Ajay Dharod, MD

Study Overview

Objective. To compare the effectiveness of a group exercise program focusing on the timing and coordination of movement (ie, On the Move [OTM]) with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability in older adults.

Design. Cross-sectional pilot study.

Setting and participants. Participants were community-dwelling older adults who were residents or members of 32 independent living facilities, senior apartment buildings, and community centers in the greater Pittsburgh, Pennsylvania, area. Participants were recruted between April 2012 and January 2014. Inclusion criteria included age 65 years or older, ability to walk independently with a gait speed of at least 0.60 m/s, and ability to follow 2-step commands. Individuals were excluded if they were non-English speaking, medically unstable, planning to leave the area for an extended time period, or had abnormal blood pressure or heart rate following a 6-minute walk test. The 32 participating facilities were randomly assigned to the OTM intervention (16 sites, 152 participants) or usual care (16 sites, 146 participants). The OTM and usual care exercise programs had the same frequency and duration (50 minutes per session, twice weekly for 12 weeks), and all exercise sessions were held on site at the facilities. The usual care program was a strength, flexibility, and endurance program based on programs that were being conducted in the participating facilities. It included a warm-up (range-of-motion exercises and stretching), upper and lower extremity strength exercises, aerobic activities, and a cool-down and was conducted with the participants sitting.

Intervention. The OTM program consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and cool down exercises, with most of the exercises conducted in a standing position (40 minutes) and the remainder (10 minutes) sitting. The stepping and walking patterns were designed to promote the timing and coordination of stepping, integrated with the phases of the gait pattern.

Main Results. The average participant age was 80.0 (SD, 8.1) years, most participants were female (84.2%) and white (83.65%), and the average number of chronic conditions was 2.8 (SD, 1.4). The 2 groups were similar except for small differences in facility type. 142 (93.4%) OTM participants and 139 (95.2%) usual care participants completed post-intervention testing. The OTM group had significantly greater mean (SD) improvements than the usual care group in gait speed (0.05 [0.13] m/s versus −0.01 [0.11] m/s; adjusted difference 0.05 [0.02] m/s; P = 0.002) and 6MWD (20.6 [57.1] m versus 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = 0.03). Class attendance was lower in the OTM group than in the usual care group (76 [50.0%] OTM participants versus 95 [65.1%] usual care participants attended at least 20 classes; P = 0.03). There were no other significant differences between the groups in primary or secondary outcomes.

Conclusion. The OTM intervention was more effective at improving mobility than a usual care exercise program.

Commentary

The ability to walk is fundamental to maintaining a high quality of life and living independently in the community. Walking difficulty is a common problem among older persons and is linked to higher rates of loss of independence, morbidity, disability, and mortality in this population [1,2]. Walking difficulty associated with aging is often reflected in reduced gait speed and walking distance. A decline in gait speed of as little as 1 m/s is associated with a 10% decrease in ability to perform activities of daily living [3,4].

According to the authors, previous studies that explored the impact of structured exercise programs on walking ability in older individuals have had mixed results. These studies typically used exercise interventions focused on improving lower extremity muscle strength, flexibility, and general conditioning. In this study, the authors examined a community-based group exercise program (OTM) that incorporated exercises targeting the timing and coordination of movement important for walking in addition to flexibility and strengthening exercises. The results showed that the OTM program was more effective at improving walking ability than usual care. This intervention produced changes in gait speed (0.5 m/s) and 6MWD (16.7 m) that met or nearly met the clinically meaningful change criteria established for research use (0.5 m/s and 20 m, respectively) [5].

The authors pointed out several strengths of this study. First, the OTM program was compared to a usual care exercise program taught by trained exercise professionals, making it more difficult to demonstrate a difference between the 2 interventions. Similar prior studies have used nonexercise controls as the comparator. In addition, the effectiveness of the OTM program was demonstrated in 3 different community settings, suggesting that it can be implemented in various settings. Finally, the study participants were frail, older-old adults, who typically are not included in exercise studies. An important limitation of this study is that because outcomes were measured only at the conclusion of the intervention, it is not known whether the walking improvements persist over time or what effects the intervention has on mobility, function, and disability over the long term.

Applications for Clinical Practice

This study adds to the current literature on group exercise programs for improving mobility among community-dwelling older adults and supports incorporation of timing and coordination exercises into such programs. As the authors note, however, follow-up studies exploring the impact of the OTM intervention on long-term disability outcomes are needed before routine implementation in clinical practice can be recommended.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To compare the effectiveness of a group exercise program focusing on the timing and coordination of movement (ie, On the Move [OTM]) with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability in older adults.

Design. Cross-sectional pilot study.

Setting and participants. Participants were community-dwelling older adults who were residents or members of 32 independent living facilities, senior apartment buildings, and community centers in the greater Pittsburgh, Pennsylvania, area. Participants were recruted between April 2012 and January 2014. Inclusion criteria included age 65 years or older, ability to walk independently with a gait speed of at least 0.60 m/s, and ability to follow 2-step commands. Individuals were excluded if they were non-English speaking, medically unstable, planning to leave the area for an extended time period, or had abnormal blood pressure or heart rate following a 6-minute walk test. The 32 participating facilities were randomly assigned to the OTM intervention (16 sites, 152 participants) or usual care (16 sites, 146 participants). The OTM and usual care exercise programs had the same frequency and duration (50 minutes per session, twice weekly for 12 weeks), and all exercise sessions were held on site at the facilities. The usual care program was a strength, flexibility, and endurance program based on programs that were being conducted in the participating facilities. It included a warm-up (range-of-motion exercises and stretching), upper and lower extremity strength exercises, aerobic activities, and a cool-down and was conducted with the participants sitting.

Intervention. The OTM program consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and cool down exercises, with most of the exercises conducted in a standing position (40 minutes) and the remainder (10 minutes) sitting. The stepping and walking patterns were designed to promote the timing and coordination of stepping, integrated with the phases of the gait pattern.

Main Results. The average participant age was 80.0 (SD, 8.1) years, most participants were female (84.2%) and white (83.65%), and the average number of chronic conditions was 2.8 (SD, 1.4). The 2 groups were similar except for small differences in facility type. 142 (93.4%) OTM participants and 139 (95.2%) usual care participants completed post-intervention testing. The OTM group had significantly greater mean (SD) improvements than the usual care group in gait speed (0.05 [0.13] m/s versus −0.01 [0.11] m/s; adjusted difference 0.05 [0.02] m/s; P = 0.002) and 6MWD (20.6 [57.1] m versus 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = 0.03). Class attendance was lower in the OTM group than in the usual care group (76 [50.0%] OTM participants versus 95 [65.1%] usual care participants attended at least 20 classes; P = 0.03). There were no other significant differences between the groups in primary or secondary outcomes.

Conclusion. The OTM intervention was more effective at improving mobility than a usual care exercise program.

Commentary

The ability to walk is fundamental to maintaining a high quality of life and living independently in the community. Walking difficulty is a common problem among older persons and is linked to higher rates of loss of independence, morbidity, disability, and mortality in this population [1,2]. Walking difficulty associated with aging is often reflected in reduced gait speed and walking distance. A decline in gait speed of as little as 1 m/s is associated with a 10% decrease in ability to perform activities of daily living [3,4].

According to the authors, previous studies that explored the impact of structured exercise programs on walking ability in older individuals have had mixed results. These studies typically used exercise interventions focused on improving lower extremity muscle strength, flexibility, and general conditioning. In this study, the authors examined a community-based group exercise program (OTM) that incorporated exercises targeting the timing and coordination of movement important for walking in addition to flexibility and strengthening exercises. The results showed that the OTM program was more effective at improving walking ability than usual care. This intervention produced changes in gait speed (0.5 m/s) and 6MWD (16.7 m) that met or nearly met the clinically meaningful change criteria established for research use (0.5 m/s and 20 m, respectively) [5].

The authors pointed out several strengths of this study. First, the OTM program was compared to a usual care exercise program taught by trained exercise professionals, making it more difficult to demonstrate a difference between the 2 interventions. Similar prior studies have used nonexercise controls as the comparator. In addition, the effectiveness of the OTM program was demonstrated in 3 different community settings, suggesting that it can be implemented in various settings. Finally, the study participants were frail, older-old adults, who typically are not included in exercise studies. An important limitation of this study is that because outcomes were measured only at the conclusion of the intervention, it is not known whether the walking improvements persist over time or what effects the intervention has on mobility, function, and disability over the long term.

Applications for Clinical Practice

This study adds to the current literature on group exercise programs for improving mobility among community-dwelling older adults and supports incorporation of timing and coordination exercises into such programs. As the authors note, however, follow-up studies exploring the impact of the OTM intervention on long-term disability outcomes are needed before routine implementation in clinical practice can be recommended.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To compare the effectiveness of a group exercise program focusing on the timing and coordination of movement (ie, On the Move [OTM]) with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability in older adults.

Design. Cross-sectional pilot study.

Setting and participants. Participants were community-dwelling older adults who were residents or members of 32 independent living facilities, senior apartment buildings, and community centers in the greater Pittsburgh, Pennsylvania, area. Participants were recruted between April 2012 and January 2014. Inclusion criteria included age 65 years or older, ability to walk independently with a gait speed of at least 0.60 m/s, and ability to follow 2-step commands. Individuals were excluded if they were non-English speaking, medically unstable, planning to leave the area for an extended time period, or had abnormal blood pressure or heart rate following a 6-minute walk test. The 32 participating facilities were randomly assigned to the OTM intervention (16 sites, 152 participants) or usual care (16 sites, 146 participants). The OTM and usual care exercise programs had the same frequency and duration (50 minutes per session, twice weekly for 12 weeks), and all exercise sessions were held on site at the facilities. The usual care program was a strength, flexibility, and endurance program based on programs that were being conducted in the participating facilities. It included a warm-up (range-of-motion exercises and stretching), upper and lower extremity strength exercises, aerobic activities, and a cool-down and was conducted with the participants sitting.

Intervention. The OTM program consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and cool down exercises, with most of the exercises conducted in a standing position (40 minutes) and the remainder (10 minutes) sitting. The stepping and walking patterns were designed to promote the timing and coordination of stepping, integrated with the phases of the gait pattern.

Main Results. The average participant age was 80.0 (SD, 8.1) years, most participants were female (84.2%) and white (83.65%), and the average number of chronic conditions was 2.8 (SD, 1.4). The 2 groups were similar except for small differences in facility type. 142 (93.4%) OTM participants and 139 (95.2%) usual care participants completed post-intervention testing. The OTM group had significantly greater mean (SD) improvements than the usual care group in gait speed (0.05 [0.13] m/s versus −0.01 [0.11] m/s; adjusted difference 0.05 [0.02] m/s; P = 0.002) and 6MWD (20.6 [57.1] m versus 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = 0.03). Class attendance was lower in the OTM group than in the usual care group (76 [50.0%] OTM participants versus 95 [65.1%] usual care participants attended at least 20 classes; P = 0.03). There were no other significant differences between the groups in primary or secondary outcomes.

Conclusion. The OTM intervention was more effective at improving mobility than a usual care exercise program.

Commentary

The ability to walk is fundamental to maintaining a high quality of life and living independently in the community. Walking difficulty is a common problem among older persons and is linked to higher rates of loss of independence, morbidity, disability, and mortality in this population [1,2]. Walking difficulty associated with aging is often reflected in reduced gait speed and walking distance. A decline in gait speed of as little as 1 m/s is associated with a 10% decrease in ability to perform activities of daily living [3,4].

According to the authors, previous studies that explored the impact of structured exercise programs on walking ability in older individuals have had mixed results. These studies typically used exercise interventions focused on improving lower extremity muscle strength, flexibility, and general conditioning. In this study, the authors examined a community-based group exercise program (OTM) that incorporated exercises targeting the timing and coordination of movement important for walking in addition to flexibility and strengthening exercises. The results showed that the OTM program was more effective at improving walking ability than usual care. This intervention produced changes in gait speed (0.5 m/s) and 6MWD (16.7 m) that met or nearly met the clinically meaningful change criteria established for research use (0.5 m/s and 20 m, respectively) [5].

The authors pointed out several strengths of this study. First, the OTM program was compared to a usual care exercise program taught by trained exercise professionals, making it more difficult to demonstrate a difference between the 2 interventions. Similar prior studies have used nonexercise controls as the comparator. In addition, the effectiveness of the OTM program was demonstrated in 3 different community settings, suggesting that it can be implemented in various settings. Finally, the study participants were frail, older-old adults, who typically are not included in exercise studies. An important limitation of this study is that because outcomes were measured only at the conclusion of the intervention, it is not known whether the walking improvements persist over time or what effects the intervention has on mobility, function, and disability over the long term.

Applications for Clinical Practice

This study adds to the current literature on group exercise programs for improving mobility among community-dwelling older adults and supports incorporation of timing and coordination exercises into such programs. As the authors note, however, follow-up studies exploring the impact of the OTM intervention on long-term disability outcomes are needed before routine implementation in clinical practice can be recommended.

—Ajay Dharod, MD, Wake Forest School of Medicine, Winston-Salem, NC

Study Overview

Objective. To evaluate the impact of addiction consultation during hospitalization on addiction severity and self-reported abstinence at 30 days post discharge.

Design. Prospective quasi-experimental study.

Setting and participants. 399 adults admitted to an urban academic medical center between 1 April 2015 and 1 April 2016 who screened as high risk for having an alcohol or drug use disorder (using the Alcohol Use Disorders Identification Test–Consumption and the National Institute on Drug Abuse single-question screen for drug use) or who were clinically identified by the primary nurse as having a substance use disorder. Pregnant patients, those who were unable to be interviewed due to medical reasons, and those who screened solely for marijuana use were excluded.

Intervention. The intervention was a multidisciplinary addiction consult team (ACT) comprising a psychiatrist, an internist with addiction expertise, advanced practice nurses, 3 social workers, a clinical pharmacist, a recovery coach, and a resource specialist. The ACT provided patients with a diagnosis and longitudinal management plan begun in the hospital including pharmacotherapy initiation when appropriate, motivational counseling, treatment planning, and direct linkage to ongoing addiction treatment upon discharge. The ACT was available to patients on 12 of the hospital’s 14 floors. Patients on the 2 floors where ACT was not implemented and patients who were eligible for inpatient addiction consults but did nor receive them served as controls. Control patients received access to a general psychiatry consult liaison team and floor social work, and management of control patients included withdrawal treatment and referral to outpatient addiction care.

Main outcome measures. The primary outcomes were change in Addiction Severity Index (ASI) composite score for alcohol and drug use and self-reported abstinence at 30 days post discharge compared to baseline. The ASI is a standardized instrument for assessing the severity of problems for patients with substance use disorder. Participants were assessed at enrollment (baseline) and at 30 and 90 days post discharge.

Main results. 256 patients received the intervention and 143 did not (control). Of the 399 participants, 265 completed the 30-day assessment, which showed that patients in the intervention group (n = 165) had a greater reduction in the ASI composite score for alcohol and drug use than patients in the control group (n = 100), with mean ASI-alcohol and ASI-drug decreases of 0.24 (vs 0.08, P < 0.001) and 0.05 (vs 0.02, P = 0.003), respectively. The intervention group also had a greater increase in number of days of abstinence than the control group (12.7 days vs 5.6 days, P < 0.001). These differences all remained statistically significant after controlling for age, gender, employment status, smoking status, and baseline addiction severity. The increase in abstinence days and reduction in alcohol use severity remained significantly greater in the intervention group 90 days after discharge.

Conclusion. Inpatient addiction consultation reduced alcohol and drug addiction severity and increased the number of days of abstinence in the 30 days following discharge.

Commentary

In the United States, national mortality rates due to unintentional overdose, driven largely by opioid misuse and abuse, have surpassed mortality due to HIV and motor vehicle accidents [1]. Individuals with substance use disorder frequently use hospital services for management of acute problems, and up to 1 in 7 hospitalized patients has an active substance use disorder [2]. Hospitalization thus provides an opportunity to engage these patients in addiction treatment. Evidence supports the use of several interventions for patients with substance use disorders in the general medical setting [2–5], but implementation of these interventions in clinical practice remains limited.

This study adds to the literature demonstrating the efficacy of hospital-based interventions for substance abuse disorders. The authors note that the ACT intervention combined pharmacotherapy and behavioral interventions that were shown in prior studies to improve treatment retention, decrease substance use, and reduce hospital readmission. In addition to reducing alcohol/drug addiction severity and increasing days of abstinence at 1 month follow-up, the ACT intervention also reduced the number of self-reported hospital and emergency department visits by treated patients for substance use issues. The effects of the intervention on abstinence days and alcohol use severity were still evident after 3 months, suggesting that similar interventions can have benefits over the long term.

The authors highlighted several limitations of this study, including lack of randomization, which led to differences between the 2 groups on several variables. They controlled for these differences in their analysis, but there is still the potential for confounding. Also, the outcomes data was gathered through patient self-reporting without biological confirmation; however, as the authors note, this approach is widely used and self-report of substance use has shown good agreement with biological measures.

Applications for Clinical Practice

Hospitalization represents an opportunity to engage persons with substance abuse disorders in addiction treatment. This study demonstrates the effectiveness of a comprehensive inpatient substance use disorder intervention in improving substance-use–related outcomes in the first month after discharge. Further study of similar interventions in other care settings and for a longer duration is warranted.

—Ajay Dharod, MD, Wake Forest School of Medicine
Winston-Salem, NC

Study Overview

Objective. To evaluate the impact of addiction consultation during hospitalization on addiction severity and self-reported abstinence at 30 days post discharge.

Design. Prospective quasi-experimental study.

Setting and participants. 399 adults admitted to an urban academic medical center between 1 April 2015 and 1 April 2016 who screened as high risk for having an alcohol or drug use disorder (using the Alcohol Use Disorders Identification Test–Consumption and the National Institute on Drug Abuse single-question screen for drug use) or who were clinically identified by the primary nurse as having a substance use disorder. Pregnant patients, those who were unable to be interviewed due to medical reasons, and those who screened solely for marijuana use were excluded.

Intervention. The intervention was a multidisciplinary addiction consult team (ACT) comprising a psychiatrist, an internist with addiction expertise, advanced practice nurses, 3 social workers, a clinical pharmacist, a recovery coach, and a resource specialist. The ACT provided patients with a diagnosis and longitudinal management plan begun in the hospital including pharmacotherapy initiation when appropriate, motivational counseling, treatment planning, and direct linkage to ongoing addiction treatment upon discharge. The ACT was available to patients on 12 of the hospital’s 14 floors. Patients on the 2 floors where ACT was not implemented and patients who were eligible for inpatient addiction consults but did nor receive them served as controls. Control patients received access to a general psychiatry consult liaison team and floor social work, and management of control patients included withdrawal treatment and referral to outpatient addiction care.

Main outcome measures. The primary outcomes were change in Addiction Severity Index (ASI) composite score for alcohol and drug use and self-reported abstinence at 30 days post discharge compared to baseline. The ASI is a standardized instrument for assessing the severity of problems for patients with substance use disorder. Participants were assessed at enrollment (baseline) and at 30 and 90 days post discharge.

Main results. 256 patients received the intervention and 143 did not (control). Of the 399 participants, 265 completed the 30-day assessment, which showed that patients in the intervention group (n = 165) had a greater reduction in the ASI composite score for alcohol and drug use than patients in the control group (n = 100), with mean ASI-alcohol and ASI-drug decreases of 0.24 (vs 0.08, P < 0.001) and 0.05 (vs 0.02, P = 0.003), respectively. The intervention group also had a greater increase in number of days of abstinence than the control group (12.7 days vs 5.6 days, P < 0.001). These differences all remained statistically significant after controlling for age, gender, employment status, smoking status, and baseline addiction severity. The increase in abstinence days and reduction in alcohol use severity remained significantly greater in the intervention group 90 days after discharge.

Conclusion. Inpatient addiction consultation reduced alcohol and drug addiction severity and increased the number of days of abstinence in the 30 days following discharge.

Commentary

In the United States, national mortality rates due to unintentional overdose, driven largely by opioid misuse and abuse, have surpassed mortality due to HIV and motor vehicle accidents [1]. Individuals with substance use disorder frequently use hospital services for management of acute problems, and up to 1 in 7 hospitalized patients has an active substance use disorder [2]. Hospitalization thus provides an opportunity to engage these patients in addiction treatment. Evidence supports the use of several interventions for patients with substance use disorders in the general medical setting [2–5], but implementation of these interventions in clinical practice remains limited.

This study adds to the literature demonstrating the efficacy of hospital-based interventions for substance abuse disorders. The authors note that the ACT intervention combined pharmacotherapy and behavioral interventions that were shown in prior studies to improve treatment retention, decrease substance use, and reduce hospital readmission. In addition to reducing alcohol/drug addiction severity and increasing days of abstinence at 1 month follow-up, the ACT intervention also reduced the number of self-reported hospital and emergency department visits by treated patients for substance use issues. The effects of the intervention on abstinence days and alcohol use severity were still evident after 3 months, suggesting that similar interventions can have benefits over the long term.

The authors highlighted several limitations of this study, including lack of randomization, which led to differences between the 2 groups on several variables. They controlled for these differences in their analysis, but there is still the potential for confounding. Also, the outcomes data was gathered through patient self-reporting without biological confirmation; however, as the authors note, this approach is widely used and self-report of substance use has shown good agreement with biological measures.

Applications for Clinical Practice

Hospitalization represents an opportunity to engage persons with substance abuse disorders in addiction treatment. This study demonstrates the effectiveness of a comprehensive inpatient substance use disorder intervention in improving substance-use–related outcomes in the first month after discharge. Further study of similar interventions in other care settings and for a longer duration is warranted.

—Ajay Dharod, MD, Wake Forest School of Medicine
Winston-Salem, NC

Study Overview

Objective. To evaluate the impact of addiction consultation during hospitalization on addiction severity and self-reported abstinence at 30 days post discharge.

Design. Prospective quasi-experimental study.

Setting and participants. 399 adults admitted to an urban academic medical center between 1 April 2015 and 1 April 2016 who screened as high risk for having an alcohol or drug use disorder (using the Alcohol Use Disorders Identification Test–Consumption and the National Institute on Drug Abuse single-question screen for drug use) or who were clinically identified by the primary nurse as having a substance use disorder. Pregnant patients, those who were unable to be interviewed due to medical reasons, and those who screened solely for marijuana use were excluded.

Intervention. The intervention was a multidisciplinary addiction consult team (ACT) comprising a psychiatrist, an internist with addiction expertise, advanced practice nurses, 3 social workers, a clinical pharmacist, a recovery coach, and a resource specialist. The ACT provided patients with a diagnosis and longitudinal management plan begun in the hospital including pharmacotherapy initiation when appropriate, motivational counseling, treatment planning, and direct linkage to ongoing addiction treatment upon discharge. The ACT was available to patients on 12 of the hospital’s 14 floors. Patients on the 2 floors where ACT was not implemented and patients who were eligible for inpatient addiction consults but did nor receive them served as controls. Control patients received access to a general psychiatry consult liaison team and floor social work, and management of control patients included withdrawal treatment and referral to outpatient addiction care.

Main outcome measures. The primary outcomes were change in Addiction Severity Index (ASI) composite score for alcohol and drug use and self-reported abstinence at 30 days post discharge compared to baseline. The ASI is a standardized instrument for assessing the severity of problems for patients with substance use disorder. Participants were assessed at enrollment (baseline) and at 30 and 90 days post discharge.

Main results. 256 patients received the intervention and 143 did not (control). Of the 399 participants, 265 completed the 30-day assessment, which showed that patients in the intervention group (n = 165) had a greater reduction in the ASI composite score for alcohol and drug use than patients in the control group (n = 100), with mean ASI-alcohol and ASI-drug decreases of 0.24 (vs 0.08, P < 0.001) and 0.05 (vs 0.02, P = 0.003), respectively. The intervention group also had a greater increase in number of days of abstinence than the control group (12.7 days vs 5.6 days, P < 0.001). These differences all remained statistically significant after controlling for age, gender, employment status, smoking status, and baseline addiction severity. The increase in abstinence days and reduction in alcohol use severity remained significantly greater in the intervention group 90 days after discharge.

Conclusion. Inpatient addiction consultation reduced alcohol and drug addiction severity and increased the number of days of abstinence in the 30 days following discharge.

Commentary

In the United States, national mortality rates due to unintentional overdose, driven largely by opioid misuse and abuse, have surpassed mortality due to HIV and motor vehicle accidents [1]. Individuals with substance use disorder frequently use hospital services for management of acute problems, and up to 1 in 7 hospitalized patients has an active substance use disorder [2]. Hospitalization thus provides an opportunity to engage these patients in addiction treatment. Evidence supports the use of several interventions for patients with substance use disorders in the general medical setting [2–5], but implementation of these interventions in clinical practice remains limited.

This study adds to the literature demonstrating the efficacy of hospital-based interventions for substance abuse disorders. The authors note that the ACT intervention combined pharmacotherapy and behavioral interventions that were shown in prior studies to improve treatment retention, decrease substance use, and reduce hospital readmission. In addition to reducing alcohol/drug addiction severity and increasing days of abstinence at 1 month follow-up, the ACT intervention also reduced the number of self-reported hospital and emergency department visits by treated patients for substance use issues. The effects of the intervention on abstinence days and alcohol use severity were still evident after 3 months, suggesting that similar interventions can have benefits over the long term.

The authors highlighted several limitations of this study, including lack of randomization, which led to differences between the 2 groups on several variables. They controlled for these differences in their analysis, but there is still the potential for confounding. Also, the outcomes data was gathered through patient self-reporting without biological confirmation; however, as the authors note, this approach is widely used and self-report of substance use has shown good agreement with biological measures.

Applications for Clinical Practice

Hospitalization represents an opportunity to engage persons with substance abuse disorders in addiction treatment. This study demonstrates the effectiveness of a comprehensive inpatient substance use disorder intervention in improving substance-use–related outcomes in the first month after discharge. Further study of similar interventions in other care settings and for a longer duration is warranted.

—Ajay Dharod, MD, Wake Forest School of Medicine
Winston-Salem, NC

Study Overview

Objective. To evaluate patient navigation (PN) for breast, cervical, and colorectal cancer (CRC) screening using a population-based information technology (IT) system within a primary care network.

Design. Randomized clinical trial.

Setting and participants. Patients were from 18 primary care practices in the Massachusetts General Primary Care Practice-Based Research Network, which included 4 community health centers. The study used a population health IT application (TopCare [SRG Technology]) to identify patients overdue for breast, cervical and/or CRC screening. Women were deemed eligible and overdue for breast cancer [1] and cervical cancer [2] screening based on United States Preventive Services Task Force (USPSTF) recommendation statements. Patients aged 50 to 75 years without prior total colectomy were considered eligible for CRC screening and overdue if they did not have a colonoscopy in the past 10 years or sigmoidoscopy/barium enema/colonography in the past 5 years.

The study identified patients at high risk for non-adherence via a point system based on history of non-adherence to cancer screening tests, missed appointments, and primary language spoken (non-English speaking). A total of 1956 patients were identified, and after excluding those who were participating in an existing PN program, left the primary care network, died, or were lost to follow-up, the final study population consisted of 1612 patients overdue for at least 1 screening at the start of the study period.

Intervention: The intervention was a PN program comprising 4 part-time patient navigators with at least 2 years’ experience with cancer navigation and who worked 50% of their time in other PN programs. The navigators tracked intervention patients using the IT system, contacted them in their own language, and used extensive outreach efforts to assist them in completing their cancer screening. Most contact with patients took place via phone calls.

Main outcome measures. The primary outcome was the mean cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in intention-to-treat analyses. Secondary outcomes included assessing the proportion of patients completing any and each cancer screening during follow-up among those who were eligible and overdue for at least 1 cancer screening at baseline in intention-to-treat analyses. Additionally, as-treated analyses were conducted, in which patients who left the network or died during follow-up were removed from the intervention and control groups and patients who could not be reached were removed from the intervention group.

Results. A total of 792 patients were randomized to theintervention group (PN) and 820 patients were randomized to usual care. The mean age in the intervention and control groups was 56.9 and 57.1 years, respectively. The intervention and control groups were well-matched in terms of sex, primary language, insurance, proportion of patients connected to a specific physician or seen in a community health center, number of clinic visits over the past 3 years, and risk for nonadherence. Among patients eligible and overdue for cancer screening, mean cancer screening completion rates were higher in the intervention group compared with the control group for all cancers combined (10.2% vs 6.8%; 95% CI [for the difference] 1.5% to 5.2%; P < 0.001) and for breast (14.7% vs 11.0%; 95% CI 0.2% to 7.3%; P = 0.04), cervical (11.1% vs 5.7%; 95% CI 0.8% to 5.2%; P = 0.002), and colon (7.6% vs 4.6%;95% CI 0.8% to 5.2%; P = 0.01) cancer. The secondary outcome, the proportion of overdue patients who completed any cancer screening during follow-up, was higher in the intervention group (25.5% vs 17.0%; 95% CI 4.7% to 12.7%; P < 0.001). More patients in the intervention group completed screening for breast (23.4% vs 16.6%; 95% CI 1.8% to 12.0%; P = 0.009), cervical (14.4% vs 8.6%; 95% CI 1.6% to 10.5%; P = 0.007), and colorectal (13.7% vs 7.0%; 95% CI 3.2% to 10.4%; P < 0.001) cancer. The effect size increased in the as-treated analyses.

Conclusion. PN, using a health IT application, improved cancer screening completion rates among patients at high risk for nonadherence over an 8-month period in an academic primary care network.

Commentary

The potential of PN to help individuals traverse the complexity of the current health care system continues to attract great interest as value-based care becomes a reality for physicians and health systems. Several studies have demonstrated PN to be an effective modality to improve adherence to recommended screenings [3–5]; however, issues surrounding cost, patient perception, and the “outsourcing” of care from the primary care physician to navigators require attention. At this time, the most robust aggregation of data demonstrating benefit outweighing harm for cancer screening is published by the USPSTF [6]. Breast cancer [7], cervical cancer [8], and CRC [9] have the greatest weight of evidence to support screening.

The study was conducted at a single academic medical center with established IT infrastructure and an established PN program, which limits application of the results to large networked organizations and/or private practice settings. One important limitation in the CRC screening component was the lack of alternatives to colonoscopy. Studies have demonstrated greater adherence to CRC screening with methods other than colonoscopy [10], especially among racial/ethnic minorities. Although the authors estimate the intervention cost approximately $100,000, the study does not include the cost of the population health IT solution. The costs associated with both the IT solution in addition to PN may ultimately outweigh the benefits. The short time frame of the study may also limit effect size and add to long-term cost considerations. Lastly, a high percentage of patients randomized to the intervention group were unable to be contacted, declined PN services, had competing comorbidities, or were screened elsewhere. On the other hand, the study has several strengths. Statistically, the study utilized intention-to-treat analyses, where estimate of treatment effect is generally conservative. As compared to the current literature, the authors evaluate 3 different types of cancer—a pragmatic approach from a clinician’s perspective. Additionally, the authors focused efforts on individuals at high risk for nonadherence, a strategy also practicable by clinicians. Another realistic element of the study is that patient navigators had other responsibilities, which implies applicability to resource-limited settings.

Applications for Clinical Practice

PN has been shown to be an effective means of improving population-based health outcomes, and this study demonstrates it improves cancer screening rates, assuming the appropriate IT infrastructure is in place. The costs and benefits of PN should be assessed when considering use of PN in nonadherent populations, and PN interventions should be tailored to available resources and the unique practice environment.

—Ajay Dharod, MD

Study Overview

Objective. To evaluate patient navigation (PN) for breast, cervical, and colorectal cancer (CRC) screening using a population-based information technology (IT) system within a primary care network.

Design. Randomized clinical trial.

Setting and participants. Patients were from 18 primary care practices in the Massachusetts General Primary Care Practice-Based Research Network, which included 4 community health centers. The study used a population health IT application (TopCare [SRG Technology]) to identify patients overdue for breast, cervical and/or CRC screening. Women were deemed eligible and overdue for breast cancer [1] and cervical cancer [2] screening based on United States Preventive Services Task Force (USPSTF) recommendation statements. Patients aged 50 to 75 years without prior total colectomy were considered eligible for CRC screening and overdue if they did not have a colonoscopy in the past 10 years or sigmoidoscopy/barium enema/colonography in the past 5 years.

The study identified patients at high risk for non-adherence via a point system based on history of non-adherence to cancer screening tests, missed appointments, and primary language spoken (non-English speaking). A total of 1956 patients were identified, and after excluding those who were participating in an existing PN program, left the primary care network, died, or were lost to follow-up, the final study population consisted of 1612 patients overdue for at least 1 screening at the start of the study period.

Intervention: The intervention was a PN program comprising 4 part-time patient navigators with at least 2 years’ experience with cancer navigation and who worked 50% of their time in other PN programs. The navigators tracked intervention patients using the IT system, contacted them in their own language, and used extensive outreach efforts to assist them in completing their cancer screening. Most contact with patients took place via phone calls.

Main outcome measures. The primary outcome was the mean cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in intention-to-treat analyses. Secondary outcomes included assessing the proportion of patients completing any and each cancer screening during follow-up among those who were eligible and overdue for at least 1 cancer screening at baseline in intention-to-treat analyses. Additionally, as-treated analyses were conducted, in which patients who left the network or died during follow-up were removed from the intervention and control groups and patients who could not be reached were removed from the intervention group.

Results. A total of 792 patients were randomized to theintervention group (PN) and 820 patients were randomized to usual care. The mean age in the intervention and control groups was 56.9 and 57.1 years, respectively. The intervention and control groups were well-matched in terms of sex, primary language, insurance, proportion of patients connected to a specific physician or seen in a community health center, number of clinic visits over the past 3 years, and risk for nonadherence. Among patients eligible and overdue for cancer screening, mean cancer screening completion rates were higher in the intervention group compared with the control group for all cancers combined (10.2% vs 6.8%; 95% CI [for the difference] 1.5% to 5.2%; P < 0.001) and for breast (14.7% vs 11.0%; 95% CI 0.2% to 7.3%; P = 0.04), cervical (11.1% vs 5.7%; 95% CI 0.8% to 5.2%; P = 0.002), and colon (7.6% vs 4.6%;95% CI 0.8% to 5.2%; P = 0.01) cancer. The secondary outcome, the proportion of overdue patients who completed any cancer screening during follow-up, was higher in the intervention group (25.5% vs 17.0%; 95% CI 4.7% to 12.7%; P < 0.001). More patients in the intervention group completed screening for breast (23.4% vs 16.6%; 95% CI 1.8% to 12.0%; P = 0.009), cervical (14.4% vs 8.6%; 95% CI 1.6% to 10.5%; P = 0.007), and colorectal (13.7% vs 7.0%; 95% CI 3.2% to 10.4%; P < 0.001) cancer. The effect size increased in the as-treated analyses.

Conclusion. PN, using a health IT application, improved cancer screening completion rates among patients at high risk for nonadherence over an 8-month period in an academic primary care network.

Commentary

The potential of PN to help individuals traverse the complexity of the current health care system continues to attract great interest as value-based care becomes a reality for physicians and health systems. Several studies have demonstrated PN to be an effective modality to improve adherence to recommended screenings [3–5]; however, issues surrounding cost, patient perception, and the “outsourcing” of care from the primary care physician to navigators require attention. At this time, the most robust aggregation of data demonstrating benefit outweighing harm for cancer screening is published by the USPSTF [6]. Breast cancer [7], cervical cancer [8], and CRC [9] have the greatest weight of evidence to support screening.

The study was conducted at a single academic medical center with established IT infrastructure and an established PN program, which limits application of the results to large networked organizations and/or private practice settings. One important limitation in the CRC screening component was the lack of alternatives to colonoscopy. Studies have demonstrated greater adherence to CRC screening with methods other than colonoscopy [10], especially among racial/ethnic minorities. Although the authors estimate the intervention cost approximately $100,000, the study does not include the cost of the population health IT solution. The costs associated with both the IT solution in addition to PN may ultimately outweigh the benefits. The short time frame of the study may also limit effect size and add to long-term cost considerations. Lastly, a high percentage of patients randomized to the intervention group were unable to be contacted, declined PN services, had competing comorbidities, or were screened elsewhere. On the other hand, the study has several strengths. Statistically, the study utilized intention-to-treat analyses, where estimate of treatment effect is generally conservative. As compared to the current literature, the authors evaluate 3 different types of cancer—a pragmatic approach from a clinician’s perspective. Additionally, the authors focused efforts on individuals at high risk for nonadherence, a strategy also practicable by clinicians. Another realistic element of the study is that patient navigators had other responsibilities, which implies applicability to resource-limited settings.

Applications for Clinical Practice

PN has been shown to be an effective means of improving population-based health outcomes, and this study demonstrates it improves cancer screening rates, assuming the appropriate IT infrastructure is in place. The costs and benefits of PN should be assessed when considering use of PN in nonadherent populations, and PN interventions should be tailored to available resources and the unique practice environment.

—Ajay Dharod, MD

Study Overview

Objective. To evaluate patient navigation (PN) for breast, cervical, and colorectal cancer (CRC) screening using a population-based information technology (IT) system within a primary care network.

Design. Randomized clinical trial.

Setting and participants. Patients were from 18 primary care practices in the Massachusetts General Primary Care Practice-Based Research Network, which included 4 community health centers. The study used a population health IT application (TopCare [SRG Technology]) to identify patients overdue for breast, cervical and/or CRC screening. Women were deemed eligible and overdue for breast cancer [1] and cervical cancer [2] screening based on United States Preventive Services Task Force (USPSTF) recommendation statements. Patients aged 50 to 75 years without prior total colectomy were considered eligible for CRC screening and overdue if they did not have a colonoscopy in the past 10 years or sigmoidoscopy/barium enema/colonography in the past 5 years.

The study identified patients at high risk for non-adherence via a point system based on history of non-adherence to cancer screening tests, missed appointments, and primary language spoken (non-English speaking). A total of 1956 patients were identified, and after excluding those who were participating in an existing PN program, left the primary care network, died, or were lost to follow-up, the final study population consisted of 1612 patients overdue for at least 1 screening at the start of the study period.

Intervention: The intervention was a PN program comprising 4 part-time patient navigators with at least 2 years’ experience with cancer navigation and who worked 50% of their time in other PN programs. The navigators tracked intervention patients using the IT system, contacted them in their own language, and used extensive outreach efforts to assist them in completing their cancer screening. Most contact with patients took place via phone calls.

Main outcome measures. The primary outcome was the mean cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in intention-to-treat analyses. Secondary outcomes included assessing the proportion of patients completing any and each cancer screening during follow-up among those who were eligible and overdue for at least 1 cancer screening at baseline in intention-to-treat analyses. Additionally, as-treated analyses were conducted, in which patients who left the network or died during follow-up were removed from the intervention and control groups and patients who could not be reached were removed from the intervention group.

Results. A total of 792 patients were randomized to theintervention group (PN) and 820 patients were randomized to usual care. The mean age in the intervention and control groups was 56.9 and 57.1 years, respectively. The intervention and control groups were well-matched in terms of sex, primary language, insurance, proportion of patients connected to a specific physician or seen in a community health center, number of clinic visits over the past 3 years, and risk for nonadherence. Among patients eligible and overdue for cancer screening, mean cancer screening completion rates were higher in the intervention group compared with the control group for all cancers combined (10.2% vs 6.8%; 95% CI [for the difference] 1.5% to 5.2%; P < 0.001) and for breast (14.7% vs 11.0%; 95% CI 0.2% to 7.3%; P = 0.04), cervical (11.1% vs 5.7%; 95% CI 0.8% to 5.2%; P = 0.002), and colon (7.6% vs 4.6%;95% CI 0.8% to 5.2%; P = 0.01) cancer. The secondary outcome, the proportion of overdue patients who completed any cancer screening during follow-up, was higher in the intervention group (25.5% vs 17.0%; 95% CI 4.7% to 12.7%; P < 0.001). More patients in the intervention group completed screening for breast (23.4% vs 16.6%; 95% CI 1.8% to 12.0%; P = 0.009), cervical (14.4% vs 8.6%; 95% CI 1.6% to 10.5%; P = 0.007), and colorectal (13.7% vs 7.0%; 95% CI 3.2% to 10.4%; P < 0.001) cancer. The effect size increased in the as-treated analyses.

Conclusion. PN, using a health IT application, improved cancer screening completion rates among patients at high risk for nonadherence over an 8-month period in an academic primary care network.

Commentary

The potential of PN to help individuals traverse the complexity of the current health care system continues to attract great interest as value-based care becomes a reality for physicians and health systems. Several studies have demonstrated PN to be an effective modality to improve adherence to recommended screenings [3–5]; however, issues surrounding cost, patient perception, and the “outsourcing” of care from the primary care physician to navigators require attention. At this time, the most robust aggregation of data demonstrating benefit outweighing harm for cancer screening is published by the USPSTF [6]. Breast cancer [7], cervical cancer [8], and CRC [9] have the greatest weight of evidence to support screening.

The study was conducted at a single academic medical center with established IT infrastructure and an established PN program, which limits application of the results to large networked organizations and/or private practice settings. One important limitation in the CRC screening component was the lack of alternatives to colonoscopy. Studies have demonstrated greater adherence to CRC screening with methods other than colonoscopy [10], especially among racial/ethnic minorities. Although the authors estimate the intervention cost approximately $100,000, the study does not include the cost of the population health IT solution. The costs associated with both the IT solution in addition to PN may ultimately outweigh the benefits. The short time frame of the study may also limit effect size and add to long-term cost considerations. Lastly, a high percentage of patients randomized to the intervention group were unable to be contacted, declined PN services, had competing comorbidities, or were screened elsewhere. On the other hand, the study has several strengths. Statistically, the study utilized intention-to-treat analyses, where estimate of treatment effect is generally conservative. As compared to the current literature, the authors evaluate 3 different types of cancer—a pragmatic approach from a clinician’s perspective. Additionally, the authors focused efforts on individuals at high risk for nonadherence, a strategy also practicable by clinicians. Another realistic element of the study is that patient navigators had other responsibilities, which implies applicability to resource-limited settings.

Applications for Clinical Practice

PN has been shown to be an effective means of improving population-based health outcomes, and this study demonstrates it improves cancer screening rates, assuming the appropriate IT infrastructure is in place. The costs and benefits of PN should be assessed when considering use of PN in nonadherent populations, and PN interventions should be tailored to available resources and the unique practice environment.

—Ajay Dharod, MD

Study Overview

Objective. To determine the efficacy and safety of delayed antibiotic prescribing strategies in acute uncomplicated respiratory infections.

Design. Randomized, multicenter, open-label clinical trial.

Setting and participants. The setting was 23 primary care centers in Spain. The study recruited patients who were 18 years of age or older with an acute uncomplicated respiratory infection (acute pharyngitis, rhinosinusitis, acute bronchitis, exacerbations of chronic bronchitis or mild to moderate chronic obstructive pulmonary disease). Patients with these infections were included by the physicians as long as they were unsure of whether to use antibiotics or not. The study protocol has been published elsewhere [1].

Intervention. Patients were randomized to 1 of 4 potential prescription strategies: (1) a delayed patient-led prescription strategy where patients were given an antibiotic prescription at first consultation but instructed to fill the prescription only if they felt substantially worse or saw no improvement in symptoms in the first few days after initial consultation; (2) a delayed prescription collection strategy requiring patients to collect their prescription from the primary care center reception desk 3 days after the first consultation; (3) an immediate prescription strategy; or (4) no antibiotic strategy. The patient-led and delayed collection strategies were considered delayed prescription strategies.

Main outcome measures. Duration of symptoms and severity of symptoms. Patients filled out a daily questionnaire for a maximum of 30 days, which listed common symptoms such as fever, discomfort or general pain, cough, difficulty sleeping, and changes in everyday life, and specific symptoms according to condition. Patients assessed severity of their symptoms using 6-point Likert scale, with scores of 1-2 considered mild, 3-4 moderate, and 5-6 severe. Secondary outcomes included antibiotic use, patient satisfaction, patients’ beliefs in the effectiveness of antibiotics, and absenteeism (absence from work or doing their daily activities).

Main results. A total of 405 patients were recruited, 398 of whom were included in the analysis. 136 patients (34.2%) were men. The mean (SD) age was 45 (17) years and 265 patients (72%) had at least a secondary education level. The most common infection was pharyngitis (n = 184; 46.2%), followed by acute bronchitis (n = 128; 32.2%). The mean severity of symptoms ranged from 1.8 to 3.5 points on the Likert scale, and mean (SD) duration of symptoms described on first visit was 6 (6) days. The mean (SD) general health status on first visit was 54 (20) based on a scale with 0 indicating worst health status and 100 indicating best health status. 314 patients (80.1%) were nonsmokers, and 372 patients (93.5%) did not have a respiratory comorbidity. The presence of symptoms on first visit was similar among the 4 groups.

The duration of the common symptoms of fever, discomfort or general pain, and cough was shorter in the immediate prescription group versus the no prescription group (P < 0.05 for all). In the immediate prescription group, the duration of patient symptoms after first visit was significantly different from that of the prescription collection and patient-led prescription groups only for discomfort or general pain. The mean (SD) duration of severe symptoms was 3.6 (3.3) days for the immediate prescription group, 4.0 (4.2) days for the prescription collection group, 5.1 (6.3) days for the patient-led prescription group, and 4.7 (3.6) days for the no prescription group. The median (interquartile range [IQR]) of severe symptoms was 3 (1–4) days for the prescription collection group and 3 (2–6) days for the patient-led prescription group. The median (IQR) of the maximum severity for any symptom was 5 (3–5) for the immediate prescription group and the prescription collection group; 5 (4–5) for the patient-led prescription group; and 5 (4–6) for the no prescription group. Patients randomized to the no prescription strategy or to either of the delayed strategies used fewer antibiotics and less frequently believed in antibiotic effectiveness. Among patients in the immediate prescription group, 91.1% used antibiotics; in the delayed patient-led, delayed collection, and no prescription groups, the  rates of antibiotic use were 32.6%, 23.0%, and 12.1%, respectively. There were very few adverse events across groups, although the no prescription group had 3 adverse events compared with 0-1 in the other groups. Satisfaction was similar across groups.

Conclusion. Delayed strategies were associated with slightly greater but clinically similar symptom burden and duration and also with substantially reduced antibiotic use when compared with an immediate strategy.

Commentary

Acute respiratory infections are a common reasons for physician visits. These infections tend to be self-limiting and overuse of antibiotics for these infections is widespread. Approximately 60% of patients with a sore throat and ~70% of patients with acute uncomplicated bronchitis receive antibiotic prescriptions despite the literature suggesting no or limited benefit [2,3].Antibiotic resistance is a growing problem and the main cause of this problem is misuse of antibiotics.

Often physicians feel pressured into prescribing anti-biotics due to patient expectation and patient satisfaction metrics. In the face of the critical need to reduce overuse, delayed antibiotic prescribing strategies offers a compromise between immediate and no prescription [4]. Delayed prescribing strategies have been evaluated previously [5–8], with findings suggesting they do reduce antibiotic use. This study strengthens the evidence base supporting the delayed strategy.

This study has a few limitations. The sample size was small, and symptom data was obtained via patient self-report. In addition, the randomization procedure was not described. However, the investigators were able to achieve good patient retention, with very few patients lost to follow-up. The investigators used an intention to treat analysis; thus, the estimate of treatment effect size can be considered conservative.

In terms of baseline characteristics of the study participants, there was a lower overall education level, fewer smokers, and less respiratory comorbidity (defined as only cardiovascular comorbidity [P = 0.12] and diabetes [P = 0.19]) in the patient-led group. Otherwise, groups were very well-matched. Most patients in the study had pharyngitis and bronchitis, limiting the inferences for patients with rhinosinusitis or exacerbation of mild-to-moderate COPD.

Applications for Clinical Practice

Delayed antibiotic prescribing for acute uncomplicated respiratory infections appears to be an acceptable strategy for reducing the overuse of antibiotics. As patients may lack knowledge of this prescribing strategy [9], clinicians may need to spend time explaining the concept. Using the term “back-up antibiotics” instead of “delayed prescription” [10] may help to increase patients’ understanding and acceptance.

—Ajay Dharod, MD

Study Overview

Objective. To determine the efficacy and safety of delayed antibiotic prescribing strategies in acute uncomplicated respiratory infections.

Design. Randomized, multicenter, open-label clinical trial.

Setting and participants. The setting was 23 primary care centers in Spain. The study recruited patients who were 18 years of age or older with an acute uncomplicated respiratory infection (acute pharyngitis, rhinosinusitis, acute bronchitis, exacerbations of chronic bronchitis or mild to moderate chronic obstructive pulmonary disease). Patients with these infections were included by the physicians as long as they were unsure of whether to use antibiotics or not. The study protocol has been published elsewhere [1].

Intervention. Patients were randomized to 1 of 4 potential prescription strategies: (1) a delayed patient-led prescription strategy where patients were given an antibiotic prescription at first consultation but instructed to fill the prescription only if they felt substantially worse or saw no improvement in symptoms in the first few days after initial consultation; (2) a delayed prescription collection strategy requiring patients to collect their prescription from the primary care center reception desk 3 days after the first consultation; (3) an immediate prescription strategy; or (4) no antibiotic strategy. The patient-led and delayed collection strategies were considered delayed prescription strategies.

Main outcome measures. Duration of symptoms and severity of symptoms. Patients filled out a daily questionnaire for a maximum of 30 days, which listed common symptoms such as fever, discomfort or general pain, cough, difficulty sleeping, and changes in everyday life, and specific symptoms according to condition. Patients assessed severity of their symptoms using 6-point Likert scale, with scores of 1-2 considered mild, 3-4 moderate, and 5-6 severe. Secondary outcomes included antibiotic use, patient satisfaction, patients’ beliefs in the effectiveness of antibiotics, and absenteeism (absence from work or doing their daily activities).

Main results. A total of 405 patients were recruited, 398 of whom were included in the analysis. 136 patients (34.2%) were men. The mean (SD) age was 45 (17) years and 265 patients (72%) had at least a secondary education level. The most common infection was pharyngitis (n = 184; 46.2%), followed by acute bronchitis (n = 128; 32.2%). The mean severity of symptoms ranged from 1.8 to 3.5 points on the Likert scale, and mean (SD) duration of symptoms described on first visit was 6 (6) days. The mean (SD) general health status on first visit was 54 (20) based on a scale with 0 indicating worst health status and 100 indicating best health status. 314 patients (80.1%) were nonsmokers, and 372 patients (93.5%) did not have a respiratory comorbidity. The presence of symptoms on first visit was similar among the 4 groups.

The duration of the common symptoms of fever, discomfort or general pain, and cough was shorter in the immediate prescription group versus the no prescription group (P < 0.05 for all). In the immediate prescription group, the duration of patient symptoms after first visit was significantly different from that of the prescription collection and patient-led prescription groups only for discomfort or general pain. The mean (SD) duration of severe symptoms was 3.6 (3.3) days for the immediate prescription group, 4.0 (4.2) days for the prescription collection group, 5.1 (6.3) days for the patient-led prescription group, and 4.7 (3.6) days for the no prescription group. The median (interquartile range [IQR]) of severe symptoms was 3 (1–4) days for the prescription collection group and 3 (2–6) days for the patient-led prescription group. The median (IQR) of the maximum severity for any symptom was 5 (3–5) for the immediate prescription group and the prescription collection group; 5 (4–5) for the patient-led prescription group; and 5 (4–6) for the no prescription group. Patients randomized to the no prescription strategy or to either of the delayed strategies used fewer antibiotics and less frequently believed in antibiotic effectiveness. Among patients in the immediate prescription group, 91.1% used antibiotics; in the delayed patient-led, delayed collection, and no prescription groups, the  rates of antibiotic use were 32.6%, 23.0%, and 12.1%, respectively. There were very few adverse events across groups, although the no prescription group had 3 adverse events compared with 0-1 in the other groups. Satisfaction was similar across groups.

Conclusion. Delayed strategies were associated with slightly greater but clinically similar symptom burden and duration and also with substantially reduced antibiotic use when compared with an immediate strategy.

Commentary

Acute respiratory infections are a common reasons for physician visits. These infections tend to be self-limiting and overuse of antibiotics for these infections is widespread. Approximately 60% of patients with a sore throat and ~70% of patients with acute uncomplicated bronchitis receive antibiotic prescriptions despite the literature suggesting no or limited benefit [2,3].Antibiotic resistance is a growing problem and the main cause of this problem is misuse of antibiotics.

Often physicians feel pressured into prescribing anti-biotics due to patient expectation and patient satisfaction metrics. In the face of the critical need to reduce overuse, delayed antibiotic prescribing strategies offers a compromise between immediate and no prescription [4]. Delayed prescribing strategies have been evaluated previously [5–8], with findings suggesting they do reduce antibiotic use. This study strengthens the evidence base supporting the delayed strategy.

This study has a few limitations. The sample size was small, and symptom data was obtained via patient self-report. In addition, the randomization procedure was not described. However, the investigators were able to achieve good patient retention, with very few patients lost to follow-up. The investigators used an intention to treat analysis; thus, the estimate of treatment effect size can be considered conservative.

In terms of baseline characteristics of the study participants, there was a lower overall education level, fewer smokers, and less respiratory comorbidity (defined as only cardiovascular comorbidity [P = 0.12] and diabetes [P = 0.19]) in the patient-led group. Otherwise, groups were very well-matched. Most patients in the study had pharyngitis and bronchitis, limiting the inferences for patients with rhinosinusitis or exacerbation of mild-to-moderate COPD.

Applications for Clinical Practice

Delayed antibiotic prescribing for acute uncomplicated respiratory infections appears to be an acceptable strategy for reducing the overuse of antibiotics. As patients may lack knowledge of this prescribing strategy [9], clinicians may need to spend time explaining the concept. Using the term “back-up antibiotics” instead of “delayed prescription” [10] may help to increase patients’ understanding and acceptance.

—Ajay Dharod, MD

Study Overview

Objective. To determine the efficacy and safety of delayed antibiotic prescribing strategies in acute uncomplicated respiratory infections.

Design. Randomized, multicenter, open-label clinical trial.

Setting and participants. The setting was 23 primary care centers in Spain. The study recruited patients who were 18 years of age or older with an acute uncomplicated respiratory infection (acute pharyngitis, rhinosinusitis, acute bronchitis, exacerbations of chronic bronchitis or mild to moderate chronic obstructive pulmonary disease). Patients with these infections were included by the physicians as long as they were unsure of whether to use antibiotics or not. The study protocol has been published elsewhere [1].

Intervention. Patients were randomized to 1 of 4 potential prescription strategies: (1) a delayed patient-led prescription strategy where patients were given an antibiotic prescription at first consultation but instructed to fill the prescription only if they felt substantially worse or saw no improvement in symptoms in the first few days after initial consultation; (2) a delayed prescription collection strategy requiring patients to collect their prescription from the primary care center reception desk 3 days after the first consultation; (3) an immediate prescription strategy; or (4) no antibiotic strategy. The patient-led and delayed collection strategies were considered delayed prescription strategies.

Main outcome measures. Duration of symptoms and severity of symptoms. Patients filled out a daily questionnaire for a maximum of 30 days, which listed common symptoms such as fever, discomfort or general pain, cough, difficulty sleeping, and changes in everyday life, and specific symptoms according to condition. Patients assessed severity of their symptoms using 6-point Likert scale, with scores of 1-2 considered mild, 3-4 moderate, and 5-6 severe. Secondary outcomes included antibiotic use, patient satisfaction, patients’ beliefs in the effectiveness of antibiotics, and absenteeism (absence from work or doing their daily activities).

Main results. A total of 405 patients were recruited, 398 of whom were included in the analysis. 136 patients (34.2%) were men. The mean (SD) age was 45 (17) years and 265 patients (72%) had at least a secondary education level. The most common infection was pharyngitis (n = 184; 46.2%), followed by acute bronchitis (n = 128; 32.2%). The mean severity of symptoms ranged from 1.8 to 3.5 points on the Likert scale, and mean (SD) duration of symptoms described on first visit was 6 (6) days. The mean (SD) general health status on first visit was 54 (20) based on a scale with 0 indicating worst health status and 100 indicating best health status. 314 patients (80.1%) were nonsmokers, and 372 patients (93.5%) did not have a respiratory comorbidity. The presence of symptoms on first visit was similar among the 4 groups.

The duration of the common symptoms of fever, discomfort or general pain, and cough was shorter in the immediate prescription group versus the no prescription group (P < 0.05 for all). In the immediate prescription group, the duration of patient symptoms after first visit was significantly different from that of the prescription collection and patient-led prescription groups only for discomfort or general pain. The mean (SD) duration of severe symptoms was 3.6 (3.3) days for the immediate prescription group, 4.0 (4.2) days for the prescription collection group, 5.1 (6.3) days for the patient-led prescription group, and 4.7 (3.6) days for the no prescription group. The median (interquartile range [IQR]) of severe symptoms was 3 (1–4) days for the prescription collection group and 3 (2–6) days for the patient-led prescription group. The median (IQR) of the maximum severity for any symptom was 5 (3–5) for the immediate prescription group and the prescription collection group; 5 (4–5) for the patient-led prescription group; and 5 (4–6) for the no prescription group. Patients randomized to the no prescription strategy or to either of the delayed strategies used fewer antibiotics and less frequently believed in antibiotic effectiveness. Among patients in the immediate prescription group, 91.1% used antibiotics; in the delayed patient-led, delayed collection, and no prescription groups, the  rates of antibiotic use were 32.6%, 23.0%, and 12.1%, respectively. There were very few adverse events across groups, although the no prescription group had 3 adverse events compared with 0-1 in the other groups. Satisfaction was similar across groups.

Conclusion. Delayed strategies were associated with slightly greater but clinically similar symptom burden and duration and also with substantially reduced antibiotic use when compared with an immediate strategy.

Commentary

Acute respiratory infections are a common reasons for physician visits. These infections tend to be self-limiting and overuse of antibiotics for these infections is widespread. Approximately 60% of patients with a sore throat and ~70% of patients with acute uncomplicated bronchitis receive antibiotic prescriptions despite the literature suggesting no or limited benefit [2,3].Antibiotic resistance is a growing problem and the main cause of this problem is misuse of antibiotics.

Often physicians feel pressured into prescribing anti-biotics due to patient expectation and patient satisfaction metrics. In the face of the critical need to reduce overuse, delayed antibiotic prescribing strategies offers a compromise between immediate and no prescription [4]. Delayed prescribing strategies have been evaluated previously [5–8], with findings suggesting they do reduce antibiotic use. This study strengthens the evidence base supporting the delayed strategy.

This study has a few limitations. The sample size was small, and symptom data was obtained via patient self-report. In addition, the randomization procedure was not described. However, the investigators were able to achieve good patient retention, with very few patients lost to follow-up. The investigators used an intention to treat analysis; thus, the estimate of treatment effect size can be considered conservative.

In terms of baseline characteristics of the study participants, there was a lower overall education level, fewer smokers, and less respiratory comorbidity (defined as only cardiovascular comorbidity [P = 0.12] and diabetes [P = 0.19]) in the patient-led group. Otherwise, groups were very well-matched. Most patients in the study had pharyngitis and bronchitis, limiting the inferences for patients with rhinosinusitis or exacerbation of mild-to-moderate COPD.

Applications for Clinical Practice

Delayed antibiotic prescribing for acute uncomplicated respiratory infections appears to be an acceptable strategy for reducing the overuse of antibiotics. As patients may lack knowledge of this prescribing strategy [9], clinicians may need to spend time explaining the concept. Using the term “back-up antibiotics” instead of “delayed prescription” [10] may help to increase patients’ understanding and acceptance.

—Ajay Dharod, MD