails, or after pelvic floor training in those with a defecatory disorder fails, according to a new medical position statement from the American Gastroenterological Association.

This recommendation is in contrast to the previous AGA medical position statement on constipation, which called for earlier assessment for colonic transit.

The change is one of only three substantive changes to the statement, which is published in the January issue of Gastroenterology; the others are the use of GRADE (Grading of Recommendations Assessment, Development, and Evaluation), which rates for each recommendation, its strength and quality of evidence, and the inclusion of newer agents; and deletion of certain older agents in treatment recommendations.

The colonic transit assessment recommendation is based in part on concerns about potential long-term side effects associated with newer agents that might be prescribed in patients with slow colonic transit.

"At present, the medical approaches used for managing normal and slow-transit constipation are similar. However, the major pharmacological trials in chronic constipation did not assess if the response to therapy is influenced by colonic transit. While newer agents may also be considered without assessing colonic transit, the long-term side effects, if any, of these agents are unknown and exposure to such potential risks might be more appropriate in patients with the more severe forms of constipation associated with slow transit," according to the statement.

Also, up to 50% of all patients with defecatory disorders have slow colonic transit as well, thus slow colonic transit does not exclude a defecatory disorder – and it also does not alter the management of defecatory disorders.

As for the approach to assessing for slow transit once a defecatory disorder is excluded, the statement says, "consideration should be given to assessing colonic transit by radiopaque markers, scintigraphy, or a wireless motility capsule in patients with persistent symptoms on laxatives."

Identifying slow colonic transit can reassure patients about the pathophysiology of their symptoms and also can serve as an objective marker for documenting response to treatment and provide physicians with the appropriate rationale for prescribing newer, often more expensive treatments.

Recommendations in the AGA statement that address the initial clinical assessment of constipation include the following:

• When feasible, medications that can cause constipation should be discontinued before further testing is initiated. This is a "strong" recommendation based on low-quality evidence.

• A careful digital rectal examination, including assessment of pelvic floor motion during simulated evacuation, is preferable to a cursory examination without these maneuvers and should be performed prior to referral for anorectal manometry. A normal exam, however, does not exclude defecatory disorders. This is a "strong" recommendation based on moderate-quality evidence.

The recommendations also address testing to assess medical causes of constipation. In addition to colonic transit testing, after ruling out a defecatory disorder, other recommended tests to assess for medical causes of constipation include a complete red blood count. Metabolic tests such as glucose, calcium, and sensitive thyroid-stimulating hormone are necessary only when other clinical features warrant these tests, and a colonoscopy and an imaging procedure for colonic lesions is only necessary in the presence of "alarm features," including blood in the stool, anemia, and weight loss, for medically refractory constipation or when age-appropriate colon cancer screening has not been performed. Anorectal manometry and a rectal balloon expulsion are indicated in those who fail to respond to laxatives but defecography only when anorectal manometry and a rectal balloon expulsion are inconclusive for defecatory disorders. All of these are "strong" recommendations based on low- or moderate-quality evidence.

Initial medical management, according to the statement, should include:

• A therapeutic trial of fiber supplementation and/or osmotic or stimulant laxatives after discontinuing medications that can cause constipation and after performing blood and other tests as guided by clinical features, but before anorectal testing.

• Use of long-term laxatives for normal and slow-transit constipation.

• Anorectal testing in patients who do not respond to these measures.

• Pelvic floor retraining by biofeedback therapy rather than laxatives in those with defecatory disorders.

These are all "strong" recommendations based on moderate- or high-quality evidence.

As for treatments to consider in patients who fail to respond to initial approaches, the AGA says that newer agents, such as lubiprostone and linaclotide, should be considered in those with normal or slow transit constipation who fail to respond to simple laxatives. Based on the GRADE ratings, this is a "weak" recommendation (implying that benefits, risks, and the burden of intervention are balanced among several legitimate management options or that appreciable uncertainty exists, and is based on moderate-quality evidence).

Also, when symptoms persist despite an adequate trial of biofeedback therapy – which improves symptoms in more than 70% of patients with defecatory disorders – anorectal tests and colonic transit should be reevaluated. This is a "strong" recommendation based on low-quality evidence.

Subtotal colectomy, as opposed to chronic laxative therapy, should be considered in those with symptomatic slow-transit constipation without a defecatory disorder, and colonic intraluminal testing should be considered to document colonic motor dysfunction prior to colectomy. These are weak recommendations based on moderate-quality evidence.

Finally, suppositories or enemas, rather than oral laxatives alone, should be considered in those with refractory pelvic floor dysfunction. This is a weak recommendation based on low-quality evidence.

These recommendations, drafted by a medical position panel and ultimately approved by the AGA Institute Governing Board, were published in conjunction with a technical review, which provides the rationale for the recommendations included in the statement.

AGA Institute Medical Position Panel members listed the following disclosures: Dr. Anthony Lembo reported serving as a consultant to, and serving as an advisory board member for Ironwood Pharmaceuticals and Forest Laboratories; Dr. Spencer D. Dorn reported serving as a consultant to Ironwood Pharmaceuticals and Forest Laboratories, and receiving research support from these companies, as well as from Synergy Pharmaceutical and Takeda Pharmaceuticals; Dr. A. E. Bharucha reported having a financial interest in a new technology related to anal manometry and serving a consultant for Helsin Therapeutics and Asubio Pharmaceuticals.

Assessment of colonic transit in a patient presenting with constipation is recommended only after excluding a defecatory disorder and after treatment with laxatives and first-line pharmacologic agents fails, or after pelvic floor training in those with a defecatory disorder fails, according to a new medical position statement from the American Gastroenterological Association.

This recommendation is in contrast to the previous AGA medical position statement on constipation, which called for earlier assessment for colonic transit.

The change is one of only three substantive changes to the statement, which is published in the January issue of Gastroenterology; the others are the use of GRADE (Grading of Recommendations Assessment, Development, and Evaluation), which rates for each recommendation, its strength and quality of evidence, and the inclusion of newer agents; and deletion of certain older agents in treatment recommendations.

The colonic transit assessment recommendation is based in part on concerns about potential long-term side effects associated with newer agents that might be prescribed in patients with slow colonic transit.

"At present, the medical approaches used for managing normal and slow-transit constipation are similar. However, the major pharmacological trials in chronic constipation did not assess if the response to therapy is influenced by colonic transit. While newer agents may also be considered without assessing colonic transit, the long-term side effects, if any, of these agents are unknown and exposure to such potential risks might be more appropriate in patients with the more severe forms of constipation associated with slow transit," according to the statement.

Also, up to 50% of all patients with defecatory disorders have slow colonic transit as well, thus slow colonic transit does not exclude a defecatory disorder – and it also does not alter the management of defecatory disorders.

As for the approach to assessing for slow transit once a defecatory disorder is excluded, the statement says, "consideration should be given to assessing colonic transit by radiopaque markers, scintigraphy, or a wireless motility capsule in patients with persistent symptoms on laxatives."

Identifying slow colonic transit can reassure patients about the pathophysiology of their symptoms and also can serve as an objective marker for documenting response to treatment and provide physicians with the appropriate rationale for prescribing newer, often more expensive treatments.

Recommendations in the AGA statement that address the initial clinical assessment of constipation include the following:

• When feasible, medications that can cause constipation should be discontinued before further testing is initiated. This is a "strong" recommendation based on low-quality evidence.

• A careful digital rectal examination, including assessment of pelvic floor motion during simulated evacuation, is preferable to a cursory examination without these maneuvers and should be performed prior to referral for anorectal manometry. A normal exam, however, does not exclude defecatory disorders. This is a "strong" recommendation based on moderate-quality evidence.

The recommendations also address testing to assess medical causes of constipation. In addition to colonic transit testing, after ruling out a defecatory disorder, other recommended tests to assess for medical causes of constipation include a complete red blood count. Metabolic tests such as glucose, calcium, and sensitive thyroid-stimulating hormone are necessary only when other clinical features warrant these tests, and a colonoscopy and an imaging procedure for colonic lesions is only necessary in the presence of "alarm features," including blood in the stool, anemia, and weight loss, for medically refractory constipation or when age-appropriate colon cancer screening has not been performed. Anorectal manometry and a rectal balloon expulsion are indicated in those who fail to respond to laxatives but defecography only when anorectal manometry and a rectal balloon expulsion are inconclusive for defecatory disorders. All of these are "strong" recommendations based on low- or moderate-quality evidence.

Initial medical management, according to the statement, should include:

• A therapeutic trial of fiber supplementation and/or osmotic or stimulant laxatives after discontinuing medications that can cause constipation and after performing blood and other tests as guided by clinical features, but before anorectal testing.

• Use of long-term laxatives for normal and slow-transit constipation.

• Anorectal testing in patients who do not respond to these measures.

• Pelvic floor retraining by biofeedback therapy rather than laxatives in those with defecatory disorders.

These are all "strong" recommendations based on moderate- or high-quality evidence.

As for treatments to consider in patients who fail to respond to initial approaches, the AGA says that newer agents, such as lubiprostone and linaclotide, should be considered in those with normal or slow transit constipation who fail to respond to simple laxatives. Based on the GRADE ratings, this is a "weak" recommendation (implying that benefits, risks, and the burden of intervention are balanced among several legitimate management options or that appreciable uncertainty exists, and is based on moderate-quality evidence).

Also, when symptoms persist despite an adequate trial of biofeedback therapy – which improves symptoms in more than 70% of patients with defecatory disorders – anorectal tests and colonic transit should be reevaluated. This is a "strong" recommendation based on low-quality evidence.

Subtotal colectomy, as opposed to chronic laxative therapy, should be considered in those with symptomatic slow-transit constipation without a defecatory disorder, and colonic intraluminal testing should be considered to document colonic motor dysfunction prior to colectomy. These are weak recommendations based on moderate-quality evidence.

Finally, suppositories or enemas, rather than oral laxatives alone, should be considered in those with refractory pelvic floor dysfunction. This is a weak recommendation based on low-quality evidence.

These recommendations, drafted by a medical position panel and ultimately approved by the AGA Institute Governing Board, were published in conjunction with a technical review, which provides the rationale for the recommendations included in the statement.

AGA Institute Medical Position Panel members listed the following disclosures: Dr. Anthony Lembo reported serving as a consultant to, and serving as an advisory board member for Ironwood Pharmaceuticals and Forest Laboratories; Dr. Spencer D. Dorn reported serving as a consultant to Ironwood Pharmaceuticals and Forest Laboratories, and receiving research support from these companies, as well as from Synergy Pharmaceutical and Takeda Pharmaceuticals; Dr. A. E. Bharucha reported having a financial interest in a new technology related to anal manometry and serving a consultant for Helsin Therapeutics and Asubio Pharmaceuticals.

Assessment of colonic transit in a patient presenting with constipation is recommended only after excluding a defecatory disorder and after treatment with laxatives and first-line pharmacologic agents fails, or after pelvic floor training in those with a defecatory disorder fails, according to a new medical position statement from the American Gastroenterological Association.

This recommendation is in contrast to the previous AGA medical position statement on constipation, which called for earlier assessment for colonic transit.

The change is one of only three substantive changes to the statement, which is published in the January issue of Gastroenterology; the others are the use of GRADE (Grading of Recommendations Assessment, Development, and Evaluation), which rates for each recommendation, its strength and quality of evidence, and the inclusion of newer agents; and deletion of certain older agents in treatment recommendations.

The colonic transit assessment recommendation is based in part on concerns about potential long-term side effects associated with newer agents that might be prescribed in patients with slow colonic transit.

"At present, the medical approaches used for managing normal and slow-transit constipation are similar. However, the major pharmacological trials in chronic constipation did not assess if the response to therapy is influenced by colonic transit. While newer agents may also be considered without assessing colonic transit, the long-term side effects, if any, of these agents are unknown and exposure to such potential risks might be more appropriate in patients with the more severe forms of constipation associated with slow transit," according to the statement.

Also, up to 50% of all patients with defecatory disorders have slow colonic transit as well, thus slow colonic transit does not exclude a defecatory disorder – and it also does not alter the management of defecatory disorders.

As for the approach to assessing for slow transit once a defecatory disorder is excluded, the statement says, "consideration should be given to assessing colonic transit by radiopaque markers, scintigraphy, or a wireless motility capsule in patients with persistent symptoms on laxatives."

Identifying slow colonic transit can reassure patients about the pathophysiology of their symptoms and also can serve as an objective marker for documenting response to treatment and provide physicians with the appropriate rationale for prescribing newer, often more expensive treatments.

Recommendations in the AGA statement that address the initial clinical assessment of constipation include the following:

• When feasible, medications that can cause constipation should be discontinued before further testing is initiated. This is a "strong" recommendation based on low-quality evidence.

• A careful digital rectal examination, including assessment of pelvic floor motion during simulated evacuation, is preferable to a cursory examination without these maneuvers and should be performed prior to referral for anorectal manometry. A normal exam, however, does not exclude defecatory disorders. This is a "strong" recommendation based on moderate-quality evidence.

The recommendations also address testing to assess medical causes of constipation. In addition to colonic transit testing, after ruling out a defecatory disorder, other recommended tests to assess for medical causes of constipation include a complete red blood count. Metabolic tests such as glucose, calcium, and sensitive thyroid-stimulating hormone are necessary only when other clinical features warrant these tests, and a colonoscopy and an imaging procedure for colonic lesions is only necessary in the presence of "alarm features," including blood in the stool, anemia, and weight loss, for medically refractory constipation or when age-appropriate colon cancer screening has not been performed. Anorectal manometry and a rectal balloon expulsion are indicated in those who fail to respond to laxatives but defecography only when anorectal manometry and a rectal balloon expulsion are inconclusive for defecatory disorders. All of these are "strong" recommendations based on low- or moderate-quality evidence.

Initial medical management, according to the statement, should include:

• A therapeutic trial of fiber supplementation and/or osmotic or stimulant laxatives after discontinuing medications that can cause constipation and after performing blood and other tests as guided by clinical features, but before anorectal testing.

• Use of long-term laxatives for normal and slow-transit constipation.

• Anorectal testing in patients who do not respond to these measures.

• Pelvic floor retraining by biofeedback therapy rather than laxatives in those with defecatory disorders.

These are all "strong" recommendations based on moderate- or high-quality evidence.

As for treatments to consider in patients who fail to respond to initial approaches, the AGA says that newer agents, such as lubiprostone and linaclotide, should be considered in those with normal or slow transit constipation who fail to respond to simple laxatives. Based on the GRADE ratings, this is a "weak" recommendation (implying that benefits, risks, and the burden of intervention are balanced among several legitimate management options or that appreciable uncertainty exists, and is based on moderate-quality evidence).

Also, when symptoms persist despite an adequate trial of biofeedback therapy – which improves symptoms in more than 70% of patients with defecatory disorders – anorectal tests and colonic transit should be reevaluated. This is a "strong" recommendation based on low-quality evidence.

Subtotal colectomy, as opposed to chronic laxative therapy, should be considered in those with symptomatic slow-transit constipation without a defecatory disorder, and colonic intraluminal testing should be considered to document colonic motor dysfunction prior to colectomy. These are weak recommendations based on moderate-quality evidence.

Finally, suppositories or enemas, rather than oral laxatives alone, should be considered in those with refractory pelvic floor dysfunction. This is a weak recommendation based on low-quality evidence.

These recommendations, drafted by a medical position panel and ultimately approved by the AGA Institute Governing Board, were published in conjunction with a technical review, which provides the rationale for the recommendations included in the statement.

AGA Institute Medical Position Panel members listed the following disclosures: Dr. Anthony Lembo reported serving as a consultant to, and serving as an advisory board member for Ironwood Pharmaceuticals and Forest Laboratories; Dr. Spencer D. Dorn reported serving as a consultant to Ironwood Pharmaceuticals and Forest Laboratories, and receiving research support from these companies, as well as from Synergy Pharmaceutical and Takeda Pharmaceuticals; Dr. A. E. Bharucha reported having a financial interest in a new technology related to anal manometry and serving a consultant for Helsin Therapeutics and Asubio Pharmaceuticals.

Depressive symptoms were associated with a doubling of the risk of Crohn’s disease in two large prospective cohorts of women, Dr. Ashwin N. Ananthakrishnan and his colleagues reported in the January issue of Clinical Gastroenterology and Hepatology (2013;11:57-62).

For women with recent and past episodes of depressive symptoms, the associations with the development of Crohn’s disease were significant, and were stronger for those with recent depression. The effect sizes were "in the same range we found for current smoking, oral contraceptive use, and NSAID use," all of which are known risk factors for Crohn’s disease, said Dr. Ananthakrishnan of Massachusetts General Hospital and Harvard Medical School, both in Boston, and his associates.

Video Source: American Gastroenterological Association YouTube channe

"Our findings support the potential importance of a biopsychosocial model in the pathogenesis of Crohn’s disease, and suggest the need for further studies on the effect of depression and stress on immune function and regulation," they noted.

Depression and life stress long have been thought to contribute to immune dysfunction and to influence both the risk for and the course of immune-mediated disorders such as Crohn’s. But until now, few studies have examined the role of mood in the onset of Crohn’s disease and ulcerative colitis, and those that did so were retrospective, failed to adjust for possible confounders, and assessed only the occurrence of major life stressors rather than the presence of depressive symptoms.

To address these shortcomings, the investigators examined the link between depressive symptoms and later onset of Crohn’s disease and ulcerative colitis using data from the prospective Nurses Health Study I and II. NHS I enrolled 121,700 female registered nurses who were 30-55 years old at baseline in 1976, and NHS II enrolled 116,686 female RNs aged 25-42 years at baseline in 1989.

For this study, Dr. Ananthakrishnan and his colleagues analyzed data for 152,461 of these participants in the two NHS cohorts. A total of 170 developed incident Crohn’s disease and 203 developed incident ulcerative colitis during follow-up.

Depressive symptoms were assessed several times in both the NHS I and II subjects using the five-question Mental Health Index (MHI-5), a subscale of the Short Form 36 health status survey. The participants received scores ranging from 1 to 100; 16,986 women (11% of the study population) received scores of 0-52, indicating the presence of depressive symptoms.

Subjects who scored from 86 to 100 composed the reference group.

The data were adjusted to account for numerous covariates that might influence risk for Crohn’s disease and ulcerative colitis, including the subjects’ race/ethnicity; smoking status; weight; menopausal status; and use of oral contraceptives, hormone therapy, and aspirin or NSAIDs.

There was a significant and linear increase in the risk of developing Crohn’s disease as MHI-5 scores decreased. Compared with the reference group, women with an MHI-5 score of 76-85 had a hazard ratio for Crohn’s disease of 1.38, those with an MHI-5 score of 53-75 had an HR of 1.59, and women with depressive symptoms and a score of 0-52 had an HR of 2.36.

No such association was seen between depressive symptoms and ulcerative colitis.

To account for the possibility that the study subjects’ depressed mood might be due to as-yet undiagnosed GI symptoms, the researchers performed a "lag" analysis excluding all cases of Crohn’s and ulcerative colitis that developed within 2 years of MHI-5 assessment. The results were unchanged in this analysis, they said.

The investigators also performed a sensitivity analysis restricted only to cases of Crohn’s disease that developed after 1996, when the NHS subjects first were routinely questioned about their use of antidepressant medications. Adjusting for the use of these drugs only slightly attenuated the strong association between depressive symptoms and Crohn’s disease.

"Preliminary animal and human studies suggest that treating depression through administration of antidepressants, or through improvement in coping mechanisms, could reduce risk of disease relapse. Whether similar interventions can also influence risk of disease onset, particularly among individuals with genetic susceptibility for Crohn’s disease or ulcerative colitis, merits further study," Dr. Ananthakrishnan and his associates said.

This study was supported by the American Gastroenterological Association, the Crohn’s and Colitis Foundation of America, the Broad Foundation, and the National Institutes of Health. Dr. Ananthakrishnan reported no potential financial conflicts of interest; his associates reported ties to Policy Analysis, Bayer HealthCare, Millennium Pharmaceuticals, and Pfizer.

Depressive symptoms were associated with a doubling of the risk of Crohn’s disease in two large prospective cohorts of women, Dr. Ashwin N. Ananthakrishnan and his colleagues reported in the January issue of Clinical Gastroenterology and Hepatology (2013;11:57-62).

For women with recent and past episodes of depressive symptoms, the associations with the development of Crohn’s disease were significant, and were stronger for those with recent depression. The effect sizes were "in the same range we found for current smoking, oral contraceptive use, and NSAID use," all of which are known risk factors for Crohn’s disease, said Dr. Ananthakrishnan of Massachusetts General Hospital and Harvard Medical School, both in Boston, and his associates.

Video Source: American Gastroenterological Association YouTube channe

"Our findings support the potential importance of a biopsychosocial model in the pathogenesis of Crohn’s disease, and suggest the need for further studies on the effect of depression and stress on immune function and regulation," they noted.

Depression and life stress long have been thought to contribute to immune dysfunction and to influence both the risk for and the course of immune-mediated disorders such as Crohn’s. But until now, few studies have examined the role of mood in the onset of Crohn’s disease and ulcerative colitis, and those that did so were retrospective, failed to adjust for possible confounders, and assessed only the occurrence of major life stressors rather than the presence of depressive symptoms.

To address these shortcomings, the investigators examined the link between depressive symptoms and later onset of Crohn’s disease and ulcerative colitis using data from the prospective Nurses Health Study I and II. NHS I enrolled 121,700 female registered nurses who were 30-55 years old at baseline in 1976, and NHS II enrolled 116,686 female RNs aged 25-42 years at baseline in 1989.

For this study, Dr. Ananthakrishnan and his colleagues analyzed data for 152,461 of these participants in the two NHS cohorts. A total of 170 developed incident Crohn’s disease and 203 developed incident ulcerative colitis during follow-up.

Depressive symptoms were assessed several times in both the NHS I and II subjects using the five-question Mental Health Index (MHI-5), a subscale of the Short Form 36 health status survey. The participants received scores ranging from 1 to 100; 16,986 women (11% of the study population) received scores of 0-52, indicating the presence of depressive symptoms.

Subjects who scored from 86 to 100 composed the reference group.

The data were adjusted to account for numerous covariates that might influence risk for Crohn’s disease and ulcerative colitis, including the subjects’ race/ethnicity; smoking status; weight; menopausal status; and use of oral contraceptives, hormone therapy, and aspirin or NSAIDs.

There was a significant and linear increase in the risk of developing Crohn’s disease as MHI-5 scores decreased. Compared with the reference group, women with an MHI-5 score of 76-85 had a hazard ratio for Crohn’s disease of 1.38, those with an MHI-5 score of 53-75 had an HR of 1.59, and women with depressive symptoms and a score of 0-52 had an HR of 2.36.

No such association was seen between depressive symptoms and ulcerative colitis.

To account for the possibility that the study subjects’ depressed mood might be due to as-yet undiagnosed GI symptoms, the researchers performed a "lag" analysis excluding all cases of Crohn’s and ulcerative colitis that developed within 2 years of MHI-5 assessment. The results were unchanged in this analysis, they said.

The investigators also performed a sensitivity analysis restricted only to cases of Crohn’s disease that developed after 1996, when the NHS subjects first were routinely questioned about their use of antidepressant medications. Adjusting for the use of these drugs only slightly attenuated the strong association between depressive symptoms and Crohn’s disease.

"Preliminary animal and human studies suggest that treating depression through administration of antidepressants, or through improvement in coping mechanisms, could reduce risk of disease relapse. Whether similar interventions can also influence risk of disease onset, particularly among individuals with genetic susceptibility for Crohn’s disease or ulcerative colitis, merits further study," Dr. Ananthakrishnan and his associates said.

This study was supported by the American Gastroenterological Association, the Crohn’s and Colitis Foundation of America, the Broad Foundation, and the National Institutes of Health. Dr. Ananthakrishnan reported no potential financial conflicts of interest; his associates reported ties to Policy Analysis, Bayer HealthCare, Millennium Pharmaceuticals, and Pfizer.

Depressive symptoms were associated with a doubling of the risk of Crohn’s disease in two large prospective cohorts of women, Dr. Ashwin N. Ananthakrishnan and his colleagues reported in the January issue of Clinical Gastroenterology and Hepatology (2013;11:57-62).

For women with recent and past episodes of depressive symptoms, the associations with the development of Crohn’s disease were significant, and were stronger for those with recent depression. The effect sizes were "in the same range we found for current smoking, oral contraceptive use, and NSAID use," all of which are known risk factors for Crohn’s disease, said Dr. Ananthakrishnan of Massachusetts General Hospital and Harvard Medical School, both in Boston, and his associates.

Video Source: American Gastroenterological Association YouTube channe

"Our findings support the potential importance of a biopsychosocial model in the pathogenesis of Crohn’s disease, and suggest the need for further studies on the effect of depression and stress on immune function and regulation," they noted.

Depression and life stress long have been thought to contribute to immune dysfunction and to influence both the risk for and the course of immune-mediated disorders such as Crohn’s. But until now, few studies have examined the role of mood in the onset of Crohn’s disease and ulcerative colitis, and those that did so were retrospective, failed to adjust for possible confounders, and assessed only the occurrence of major life stressors rather than the presence of depressive symptoms.

To address these shortcomings, the investigators examined the link between depressive symptoms and later onset of Crohn’s disease and ulcerative colitis using data from the prospective Nurses Health Study I and II. NHS I enrolled 121,700 female registered nurses who were 30-55 years old at baseline in 1976, and NHS II enrolled 116,686 female RNs aged 25-42 years at baseline in 1989.

For this study, Dr. Ananthakrishnan and his colleagues analyzed data for 152,461 of these participants in the two NHS cohorts. A total of 170 developed incident Crohn’s disease and 203 developed incident ulcerative colitis during follow-up.

Depressive symptoms were assessed several times in both the NHS I and II subjects using the five-question Mental Health Index (MHI-5), a subscale of the Short Form 36 health status survey. The participants received scores ranging from 1 to 100; 16,986 women (11% of the study population) received scores of 0-52, indicating the presence of depressive symptoms.

Subjects who scored from 86 to 100 composed the reference group.

The data were adjusted to account for numerous covariates that might influence risk for Crohn’s disease and ulcerative colitis, including the subjects’ race/ethnicity; smoking status; weight; menopausal status; and use of oral contraceptives, hormone therapy, and aspirin or NSAIDs.

There was a significant and linear increase in the risk of developing Crohn’s disease as MHI-5 scores decreased. Compared with the reference group, women with an MHI-5 score of 76-85 had a hazard ratio for Crohn’s disease of 1.38, those with an MHI-5 score of 53-75 had an HR of 1.59, and women with depressive symptoms and a score of 0-52 had an HR of 2.36.

No such association was seen between depressive symptoms and ulcerative colitis.

To account for the possibility that the study subjects’ depressed mood might be due to as-yet undiagnosed GI symptoms, the researchers performed a "lag" analysis excluding all cases of Crohn’s and ulcerative colitis that developed within 2 years of MHI-5 assessment. The results were unchanged in this analysis, they said.

The investigators also performed a sensitivity analysis restricted only to cases of Crohn’s disease that developed after 1996, when the NHS subjects first were routinely questioned about their use of antidepressant medications. Adjusting for the use of these drugs only slightly attenuated the strong association between depressive symptoms and Crohn’s disease.

"Preliminary animal and human studies suggest that treating depression through administration of antidepressants, or through improvement in coping mechanisms, could reduce risk of disease relapse. Whether similar interventions can also influence risk of disease onset, particularly among individuals with genetic susceptibility for Crohn’s disease or ulcerative colitis, merits further study," Dr. Ananthakrishnan and his associates said.

This study was supported by the American Gastroenterological Association, the Crohn’s and Colitis Foundation of America, the Broad Foundation, and the National Institutes of Health. Dr. Ananthakrishnan reported no potential financial conflicts of interest; his associates reported ties to Policy Analysis, Bayer HealthCare, Millennium Pharmaceuticals, and Pfizer.

The vaccines against human papillomavirus (HPV) are the only ones designed to prevent cancer caused by a virus^1,2—surely a good goal. But because HPV is sexually transmitted, HPV vaccination has met with public controversy.³ To counter the objections and better protect their patients’ health, primary care providers and other clinicians need a clear understanding of the benefits and the low risk of HPV vaccination—and the reasons so many people object to it.³

In this article, we will review:

• The impact of HPV-related diseases
• The basic biologic features of HPV vaccines
• The host immune response to natural HPV infection vs the response to HPV vaccines
• The clinical efficacy and safety of HPV vaccines
• The latest guidelines for HPV vaccination
• The challenges to vaccination implementation
• Frequently asked practical questions about HPV vaccination.

HPV-RELATED DISEASES: FROM BOTHERSOME TO DEADLY

Clinical sequelae of HPV infection include genital warts; cancers of the cervix, vulva, vagina, anus, penis, and oropharynx; and recurrent respiratory papillomatosis.^4–6

Genital warts

HPV types 6 and 11 are responsible for more than 90% of the 1 million new cases of genital warts diagnosed annually in the United States.^7–10

Bothersome and embarrassing, HPV-related genital warts can cause itching, burning, erythema, and pain, as well as epithelial erosions, ulcerations, depigmentation, and urethral and vaginal bleeding and discharge.^11,12 Although they are benign in the oncologic sense, they can cause a good deal of emotional and financial stress. Patients may feel anxiety, embarrassment,¹³ and vulnerability. Adolescents and adults who have or have had genital warts need to inform their current and future partners or else risk infecting them—and facing the consequences.

Direct health care costs of genital warts in the United States have been estimated to be at least $200 million per year.¹⁴

Cervical cancer

Cervical cancer cannot develop unless the cervical epithelium is infected with one of the oncogenic HPV types. Indeed, oncogenic HPV is present in as many as 99.8% of cervical cancer specimens.¹⁵ HPV 16 and 18 are the most oncogenic HPV genotypes and account for 75% of all cases of cervical cancer. Ten other HPV genotypes account for the remaining 25%.¹⁶

In 2012, there were an estimated 12,170 new cases of invasive cervical cancer in the United States and 4,220 related deaths.¹⁷ The cost associated with cervical cancer screening, managing abnormal findings, and treating invasive cervical cancer in the United States is estimated to be $3.3 billion per year.¹⁸

Although the incidence and the mortality rates of cervical cancer have decreased more than 50% in the United States over the past 3 decades thanks to screening,¹⁹ cervical cancer remains the second leading cause of death from cancer in women worldwide. Each year, an estimated 500,000 women contract the disease and 240,000 die of it.²⁰

Anal cancer

A recent study indicated that oncogenic HPV can also cause anal cancer, and the proportion of such cancers associated with HPV 16 or HPV 18 infection is as high as or higher than for cervical cancers, and estimated at 80%.²¹

The incidence of anal cancer is increasing by approximately 2% per year in both men and women in the general population,²² and rates are even higher in men who have sex with men and people infected with the human immunodeficiency virus.²³

Hu and Goldie²⁴ estimated that the lifetime costs of caring for all the people in the United States who in just 1 year (2003) acquired anal cancer attributable to HPV would total $92 million.

Oropharyngeal cancer

HPV types 16, 18, 31, 33, and 35 also cause oropharyngeal cancer. HPV 16 accounts for more than 90% of cases of HPV-related oropharyngeal cancer.²⁵

Chaturvedi et al⁶ tested tissue samples from three national cancer registries and found that the number of oropharyngeal cancers that were HPV-positive increased from 16.3% in 1984–1989 to 71.7% in 2000–2004, while the number of HPV-negative oropharyngeal cancers fell by 50%, paralleling the drop in cigarette smoking in the United States.

Hu and Goldie²⁴ estimated that the total lifetime cost for all new HPV-related oropharyngeal cancers that arose in 2003 would come to $38.1 million.²⁴

Vulvar and vaginal cancers

HPV 16 and 18 are also responsible for approximately 50% of vulvar cancers and 50% to 75% of vaginal cancers.^4,5

Recurrent respiratory papillomatosis

HPV 6 and 11 cause almost all cases of juvenile- and adult-onset recurrent respiratory papillomatosis.²⁶ The annual cost for surgical procedures for this condition in the United States has been estimated at $151 million.²⁷

HPV VACCINES ARE NONINFECTIOUS AND NONCARCINOGENIC

Currently, two HPV vaccines are available: a quadrivalent vaccine against types 6, 11, 16, and 18 (Gardasil; Merck) and a bivalent vaccine against types 16 and 18 (Cervarix; Glaxo-SmithKline). The quadrivalent vaccine was approved by the US Food and Drug Administration (FDA) in 2006, and the bivalent vaccine was approved in 2009.^28,29

Both vaccines contain virus-like particles, ie, viral capsids that contain no DNA. HPV has a circular DNA genome of 8,000 nucleotides divided into two regions: the early region, for viral replication, and the late region, for viral capsid production. The host produces neutralizing antibodies in response to the L1 capsid protein, which is different in different HPV types.

In manufacturing the vaccines, the viral L1 gene is incorporated into a yeast genome or an insect virus genome using recombinant DNA technology (Figure 1). Grown in culture, the yeast or the insect cells produce the HPV L1 major capsid protein, which has the intrinsic capacity to self-assemble into virus-like particles.^30–33 These particles are subsequently purified for use in the vaccines.³⁴

Recombinant virus-like particles are morphologically indistinguishable from authentic HPV virions and contain the same typespecific antigens present in authentic virions. Therefore, they are highly effective in inducing a host humoral immune response. And because they do not contain HPV DNA, the recombinant HPV vaccines are noninfectious and noncarcinogenic.³⁵

VACCINATION INDUCES A STRONGER IMMUNE RESPONSE THAN INFECTION

HPV infections trigger both a humoral and a cellular response in the host immune system.

The humoral immune response to HPV infection involves producing neutralizing antibody against the specific HPV type, specifically the specific L1 major capsid protein. This process is typically somewhat slow and weak, and only about 60% of women with a new HPV infection develop antibodies to it.^36,37

HPV has several ways to evade the host immune system. It does not infect or replicate within the antigen-presenting cells in the epithelium. In addition, HPV-infected keratinocytes are less susceptible to cytotoxic lymphocytic-mediated lysis. Moreover, HPV infection cause very little tissue destruction. And finally, natural cervical HPV infection does not result in viremia. As a result, antigen-presenting cells have no chance to engulf the virions and present virion-derived antigen to the host immune system. The immune system outside the epithelium has limited opportunity to detect the virus because HPV infection does not have a blood-borne phase.^38,39

The cell-mediated immune response to early HPV oncoproteins may help eliminate established HPV infection.⁴⁰ In contrast to antibodies, the T-cell response to HPV has not been shown to be specific to HPV type.⁴¹ Clinically, cervical HPV infection is common, but most lesions go into remission or resolve as a result of the cell-mediated immune response.^40,41

In contrast to the weak, somewhat ineffective immune response to natural HPV infection, the antibody response to HPV vaccines is rather robust. In randomized controlled trials, almost all vaccinated people have seroconverted. The peak antibody concentrations are 50 to 10,000 times greater than in natural infection. Furthermore, the neutralizing antibodies induced by HPV vaccines persist for as long as 7 to 9 years after immunization.⁴² However, the protection provided by HPV vaccines against HPV-related cervical intraepithelial neoplasia does not necessarily correlate with the antibody concentration.^43–47

Why does the vaccine work so well?

Why are vaccine-induced antibody responses so much stronger than those induced by natural HPV infection?

The first reason is that the vaccine, delivered intramuscularly, rapidly enters into blood vessels and the lymphatic system. In contrast, in natural intraepithelial infection, the virus is shed from mucosal surfaces and does not result in viremia.⁴⁸

In addition, the strong immunogenic nature of the virus-like particles induces a robust host antibody response even in the absence of adjuvant because of concentrated neutralizing epitopes and excellent induction of the T-helper cell response.^35,49,50

The neutralizing antibody to L1 prevents HPV infection by blocking HPV from binding to the basement membrane as well as to the epithelial cell receptor during epithelial microabrasion and viral entry. The subsequent micro-wound healing leads to serous exudation and rapid access of serum immunoglobulin G (IgG) to HPV virus particles and encounters with circulatory B memory cells.

Furthermore, emerging evidence suggests that even very low antibody concentrations are sufficient to prevent viral entry into cervical epithelial cells.^{46–48,51–53}

THE HPV VACCINES ARE HIGHLY EFFECTIVE AND SAFE

The efficacy and safety of the quadrivalent and the bivalent HPV vaccines have been evaluated in large randomized clinical trials.^{23,28,29,54,55} Table 1 summarizes the key findings.

The Females United to Unilaterally Reduce Endo/ectocervical Disease (FUTURE I)⁵⁴ and FUTURE II²⁸ trials showed conclusively that the quadrivalent HPV vaccine is 98% to 100% efficacious in preventing HPV 16- and 18-related cervical intraepithelial neoplasia, carcinoma in situ, and invasive cervical cancer in women who had not been infected with HPV before. Similarly, the Papilloma Trial against Cancer in Young Adults (PATRICIA) concluded that the bivalent HPV vaccine is 93% efficacious.²⁹

Giuliano et al⁵⁵ and Palefsky et al²³ conducted randomized clinical trials of the quadrivalent HPV vaccine for preventing genital disease and anal intraepithelial neoplasia in boys and men; the efficacy rates were 90.4%⁵⁵ and 77.5%.²³

A recent Finnish trial in boys age 10 to 18 found 100% seroconversion rates for HPV 16 and HPV 18 antibodies after they received bivalent HPV vaccine.⁵⁶ Similar efficacy has been demonstrated for the quadrivalent HPV vaccine in boys.⁵⁷

Adverse events after vaccination

After the FDA approved the quadrivalent HPV vaccine for girls in 2006, the US Centers for Disease Control and Prevention (CDC) conducted a thorough survey of adverse events after immunization from June 1, 2006 through December 31, 2008.⁵⁸ There were about 54 reports of adverse events per 100,000 distributed vaccine doses, similar to rates for other vaccines. However, the incidence rates of syncope and venous thrombosis were disproportionately higher, according to data from the US Vaccine Adverse Event Reporting System. The rate of syncope was 8.2 per 100,000 vaccine doses, and the rate of venous thrombotic events was 0.2 per 100,000 doses.⁵⁸

There were 32 reports of deaths after HPV vaccination, but these were without clear causation. Hence, this information must be interpreted with caution and should not be used to infer causal associations between HPV vaccines and adverse outcomes. The causes of death included diabetic ketoacidosis, pulmonary embolism, prescription drug abuse, amyotrophic lateral sclerosis, meningoencephalitis, influenza B viral sepsis, arrhythmia, myocarditis, and idiopathic seizure disorder.⁵⁸

Furthermore, it is important to note that vasovagal syncope and venous thromboembolic events are more common in young females in general.⁵⁹ For example, the background rates of venous thromboembolism in females age 14 to 29 using oral contraceptives is 21 to 31 per 100,000 woman-years.⁶⁰

Overall, the quadrivalent HPV vaccine is well tolerated and clinically safe. Postlicensure evaluation found that the quadrivalent and bivalent HPV vaccines had similar safety profiles.⁶¹

Vaccination is contraindicated in people with known hypersensitivity or prior severe allergic reactions to vaccine or yeast or who have bleeding disorders.

HPV VACCINATION DOES MORE THAN PREVENT CERVICAL CANCER IN FEMALES

The quadrivalent HPV vaccine was licensed by the FDA in 2006 for use in females age 9 to 26 to prevent cervical cancer, cervical cancer precursors, vaginal and vulval cancer precursors, and anogenital warts caused by HPV types 6, 11, 16, and 18. The CDC’s Advisory Committee on Immunization Practices (ACIP) issued its recommendation for initiating HPV vaccination for females age 11 to 12 in March 2007. The ACIP stated that the vaccine could be given to girls as early as age 9 and recommended catch-up vaccinations for those age 13 to 26.^62,63

The quadrivalent HPV vaccine was licensed by the FDA in 2009 for use in boys and men for the prevention of genital warts. In December 2010, the quadrivalent HPV vaccine received extended licensure from the FDA for use in males and females for the prevention of anal cancer. In October 2011, the ACIP voted to recommend routine use of the quadrivalent HPV vaccine for boys age 11 to 12; catch-up vaccination should occur for those age 13 to 22, with an option to vaccinate men age 23 to 26.

These recommendations replace the “permissive use” recommendations from the ACIP in October 2009 that said the quadrivalent HPV vaccine may be given to males age 9 to 26.⁶⁴ This shift from a permissive to an active recommendation connotes a positive change reflecting recognition of rising oropharyngeal cancer rates attributable to oncogenic, preventable HPV, rising HPV-related anal cancer incidence, and the burden of the disease in female partners of infected men, with associated rising health care costs.

The bivalent HPV vaccine received FDA licensure in October 2009 for use in females age 10 to 25 to prevent cervical cancer and precursor lesions. The ACIP included the bivalent HPV vaccine in its updated recommendations in May 2010 for use in girls age 11 to 12. Numerous national and international organizations have endorsed HPV vaccination.^65–71

Table 2 outlines the recommendations from these organizations.

HPV VACCINATION RATES ARE STILL LOW

HPV vaccine offers us the hope of eventually eradicating cervical cancer. However, the immunization program still faces many challenges, since HPV vaccination touches on issues related to adolescent sexuality, parental autonomy, and cost. As a result, HPV immunization rates remain relatively low in the United States according to several national surveys. Only 40% to 49% of girls eligible for the vaccine received even one dose, and of those who received even one dose, only 32% to 53.3% came back for all three doses.^72–75 Furthermore, indigent and minority teens were less likely to finish the three-dose HPV vaccine series.

Why are the vaccination rates so low?

Parental barriers. In one survey,⁷³ reasons that parents gave for not having their daughters vaccinated included:

• Lack of knowledge of the vaccine (19.4%)
• Lack of perceived need for the vaccine (18.8%)
• Belief that their daughter was not sexually active (18.3%)
• Clinician not recommending vaccination (13.1%).

In an effort to improve HPV vaccination rates,⁴¹ several states proposed legislation for mandatory HPV vaccination of schoolgirls shortly after licensure of the quadrivalent HPV vaccine.³ Since then, we have seen a wave of public opposition rooted in concerns and misinformation about safety, teenage sexuality, governmental coercion, and cost. Widespread media coverage has also highlighted unsubstantiated claims about side effects attributable to the vaccine that can raise parents’ mistrust of vaccines.⁷⁶ Concerns have also been raised about a threat to parental autonomy in how and when to educate their children about sex.⁷⁷

Moreover, the vaccine has raised ethical concerns in some parents and politicians that mandatory vaccination could undermine abstinence messages in sexual education and may alter sexual activity by condoning risky behavior.⁷⁸ However, a recent study indicated that there is no significant change in sexual behavior related to HPV vaccination in young girls.⁷⁹

In 2012, Mullins et al⁸⁰ also found that an urban population of adolescent girls (76.4% black, 57.5% sexually experienced) did not feel they could forgo safer sexual practices after first HPV vaccination, although the girls did perceive less risk from HPV than from other sexually transmitted infections after HPV vaccination (P < .001).⁸⁰ Inadequate knowledge about HPV-related disease and HPV vaccine correlated with less perceived risk from HPV after vaccination among the girls, and a lack of knowledge about HPV and less communication with their daughters about HPV correlated with less perceived risk from HPV in the mothers of the study population.⁸¹

Health-care-provider barriers. Physician endorsement of vaccines represents a key predictor of vaccine acceptance by patients, families, and other clinicians.^82–84 In 2008, a cross-sectional, Internet-based survey of 1,122 Texas pediatricians, family practice physicians, obstetricians, gynecologists, and internal medicine physicians providing direct patient care found that only 48.5% always recommended HPV vaccination to girls.⁷⁴ Of all respondents, 68.4% were likely to recommend the vaccine to boys, and 41.7% agreed with mandated vaccination. Thus, more than half of the physicians were not following the current recommendations for universal HPV vaccination for 11- to -12-year-olds.

In a survey of 1,013 physicians during the spring and summer of 2009, only 34.6% said they always recommend HPV vaccination to early adolescents, 52.7% to middle adolescents, and 50.2% to late adolescents and young adults.⁸⁵ Pediatricians were more likely than family physicians and obstetrician-gynecologists to always recommend HPV vaccine across all age groups (P < .001). Educational interventions targeting various specialties may help overcome physician-related barriers to immunization.⁸⁵

Financial barriers. HPV vaccine, which must be given in three doses, is more expensive than other vaccines, and this expense is yet another barrier, especially for the uninsured.⁸⁶ Australia launched a government-funded program of HPV vaccination (with the quadrivalent vaccine) in schools in 2007, and it has been very successful. Garland et al⁸⁷ reported that new cases of genital warts have decreased by 73% since the program began, and the rate of high-grade abnormalities on Papanicolaou testing has declined by a small but significant amount.

For HPV vaccination to have an impact on public health, vaccination rates in the general population need to be high. In order to achieve these rates, we need to educate our patients on vaccine safety and efficacy and counsel vaccine recipients about the prevention of sexually transmitted infections and the importance of regular cervical cancer screening after age 21. Clinicians can actively “myth-bust” with patients, who may not realize that the vaccine should be given despite a history of HPV infection or abnormal Pap smear.

FREQUENTLY ASKED QUESTIONS

What if the patient is late for a shot?

The current recommended vaccination schedule for the bivalent and quadrivalent HPV vaccines is a three-dose series administered at 0, 2, and 6 months, given as an intramuscular injection, preferably in the deltoid muscle. The minimal dosing interval is 4 weeks between the first and second doses and 12 weeks between the second and third doses.

The vaccines use different adjuncts with different specific mechanisms for immunogenicity; therefore, it is recommended that the same vaccine be used for the entire three-dose series. However, if circumstances preclude the completion of a series with the same vaccine, the other HPV vaccine may be used.⁶³ Starting the series over is not recommended.

Long-term studies demonstrated clinical efficacy 8.5 years after vaccination.⁴⁷ Amnestic response by virtue of activation of pools of memory B cells has been demonstrated, suggesting the vaccine may afford lifelong immunity.⁸⁸

Is a pregnancy test needed before HPV vaccination?

The ACIP states that pregnancy testing is not required before receiving either of the available HPV vaccines.

A recent retrospective review of phase III efficacy trials and pregnancy registry surveillance data for both vaccines revealed no increase in spontaneous abortions, fetal malformations, or adverse pregnancy outcomes.⁸⁹ Data are limited on bivalent and quadrivalent HPV vaccine given within 30 days of pregnancy and subsequent pregnancy and fetal outcomes. Both vaccines have been assigned a pregnancy rating of category B; however, the ACIP recommends that neither vaccine be given if the recipient is known to be pregnant. If pregnancy occurs, it is recommended that the remainder of the series be deferred until after delivery.⁶²

It is not known whether the vaccine is excreted in breast milk. The manufacturers of both the bivalent and quadrivalent HPV vaccines recommend caution when vaccinating lactating women.^30,31

Can HPV vaccine be given with other vaccines?

In randomized trials, giving the bivalent HPV vaccine with the combined hepatitis A, hepatitis B, meningococcal conjugate and the combined tetanus, diphtheria, and acellular pertussis vaccines did not interfere with the immunogenic response, was safe, and was well tolerated.^90,91 Coadministration of the quadrivalent HPV vaccine has been studied only with hepatitis B vaccine, with similar safety and efficacy noted.

The ACIP recommends giving HPV vaccine at the same visit with other age-appropriate immunizations to increase the likelihood of adherence to recommended vaccination schedules.⁶²

Is HPV vaccination cost-effective?

Kim and Goldie⁸⁶ performed a cost-effectiveness analysis of HPV vaccination of girls at age 12 and catch-up vaccination up to the ages of 18, 21, and 26. For their analysis, they considered prevention of cancers associated with HPV types 16 and 18, of genital warts associated with types 6 and 11, and of recurrent respiratory papillomatosis. They also assumed that immunity would be lifelong, and current screening practices would continue.

They calculated that routine vaccination of 12-year-old girls resulted in an incremental cost-effective ratio of $34,900 per quality-adjusted life-year (QALY) gained. A threshold of less than $50,000 per QALY gained is considered reasonably cost-effective, with an upper limit of $100,000 considered acceptable.⁹²

In the same analysis by Kim and Goldie,⁸⁶ catch-up vaccination of girls through age 18 resulted in a cost of $50,000 to $100,000 per QALY gained, and catch-up vaccination of females through age 26 was significantly less cost-effective at more then $130,000 per QALY gained. The vaccine was also significantly less cost-effective if 5% of the population was neither screened nor vaccinated, if a 10-year booster was required, and if frequent cervical cancer screening intervals were adopted.

This analysis did not include costs related to the evaluation and treatment of abnormal Pap smears and cross-protection against other HPV-related cancers.

The cost-effectiveness of HPV vaccination depends on reaching more girls at younger ages (ideally before sexual debut) and completing the three-dose schedule to optimize duration of immunity.⁹² Appropriate modification of the current recommendations for the intervals of cervical cancer screening for vaccinated individuals will further improve the cost-effectiveness of vaccination. The inclusion of male vaccination generally has more favorable cost per QALY in scenarios in which female coverage rates are less than 50%⁹³ and among men who have sex with men.⁹⁴

TO ERADICATE CERVICAL CANCER

Given the remarkable efficacy and expected long-term immunogenicity of HPV vaccines, we anticipate a decline in HPV-related cervical cancer and other related diseases in the years to come. However, modeling studies predicting the impact of HPV vaccination suggest that although substantial reductions in diseases can be expected, the benefit, assuming high vaccination rates, will not be apparent for at least another decade.⁹⁵ Furthermore, the current HPV vaccines contain only HPV 16 and 18 L1 protein for cancer protection and, therefore, do not provide optimal protection against all oncogenic HPV-related cancers.

The real hope of eradicating cervical cancer and all HPV-related disease relies on a successful global implementation of multivalent HPV vaccination, effective screening strategies, and successful treatment.

The vaccines against human papillomavirus (HPV) are the only ones designed to prevent cancer caused by a virus^1,2—surely a good goal. But because HPV is sexually transmitted, HPV vaccination has met with public controversy.³ To counter the objections and better protect their patients’ health, primary care providers and other clinicians need a clear understanding of the benefits and the low risk of HPV vaccination—and the reasons so many people object to it.³

In this article, we will review:

• The impact of HPV-related diseases
• The basic biologic features of HPV vaccines
• The host immune response to natural HPV infection vs the response to HPV vaccines
• The clinical efficacy and safety of HPV vaccines
• The latest guidelines for HPV vaccination
• The challenges to vaccination implementation
• Frequently asked practical questions about HPV vaccination.

HPV-RELATED DISEASES: FROM BOTHERSOME TO DEADLY

Clinical sequelae of HPV infection include genital warts; cancers of the cervix, vulva, vagina, anus, penis, and oropharynx; and recurrent respiratory papillomatosis.^4–6

Genital warts

HPV types 6 and 11 are responsible for more than 90% of the 1 million new cases of genital warts diagnosed annually in the United States.^7–10

Bothersome and embarrassing, HPV-related genital warts can cause itching, burning, erythema, and pain, as well as epithelial erosions, ulcerations, depigmentation, and urethral and vaginal bleeding and discharge.^11,12 Although they are benign in the oncologic sense, they can cause a good deal of emotional and financial stress. Patients may feel anxiety, embarrassment,¹³ and vulnerability. Adolescents and adults who have or have had genital warts need to inform their current and future partners or else risk infecting them—and facing the consequences.

Direct health care costs of genital warts in the United States have been estimated to be at least $200 million per year.¹⁴

Cervical cancer

Cervical cancer cannot develop unless the cervical epithelium is infected with one of the oncogenic HPV types. Indeed, oncogenic HPV is present in as many as 99.8% of cervical cancer specimens.¹⁵ HPV 16 and 18 are the most oncogenic HPV genotypes and account for 75% of all cases of cervical cancer. Ten other HPV genotypes account for the remaining 25%.¹⁶

In 2012, there were an estimated 12,170 new cases of invasive cervical cancer in the United States and 4,220 related deaths.¹⁷ The cost associated with cervical cancer screening, managing abnormal findings, and treating invasive cervical cancer in the United States is estimated to be $3.3 billion per year.¹⁸

Although the incidence and the mortality rates of cervical cancer have decreased more than 50% in the United States over the past 3 decades thanks to screening,¹⁹ cervical cancer remains the second leading cause of death from cancer in women worldwide. Each year, an estimated 500,000 women contract the disease and 240,000 die of it.²⁰

Anal cancer

A recent study indicated that oncogenic HPV can also cause anal cancer, and the proportion of such cancers associated with HPV 16 or HPV 18 infection is as high as or higher than for cervical cancers, and estimated at 80%.²¹

The incidence of anal cancer is increasing by approximately 2% per year in both men and women in the general population,²² and rates are even higher in men who have sex with men and people infected with the human immunodeficiency virus.²³

Hu and Goldie²⁴ estimated that the lifetime costs of caring for all the people in the United States who in just 1 year (2003) acquired anal cancer attributable to HPV would total $92 million.

Oropharyngeal cancer

HPV types 16, 18, 31, 33, and 35 also cause oropharyngeal cancer. HPV 16 accounts for more than 90% of cases of HPV-related oropharyngeal cancer.²⁵

Chaturvedi et al⁶ tested tissue samples from three national cancer registries and found that the number of oropharyngeal cancers that were HPV-positive increased from 16.3% in 1984–1989 to 71.7% in 2000–2004, while the number of HPV-negative oropharyngeal cancers fell by 50%, paralleling the drop in cigarette smoking in the United States.

Hu and Goldie²⁴ estimated that the total lifetime cost for all new HPV-related oropharyngeal cancers that arose in 2003 would come to $38.1 million.²⁴

Vulvar and vaginal cancers

HPV 16 and 18 are also responsible for approximately 50% of vulvar cancers and 50% to 75% of vaginal cancers.^4,5

Recurrent respiratory papillomatosis

HPV 6 and 11 cause almost all cases of juvenile- and adult-onset recurrent respiratory papillomatosis.²⁶ The annual cost for surgical procedures for this condition in the United States has been estimated at $151 million.²⁷

HPV VACCINES ARE NONINFECTIOUS AND NONCARCINOGENIC

Currently, two HPV vaccines are available: a quadrivalent vaccine against types 6, 11, 16, and 18 (Gardasil; Merck) and a bivalent vaccine against types 16 and 18 (Cervarix; Glaxo-SmithKline). The quadrivalent vaccine was approved by the US Food and Drug Administration (FDA) in 2006, and the bivalent vaccine was approved in 2009.^28,29

Both vaccines contain virus-like particles, ie, viral capsids that contain no DNA. HPV has a circular DNA genome of 8,000 nucleotides divided into two regions: the early region, for viral replication, and the late region, for viral capsid production. The host produces neutralizing antibodies in response to the L1 capsid protein, which is different in different HPV types.

In manufacturing the vaccines, the viral L1 gene is incorporated into a yeast genome or an insect virus genome using recombinant DNA technology (Figure 1). Grown in culture, the yeast or the insect cells produce the HPV L1 major capsid protein, which has the intrinsic capacity to self-assemble into virus-like particles.^30–33 These particles are subsequently purified for use in the vaccines.³⁴

Recombinant virus-like particles are morphologically indistinguishable from authentic HPV virions and contain the same typespecific antigens present in authentic virions. Therefore, they are highly effective in inducing a host humoral immune response. And because they do not contain HPV DNA, the recombinant HPV vaccines are noninfectious and noncarcinogenic.³⁵

VACCINATION INDUCES A STRONGER IMMUNE RESPONSE THAN INFECTION

HPV infections trigger both a humoral and a cellular response in the host immune system.

The humoral immune response to HPV infection involves producing neutralizing antibody against the specific HPV type, specifically the specific L1 major capsid protein. This process is typically somewhat slow and weak, and only about 60% of women with a new HPV infection develop antibodies to it.^36,37

HPV has several ways to evade the host immune system. It does not infect or replicate within the antigen-presenting cells in the epithelium. In addition, HPV-infected keratinocytes are less susceptible to cytotoxic lymphocytic-mediated lysis. Moreover, HPV infection cause very little tissue destruction. And finally, natural cervical HPV infection does not result in viremia. As a result, antigen-presenting cells have no chance to engulf the virions and present virion-derived antigen to the host immune system. The immune system outside the epithelium has limited opportunity to detect the virus because HPV infection does not have a blood-borne phase.^38,39

The cell-mediated immune response to early HPV oncoproteins may help eliminate established HPV infection.⁴⁰ In contrast to antibodies, the T-cell response to HPV has not been shown to be specific to HPV type.⁴¹ Clinically, cervical HPV infection is common, but most lesions go into remission or resolve as a result of the cell-mediated immune response.^40,41

In contrast to the weak, somewhat ineffective immune response to natural HPV infection, the antibody response to HPV vaccines is rather robust. In randomized controlled trials, almost all vaccinated people have seroconverted. The peak antibody concentrations are 50 to 10,000 times greater than in natural infection. Furthermore, the neutralizing antibodies induced by HPV vaccines persist for as long as 7 to 9 years after immunization.⁴² However, the protection provided by HPV vaccines against HPV-related cervical intraepithelial neoplasia does not necessarily correlate with the antibody concentration.^43–47

Why does the vaccine work so well?

Why are vaccine-induced antibody responses so much stronger than those induced by natural HPV infection?

The first reason is that the vaccine, delivered intramuscularly, rapidly enters into blood vessels and the lymphatic system. In contrast, in natural intraepithelial infection, the virus is shed from mucosal surfaces and does not result in viremia.⁴⁸

In addition, the strong immunogenic nature of the virus-like particles induces a robust host antibody response even in the absence of adjuvant because of concentrated neutralizing epitopes and excellent induction of the T-helper cell response.^35,49,50

The neutralizing antibody to L1 prevents HPV infection by blocking HPV from binding to the basement membrane as well as to the epithelial cell receptor during epithelial microabrasion and viral entry. The subsequent micro-wound healing leads to serous exudation and rapid access of serum immunoglobulin G (IgG) to HPV virus particles and encounters with circulatory B memory cells.

Furthermore, emerging evidence suggests that even very low antibody concentrations are sufficient to prevent viral entry into cervical epithelial cells.^{46–48,51–53}

THE HPV VACCINES ARE HIGHLY EFFECTIVE AND SAFE

The efficacy and safety of the quadrivalent and the bivalent HPV vaccines have been evaluated in large randomized clinical trials.^{23,28,29,54,55} Table 1 summarizes the key findings.

The Females United to Unilaterally Reduce Endo/ectocervical Disease (FUTURE I)⁵⁴ and FUTURE II²⁸ trials showed conclusively that the quadrivalent HPV vaccine is 98% to 100% efficacious in preventing HPV 16- and 18-related cervical intraepithelial neoplasia, carcinoma in situ, and invasive cervical cancer in women who had not been infected with HPV before. Similarly, the Papilloma Trial against Cancer in Young Adults (PATRICIA) concluded that the bivalent HPV vaccine is 93% efficacious.²⁹

Giuliano et al⁵⁵ and Palefsky et al²³ conducted randomized clinical trials of the quadrivalent HPV vaccine for preventing genital disease and anal intraepithelial neoplasia in boys and men; the efficacy rates were 90.4%⁵⁵ and 77.5%.²³

A recent Finnish trial in boys age 10 to 18 found 100% seroconversion rates for HPV 16 and HPV 18 antibodies after they received bivalent HPV vaccine.⁵⁶ Similar efficacy has been demonstrated for the quadrivalent HPV vaccine in boys.⁵⁷

Adverse events after vaccination

After the FDA approved the quadrivalent HPV vaccine for girls in 2006, the US Centers for Disease Control and Prevention (CDC) conducted a thorough survey of adverse events after immunization from June 1, 2006 through December 31, 2008.⁵⁸ There were about 54 reports of adverse events per 100,000 distributed vaccine doses, similar to rates for other vaccines. However, the incidence rates of syncope and venous thrombosis were disproportionately higher, according to data from the US Vaccine Adverse Event Reporting System. The rate of syncope was 8.2 per 100,000 vaccine doses, and the rate of venous thrombotic events was 0.2 per 100,000 doses.⁵⁸

There were 32 reports of deaths after HPV vaccination, but these were without clear causation. Hence, this information must be interpreted with caution and should not be used to infer causal associations between HPV vaccines and adverse outcomes. The causes of death included diabetic ketoacidosis, pulmonary embolism, prescription drug abuse, amyotrophic lateral sclerosis, meningoencephalitis, influenza B viral sepsis, arrhythmia, myocarditis, and idiopathic seizure disorder.⁵⁸

Furthermore, it is important to note that vasovagal syncope and venous thromboembolic events are more common in young females in general.⁵⁹ For example, the background rates of venous thromboembolism in females age 14 to 29 using oral contraceptives is 21 to 31 per 100,000 woman-years.⁶⁰

Overall, the quadrivalent HPV vaccine is well tolerated and clinically safe. Postlicensure evaluation found that the quadrivalent and bivalent HPV vaccines had similar safety profiles.⁶¹

Vaccination is contraindicated in people with known hypersensitivity or prior severe allergic reactions to vaccine or yeast or who have bleeding disorders.

HPV VACCINATION DOES MORE THAN PREVENT CERVICAL CANCER IN FEMALES

The quadrivalent HPV vaccine was licensed by the FDA in 2006 for use in females age 9 to 26 to prevent cervical cancer, cervical cancer precursors, vaginal and vulval cancer precursors, and anogenital warts caused by HPV types 6, 11, 16, and 18. The CDC’s Advisory Committee on Immunization Practices (ACIP) issued its recommendation for initiating HPV vaccination for females age 11 to 12 in March 2007. The ACIP stated that the vaccine could be given to girls as early as age 9 and recommended catch-up vaccinations for those age 13 to 26.^62,63

The quadrivalent HPV vaccine was licensed by the FDA in 2009 for use in boys and men for the prevention of genital warts. In December 2010, the quadrivalent HPV vaccine received extended licensure from the FDA for use in males and females for the prevention of anal cancer. In October 2011, the ACIP voted to recommend routine use of the quadrivalent HPV vaccine for boys age 11 to 12; catch-up vaccination should occur for those age 13 to 22, with an option to vaccinate men age 23 to 26.

These recommendations replace the “permissive use” recommendations from the ACIP in October 2009 that said the quadrivalent HPV vaccine may be given to males age 9 to 26.⁶⁴ This shift from a permissive to an active recommendation connotes a positive change reflecting recognition of rising oropharyngeal cancer rates attributable to oncogenic, preventable HPV, rising HPV-related anal cancer incidence, and the burden of the disease in female partners of infected men, with associated rising health care costs.

The bivalent HPV vaccine received FDA licensure in October 2009 for use in females age 10 to 25 to prevent cervical cancer and precursor lesions. The ACIP included the bivalent HPV vaccine in its updated recommendations in May 2010 for use in girls age 11 to 12. Numerous national and international organizations have endorsed HPV vaccination.^65–71

Table 2 outlines the recommendations from these organizations.

HPV VACCINATION RATES ARE STILL LOW

HPV vaccine offers us the hope of eventually eradicating cervical cancer. However, the immunization program still faces many challenges, since HPV vaccination touches on issues related to adolescent sexuality, parental autonomy, and cost. As a result, HPV immunization rates remain relatively low in the United States according to several national surveys. Only 40% to 49% of girls eligible for the vaccine received even one dose, and of those who received even one dose, only 32% to 53.3% came back for all three doses.^72–75 Furthermore, indigent and minority teens were less likely to finish the three-dose HPV vaccine series.

Why are the vaccination rates so low?

Parental barriers. In one survey,⁷³ reasons that parents gave for not having their daughters vaccinated included:

• Lack of knowledge of the vaccine (19.4%)
• Lack of perceived need for the vaccine (18.8%)
• Belief that their daughter was not sexually active (18.3%)
• Clinician not recommending vaccination (13.1%).

In an effort to improve HPV vaccination rates,⁴¹ several states proposed legislation for mandatory HPV vaccination of schoolgirls shortly after licensure of the quadrivalent HPV vaccine.³ Since then, we have seen a wave of public opposition rooted in concerns and misinformation about safety, teenage sexuality, governmental coercion, and cost. Widespread media coverage has also highlighted unsubstantiated claims about side effects attributable to the vaccine that can raise parents’ mistrust of vaccines.⁷⁶ Concerns have also been raised about a threat to parental autonomy in how and when to educate their children about sex.⁷⁷

Moreover, the vaccine has raised ethical concerns in some parents and politicians that mandatory vaccination could undermine abstinence messages in sexual education and may alter sexual activity by condoning risky behavior.⁷⁸ However, a recent study indicated that there is no significant change in sexual behavior related to HPV vaccination in young girls.⁷⁹

In 2012, Mullins et al⁸⁰ also found that an urban population of adolescent girls (76.4% black, 57.5% sexually experienced) did not feel they could forgo safer sexual practices after first HPV vaccination, although the girls did perceive less risk from HPV than from other sexually transmitted infections after HPV vaccination (P < .001).⁸⁰ Inadequate knowledge about HPV-related disease and HPV vaccine correlated with less perceived risk from HPV after vaccination among the girls, and a lack of knowledge about HPV and less communication with their daughters about HPV correlated with less perceived risk from HPV in the mothers of the study population.⁸¹

Health-care-provider barriers. Physician endorsement of vaccines represents a key predictor of vaccine acceptance by patients, families, and other clinicians.^82–84 In 2008, a cross-sectional, Internet-based survey of 1,122 Texas pediatricians, family practice physicians, obstetricians, gynecologists, and internal medicine physicians providing direct patient care found that only 48.5% always recommended HPV vaccination to girls.⁷⁴ Of all respondents, 68.4% were likely to recommend the vaccine to boys, and 41.7% agreed with mandated vaccination. Thus, more than half of the physicians were not following the current recommendations for universal HPV vaccination for 11- to -12-year-olds.

In a survey of 1,013 physicians during the spring and summer of 2009, only 34.6% said they always recommend HPV vaccination to early adolescents, 52.7% to middle adolescents, and 50.2% to late adolescents and young adults.⁸⁵ Pediatricians were more likely than family physicians and obstetrician-gynecologists to always recommend HPV vaccine across all age groups (P < .001). Educational interventions targeting various specialties may help overcome physician-related barriers to immunization.⁸⁵

Financial barriers. HPV vaccine, which must be given in three doses, is more expensive than other vaccines, and this expense is yet another barrier, especially for the uninsured.⁸⁶ Australia launched a government-funded program of HPV vaccination (with the quadrivalent vaccine) in schools in 2007, and it has been very successful. Garland et al⁸⁷ reported that new cases of genital warts have decreased by 73% since the program began, and the rate of high-grade abnormalities on Papanicolaou testing has declined by a small but significant amount.

For HPV vaccination to have an impact on public health, vaccination rates in the general population need to be high. In order to achieve these rates, we need to educate our patients on vaccine safety and efficacy and counsel vaccine recipients about the prevention of sexually transmitted infections and the importance of regular cervical cancer screening after age 21. Clinicians can actively “myth-bust” with patients, who may not realize that the vaccine should be given despite a history of HPV infection or abnormal Pap smear.

FREQUENTLY ASKED QUESTIONS

What if the patient is late for a shot?

The current recommended vaccination schedule for the bivalent and quadrivalent HPV vaccines is a three-dose series administered at 0, 2, and 6 months, given as an intramuscular injection, preferably in the deltoid muscle. The minimal dosing interval is 4 weeks between the first and second doses and 12 weeks between the second and third doses.

The vaccines use different adjuncts with different specific mechanisms for immunogenicity; therefore, it is recommended that the same vaccine be used for the entire three-dose series. However, if circumstances preclude the completion of a series with the same vaccine, the other HPV vaccine may be used.⁶³ Starting the series over is not recommended.

Long-term studies demonstrated clinical efficacy 8.5 years after vaccination.⁴⁷ Amnestic response by virtue of activation of pools of memory B cells has been demonstrated, suggesting the vaccine may afford lifelong immunity.⁸⁸

Is a pregnancy test needed before HPV vaccination?

The ACIP states that pregnancy testing is not required before receiving either of the available HPV vaccines.

A recent retrospective review of phase III efficacy trials and pregnancy registry surveillance data for both vaccines revealed no increase in spontaneous abortions, fetal malformations, or adverse pregnancy outcomes.⁸⁹ Data are limited on bivalent and quadrivalent HPV vaccine given within 30 days of pregnancy and subsequent pregnancy and fetal outcomes. Both vaccines have been assigned a pregnancy rating of category B; however, the ACIP recommends that neither vaccine be given if the recipient is known to be pregnant. If pregnancy occurs, it is recommended that the remainder of the series be deferred until after delivery.⁶²

It is not known whether the vaccine is excreted in breast milk. The manufacturers of both the bivalent and quadrivalent HPV vaccines recommend caution when vaccinating lactating women.^30,31

Can HPV vaccine be given with other vaccines?

In randomized trials, giving the bivalent HPV vaccine with the combined hepatitis A, hepatitis B, meningococcal conjugate and the combined tetanus, diphtheria, and acellular pertussis vaccines did not interfere with the immunogenic response, was safe, and was well tolerated.^90,91 Coadministration of the quadrivalent HPV vaccine has been studied only with hepatitis B vaccine, with similar safety and efficacy noted.

The ACIP recommends giving HPV vaccine at the same visit with other age-appropriate immunizations to increase the likelihood of adherence to recommended vaccination schedules.⁶²

Is HPV vaccination cost-effective?

Kim and Goldie⁸⁶ performed a cost-effectiveness analysis of HPV vaccination of girls at age 12 and catch-up vaccination up to the ages of 18, 21, and 26. For their analysis, they considered prevention of cancers associated with HPV types 16 and 18, of genital warts associated with types 6 and 11, and of recurrent respiratory papillomatosis. They also assumed that immunity would be lifelong, and current screening practices would continue.

They calculated that routine vaccination of 12-year-old girls resulted in an incremental cost-effective ratio of $34,900 per quality-adjusted life-year (QALY) gained. A threshold of less than $50,000 per QALY gained is considered reasonably cost-effective, with an upper limit of $100,000 considered acceptable.⁹²

In the same analysis by Kim and Goldie,⁸⁶ catch-up vaccination of girls through age 18 resulted in a cost of $50,000 to $100,000 per QALY gained, and catch-up vaccination of females through age 26 was significantly less cost-effective at more then $130,000 per QALY gained. The vaccine was also significantly less cost-effective if 5% of the population was neither screened nor vaccinated, if a 10-year booster was required, and if frequent cervical cancer screening intervals were adopted.

This analysis did not include costs related to the evaluation and treatment of abnormal Pap smears and cross-protection against other HPV-related cancers.

The cost-effectiveness of HPV vaccination depends on reaching more girls at younger ages (ideally before sexual debut) and completing the three-dose schedule to optimize duration of immunity.⁹² Appropriate modification of the current recommendations for the intervals of cervical cancer screening for vaccinated individuals will further improve the cost-effectiveness of vaccination. The inclusion of male vaccination generally has more favorable cost per QALY in scenarios in which female coverage rates are less than 50%⁹³ and among men who have sex with men.⁹⁴

TO ERADICATE CERVICAL CANCER

Given the remarkable efficacy and expected long-term immunogenicity of HPV vaccines, we anticipate a decline in HPV-related cervical cancer and other related diseases in the years to come. However, modeling studies predicting the impact of HPV vaccination suggest that although substantial reductions in diseases can be expected, the benefit, assuming high vaccination rates, will not be apparent for at least another decade.⁹⁵ Furthermore, the current HPV vaccines contain only HPV 16 and 18 L1 protein for cancer protection and, therefore, do not provide optimal protection against all oncogenic HPV-related cancers.

The real hope of eradicating cervical cancer and all HPV-related disease relies on a successful global implementation of multivalent HPV vaccination, effective screening strategies, and successful treatment.

The vaccines against human papillomavirus (HPV) are the only ones designed to prevent cancer caused by a virus^1,2—surely a good goal. But because HPV is sexually transmitted, HPV vaccination has met with public controversy.³ To counter the objections and better protect their patients’ health, primary care providers and other clinicians need a clear understanding of the benefits and the low risk of HPV vaccination—and the reasons so many people object to it.³

In this article, we will review:

• The impact of HPV-related diseases
• The basic biologic features of HPV vaccines
• The host immune response to natural HPV infection vs the response to HPV vaccines
• The clinical efficacy and safety of HPV vaccines
• The latest guidelines for HPV vaccination
• The challenges to vaccination implementation
• Frequently asked practical questions about HPV vaccination.

HPV-RELATED DISEASES: FROM BOTHERSOME TO DEADLY

Clinical sequelae of HPV infection include genital warts; cancers of the cervix, vulva, vagina, anus, penis, and oropharynx; and recurrent respiratory papillomatosis.^4–6

Genital warts

HPV types 6 and 11 are responsible for more than 90% of the 1 million new cases of genital warts diagnosed annually in the United States.^7–10

Bothersome and embarrassing, HPV-related genital warts can cause itching, burning, erythema, and pain, as well as epithelial erosions, ulcerations, depigmentation, and urethral and vaginal bleeding and discharge.^11,12 Although they are benign in the oncologic sense, they can cause a good deal of emotional and financial stress. Patients may feel anxiety, embarrassment,¹³ and vulnerability. Adolescents and adults who have or have had genital warts need to inform their current and future partners or else risk infecting them—and facing the consequences.

Direct health care costs of genital warts in the United States have been estimated to be at least $200 million per year.¹⁴

Cervical cancer

Cervical cancer cannot develop unless the cervical epithelium is infected with one of the oncogenic HPV types. Indeed, oncogenic HPV is present in as many as 99.8% of cervical cancer specimens.¹⁵ HPV 16 and 18 are the most oncogenic HPV genotypes and account for 75% of all cases of cervical cancer. Ten other HPV genotypes account for the remaining 25%.¹⁶

In 2012, there were an estimated 12,170 new cases of invasive cervical cancer in the United States and 4,220 related deaths.¹⁷ The cost associated with cervical cancer screening, managing abnormal findings, and treating invasive cervical cancer in the United States is estimated to be $3.3 billion per year.¹⁸

Although the incidence and the mortality rates of cervical cancer have decreased more than 50% in the United States over the past 3 decades thanks to screening,¹⁹ cervical cancer remains the second leading cause of death from cancer in women worldwide. Each year, an estimated 500,000 women contract the disease and 240,000 die of it.²⁰

Anal cancer

A recent study indicated that oncogenic HPV can also cause anal cancer, and the proportion of such cancers associated with HPV 16 or HPV 18 infection is as high as or higher than for cervical cancers, and estimated at 80%.²¹

The incidence of anal cancer is increasing by approximately 2% per year in both men and women in the general population,²² and rates are even higher in men who have sex with men and people infected with the human immunodeficiency virus.²³

Hu and Goldie²⁴ estimated that the lifetime costs of caring for all the people in the United States who in just 1 year (2003) acquired anal cancer attributable to HPV would total $92 million.

Oropharyngeal cancer

HPV types 16, 18, 31, 33, and 35 also cause oropharyngeal cancer. HPV 16 accounts for more than 90% of cases of HPV-related oropharyngeal cancer.²⁵

Chaturvedi et al⁶ tested tissue samples from three national cancer registries and found that the number of oropharyngeal cancers that were HPV-positive increased from 16.3% in 1984–1989 to 71.7% in 2000–2004, while the number of HPV-negative oropharyngeal cancers fell by 50%, paralleling the drop in cigarette smoking in the United States.

Hu and Goldie²⁴ estimated that the total lifetime cost for all new HPV-related oropharyngeal cancers that arose in 2003 would come to $38.1 million.²⁴

Vulvar and vaginal cancers

HPV 16 and 18 are also responsible for approximately 50% of vulvar cancers and 50% to 75% of vaginal cancers.^4,5

Recurrent respiratory papillomatosis

HPV 6 and 11 cause almost all cases of juvenile- and adult-onset recurrent respiratory papillomatosis.²⁶ The annual cost for surgical procedures for this condition in the United States has been estimated at $151 million.²⁷

HPV VACCINES ARE NONINFECTIOUS AND NONCARCINOGENIC

Currently, two HPV vaccines are available: a quadrivalent vaccine against types 6, 11, 16, and 18 (Gardasil; Merck) and a bivalent vaccine against types 16 and 18 (Cervarix; Glaxo-SmithKline). The quadrivalent vaccine was approved by the US Food and Drug Administration (FDA) in 2006, and the bivalent vaccine was approved in 2009.^28,29

Both vaccines contain virus-like particles, ie, viral capsids that contain no DNA. HPV has a circular DNA genome of 8,000 nucleotides divided into two regions: the early region, for viral replication, and the late region, for viral capsid production. The host produces neutralizing antibodies in response to the L1 capsid protein, which is different in different HPV types.

In manufacturing the vaccines, the viral L1 gene is incorporated into a yeast genome or an insect virus genome using recombinant DNA technology (Figure 1). Grown in culture, the yeast or the insect cells produce the HPV L1 major capsid protein, which has the intrinsic capacity to self-assemble into virus-like particles.^30–33 These particles are subsequently purified for use in the vaccines.³⁴

Recombinant virus-like particles are morphologically indistinguishable from authentic HPV virions and contain the same typespecific antigens present in authentic virions. Therefore, they are highly effective in inducing a host humoral immune response. And because they do not contain HPV DNA, the recombinant HPV vaccines are noninfectious and noncarcinogenic.³⁵

VACCINATION INDUCES A STRONGER IMMUNE RESPONSE THAN INFECTION

HPV infections trigger both a humoral and a cellular response in the host immune system.

The humoral immune response to HPV infection involves producing neutralizing antibody against the specific HPV type, specifically the specific L1 major capsid protein. This process is typically somewhat slow and weak, and only about 60% of women with a new HPV infection develop antibodies to it.^36,37

HPV has several ways to evade the host immune system. It does not infect or replicate within the antigen-presenting cells in the epithelium. In addition, HPV-infected keratinocytes are less susceptible to cytotoxic lymphocytic-mediated lysis. Moreover, HPV infection cause very little tissue destruction. And finally, natural cervical HPV infection does not result in viremia. As a result, antigen-presenting cells have no chance to engulf the virions and present virion-derived antigen to the host immune system. The immune system outside the epithelium has limited opportunity to detect the virus because HPV infection does not have a blood-borne phase.^38,39

The cell-mediated immune response to early HPV oncoproteins may help eliminate established HPV infection.⁴⁰ In contrast to antibodies, the T-cell response to HPV has not been shown to be specific to HPV type.⁴¹ Clinically, cervical HPV infection is common, but most lesions go into remission or resolve as a result of the cell-mediated immune response.^40,41

In contrast to the weak, somewhat ineffective immune response to natural HPV infection, the antibody response to HPV vaccines is rather robust. In randomized controlled trials, almost all vaccinated people have seroconverted. The peak antibody concentrations are 50 to 10,000 times greater than in natural infection. Furthermore, the neutralizing antibodies induced by HPV vaccines persist for as long as 7 to 9 years after immunization.⁴² However, the protection provided by HPV vaccines against HPV-related cervical intraepithelial neoplasia does not necessarily correlate with the antibody concentration.^43–47

Why does the vaccine work so well?

Why are vaccine-induced antibody responses so much stronger than those induced by natural HPV infection?

The first reason is that the vaccine, delivered intramuscularly, rapidly enters into blood vessels and the lymphatic system. In contrast, in natural intraepithelial infection, the virus is shed from mucosal surfaces and does not result in viremia.⁴⁸

In addition, the strong immunogenic nature of the virus-like particles induces a robust host antibody response even in the absence of adjuvant because of concentrated neutralizing epitopes and excellent induction of the T-helper cell response.^35,49,50

The neutralizing antibody to L1 prevents HPV infection by blocking HPV from binding to the basement membrane as well as to the epithelial cell receptor during epithelial microabrasion and viral entry. The subsequent micro-wound healing leads to serous exudation and rapid access of serum immunoglobulin G (IgG) to HPV virus particles and encounters with circulatory B memory cells.

Furthermore, emerging evidence suggests that even very low antibody concentrations are sufficient to prevent viral entry into cervical epithelial cells.^{46–48,51–53}

THE HPV VACCINES ARE HIGHLY EFFECTIVE AND SAFE

The efficacy and safety of the quadrivalent and the bivalent HPV vaccines have been evaluated in large randomized clinical trials.^{23,28,29,54,55} Table 1 summarizes the key findings.

The Females United to Unilaterally Reduce Endo/ectocervical Disease (FUTURE I)⁵⁴ and FUTURE II²⁸ trials showed conclusively that the quadrivalent HPV vaccine is 98% to 100% efficacious in preventing HPV 16- and 18-related cervical intraepithelial neoplasia, carcinoma in situ, and invasive cervical cancer in women who had not been infected with HPV before. Similarly, the Papilloma Trial against Cancer in Young Adults (PATRICIA) concluded that the bivalent HPV vaccine is 93% efficacious.²⁹

Giuliano et al⁵⁵ and Palefsky et al²³ conducted randomized clinical trials of the quadrivalent HPV vaccine for preventing genital disease and anal intraepithelial neoplasia in boys and men; the efficacy rates were 90.4%⁵⁵ and 77.5%.²³

A recent Finnish trial in boys age 10 to 18 found 100% seroconversion rates for HPV 16 and HPV 18 antibodies after they received bivalent HPV vaccine.⁵⁶ Similar efficacy has been demonstrated for the quadrivalent HPV vaccine in boys.⁵⁷

Adverse events after vaccination

After the FDA approved the quadrivalent HPV vaccine for girls in 2006, the US Centers for Disease Control and Prevention (CDC) conducted a thorough survey of adverse events after immunization from June 1, 2006 through December 31, 2008.⁵⁸ There were about 54 reports of adverse events per 100,000 distributed vaccine doses, similar to rates for other vaccines. However, the incidence rates of syncope and venous thrombosis were disproportionately higher, according to data from the US Vaccine Adverse Event Reporting System. The rate of syncope was 8.2 per 100,000 vaccine doses, and the rate of venous thrombotic events was 0.2 per 100,000 doses.⁵⁸

There were 32 reports of deaths after HPV vaccination, but these were without clear causation. Hence, this information must be interpreted with caution and should not be used to infer causal associations between HPV vaccines and adverse outcomes. The causes of death included diabetic ketoacidosis, pulmonary embolism, prescription drug abuse, amyotrophic lateral sclerosis, meningoencephalitis, influenza B viral sepsis, arrhythmia, myocarditis, and idiopathic seizure disorder.⁵⁸

Furthermore, it is important to note that vasovagal syncope and venous thromboembolic events are more common in young females in general.⁵⁹ For example, the background rates of venous thromboembolism in females age 14 to 29 using oral contraceptives is 21 to 31 per 100,000 woman-years.⁶⁰

Overall, the quadrivalent HPV vaccine is well tolerated and clinically safe. Postlicensure evaluation found that the quadrivalent and bivalent HPV vaccines had similar safety profiles.⁶¹

Vaccination is contraindicated in people with known hypersensitivity or prior severe allergic reactions to vaccine or yeast or who have bleeding disorders.

HPV VACCINATION DOES MORE THAN PREVENT CERVICAL CANCER IN FEMALES

The quadrivalent HPV vaccine was licensed by the FDA in 2006 for use in females age 9 to 26 to prevent cervical cancer, cervical cancer precursors, vaginal and vulval cancer precursors, and anogenital warts caused by HPV types 6, 11, 16, and 18. The CDC’s Advisory Committee on Immunization Practices (ACIP) issued its recommendation for initiating HPV vaccination for females age 11 to 12 in March 2007. The ACIP stated that the vaccine could be given to girls as early as age 9 and recommended catch-up vaccinations for those age 13 to 26.^62,63

The quadrivalent HPV vaccine was licensed by the FDA in 2009 for use in boys and men for the prevention of genital warts. In December 2010, the quadrivalent HPV vaccine received extended licensure from the FDA for use in males and females for the prevention of anal cancer. In October 2011, the ACIP voted to recommend routine use of the quadrivalent HPV vaccine for boys age 11 to 12; catch-up vaccination should occur for those age 13 to 22, with an option to vaccinate men age 23 to 26.

These recommendations replace the “permissive use” recommendations from the ACIP in October 2009 that said the quadrivalent HPV vaccine may be given to males age 9 to 26.⁶⁴ This shift from a permissive to an active recommendation connotes a positive change reflecting recognition of rising oropharyngeal cancer rates attributable to oncogenic, preventable HPV, rising HPV-related anal cancer incidence, and the burden of the disease in female partners of infected men, with associated rising health care costs.

The bivalent HPV vaccine received FDA licensure in October 2009 for use in females age 10 to 25 to prevent cervical cancer and precursor lesions. The ACIP included the bivalent HPV vaccine in its updated recommendations in May 2010 for use in girls age 11 to 12. Numerous national and international organizations have endorsed HPV vaccination.^65–71

Table 2 outlines the recommendations from these organizations.

HPV VACCINATION RATES ARE STILL LOW

HPV vaccine offers us the hope of eventually eradicating cervical cancer. However, the immunization program still faces many challenges, since HPV vaccination touches on issues related to adolescent sexuality, parental autonomy, and cost. As a result, HPV immunization rates remain relatively low in the United States according to several national surveys. Only 40% to 49% of girls eligible for the vaccine received even one dose, and of those who received even one dose, only 32% to 53.3% came back for all three doses.^72–75 Furthermore, indigent and minority teens were less likely to finish the three-dose HPV vaccine series.

Why are the vaccination rates so low?

Parental barriers. In one survey,⁷³ reasons that parents gave for not having their daughters vaccinated included:

• Lack of knowledge of the vaccine (19.4%)
• Lack of perceived need for the vaccine (18.8%)
• Belief that their daughter was not sexually active (18.3%)
• Clinician not recommending vaccination (13.1%).

In an effort to improve HPV vaccination rates,⁴¹ several states proposed legislation for mandatory HPV vaccination of schoolgirls shortly after licensure of the quadrivalent HPV vaccine.³ Since then, we have seen a wave of public opposition rooted in concerns and misinformation about safety, teenage sexuality, governmental coercion, and cost. Widespread media coverage has also highlighted unsubstantiated claims about side effects attributable to the vaccine that can raise parents’ mistrust of vaccines.⁷⁶ Concerns have also been raised about a threat to parental autonomy in how and when to educate their children about sex.⁷⁷

Moreover, the vaccine has raised ethical concerns in some parents and politicians that mandatory vaccination could undermine abstinence messages in sexual education and may alter sexual activity by condoning risky behavior.⁷⁸ However, a recent study indicated that there is no significant change in sexual behavior related to HPV vaccination in young girls.⁷⁹

In 2012, Mullins et al⁸⁰ also found that an urban population of adolescent girls (76.4% black, 57.5% sexually experienced) did not feel they could forgo safer sexual practices after first HPV vaccination, although the girls did perceive less risk from HPV than from other sexually transmitted infections after HPV vaccination (P < .001).⁸⁰ Inadequate knowledge about HPV-related disease and HPV vaccine correlated with less perceived risk from HPV after vaccination among the girls, and a lack of knowledge about HPV and less communication with their daughters about HPV correlated with less perceived risk from HPV in the mothers of the study population.⁸¹

Health-care-provider barriers. Physician endorsement of vaccines represents a key predictor of vaccine acceptance by patients, families, and other clinicians.^82–84 In 2008, a cross-sectional, Internet-based survey of 1,122 Texas pediatricians, family practice physicians, obstetricians, gynecologists, and internal medicine physicians providing direct patient care found that only 48.5% always recommended HPV vaccination to girls.⁷⁴ Of all respondents, 68.4% were likely to recommend the vaccine to boys, and 41.7% agreed with mandated vaccination. Thus, more than half of the physicians were not following the current recommendations for universal HPV vaccination for 11- to -12-year-olds.

In a survey of 1,013 physicians during the spring and summer of 2009, only 34.6% said they always recommend HPV vaccination to early adolescents, 52.7% to middle adolescents, and 50.2% to late adolescents and young adults.⁸⁵ Pediatricians were more likely than family physicians and obstetrician-gynecologists to always recommend HPV vaccine across all age groups (P < .001). Educational interventions targeting various specialties may help overcome physician-related barriers to immunization.⁸⁵

Financial barriers. HPV vaccine, which must be given in three doses, is more expensive than other vaccines, and this expense is yet another barrier, especially for the uninsured.⁸⁶ Australia launched a government-funded program of HPV vaccination (with the quadrivalent vaccine) in schools in 2007, and it has been very successful. Garland et al⁸⁷ reported that new cases of genital warts have decreased by 73% since the program began, and the rate of high-grade abnormalities on Papanicolaou testing has declined by a small but significant amount.

For HPV vaccination to have an impact on public health, vaccination rates in the general population need to be high. In order to achieve these rates, we need to educate our patients on vaccine safety and efficacy and counsel vaccine recipients about the prevention of sexually transmitted infections and the importance of regular cervical cancer screening after age 21. Clinicians can actively “myth-bust” with patients, who may not realize that the vaccine should be given despite a history of HPV infection or abnormal Pap smear.

FREQUENTLY ASKED QUESTIONS

What if the patient is late for a shot?

The current recommended vaccination schedule for the bivalent and quadrivalent HPV vaccines is a three-dose series administered at 0, 2, and 6 months, given as an intramuscular injection, preferably in the deltoid muscle. The minimal dosing interval is 4 weeks between the first and second doses and 12 weeks between the second and third doses.

The vaccines use different adjuncts with different specific mechanisms for immunogenicity; therefore, it is recommended that the same vaccine be used for the entire three-dose series. However, if circumstances preclude the completion of a series with the same vaccine, the other HPV vaccine may be used.⁶³ Starting the series over is not recommended.

Long-term studies demonstrated clinical efficacy 8.5 years after vaccination.⁴⁷ Amnestic response by virtue of activation of pools of memory B cells has been demonstrated, suggesting the vaccine may afford lifelong immunity.⁸⁸

Is a pregnancy test needed before HPV vaccination?

The ACIP states that pregnancy testing is not required before receiving either of the available HPV vaccines.

A recent retrospective review of phase III efficacy trials and pregnancy registry surveillance data for both vaccines revealed no increase in spontaneous abortions, fetal malformations, or adverse pregnancy outcomes.⁸⁹ Data are limited on bivalent and quadrivalent HPV vaccine given within 30 days of pregnancy and subsequent pregnancy and fetal outcomes. Both vaccines have been assigned a pregnancy rating of category B; however, the ACIP recommends that neither vaccine be given if the recipient is known to be pregnant. If pregnancy occurs, it is recommended that the remainder of the series be deferred until after delivery.⁶²

It is not known whether the vaccine is excreted in breast milk. The manufacturers of both the bivalent and quadrivalent HPV vaccines recommend caution when vaccinating lactating women.^30,31

Can HPV vaccine be given with other vaccines?

In randomized trials, giving the bivalent HPV vaccine with the combined hepatitis A, hepatitis B, meningococcal conjugate and the combined tetanus, diphtheria, and acellular pertussis vaccines did not interfere with the immunogenic response, was safe, and was well tolerated.^90,91 Coadministration of the quadrivalent HPV vaccine has been studied only with hepatitis B vaccine, with similar safety and efficacy noted.

The ACIP recommends giving HPV vaccine at the same visit with other age-appropriate immunizations to increase the likelihood of adherence to recommended vaccination schedules.⁶²

Is HPV vaccination cost-effective?

Kim and Goldie⁸⁶ performed a cost-effectiveness analysis of HPV vaccination of girls at age 12 and catch-up vaccination up to the ages of 18, 21, and 26. For their analysis, they considered prevention of cancers associated with HPV types 16 and 18, of genital warts associated with types 6 and 11, and of recurrent respiratory papillomatosis. They also assumed that immunity would be lifelong, and current screening practices would continue.

They calculated that routine vaccination of 12-year-old girls resulted in an incremental cost-effective ratio of $34,900 per quality-adjusted life-year (QALY) gained. A threshold of less than $50,000 per QALY gained is considered reasonably cost-effective, with an upper limit of $100,000 considered acceptable.⁹²

In the same analysis by Kim and Goldie,⁸⁶ catch-up vaccination of girls through age 18 resulted in a cost of $50,000 to $100,000 per QALY gained, and catch-up vaccination of females through age 26 was significantly less cost-effective at more then $130,000 per QALY gained. The vaccine was also significantly less cost-effective if 5% of the population was neither screened nor vaccinated, if a 10-year booster was required, and if frequent cervical cancer screening intervals were adopted.

This analysis did not include costs related to the evaluation and treatment of abnormal Pap smears and cross-protection against other HPV-related cancers.

The cost-effectiveness of HPV vaccination depends on reaching more girls at younger ages (ideally before sexual debut) and completing the three-dose schedule to optimize duration of immunity.⁹² Appropriate modification of the current recommendations for the intervals of cervical cancer screening for vaccinated individuals will further improve the cost-effectiveness of vaccination. The inclusion of male vaccination generally has more favorable cost per QALY in scenarios in which female coverage rates are less than 50%⁹³ and among men who have sex with men.⁹⁴

TO ERADICATE CERVICAL CANCER

Given the remarkable efficacy and expected long-term immunogenicity of HPV vaccines, we anticipate a decline in HPV-related cervical cancer and other related diseases in the years to come. However, modeling studies predicting the impact of HPV vaccination suggest that although substantial reductions in diseases can be expected, the benefit, assuming high vaccination rates, will not be apparent for at least another decade.⁹⁵ Furthermore, the current HPV vaccines contain only HPV 16 and 18 L1 protein for cancer protection and, therefore, do not provide optimal protection against all oncogenic HPV-related cancers.

The real hope of eradicating cervical cancer and all HPV-related disease relies on a successful global implementation of multivalent HPV vaccination, effective screening strategies, and successful treatment.