Improved Patient Outcomes and Reduced Wait Times: Transforming a VA Outpatient Substance Use Disorder Program

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Systematic evaluation and redesign of a substance use disorder treatment program resulted in elimination of wait times, same-day treatment, and increased pharmacotherapy for patients with alcohol and opioid use disorders.

Substance use disorders (SUDs) are an increasing public health concern in the US. The 2015 National Survey on Drug Use and Health indicated that 27 million people (8% of the US population) reported current use of recreational drugs or misuse of alcohol or prescription medications.1 The 2013 National Survey on Drug Use and Health indicated that 1.5 million veterans (roughly 6.6%) met the criteria for a SUD.2 More than 50% of patients awaiting entry into a SUD treatment program will never achieve admission due, in part, to long wait times.3-5

National attention has been focused on increasing veteran access to quality treatment based on evidence-based practices (EBPs). Several national legislative measures and treatment protocols have been implemented: the Uniform Mental Health Services in US Department of Veterans Affairs (VA) medical centers and clinics; Veterans Access, Choice, and Accountability Act (2014); Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD) Training Program; and the Psychotropic Drug Safety Initiative (PDSI).6-8 Consistent with these directives and in line with American Society of Addiction Medicine (ASAM) and Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines for medication-assisted therapies (MAT),the James A. Haley Veterans’ Hospital (JAHVH) Mental Health and Behavioral Sciences Service (MH&BSS) Substance Use Disorders Service (SUDS) in Tampa, Florida, implemented an evidence-based, treatment-on-demand model of care.9-11

Meeting SUD Treatment Needs

What does the new supervisor of a clinical program do when a 24-employee outpatient VA Alcohol and Drug Addiction Treatment Program (ADATP) has an average 33-day wait time for treatment with 54% of patients lost to care between initial evaluation and admission?12 Patients lacked consistent access to SUD pharmacotherapy. The national VA clinical performance indicators were substandard and there are no additional resources available to apply to the program.

At JAHVH the program supervisor enlisted hospital leadership to support program redesign. The redesign sought to improve operational efficiency and eliminate patient wait time; adopt national standards for assessment and treatment developed by ASAM; implement strictly evidence-based psychotherapeutic treatments; educate program psychiatrists about evidence-based psychopharmacologic treatments and hold them accountable for patient adherence; streamline documentation templates; free clinical providers from nonclinical tasks; create an inpatient addiction consult team to diagnose and treat chronic hospitalized patients with SUDs; ensure continuity of care; and, standardize consistent, objective measures of patient response to treatment to track the program’s effectiveness.

In this article, the authors provide an explanation of the clinical, theoretical foundation and the practical steps taken to design and implement this transformation. They then describe the lessons learned, hoping that their process will serve as a model for those in similar situations.

Program Redesign

July 1, 2015, a new program supervisor was hired and began a 2-month evaluation and analysis of the program with input from leadership, staff, and hospital/community stakeholders. September 1, the monthlong process of developing the redesign began. On September 30 the plan was presented to, and approved by, MH&BSS leadership. October was spent preparing for change with an implementation date of November 2 selected. On November 2, 2015, the complete redesign was implemented.

 

 

Needs Assessment

A needs assessment yielded improvement opportunities in program structure (levels of care); clinical content; staff and resource allocation, including clinical workflow and management systems. Staff identified philosophical and practical variance in the program, often leading to confusion for patients and clinicians and potentially resulting in disparate quality care and patient outcomes. Recommendations for addressing these needs included incorporating ASAM guidelines for assignment to clinically appropriate levels of care, implementation of consistent EBPs for SUD and comorbid conditions,9 and emphasis on staff training and development to champion evidence-based program philosophy and service delivery.

The assessment determined that the average waitlist time was 33 days, and patients were required to abstain from substance or alcohol use prior to admission to the Intensive Outpatient Program. If a waitlisted patient relapsed, she or he was removed from the waitlist and denied admission. A study conducted at JAHVH reported that 54% of waitlisted patients in this clinic (prior to November 2, 2015) never were admitted to the program.12 Access to care was considered a significant issue.

Program Implementation

September was spent developing a comprehensive redesign of the SUD clinic. The vision included incorporating all ASAM levels of care; creating an evidence-based, treatment-on-demand model of care; and, securing the support of MH&BSS leadership team, staff, and patients for the redesign. The supervisory clinician interviewed staff both individually and as a group. Clinicians were provided extensive training on EBP for SUDs, including psychotherapies, psychosocial treatments, and psychopharmacologic interventions. A journal club was started with staff-generated topics that offered articles sharing current research, EBPs, and psychotherapeutic techniques, continuing education on substances, and management of coexisting diagnoses. Clinicians increased the frequency of SUD in-service trainings. Psychiatrists provided several Grand Rounds to the MH&BSS service. All counselors were assigned to 1 of the program’s 3 clinical psychologists for individual weekly clinical supervision.

By providing all staff with current, evidence-based, clinically relevant treatment information and emphasizing its relationship to successful patient outcomes, program leadership energized staff support. Staff were encouraged to perform at the top of their scope of practice and engage in training and consultation. Each staff member was delegated a role in the process to inspire buy-in.

Preparation for the Shift

October was spent preparing for a seamless, one-day implementation of proposed changes, including implementation of updated clinical policies, procedures, and document templates (rewritten to include only clinically appropriate information required by VA policy or the Joint Commission); streamlined staff schedules; and utilization of staff-developed and research/policy-driven EBP handbook. Finally, the Brief Addiction Monitor (BAM) was selected as objective criteria to consistently assess patient progress in treatment, and staff were instructed to use this measure at regular intervals and for all levels of care.

Emphasis was placed on ongoing fortification of staff and patient support for the reorganization. For example, the Addiction Severity Index, though not required by policy, was historically used, adding 90 minutes to the evaluation and admission session. Staff agreed to remove this measure to improve clinician availability. Staff were also empowered to rename the redesigned program, and chose Substance Use Disorders Service (SUDS).

 

 

Process Changes

To achieve same-day access to clinical care, program leadership created a daily morning orientation group. Patients are scheduled or may attend as a walk-in. The orientation’s purpose is to explain what services are available and to offer each patient an opportunity for immediate evaluation and treatment. Staff schedules were modified to provide patient evaluation appointment slots immediately following orientation. The number of immediate evaluation slots was initially assessed by analyzing the demand for treatment over the previous 6 months, determining the daily mean, and setting the number of slots to accommodate 3 standard deviations above the daily mean. If a patient in a daily orientation group expresses a willingness to engage in treatment, he or she is immediately evaluated by a counselor during a 90-minute session and seen by a psychiatrist to determine whether pharmacologic treatment would be appropriate. If needed, the medication is prescribed that day. The primary purpose of the patient’s initial clinical evaluation is to determine the most appropriate level of care based on ASAM criteria. Also available were 90-minute afternoon evaluation appointments with psychiatrists for patients who walk into the clinic after the morning orientation group had ended.

Prior to the redesign, clinic psychiatrists were minimally prescribing evidence-based pharmacotherapy for sobriety support. At the time of redesign, only 8% of patients diagnosed with opioid use disorders (OUDs) were prescribed buprenorphine/naloxone or naltrexone. Just 1.9% of patients diagnosed with alcohol use disorder (AUD) were prescribed naltrexone or acamprosate. With the redesign, access to these medications has significantly expanded.

All templates were redesigned to ensure consistent documentation. This change decreased the overall provider task burden, and explicitly supported the use of ASAM multidimensional criteria and the Brief Addiction Monitor (BAM) to identify a pretreatment baseline score and track each patient’s clinical progress.13 Evidence-based written curricula were standardized for individual and group psychotherapies to reduce provider and programmatic variation.

The redesign creates distinct levels of care based on ASAM criteria, including harm reduction, ambulatory detoxification, outpatient group and individual psychotherapy, an evidence-based Intensive Outpatient Program (IOP), and aftercare. Application of the ASAM standards has allowed clinicians to make accurate placement decisions that best meet individual patient needs and to serve as effective stewards even with limited treatment and financial resources. Although JAHVH does not have a residential SUD program, procedures were developed to refer veterans to community-based residential treatment programs when appropriate.

Group Therapies

With the redesign, SUDS was no longer exclusively a 12-step program; however, it still supported and recognized the value of this approach for some patients. A psychologist periodically audits group sessions to prevent drift from that group’s curriculum. Counselors are assigned to weekly hour-long clinical supervision sessions with a psychologist to review patient care and reinforce the application of evidence-based individualized treatment.

After reviewing empirical literature and VA directives, CBT-SUD was adopted. It encompasses individual and group interventions, such as motivational interviewing (MI), contingency management (CM), and medication-assisted therapies as primary therapeutic treatment modalities, all of which have demonstrated efficacy as measured by length of sobriety postintervention.9,14,15

 

 

Clinical Staff Improvements

Staff were reorganized into 3 interdisciplinary treatment teams. A weekly team meeting is scheduled to coordinate care and discuss the treatment of complex patients. Clinical staff focus has shifted from case-management to diagnosis and treatment; now patients are referred to their primary care team’s social worker for case management services. Allowing clinical staff to focus solely on the diagnosis and clinical treatment of SUDs has significantly enhanced productivity and morale.

Staff receive training in the newly adopted interventions during brief monthly refresher courses provided by inhouse psychologists. Additional training includes participation in local and national SUD teleconferences and onsite meetings with experts in harm reduction and motivational interventions. During the transition, clinicians were encouraged to attend staff resiliency training. Continuing education was available to the SUDS psychiatrists and all inpatient and outpatient psychiatrists at JAHVH. Recently, this educational initiative was expanded to include all primary care and inpatient internal medicine physicians.

Implementation

On November 2, 2015, all planned programmatic changes were simultaneously implemented. On that day, clinician and patient schedules changed, the new EBP curriculum was administered, the use of streamlined documentation procedures began, and daily orientation groups followed by same-day evaluations were initiated.

The pretreatment sobriety requirement was eliminated as a barrier to care, and the program began to use a harm-reduction treatment track as recommended by ASAM guidelines. Patients with urgent or emergent medical or psychiatric problems were immediately assessed by SUDS health care providers and treated in the clinic or transported to the emergency department. Previously unavailable, patient access to ambulatory detoxification was initiated. The prescription of buprenorphine/naloxone for the treatment of OUD treatments increased from 1 prescriber to all 3.

Three months after program reorganization, the leadership reviewed overall workflow, conducted patient satisfaction surveys, and evaluated facility use and productivity. To address patient needs and facilitate optimal use of space, the number of same-day evaluation slots was reduced while the number of individual therapy slots was increased.

Staff meet in workgroups to discuss EBPs and further refine content with feedback from the supervisory clinician and team psychologists who routinely audit group therapy sessions. Staff report ongoing benefit from weekly supervision with a clinical psychologist. An inpatient addiction consultation team that uses existing manpower and resources has been developed.

Program Goals and Outcomes

The SUDS program serves more patients at multiple levels of standardized care with 2 fewer full-time positions. One counselor and one advanced practice registered nurse were reallocated to different programs within the JAHVH VA mental health clinic. Following a review of all program clinic profiles in the VA’s Computerized Patient Record System (CPRS) for utilization, accuracy, and necessity, and allowing for accurate program data capture, the transition resulted in a reduction of distinct clinics from 114 to 67 (-58.7%). In fiscal year 2018, review of CPRS yielded 19,786 total visits (3,645 unique visits).

Eliminate Patient Wait Tme

Patient wait time, as measured in CPRS from date of initial evaluation to date of treatment was reduced from an average of 33 days to 0 within 2 weeks of program implementation. A review of CPRS data also indicated that preadmission attrition dropped from 54% to < 1%; all patients desiring treatment are assigned a counselor and treatment is initiated the same day.

 

 

Adopt ASAM Criteria

After the redesign, patients have received more appropriate care based on individualized treatment plans. Due to the implementation of a fluid and supportive model, patients can move through levels of care as clinical need dictates rather than failing treatment and having to reengage. Staff receive ongoing education on the use of ASAM. Evaluation and treatment plan templates now reflect assignment to level of care rationale using ASAM guidelines.

Use of Evidence-Based Psychotherapeutic Treatments

More consistent, coordinated, and effective psychotherapies have improved patient care. The program’s previous issues with patients receiving conflicting treatment guidance from different providers has been resolved. Duplicate and ineffective treatments, including multiple readmissions to the IOP level of care, overemphasis of abstinence-based modalities for patients in active use, and referrals to inpatient SUD care under the assumption that “higher level of care is better” have ceased through staff education, leadership support, and appropriate staffing and communication. Review of patient advocate complaints tracked by and resolved by the service demonstrated an 80% decrease in patient advocate complaints regarding SUD clinic services.

Implement Evidence-Based Psychopharmacologic Treatments

The pharmacotherapy education initiative yielded tangible benefits and is likely a significant contributor to the program’s improved clinical outcomes. Prescription of pharmacotherapy for patients with OUD has risen from 8% to 25.1% in eligible patients. Appropriate medication prescription for the treatment of AUD has risen from 1.9% to 9.8% in eligible patients. These data are reflected in the VA Pharmaceutical Drug Safety Initiative (PDSI) dashboard.

Streamline Documentation

Significantly reducing the charting burden was likely a significant contributor to increased provider productivity and improved patient outcomes. Regular meetings between SUDS leadership and clinical informatics ensure that standardized note templates meet hospital policy and gather all necessary accreditation information.

Improve Employee Morale

Increased staff morale is indicated by a noticeable reduction in employee sick days; a decrease of > 20% (over the same time period the previous year), per the VA electronic timekeeping system, during the first 6 months following the November 2 program implementation.

SUDS Inpatient Addiction Consult Team

In January of 2017, SUDS began an inpatient medicine consultation service to offer evaluation, pharmacotherapy, and supportive counseling to patients diagnosed with SUDs who had been admitted to inpatient medical and surgical services. This team includes existing SUDS staff members reallocated to the inpatient service, is led by a SUDS psychiatrist, and includes 3 multidisciplinary clinicians with extensive training in assessment, diagnosis, and treatment planning of SUDs and comorbid conditions. Prior to implementation, the SUDS inpatient addiction consult team met with hospital leadership and attending physicians for inpatient medicine and psychiatry physicians.

To access the SUDS inpatient addiction consult team, physicians request a consult. Patients are offered an evaluation and are assigned to a level of care with orders for outpatient appointments with a counselor and psychiatrist within 7 days of hospital discharge. Medication-assisted treatment for chronic SUDs is implemented while patients remain admitted to the inpatient medical service. In fiscal year 2018, the SUDS inpatient addiction consult team performed 1,428 inpatient evaluations.

 

 

Consistent Treatment Outcome Measures

The BAM is a clinical tool designed to measure patient outcomes in substance use disorders.13 Its 17-item scale measures substance use risk factors that may lead to relapse, and protective factors that are recovery-oriented behaviors that help prevent relapse. It demonstrates sensitivity to change and has excellent test-retest reliability. The BAM has been in use in the addictions treatment program since 2011 but was previously administered only after admission to the IOP and again after a 30- to 90-day follow-up period. Since the program redesign, all SUDS patients are administered the BAM at their initial evaluation and at each individual appointment thereafter. The initial BAM assessment encompasses the previous 30 days; this 30-day version is also used for monthly follow-ups. For BAM assessments that occur within 30 days from the time of the last evaluation, a 7-day version is used. Prior to the redesign, about 24% of patients received a follow-up 30-day BAM assessment.12 Per CPRS review of veterans participating in continued treatment, the rate rose to 100% 3 months after the redesign.

When program staff compared preredesign and postredesign BAM data, they detected significant clinical differences. Data demonstrate a 22.2% improvement in protective factors, including patient confidence in their ability to remain abstinent; engaging in self-help activities, such as attending Alcoholics Anonymous meetings; engaging in organized spiritual activities; going to school, working, or volunteering; securing a regular income; and time spent with friends or family who are supportive of recovery.

The data also show a marked reduction in substance use at follow-up points in treatment and a corresponding decrease in risk factors. One item of the BAM assesses patient level of satisfaction with their treatment. Since the redesign, patients report that they are “considerably” satisfied with their SUD treatment.

Currently, program staff are conducting a review of BAM scores by level of care to further parse the impact of various treatments and best target patient need using measurement-based care and EBP, such as contingency management, which provides small monetary incentives when patients maintain clean urine drug screens.16 In addition, the program plans to achieve more uniformity in BAM assessment intervals at all levels of care, and possibly also integrate BAM data into SUD group therapies. Correlation of the BAM scores to other metrics, such as readmission to inpatient medicine, relapse, urine drug screen, or critical laboratory values, will provide additional insight into impact of programmatic changes.

Discussion

Feedback from other clinics and services within the hospital has been very positive. Some providers have reported that they appreciate the ease and availability of access to SUDS. Additionally, patients engaged in treatment prior to the redesign have been contacted for an updated evaluation and assignment to a counselor and appropriate level of care. From the staff’s perspective, the shift to immediate access to care has allowed a more streamlined process with fewer hurdles for patient admission. Staff report that they now feel empowered to meet the needs of veterans in a comprehensive, same-day fashion.

 

 

The success of our redesign was contingent on internal and external stakeholder buy-in and input, clear communication of vision and rationale from leadership, with an emphasis on implementing an evidence-based, treatment-on-demand model of care that showed fidelity to VA and Joint Commission policy. Regular review and revision of local policies and procedures, both to support additional changes and improve access to high-quality care, were also critical to success. Revision of documentation to streamline staff workload encouraged an emphasis on patient care as an organizing principle of our changes. Support from leadership for ongoing, monthly trainings in evidence-based psychotherapies and pharmacologic treatments helped ensure continued professional development of skill and knowledge and improve the mental health outcomes of our patients. Staff were encouraged to attend roundtable discussions regarding program redesign. Program leadership considered staff as important stakeholders in the redesigned.

The successful implementation of these changes has revealed several important elements regarding patient care. The first lesson was that improving access and integrating best practices is possible without additional resources, outside monies, or disruption to patient services. With the support of MH&BSS leadership, the program streamlined existing processes and used both staff and clinic resources more efficiently.

The second lesson involved the importance of continually reviewing and revising standard operating procedures to match the needs of the current patient population. Policies and procedures that once were viewed as potential barriers to change have been replaced with a more flexible approach and willingness to evolve.

As a result, far fewer patients have been lost to treatment. The time and resources that staff historically dedicated to nonclinical patient care are now redirected to immediate service provision. This increase in operational efficiency and treatment efficacy has resulted in a boost to staff morale, even during a time of immense change and increased productivity. Program staff are now able to personally witness the significant changes in their patients’ lives and feel a sense of pride at being a member of a hard-working team that provides the highest quality of substance use treatment. This is critical to job satisfaction and meets the VA mission to provide timely, effective, and evidence-based treatments to patients.

Conclusion

JAHVH strives to continue to provide the highest quality of SUD treatment available. Future directions aim to streamline clinic operations by constantly monitoring and reviewing workloads, while also considering patient feedback. A continuous review of EBP is part of our clinic’s culture. Program leadership endeavors to promote an open environment where providers can share their triumphs and frustrations and foster a team approach to problem solving. Further plans include expanding the range of treatment levels offered by developing a residential SUD treatment facility.

References

1. Substance Abuse and Mental Health Services Administration. 2015 National Survey on Drug Use and Health: Summary of the Effects of the 2015 NSDUH Questionnaire Redesign: Implications for Data Users. https://www.samhsa.gov/data/sites/default/files/NSDUH-TrendBreak-2015.pdf. Published June 2016. Accessed June 12, 2019.

2. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014.

3. Donovan DM, Rosengren DB, Downey L, Cox GB, Sloan PDSKL. Attrition prevention with individuals awaiting publicly funded drug treatment. Addiction. 2001;96(8):1149-1160.

4. Hser Y, Maglione M, Polinsky ML, Anglin MD. Predicting treatment entry among treatment-seeking drug abusers. J Subst Abuse Treatment. 1997;15(3):213-220.

5. Stark MJ, Campbell BK, Brinkerhoff CV. “Hello, may we help you?” A study of attrition prevention at the time of the first phone contact with substance-abusing clients. Am J Drug Alcohol Abuse. 1990;16:67-76.

6. US Department of Veterans Affairs. Uniform Mental Health Services in VA Medical Centers and Clinics. VHA Handbook 1160.01. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1762. Updated November 2015. Accessed December 12, 2017.

7. Veterans Access, Choice and Accountability Act of 2014, 2 USC § 933.

8. DeMarce JM, Gnys M, Raffa SD, Karlin, BE. Cognitive Behavioral Therapy for Substance Use Disorders Among Veterans: Therapist Manual. Washington, DC: US Department of Veterans Affairs; 2014.

9. Mee-Lee D, Shulman GD, Fishman MJ, Gastfriend DR, Miller MM, eds. The ASAM Criteria: Treatment Criteria for Addictive, Substance-Related, and Co-Occurring Conditions. 3rd ed. Carson City, NV: The Change Companies; 2013.

10. Substance Abuse and Mental Health Services Administration and National Institute on Alcohol Abuse and Alcoholism. Medication for the Treatment of Alcohol Use Disorder: A Brief Guide. HHS Publication No. (SMA) 15-4907. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2015.

11. Substance Abuse and Mental Health Services Administration and National Institute on Alcohol Abuse and Alcoholism. Medication for Opioid Use Disorder – Full Document. HHS Publication No. (SMA) 18-5063FULLDOC. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2018.

12. Winn JL, Shealy SE, Kropp GJ, Felkins-Dohm D, Gonzales-Nolas C, Francis E. Housing assistance and case management: Improving access to substance use disorder treatment for homeless veterans. Psychological Serv. 2013;10(2):233-240.

13. Cacciola JS, Alterman AI, DePhilippis D, et al. Development and initial evaluation of the Brief Addiction Monitor (BAM). J Subst Abuse Treatment. 2013;44(3):256-263.

14. McHugh RK, Hearon BA, Otto MW. Cognitive-behavioral therapy for substance use disorders, Psychiatr Clinics North Am. 2010;33:511–525.

15. Karlin, BE, Cross, G. From the laboratory to the therapy room: national dissemination and implementation of evidence-based psychotherapies in the U.S. Department of Veterans Affairs health care system. Am Psychol. 2014;69:19-33.

16. DePhilippis D, Petry NM, Bonn-Miller MO, Rosenbach SB, McKay JR. The national implementation of contingency management (CM) in the Department of Veterans Affairs: attendance at CM sessions and substance use outcomes, Drug Alcohol Dependence. 2018;185:367-373.

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Cortney McCormick is Administrative Section Chief; William Hervey is a Supervisory Psychiatrist; Christopher Monahan is a Supervisory Psychologist; Jaime Winn is a Clinical Psychologist; Carri-Ann Gibson is Specialty Programs Section Chief; and Glenn Catalano is Associate Chief of Staff and Chief of the Mental Health and Behavioral Sciences Service; all at James A. Haley Veterans’ Hospital in Tampa, Florida. Carri-Ann Gibson is an Assistant Professor; William Hervey is an Associate Professor; and Glenn Catalano is a Professor; all at the University of South Florida College of Medicine in Tampa.
Correspondence: Glenn Catalano ([email protected])

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The authors report no actual or potential conflicts of interest with regard to this article.

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Cortney McCormick is Administrative Section Chief; William Hervey is a Supervisory Psychiatrist; Christopher Monahan is a Supervisory Psychologist; Jaime Winn is a Clinical Psychologist; Carri-Ann Gibson is Specialty Programs Section Chief; and Glenn Catalano is Associate Chief of Staff and Chief of the Mental Health and Behavioral Sciences Service; all at James A. Haley Veterans’ Hospital in Tampa, Florida. Carri-Ann Gibson is an Assistant Professor; William Hervey is an Associate Professor; and Glenn Catalano is a Professor; all at the University of South Florida College of Medicine in Tampa.
Correspondence: Glenn Catalano ([email protected])

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Author and Disclosure Information

Cortney McCormick is Administrative Section Chief; William Hervey is a Supervisory Psychiatrist; Christopher Monahan is a Supervisory Psychologist; Jaime Winn is a Clinical Psychologist; Carri-Ann Gibson is Specialty Programs Section Chief; and Glenn Catalano is Associate Chief of Staff and Chief of the Mental Health and Behavioral Sciences Service; all at James A. Haley Veterans’ Hospital in Tampa, Florida. Carri-Ann Gibson is an Assistant Professor; William Hervey is an Associate Professor; and Glenn Catalano is a Professor; all at the University of South Florida College of Medicine in Tampa.
Correspondence: Glenn Catalano ([email protected])

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Systematic evaluation and redesign of a substance use disorder treatment program resulted in elimination of wait times, same-day treatment, and increased pharmacotherapy for patients with alcohol and opioid use disorders.
Systematic evaluation and redesign of a substance use disorder treatment program resulted in elimination of wait times, same-day treatment, and increased pharmacotherapy for patients with alcohol and opioid use disorders.

Substance use disorders (SUDs) are an increasing public health concern in the US. The 2015 National Survey on Drug Use and Health indicated that 27 million people (8% of the US population) reported current use of recreational drugs or misuse of alcohol or prescription medications.1 The 2013 National Survey on Drug Use and Health indicated that 1.5 million veterans (roughly 6.6%) met the criteria for a SUD.2 More than 50% of patients awaiting entry into a SUD treatment program will never achieve admission due, in part, to long wait times.3-5

National attention has been focused on increasing veteran access to quality treatment based on evidence-based practices (EBPs). Several national legislative measures and treatment protocols have been implemented: the Uniform Mental Health Services in US Department of Veterans Affairs (VA) medical centers and clinics; Veterans Access, Choice, and Accountability Act (2014); Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD) Training Program; and the Psychotropic Drug Safety Initiative (PDSI).6-8 Consistent with these directives and in line with American Society of Addiction Medicine (ASAM) and Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines for medication-assisted therapies (MAT),the James A. Haley Veterans’ Hospital (JAHVH) Mental Health and Behavioral Sciences Service (MH&BSS) Substance Use Disorders Service (SUDS) in Tampa, Florida, implemented an evidence-based, treatment-on-demand model of care.9-11

Meeting SUD Treatment Needs

What does the new supervisor of a clinical program do when a 24-employee outpatient VA Alcohol and Drug Addiction Treatment Program (ADATP) has an average 33-day wait time for treatment with 54% of patients lost to care between initial evaluation and admission?12 Patients lacked consistent access to SUD pharmacotherapy. The national VA clinical performance indicators were substandard and there are no additional resources available to apply to the program.

At JAHVH the program supervisor enlisted hospital leadership to support program redesign. The redesign sought to improve operational efficiency and eliminate patient wait time; adopt national standards for assessment and treatment developed by ASAM; implement strictly evidence-based psychotherapeutic treatments; educate program psychiatrists about evidence-based psychopharmacologic treatments and hold them accountable for patient adherence; streamline documentation templates; free clinical providers from nonclinical tasks; create an inpatient addiction consult team to diagnose and treat chronic hospitalized patients with SUDs; ensure continuity of care; and, standardize consistent, objective measures of patient response to treatment to track the program’s effectiveness.

In this article, the authors provide an explanation of the clinical, theoretical foundation and the practical steps taken to design and implement this transformation. They then describe the lessons learned, hoping that their process will serve as a model for those in similar situations.

Program Redesign

July 1, 2015, a new program supervisor was hired and began a 2-month evaluation and analysis of the program with input from leadership, staff, and hospital/community stakeholders. September 1, the monthlong process of developing the redesign began. On September 30 the plan was presented to, and approved by, MH&BSS leadership. October was spent preparing for change with an implementation date of November 2 selected. On November 2, 2015, the complete redesign was implemented.

 

 

Needs Assessment

A needs assessment yielded improvement opportunities in program structure (levels of care); clinical content; staff and resource allocation, including clinical workflow and management systems. Staff identified philosophical and practical variance in the program, often leading to confusion for patients and clinicians and potentially resulting in disparate quality care and patient outcomes. Recommendations for addressing these needs included incorporating ASAM guidelines for assignment to clinically appropriate levels of care, implementation of consistent EBPs for SUD and comorbid conditions,9 and emphasis on staff training and development to champion evidence-based program philosophy and service delivery.

The assessment determined that the average waitlist time was 33 days, and patients were required to abstain from substance or alcohol use prior to admission to the Intensive Outpatient Program. If a waitlisted patient relapsed, she or he was removed from the waitlist and denied admission. A study conducted at JAHVH reported that 54% of waitlisted patients in this clinic (prior to November 2, 2015) never were admitted to the program.12 Access to care was considered a significant issue.

Program Implementation

September was spent developing a comprehensive redesign of the SUD clinic. The vision included incorporating all ASAM levels of care; creating an evidence-based, treatment-on-demand model of care; and, securing the support of MH&BSS leadership team, staff, and patients for the redesign. The supervisory clinician interviewed staff both individually and as a group. Clinicians were provided extensive training on EBP for SUDs, including psychotherapies, psychosocial treatments, and psychopharmacologic interventions. A journal club was started with staff-generated topics that offered articles sharing current research, EBPs, and psychotherapeutic techniques, continuing education on substances, and management of coexisting diagnoses. Clinicians increased the frequency of SUD in-service trainings. Psychiatrists provided several Grand Rounds to the MH&BSS service. All counselors were assigned to 1 of the program’s 3 clinical psychologists for individual weekly clinical supervision.

By providing all staff with current, evidence-based, clinically relevant treatment information and emphasizing its relationship to successful patient outcomes, program leadership energized staff support. Staff were encouraged to perform at the top of their scope of practice and engage in training and consultation. Each staff member was delegated a role in the process to inspire buy-in.

Preparation for the Shift

October was spent preparing for a seamless, one-day implementation of proposed changes, including implementation of updated clinical policies, procedures, and document templates (rewritten to include only clinically appropriate information required by VA policy or the Joint Commission); streamlined staff schedules; and utilization of staff-developed and research/policy-driven EBP handbook. Finally, the Brief Addiction Monitor (BAM) was selected as objective criteria to consistently assess patient progress in treatment, and staff were instructed to use this measure at regular intervals and for all levels of care.

Emphasis was placed on ongoing fortification of staff and patient support for the reorganization. For example, the Addiction Severity Index, though not required by policy, was historically used, adding 90 minutes to the evaluation and admission session. Staff agreed to remove this measure to improve clinician availability. Staff were also empowered to rename the redesigned program, and chose Substance Use Disorders Service (SUDS).

 

 

Process Changes

To achieve same-day access to clinical care, program leadership created a daily morning orientation group. Patients are scheduled or may attend as a walk-in. The orientation’s purpose is to explain what services are available and to offer each patient an opportunity for immediate evaluation and treatment. Staff schedules were modified to provide patient evaluation appointment slots immediately following orientation. The number of immediate evaluation slots was initially assessed by analyzing the demand for treatment over the previous 6 months, determining the daily mean, and setting the number of slots to accommodate 3 standard deviations above the daily mean. If a patient in a daily orientation group expresses a willingness to engage in treatment, he or she is immediately evaluated by a counselor during a 90-minute session and seen by a psychiatrist to determine whether pharmacologic treatment would be appropriate. If needed, the medication is prescribed that day. The primary purpose of the patient’s initial clinical evaluation is to determine the most appropriate level of care based on ASAM criteria. Also available were 90-minute afternoon evaluation appointments with psychiatrists for patients who walk into the clinic after the morning orientation group had ended.

Prior to the redesign, clinic psychiatrists were minimally prescribing evidence-based pharmacotherapy for sobriety support. At the time of redesign, only 8% of patients diagnosed with opioid use disorders (OUDs) were prescribed buprenorphine/naloxone or naltrexone. Just 1.9% of patients diagnosed with alcohol use disorder (AUD) were prescribed naltrexone or acamprosate. With the redesign, access to these medications has significantly expanded.

All templates were redesigned to ensure consistent documentation. This change decreased the overall provider task burden, and explicitly supported the use of ASAM multidimensional criteria and the Brief Addiction Monitor (BAM) to identify a pretreatment baseline score and track each patient’s clinical progress.13 Evidence-based written curricula were standardized for individual and group psychotherapies to reduce provider and programmatic variation.

The redesign creates distinct levels of care based on ASAM criteria, including harm reduction, ambulatory detoxification, outpatient group and individual psychotherapy, an evidence-based Intensive Outpatient Program (IOP), and aftercare. Application of the ASAM standards has allowed clinicians to make accurate placement decisions that best meet individual patient needs and to serve as effective stewards even with limited treatment and financial resources. Although JAHVH does not have a residential SUD program, procedures were developed to refer veterans to community-based residential treatment programs when appropriate.

Group Therapies

With the redesign, SUDS was no longer exclusively a 12-step program; however, it still supported and recognized the value of this approach for some patients. A psychologist periodically audits group sessions to prevent drift from that group’s curriculum. Counselors are assigned to weekly hour-long clinical supervision sessions with a psychologist to review patient care and reinforce the application of evidence-based individualized treatment.

After reviewing empirical literature and VA directives, CBT-SUD was adopted. It encompasses individual and group interventions, such as motivational interviewing (MI), contingency management (CM), and medication-assisted therapies as primary therapeutic treatment modalities, all of which have demonstrated efficacy as measured by length of sobriety postintervention.9,14,15

 

 

Clinical Staff Improvements

Staff were reorganized into 3 interdisciplinary treatment teams. A weekly team meeting is scheduled to coordinate care and discuss the treatment of complex patients. Clinical staff focus has shifted from case-management to diagnosis and treatment; now patients are referred to their primary care team’s social worker for case management services. Allowing clinical staff to focus solely on the diagnosis and clinical treatment of SUDs has significantly enhanced productivity and morale.

Staff receive training in the newly adopted interventions during brief monthly refresher courses provided by inhouse psychologists. Additional training includes participation in local and national SUD teleconferences and onsite meetings with experts in harm reduction and motivational interventions. During the transition, clinicians were encouraged to attend staff resiliency training. Continuing education was available to the SUDS psychiatrists and all inpatient and outpatient psychiatrists at JAHVH. Recently, this educational initiative was expanded to include all primary care and inpatient internal medicine physicians.

Implementation

On November 2, 2015, all planned programmatic changes were simultaneously implemented. On that day, clinician and patient schedules changed, the new EBP curriculum was administered, the use of streamlined documentation procedures began, and daily orientation groups followed by same-day evaluations were initiated.

The pretreatment sobriety requirement was eliminated as a barrier to care, and the program began to use a harm-reduction treatment track as recommended by ASAM guidelines. Patients with urgent or emergent medical or psychiatric problems were immediately assessed by SUDS health care providers and treated in the clinic or transported to the emergency department. Previously unavailable, patient access to ambulatory detoxification was initiated. The prescription of buprenorphine/naloxone for the treatment of OUD treatments increased from 1 prescriber to all 3.

Three months after program reorganization, the leadership reviewed overall workflow, conducted patient satisfaction surveys, and evaluated facility use and productivity. To address patient needs and facilitate optimal use of space, the number of same-day evaluation slots was reduced while the number of individual therapy slots was increased.

Staff meet in workgroups to discuss EBPs and further refine content with feedback from the supervisory clinician and team psychologists who routinely audit group therapy sessions. Staff report ongoing benefit from weekly supervision with a clinical psychologist. An inpatient addiction consultation team that uses existing manpower and resources has been developed.

Program Goals and Outcomes

The SUDS program serves more patients at multiple levels of standardized care with 2 fewer full-time positions. One counselor and one advanced practice registered nurse were reallocated to different programs within the JAHVH VA mental health clinic. Following a review of all program clinic profiles in the VA’s Computerized Patient Record System (CPRS) for utilization, accuracy, and necessity, and allowing for accurate program data capture, the transition resulted in a reduction of distinct clinics from 114 to 67 (-58.7%). In fiscal year 2018, review of CPRS yielded 19,786 total visits (3,645 unique visits).

Eliminate Patient Wait Tme

Patient wait time, as measured in CPRS from date of initial evaluation to date of treatment was reduced from an average of 33 days to 0 within 2 weeks of program implementation. A review of CPRS data also indicated that preadmission attrition dropped from 54% to < 1%; all patients desiring treatment are assigned a counselor and treatment is initiated the same day.

 

 

Adopt ASAM Criteria

After the redesign, patients have received more appropriate care based on individualized treatment plans. Due to the implementation of a fluid and supportive model, patients can move through levels of care as clinical need dictates rather than failing treatment and having to reengage. Staff receive ongoing education on the use of ASAM. Evaluation and treatment plan templates now reflect assignment to level of care rationale using ASAM guidelines.

Use of Evidence-Based Psychotherapeutic Treatments

More consistent, coordinated, and effective psychotherapies have improved patient care. The program’s previous issues with patients receiving conflicting treatment guidance from different providers has been resolved. Duplicate and ineffective treatments, including multiple readmissions to the IOP level of care, overemphasis of abstinence-based modalities for patients in active use, and referrals to inpatient SUD care under the assumption that “higher level of care is better” have ceased through staff education, leadership support, and appropriate staffing and communication. Review of patient advocate complaints tracked by and resolved by the service demonstrated an 80% decrease in patient advocate complaints regarding SUD clinic services.

Implement Evidence-Based Psychopharmacologic Treatments

The pharmacotherapy education initiative yielded tangible benefits and is likely a significant contributor to the program’s improved clinical outcomes. Prescription of pharmacotherapy for patients with OUD has risen from 8% to 25.1% in eligible patients. Appropriate medication prescription for the treatment of AUD has risen from 1.9% to 9.8% in eligible patients. These data are reflected in the VA Pharmaceutical Drug Safety Initiative (PDSI) dashboard.

Streamline Documentation

Significantly reducing the charting burden was likely a significant contributor to increased provider productivity and improved patient outcomes. Regular meetings between SUDS leadership and clinical informatics ensure that standardized note templates meet hospital policy and gather all necessary accreditation information.

Improve Employee Morale

Increased staff morale is indicated by a noticeable reduction in employee sick days; a decrease of > 20% (over the same time period the previous year), per the VA electronic timekeeping system, during the first 6 months following the November 2 program implementation.

SUDS Inpatient Addiction Consult Team

In January of 2017, SUDS began an inpatient medicine consultation service to offer evaluation, pharmacotherapy, and supportive counseling to patients diagnosed with SUDs who had been admitted to inpatient medical and surgical services. This team includes existing SUDS staff members reallocated to the inpatient service, is led by a SUDS psychiatrist, and includes 3 multidisciplinary clinicians with extensive training in assessment, diagnosis, and treatment planning of SUDs and comorbid conditions. Prior to implementation, the SUDS inpatient addiction consult team met with hospital leadership and attending physicians for inpatient medicine and psychiatry physicians.

To access the SUDS inpatient addiction consult team, physicians request a consult. Patients are offered an evaluation and are assigned to a level of care with orders for outpatient appointments with a counselor and psychiatrist within 7 days of hospital discharge. Medication-assisted treatment for chronic SUDs is implemented while patients remain admitted to the inpatient medical service. In fiscal year 2018, the SUDS inpatient addiction consult team performed 1,428 inpatient evaluations.

 

 

Consistent Treatment Outcome Measures

The BAM is a clinical tool designed to measure patient outcomes in substance use disorders.13 Its 17-item scale measures substance use risk factors that may lead to relapse, and protective factors that are recovery-oriented behaviors that help prevent relapse. It demonstrates sensitivity to change and has excellent test-retest reliability. The BAM has been in use in the addictions treatment program since 2011 but was previously administered only after admission to the IOP and again after a 30- to 90-day follow-up period. Since the program redesign, all SUDS patients are administered the BAM at their initial evaluation and at each individual appointment thereafter. The initial BAM assessment encompasses the previous 30 days; this 30-day version is also used for monthly follow-ups. For BAM assessments that occur within 30 days from the time of the last evaluation, a 7-day version is used. Prior to the redesign, about 24% of patients received a follow-up 30-day BAM assessment.12 Per CPRS review of veterans participating in continued treatment, the rate rose to 100% 3 months after the redesign.

When program staff compared preredesign and postredesign BAM data, they detected significant clinical differences. Data demonstrate a 22.2% improvement in protective factors, including patient confidence in their ability to remain abstinent; engaging in self-help activities, such as attending Alcoholics Anonymous meetings; engaging in organized spiritual activities; going to school, working, or volunteering; securing a regular income; and time spent with friends or family who are supportive of recovery.

The data also show a marked reduction in substance use at follow-up points in treatment and a corresponding decrease in risk factors. One item of the BAM assesses patient level of satisfaction with their treatment. Since the redesign, patients report that they are “considerably” satisfied with their SUD treatment.

Currently, program staff are conducting a review of BAM scores by level of care to further parse the impact of various treatments and best target patient need using measurement-based care and EBP, such as contingency management, which provides small monetary incentives when patients maintain clean urine drug screens.16 In addition, the program plans to achieve more uniformity in BAM assessment intervals at all levels of care, and possibly also integrate BAM data into SUD group therapies. Correlation of the BAM scores to other metrics, such as readmission to inpatient medicine, relapse, urine drug screen, or critical laboratory values, will provide additional insight into impact of programmatic changes.

Discussion

Feedback from other clinics and services within the hospital has been very positive. Some providers have reported that they appreciate the ease and availability of access to SUDS. Additionally, patients engaged in treatment prior to the redesign have been contacted for an updated evaluation and assignment to a counselor and appropriate level of care. From the staff’s perspective, the shift to immediate access to care has allowed a more streamlined process with fewer hurdles for patient admission. Staff report that they now feel empowered to meet the needs of veterans in a comprehensive, same-day fashion.

 

 

The success of our redesign was contingent on internal and external stakeholder buy-in and input, clear communication of vision and rationale from leadership, with an emphasis on implementing an evidence-based, treatment-on-demand model of care that showed fidelity to VA and Joint Commission policy. Regular review and revision of local policies and procedures, both to support additional changes and improve access to high-quality care, were also critical to success. Revision of documentation to streamline staff workload encouraged an emphasis on patient care as an organizing principle of our changes. Support from leadership for ongoing, monthly trainings in evidence-based psychotherapies and pharmacologic treatments helped ensure continued professional development of skill and knowledge and improve the mental health outcomes of our patients. Staff were encouraged to attend roundtable discussions regarding program redesign. Program leadership considered staff as important stakeholders in the redesigned.

The successful implementation of these changes has revealed several important elements regarding patient care. The first lesson was that improving access and integrating best practices is possible without additional resources, outside monies, or disruption to patient services. With the support of MH&BSS leadership, the program streamlined existing processes and used both staff and clinic resources more efficiently.

The second lesson involved the importance of continually reviewing and revising standard operating procedures to match the needs of the current patient population. Policies and procedures that once were viewed as potential barriers to change have been replaced with a more flexible approach and willingness to evolve.

As a result, far fewer patients have been lost to treatment. The time and resources that staff historically dedicated to nonclinical patient care are now redirected to immediate service provision. This increase in operational efficiency and treatment efficacy has resulted in a boost to staff morale, even during a time of immense change and increased productivity. Program staff are now able to personally witness the significant changes in their patients’ lives and feel a sense of pride at being a member of a hard-working team that provides the highest quality of substance use treatment. This is critical to job satisfaction and meets the VA mission to provide timely, effective, and evidence-based treatments to patients.

Conclusion

JAHVH strives to continue to provide the highest quality of SUD treatment available. Future directions aim to streamline clinic operations by constantly monitoring and reviewing workloads, while also considering patient feedback. A continuous review of EBP is part of our clinic’s culture. Program leadership endeavors to promote an open environment where providers can share their triumphs and frustrations and foster a team approach to problem solving. Further plans include expanding the range of treatment levels offered by developing a residential SUD treatment facility.

Substance use disorders (SUDs) are an increasing public health concern in the US. The 2015 National Survey on Drug Use and Health indicated that 27 million people (8% of the US population) reported current use of recreational drugs or misuse of alcohol or prescription medications.1 The 2013 National Survey on Drug Use and Health indicated that 1.5 million veterans (roughly 6.6%) met the criteria for a SUD.2 More than 50% of patients awaiting entry into a SUD treatment program will never achieve admission due, in part, to long wait times.3-5

National attention has been focused on increasing veteran access to quality treatment based on evidence-based practices (EBPs). Several national legislative measures and treatment protocols have been implemented: the Uniform Mental Health Services in US Department of Veterans Affairs (VA) medical centers and clinics; Veterans Access, Choice, and Accountability Act (2014); Cognitive Behavioral Therapy for Substance Use Disorders (CBT-SUD) Training Program; and the Psychotropic Drug Safety Initiative (PDSI).6-8 Consistent with these directives and in line with American Society of Addiction Medicine (ASAM) and Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines for medication-assisted therapies (MAT),the James A. Haley Veterans’ Hospital (JAHVH) Mental Health and Behavioral Sciences Service (MH&BSS) Substance Use Disorders Service (SUDS) in Tampa, Florida, implemented an evidence-based, treatment-on-demand model of care.9-11

Meeting SUD Treatment Needs

What does the new supervisor of a clinical program do when a 24-employee outpatient VA Alcohol and Drug Addiction Treatment Program (ADATP) has an average 33-day wait time for treatment with 54% of patients lost to care between initial evaluation and admission?12 Patients lacked consistent access to SUD pharmacotherapy. The national VA clinical performance indicators were substandard and there are no additional resources available to apply to the program.

At JAHVH the program supervisor enlisted hospital leadership to support program redesign. The redesign sought to improve operational efficiency and eliminate patient wait time; adopt national standards for assessment and treatment developed by ASAM; implement strictly evidence-based psychotherapeutic treatments; educate program psychiatrists about evidence-based psychopharmacologic treatments and hold them accountable for patient adherence; streamline documentation templates; free clinical providers from nonclinical tasks; create an inpatient addiction consult team to diagnose and treat chronic hospitalized patients with SUDs; ensure continuity of care; and, standardize consistent, objective measures of patient response to treatment to track the program’s effectiveness.

In this article, the authors provide an explanation of the clinical, theoretical foundation and the practical steps taken to design and implement this transformation. They then describe the lessons learned, hoping that their process will serve as a model for those in similar situations.

Program Redesign

July 1, 2015, a new program supervisor was hired and began a 2-month evaluation and analysis of the program with input from leadership, staff, and hospital/community stakeholders. September 1, the monthlong process of developing the redesign began. On September 30 the plan was presented to, and approved by, MH&BSS leadership. October was spent preparing for change with an implementation date of November 2 selected. On November 2, 2015, the complete redesign was implemented.

 

 

Needs Assessment

A needs assessment yielded improvement opportunities in program structure (levels of care); clinical content; staff and resource allocation, including clinical workflow and management systems. Staff identified philosophical and practical variance in the program, often leading to confusion for patients and clinicians and potentially resulting in disparate quality care and patient outcomes. Recommendations for addressing these needs included incorporating ASAM guidelines for assignment to clinically appropriate levels of care, implementation of consistent EBPs for SUD and comorbid conditions,9 and emphasis on staff training and development to champion evidence-based program philosophy and service delivery.

The assessment determined that the average waitlist time was 33 days, and patients were required to abstain from substance or alcohol use prior to admission to the Intensive Outpatient Program. If a waitlisted patient relapsed, she or he was removed from the waitlist and denied admission. A study conducted at JAHVH reported that 54% of waitlisted patients in this clinic (prior to November 2, 2015) never were admitted to the program.12 Access to care was considered a significant issue.

Program Implementation

September was spent developing a comprehensive redesign of the SUD clinic. The vision included incorporating all ASAM levels of care; creating an evidence-based, treatment-on-demand model of care; and, securing the support of MH&BSS leadership team, staff, and patients for the redesign. The supervisory clinician interviewed staff both individually and as a group. Clinicians were provided extensive training on EBP for SUDs, including psychotherapies, psychosocial treatments, and psychopharmacologic interventions. A journal club was started with staff-generated topics that offered articles sharing current research, EBPs, and psychotherapeutic techniques, continuing education on substances, and management of coexisting diagnoses. Clinicians increased the frequency of SUD in-service trainings. Psychiatrists provided several Grand Rounds to the MH&BSS service. All counselors were assigned to 1 of the program’s 3 clinical psychologists for individual weekly clinical supervision.

By providing all staff with current, evidence-based, clinically relevant treatment information and emphasizing its relationship to successful patient outcomes, program leadership energized staff support. Staff were encouraged to perform at the top of their scope of practice and engage in training and consultation. Each staff member was delegated a role in the process to inspire buy-in.

Preparation for the Shift

October was spent preparing for a seamless, one-day implementation of proposed changes, including implementation of updated clinical policies, procedures, and document templates (rewritten to include only clinically appropriate information required by VA policy or the Joint Commission); streamlined staff schedules; and utilization of staff-developed and research/policy-driven EBP handbook. Finally, the Brief Addiction Monitor (BAM) was selected as objective criteria to consistently assess patient progress in treatment, and staff were instructed to use this measure at regular intervals and for all levels of care.

Emphasis was placed on ongoing fortification of staff and patient support for the reorganization. For example, the Addiction Severity Index, though not required by policy, was historically used, adding 90 minutes to the evaluation and admission session. Staff agreed to remove this measure to improve clinician availability. Staff were also empowered to rename the redesigned program, and chose Substance Use Disorders Service (SUDS).

 

 

Process Changes

To achieve same-day access to clinical care, program leadership created a daily morning orientation group. Patients are scheduled or may attend as a walk-in. The orientation’s purpose is to explain what services are available and to offer each patient an opportunity for immediate evaluation and treatment. Staff schedules were modified to provide patient evaluation appointment slots immediately following orientation. The number of immediate evaluation slots was initially assessed by analyzing the demand for treatment over the previous 6 months, determining the daily mean, and setting the number of slots to accommodate 3 standard deviations above the daily mean. If a patient in a daily orientation group expresses a willingness to engage in treatment, he or she is immediately evaluated by a counselor during a 90-minute session and seen by a psychiatrist to determine whether pharmacologic treatment would be appropriate. If needed, the medication is prescribed that day. The primary purpose of the patient’s initial clinical evaluation is to determine the most appropriate level of care based on ASAM criteria. Also available were 90-minute afternoon evaluation appointments with psychiatrists for patients who walk into the clinic after the morning orientation group had ended.

Prior to the redesign, clinic psychiatrists were minimally prescribing evidence-based pharmacotherapy for sobriety support. At the time of redesign, only 8% of patients diagnosed with opioid use disorders (OUDs) were prescribed buprenorphine/naloxone or naltrexone. Just 1.9% of patients diagnosed with alcohol use disorder (AUD) were prescribed naltrexone or acamprosate. With the redesign, access to these medications has significantly expanded.

All templates were redesigned to ensure consistent documentation. This change decreased the overall provider task burden, and explicitly supported the use of ASAM multidimensional criteria and the Brief Addiction Monitor (BAM) to identify a pretreatment baseline score and track each patient’s clinical progress.13 Evidence-based written curricula were standardized for individual and group psychotherapies to reduce provider and programmatic variation.

The redesign creates distinct levels of care based on ASAM criteria, including harm reduction, ambulatory detoxification, outpatient group and individual psychotherapy, an evidence-based Intensive Outpatient Program (IOP), and aftercare. Application of the ASAM standards has allowed clinicians to make accurate placement decisions that best meet individual patient needs and to serve as effective stewards even with limited treatment and financial resources. Although JAHVH does not have a residential SUD program, procedures were developed to refer veterans to community-based residential treatment programs when appropriate.

Group Therapies

With the redesign, SUDS was no longer exclusively a 12-step program; however, it still supported and recognized the value of this approach for some patients. A psychologist periodically audits group sessions to prevent drift from that group’s curriculum. Counselors are assigned to weekly hour-long clinical supervision sessions with a psychologist to review patient care and reinforce the application of evidence-based individualized treatment.

After reviewing empirical literature and VA directives, CBT-SUD was adopted. It encompasses individual and group interventions, such as motivational interviewing (MI), contingency management (CM), and medication-assisted therapies as primary therapeutic treatment modalities, all of which have demonstrated efficacy as measured by length of sobriety postintervention.9,14,15

 

 

Clinical Staff Improvements

Staff were reorganized into 3 interdisciplinary treatment teams. A weekly team meeting is scheduled to coordinate care and discuss the treatment of complex patients. Clinical staff focus has shifted from case-management to diagnosis and treatment; now patients are referred to their primary care team’s social worker for case management services. Allowing clinical staff to focus solely on the diagnosis and clinical treatment of SUDs has significantly enhanced productivity and morale.

Staff receive training in the newly adopted interventions during brief monthly refresher courses provided by inhouse psychologists. Additional training includes participation in local and national SUD teleconferences and onsite meetings with experts in harm reduction and motivational interventions. During the transition, clinicians were encouraged to attend staff resiliency training. Continuing education was available to the SUDS psychiatrists and all inpatient and outpatient psychiatrists at JAHVH. Recently, this educational initiative was expanded to include all primary care and inpatient internal medicine physicians.

Implementation

On November 2, 2015, all planned programmatic changes were simultaneously implemented. On that day, clinician and patient schedules changed, the new EBP curriculum was administered, the use of streamlined documentation procedures began, and daily orientation groups followed by same-day evaluations were initiated.

The pretreatment sobriety requirement was eliminated as a barrier to care, and the program began to use a harm-reduction treatment track as recommended by ASAM guidelines. Patients with urgent or emergent medical or psychiatric problems were immediately assessed by SUDS health care providers and treated in the clinic or transported to the emergency department. Previously unavailable, patient access to ambulatory detoxification was initiated. The prescription of buprenorphine/naloxone for the treatment of OUD treatments increased from 1 prescriber to all 3.

Three months after program reorganization, the leadership reviewed overall workflow, conducted patient satisfaction surveys, and evaluated facility use and productivity. To address patient needs and facilitate optimal use of space, the number of same-day evaluation slots was reduced while the number of individual therapy slots was increased.

Staff meet in workgroups to discuss EBPs and further refine content with feedback from the supervisory clinician and team psychologists who routinely audit group therapy sessions. Staff report ongoing benefit from weekly supervision with a clinical psychologist. An inpatient addiction consultation team that uses existing manpower and resources has been developed.

Program Goals and Outcomes

The SUDS program serves more patients at multiple levels of standardized care with 2 fewer full-time positions. One counselor and one advanced practice registered nurse were reallocated to different programs within the JAHVH VA mental health clinic. Following a review of all program clinic profiles in the VA’s Computerized Patient Record System (CPRS) for utilization, accuracy, and necessity, and allowing for accurate program data capture, the transition resulted in a reduction of distinct clinics from 114 to 67 (-58.7%). In fiscal year 2018, review of CPRS yielded 19,786 total visits (3,645 unique visits).

Eliminate Patient Wait Tme

Patient wait time, as measured in CPRS from date of initial evaluation to date of treatment was reduced from an average of 33 days to 0 within 2 weeks of program implementation. A review of CPRS data also indicated that preadmission attrition dropped from 54% to < 1%; all patients desiring treatment are assigned a counselor and treatment is initiated the same day.

 

 

Adopt ASAM Criteria

After the redesign, patients have received more appropriate care based on individualized treatment plans. Due to the implementation of a fluid and supportive model, patients can move through levels of care as clinical need dictates rather than failing treatment and having to reengage. Staff receive ongoing education on the use of ASAM. Evaluation and treatment plan templates now reflect assignment to level of care rationale using ASAM guidelines.

Use of Evidence-Based Psychotherapeutic Treatments

More consistent, coordinated, and effective psychotherapies have improved patient care. The program’s previous issues with patients receiving conflicting treatment guidance from different providers has been resolved. Duplicate and ineffective treatments, including multiple readmissions to the IOP level of care, overemphasis of abstinence-based modalities for patients in active use, and referrals to inpatient SUD care under the assumption that “higher level of care is better” have ceased through staff education, leadership support, and appropriate staffing and communication. Review of patient advocate complaints tracked by and resolved by the service demonstrated an 80% decrease in patient advocate complaints regarding SUD clinic services.

Implement Evidence-Based Psychopharmacologic Treatments

The pharmacotherapy education initiative yielded tangible benefits and is likely a significant contributor to the program’s improved clinical outcomes. Prescription of pharmacotherapy for patients with OUD has risen from 8% to 25.1% in eligible patients. Appropriate medication prescription for the treatment of AUD has risen from 1.9% to 9.8% in eligible patients. These data are reflected in the VA Pharmaceutical Drug Safety Initiative (PDSI) dashboard.

Streamline Documentation

Significantly reducing the charting burden was likely a significant contributor to increased provider productivity and improved patient outcomes. Regular meetings between SUDS leadership and clinical informatics ensure that standardized note templates meet hospital policy and gather all necessary accreditation information.

Improve Employee Morale

Increased staff morale is indicated by a noticeable reduction in employee sick days; a decrease of > 20% (over the same time period the previous year), per the VA electronic timekeeping system, during the first 6 months following the November 2 program implementation.

SUDS Inpatient Addiction Consult Team

In January of 2017, SUDS began an inpatient medicine consultation service to offer evaluation, pharmacotherapy, and supportive counseling to patients diagnosed with SUDs who had been admitted to inpatient medical and surgical services. This team includes existing SUDS staff members reallocated to the inpatient service, is led by a SUDS psychiatrist, and includes 3 multidisciplinary clinicians with extensive training in assessment, diagnosis, and treatment planning of SUDs and comorbid conditions. Prior to implementation, the SUDS inpatient addiction consult team met with hospital leadership and attending physicians for inpatient medicine and psychiatry physicians.

To access the SUDS inpatient addiction consult team, physicians request a consult. Patients are offered an evaluation and are assigned to a level of care with orders for outpatient appointments with a counselor and psychiatrist within 7 days of hospital discharge. Medication-assisted treatment for chronic SUDs is implemented while patients remain admitted to the inpatient medical service. In fiscal year 2018, the SUDS inpatient addiction consult team performed 1,428 inpatient evaluations.

 

 

Consistent Treatment Outcome Measures

The BAM is a clinical tool designed to measure patient outcomes in substance use disorders.13 Its 17-item scale measures substance use risk factors that may lead to relapse, and protective factors that are recovery-oriented behaviors that help prevent relapse. It demonstrates sensitivity to change and has excellent test-retest reliability. The BAM has been in use in the addictions treatment program since 2011 but was previously administered only after admission to the IOP and again after a 30- to 90-day follow-up period. Since the program redesign, all SUDS patients are administered the BAM at their initial evaluation and at each individual appointment thereafter. The initial BAM assessment encompasses the previous 30 days; this 30-day version is also used for monthly follow-ups. For BAM assessments that occur within 30 days from the time of the last evaluation, a 7-day version is used. Prior to the redesign, about 24% of patients received a follow-up 30-day BAM assessment.12 Per CPRS review of veterans participating in continued treatment, the rate rose to 100% 3 months after the redesign.

When program staff compared preredesign and postredesign BAM data, they detected significant clinical differences. Data demonstrate a 22.2% improvement in protective factors, including patient confidence in their ability to remain abstinent; engaging in self-help activities, such as attending Alcoholics Anonymous meetings; engaging in organized spiritual activities; going to school, working, or volunteering; securing a regular income; and time spent with friends or family who are supportive of recovery.

The data also show a marked reduction in substance use at follow-up points in treatment and a corresponding decrease in risk factors. One item of the BAM assesses patient level of satisfaction with their treatment. Since the redesign, patients report that they are “considerably” satisfied with their SUD treatment.

Currently, program staff are conducting a review of BAM scores by level of care to further parse the impact of various treatments and best target patient need using measurement-based care and EBP, such as contingency management, which provides small monetary incentives when patients maintain clean urine drug screens.16 In addition, the program plans to achieve more uniformity in BAM assessment intervals at all levels of care, and possibly also integrate BAM data into SUD group therapies. Correlation of the BAM scores to other metrics, such as readmission to inpatient medicine, relapse, urine drug screen, or critical laboratory values, will provide additional insight into impact of programmatic changes.

Discussion

Feedback from other clinics and services within the hospital has been very positive. Some providers have reported that they appreciate the ease and availability of access to SUDS. Additionally, patients engaged in treatment prior to the redesign have been contacted for an updated evaluation and assignment to a counselor and appropriate level of care. From the staff’s perspective, the shift to immediate access to care has allowed a more streamlined process with fewer hurdles for patient admission. Staff report that they now feel empowered to meet the needs of veterans in a comprehensive, same-day fashion.

 

 

The success of our redesign was contingent on internal and external stakeholder buy-in and input, clear communication of vision and rationale from leadership, with an emphasis on implementing an evidence-based, treatment-on-demand model of care that showed fidelity to VA and Joint Commission policy. Regular review and revision of local policies and procedures, both to support additional changes and improve access to high-quality care, were also critical to success. Revision of documentation to streamline staff workload encouraged an emphasis on patient care as an organizing principle of our changes. Support from leadership for ongoing, monthly trainings in evidence-based psychotherapies and pharmacologic treatments helped ensure continued professional development of skill and knowledge and improve the mental health outcomes of our patients. Staff were encouraged to attend roundtable discussions regarding program redesign. Program leadership considered staff as important stakeholders in the redesigned.

The successful implementation of these changes has revealed several important elements regarding patient care. The first lesson was that improving access and integrating best practices is possible without additional resources, outside monies, or disruption to patient services. With the support of MH&BSS leadership, the program streamlined existing processes and used both staff and clinic resources more efficiently.

The second lesson involved the importance of continually reviewing and revising standard operating procedures to match the needs of the current patient population. Policies and procedures that once were viewed as potential barriers to change have been replaced with a more flexible approach and willingness to evolve.

As a result, far fewer patients have been lost to treatment. The time and resources that staff historically dedicated to nonclinical patient care are now redirected to immediate service provision. This increase in operational efficiency and treatment efficacy has resulted in a boost to staff morale, even during a time of immense change and increased productivity. Program staff are now able to personally witness the significant changes in their patients’ lives and feel a sense of pride at being a member of a hard-working team that provides the highest quality of substance use treatment. This is critical to job satisfaction and meets the VA mission to provide timely, effective, and evidence-based treatments to patients.

Conclusion

JAHVH strives to continue to provide the highest quality of SUD treatment available. Future directions aim to streamline clinic operations by constantly monitoring and reviewing workloads, while also considering patient feedback. A continuous review of EBP is part of our clinic’s culture. Program leadership endeavors to promote an open environment where providers can share their triumphs and frustrations and foster a team approach to problem solving. Further plans include expanding the range of treatment levels offered by developing a residential SUD treatment facility.

References

1. Substance Abuse and Mental Health Services Administration. 2015 National Survey on Drug Use and Health: Summary of the Effects of the 2015 NSDUH Questionnaire Redesign: Implications for Data Users. https://www.samhsa.gov/data/sites/default/files/NSDUH-TrendBreak-2015.pdf. Published June 2016. Accessed June 12, 2019.

2. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014.

3. Donovan DM, Rosengren DB, Downey L, Cox GB, Sloan PDSKL. Attrition prevention with individuals awaiting publicly funded drug treatment. Addiction. 2001;96(8):1149-1160.

4. Hser Y, Maglione M, Polinsky ML, Anglin MD. Predicting treatment entry among treatment-seeking drug abusers. J Subst Abuse Treatment. 1997;15(3):213-220.

5. Stark MJ, Campbell BK, Brinkerhoff CV. “Hello, may we help you?” A study of attrition prevention at the time of the first phone contact with substance-abusing clients. Am J Drug Alcohol Abuse. 1990;16:67-76.

6. US Department of Veterans Affairs. Uniform Mental Health Services in VA Medical Centers and Clinics. VHA Handbook 1160.01. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1762. Updated November 2015. Accessed December 12, 2017.

7. Veterans Access, Choice and Accountability Act of 2014, 2 USC § 933.

8. DeMarce JM, Gnys M, Raffa SD, Karlin, BE. Cognitive Behavioral Therapy for Substance Use Disorders Among Veterans: Therapist Manual. Washington, DC: US Department of Veterans Affairs; 2014.

9. Mee-Lee D, Shulman GD, Fishman MJ, Gastfriend DR, Miller MM, eds. The ASAM Criteria: Treatment Criteria for Addictive, Substance-Related, and Co-Occurring Conditions. 3rd ed. Carson City, NV: The Change Companies; 2013.

10. Substance Abuse and Mental Health Services Administration and National Institute on Alcohol Abuse and Alcoholism. Medication for the Treatment of Alcohol Use Disorder: A Brief Guide. HHS Publication No. (SMA) 15-4907. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2015.

11. Substance Abuse and Mental Health Services Administration and National Institute on Alcohol Abuse and Alcoholism. Medication for Opioid Use Disorder – Full Document. HHS Publication No. (SMA) 18-5063FULLDOC. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2018.

12. Winn JL, Shealy SE, Kropp GJ, Felkins-Dohm D, Gonzales-Nolas C, Francis E. Housing assistance and case management: Improving access to substance use disorder treatment for homeless veterans. Psychological Serv. 2013;10(2):233-240.

13. Cacciola JS, Alterman AI, DePhilippis D, et al. Development and initial evaluation of the Brief Addiction Monitor (BAM). J Subst Abuse Treatment. 2013;44(3):256-263.

14. McHugh RK, Hearon BA, Otto MW. Cognitive-behavioral therapy for substance use disorders, Psychiatr Clinics North Am. 2010;33:511–525.

15. Karlin, BE, Cross, G. From the laboratory to the therapy room: national dissemination and implementation of evidence-based psychotherapies in the U.S. Department of Veterans Affairs health care system. Am Psychol. 2014;69:19-33.

16. DePhilippis D, Petry NM, Bonn-Miller MO, Rosenbach SB, McKay JR. The national implementation of contingency management (CM) in the Department of Veterans Affairs: attendance at CM sessions and substance use outcomes, Drug Alcohol Dependence. 2018;185:367-373.

References

1. Substance Abuse and Mental Health Services Administration. 2015 National Survey on Drug Use and Health: Summary of the Effects of the 2015 NSDUH Questionnaire Redesign: Implications for Data Users. https://www.samhsa.gov/data/sites/default/files/NSDUH-TrendBreak-2015.pdf. Published June 2016. Accessed June 12, 2019.

2. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014.

3. Donovan DM, Rosengren DB, Downey L, Cox GB, Sloan PDSKL. Attrition prevention with individuals awaiting publicly funded drug treatment. Addiction. 2001;96(8):1149-1160.

4. Hser Y, Maglione M, Polinsky ML, Anglin MD. Predicting treatment entry among treatment-seeking drug abusers. J Subst Abuse Treatment. 1997;15(3):213-220.

5. Stark MJ, Campbell BK, Brinkerhoff CV. “Hello, may we help you?” A study of attrition prevention at the time of the first phone contact with substance-abusing clients. Am J Drug Alcohol Abuse. 1990;16:67-76.

6. US Department of Veterans Affairs. Uniform Mental Health Services in VA Medical Centers and Clinics. VHA Handbook 1160.01. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1762. Updated November 2015. Accessed December 12, 2017.

7. Veterans Access, Choice and Accountability Act of 2014, 2 USC § 933.

8. DeMarce JM, Gnys M, Raffa SD, Karlin, BE. Cognitive Behavioral Therapy for Substance Use Disorders Among Veterans: Therapist Manual. Washington, DC: US Department of Veterans Affairs; 2014.

9. Mee-Lee D, Shulman GD, Fishman MJ, Gastfriend DR, Miller MM, eds. The ASAM Criteria: Treatment Criteria for Addictive, Substance-Related, and Co-Occurring Conditions. 3rd ed. Carson City, NV: The Change Companies; 2013.

10. Substance Abuse and Mental Health Services Administration and National Institute on Alcohol Abuse and Alcoholism. Medication for the Treatment of Alcohol Use Disorder: A Brief Guide. HHS Publication No. (SMA) 15-4907. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2015.

11. Substance Abuse and Mental Health Services Administration and National Institute on Alcohol Abuse and Alcoholism. Medication for Opioid Use Disorder – Full Document. HHS Publication No. (SMA) 18-5063FULLDOC. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2018.

12. Winn JL, Shealy SE, Kropp GJ, Felkins-Dohm D, Gonzales-Nolas C, Francis E. Housing assistance and case management: Improving access to substance use disorder treatment for homeless veterans. Psychological Serv. 2013;10(2):233-240.

13. Cacciola JS, Alterman AI, DePhilippis D, et al. Development and initial evaluation of the Brief Addiction Monitor (BAM). J Subst Abuse Treatment. 2013;44(3):256-263.

14. McHugh RK, Hearon BA, Otto MW. Cognitive-behavioral therapy for substance use disorders, Psychiatr Clinics North Am. 2010;33:511–525.

15. Karlin, BE, Cross, G. From the laboratory to the therapy room: national dissemination and implementation of evidence-based psychotherapies in the U.S. Department of Veterans Affairs health care system. Am Psychol. 2014;69:19-33.

16. DePhilippis D, Petry NM, Bonn-Miller MO, Rosenbach SB, McKay JR. The national implementation of contingency management (CM) in the Department of Veterans Affairs: attendance at CM sessions and substance use outcomes, Drug Alcohol Dependence. 2018;185:367-373.

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Accelerated Hepatitis A and B Immunization in a Substance Abuse Treatment Program

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Accelerated Hepatitis A and B Immunization in a Substance Abuse Treatment Program
An accelerated dosing program for hepatitis A and B vaccination among veterans receiving treatment for addictive disorders was successfully implemented, although many veterans with hepatitis C did not complete the immunization series.

Homeless individuals and IV drug users are susceptible to hepatitis A, B, and C infections, and co-infection with these diseases may complicate treatment and result in poor medical outcomes.1 Vaccination offers the best protection against hepatitis A and B, particularly among high-risk populations.2,3 Immunization against hepatitis A and B is of even greater importance for patients with hepatitis C, because there is no specific hepatitis C vaccine, and concomitant infections of B with C are damaging to the liver.4

Veterans have a rate of hepatitis C infection that is 3 times that of the general population.5 Some evidence exists that veterans with serious mental illness (SMI) have a higher rate of hepatitis C infection relative to patients without SMI. Co-occurring substance abuse may add another layer of vulnerability to hepatitis C infection, particularly for homeless veterans.5-7

Mental Health and Primary Care Integration

Substance abuse and dual-diagnosis treatment programs (ie, those programs that treat both substance abuse and co-occurring serious mental health problems, such as bipolar disorder, severe major depressive disorder, psychotic disorders, and posttraumatic stress disorder [PTSD]) that have integrated mental health and primary care into their treatment programs may offer a window of opportunity for risk-reducing interventions. These interventions include testing and education of patients regarding infectious diseases, such as viral hepatitis and HIV, and completion of the hepatitis A/B immunization series.

The James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, has demonstrated some limited success in the past with integrating a standard dosing schedule for hepatitis A/B vaccination into its substance abuse treatment program (SATP), though recent evidence points to more promising results using an accelerated regimen as indicated by a high completion rate for hepatitis B vaccination in a methadone clinic.8,9 A relatively low proportion of SATPs in the U.S. provide testing, education, or vaccination for hepatitis A and B, especially considering the public health importance of controlling these diseases in the substance abusing populations.10,11

Related: Combination Pill Approved for HCV

In 1999, a primary care team was added to the alcohol and drug abuse treatment program at JAHVH.In 2005, the nurses in the program began scheduling vaccinations and screening patients for medical and psychiatric issues, pain, hypertension, diabetes, hepatitis C, alcohol use, depression, PTSD, prostate and colorectal cancers.12 Such a multidisciplinary approach provides many treatment advantages for patients and may save lives.13

Even with a multidisciplinary approach, the nurses found it difficult to provide adequate hepatitis A/B immunization within the 3- to 6-week intensive SATP, because standard immunization dosing regimens are spread over 6 months.14 As with all types of immunizations, long dosing schedules may reduce patient adherence and result in inadequate seroprotection.15 Thus, there is a need to provide a completed immunization series in a more expeditious fashion, and an accelerated dosing regimen makes that possible.15,16

Hepatitis A/B Vaccination

Twinrix (GlaxoSmithKline, Brentford, United Kingdom) is a vaccine that provides dual immunization for hepatitis A and B. Whereas the standard vaccination schedule takes 6 months to complete, the accelerated dosing schedule can be used to complete the first 3 doses in less than a month. The accelerated dosing schedule was incorporated into the JAHVH clinic to capture as many patients as possible in the 3- to 6-week time frame: The first dose is administered and followed by a second dose 7 days later. The third dose is administered 21 to 30 days after the first dose. Twelve months after the first dose, a booster dose is given. 

After the first 3 accelerated doses, > 98% of patients show a sustained immune response to hepatitis A, and > 63% demonstrate immunity to hepatitis B. If a 12-month booster injection is given, 100% of patients may receive immunity to hepatitis A and > 96% may have immunity to hepatitis B.16 Another study of the combined vaccine showed even greater seroprotection for hepatitis A and B after only 1 month, 100% and 82%, respectively.17

Related: Viral Hepatitis Awareness

This JAHVH retrospective feasibility study describes a risk-reduction program for hepatitis A/B prevention that was implemented within a 3- to 4-week intensive outpatient SATP and a 6-week dual-diagnosis treatment program. The study includes the development and implementation of the program, designed to vaccinate patients using the accelerated Twinrix schedule. To ascertain the feasibility of this vaccination approach, historical medical records were used to describe and examine the vaccination initiation and follow-up rates of the treatment program participants who received the hepatitis A/B immunization series during their intensive SATP.

Study Design

A retrospective review of medical records was conducted for all participants who were admitted to the intensive JAHVH SATP between October 1, 2008, and September 30, 2009. This study was reviewed and approved by the JAHVH research and development committee and its associated University of South Florida institutional review board. Informed consent to participate was not obtained, because the study was retrospective.

 

 

Patient Identification and Education

All program participants were offered testing for HIV and hepatitis A, B, and C. Program participants were educated about hepatitis and HIV transmission, as well as about the long-term effects of continued substance abuse on the progression of hepatitis C. Education about hepatitis, HIV, and substance abuse was provided in a group setting by a member of the program’s nursing staff. One-on-one risk education counseling was also provided when requested or otherwise indicated.

Laboratory testing was performed following each participant’s initial physical examination (within 3 to 5 days of program admission), and the nursing staff reviewed the results before vaccination. Explanation of laboratory results and an individualized immunization regimen were provided to each participant. On review of participants’ laboratory results, those with seroconversion of both hepatitis A and B were not given the combined immunization. Participants who had seroconversion of hepatitis A were offered the hepatitis B vaccination series, and vice versa.

Immunization Process

Participants who lacked prior immunization for hepatitis A and B and had no seroconversion of either hepatitis A or B were offered vaccination. Some patients declined vaccination, even though they were eligible. Their reasons were not formally assessed.

Related: Nivolumab Approved for Expanded Indication

Patients who accepted the vaccination were given the accelerated regimen.16 Participants were educated on the importance of compliance with the vaccination series and provided with follow-up immunization dates and a reminder for the 1-year booster vaccine. The immunizations were ordered by the program’s primary care NP and administered by a licensed practical nurse. The nurse who administered the injections took responsibility for scheduling the patients for all their subsequent injections, including the 1-year booster.

Follow-up Care

If the third injection was not completed before discharge, patients were given a follow-up appointment with the nurse if they remained in the JAHVH service area. If they were leaving the area, they were given instructions on how to follow-up at another VA facility to continue their immunization schedule. A note was written in the electronic medical record documenting their abbreviated hepatitis A/B immunization schedule, which could be accessed by other providers at other VA facilities. Patients who did not show up for any follow-up appointments (third injection or the 1-year booster injection) were contacted and reminded about the importance of completing the immunization series and to schedule an appointment.

Statistical Analysis

All data were analyzed using IBM Statistical Package for the Social Sciences (IBM SPSS, Armonk, New York) with a focus on identifying differences between vaccination-eligible patients (n = 269) who did (n = 128) and did not (n = 141) initiate the immunization schedule during the treatment program. Chi-square and Fisher exact tests were used to assess statistical differences in initiation of the immunization schedule related to categoric variables (ie, marital status, race, history of IV drug abuse, cigarette smoking status, housing status, legal status, history of combat, having a psychiatric or medical diagnosis, and program track). Independent sample t tests were used to test for differences between these 2 groups on the continuous variables, including age, number of previous treatment programs, Global Assessment of Functioning score, severity of smoking dependence as measured by the Fagerström Test for Nicotine Dependence, and the Addiction Severity Index scales.18-20

Results

The sample consisted of 284 successive admissions to an intensive outpatient program for veterans with substance use disorders. About one-third of the patients were homeless at the time of admission to the treatment, and 87% required contracted housing while completing treatment for reasons related to lack of housing, transportation, clinical necessity, or a combination of those factors (Table 1). The most common substance problems were alcohol and cocaine dependence, and 21% (n = 59) of the patients acknowledged a history of IV drug use during their initial psychiatric evaluation. Seventy percent were dually diagnosed with some other Axis I disorder, and 40% had a history of serious mental illness. More than one-fourth (n = 77) of the patients admitted to the intensive outpatient SATP were seropositive for hepatitis A, B and/or C, and the most common hepatitis diagnosis was hepatitis C (n = 71).

Accelerated Immunization Regimen

Patients were eligible to receive the accelerated vaccination schedule only if they had no prior immunization for hepatitis A or B and if they had no seroconversion for either hepatitis A or B. Six people had hepatitis B alone, 7 had hepatitis B and C, 1 had hepatitis A and C, and 1 had all 3 (Table 2). Thus, 15 participants were ineligible to receive the accelerated hepatitis A/B immunization. Chi-square, Fisher exact, and independent sample t tests showed that among those who were vaccination-eligible (269), there were no significant differences in any of the demographic or clinical characteristics between those who initiated the vaccination schedule and those who did not. Among those who completed the first 3 vaccine injections, those who received the 1-year booster injection (54) did not differ (on any demographic or clinical variables) from those who did not (58).

 

 

Nearly half (48%) of all the eligible patients admitted to the program began the accelerated immunization schedule for hepatitis A and B.  Of those, 88% completed the first 3 injections in the series. Among the patients who received the first 3 injections, 48% received the 1-year booster injection—a 20% completion rate for the vaccination-eligible sample overall (Table 3).

Of the 74 patients who did not complete their vaccinations once initiating the accelerated schedule, the most common reason identified was that the patient moved away (37), or no reason could be identified (33). It was uncommon for a patient not to complete the vaccination schedule because of terminating treatment prematurely (4).

Compared with the vaccine-eligible patients without hepatitis C (207), patients with hepatitis C were less likely to receive any vaccination injections (Table 3). Specifically, 51% of the vaccination-eligible patients who did not have hepatitis C began the vaccination regimen. However, only 22 patients with hepatitis C, or
35% of all vaccination-eligible patients with hepatitis C, began the vaccination regimen. Patients with hepatitis C were also less likely than those without hepatitis C to complete the first 3 injections of the vaccination series once they had initiated it (77%, vs 90%, respectively). This difference continued to be apparent at the time of the 12-month booster injection. Only 35% of vaccine-eligible individuals with hepatitis C received the 12-month booster injection, whereas 51% of vaccination-eligible individuals without hepatitis C received the 12-month booster injection. As with the sample overall, the most common reason patients with hepatitis C did not complete the vaccination regimen was because they moved away (9), followed by no identified reason (5), and premature termination of treatment (2).

Discussion

Individuals abusing alcohol and drugs have an increased vulnerability for infectious diseases, and homeless veterans with substance use disorders may be at a particularly heightened risk.21,22 This study describes a sample of veterans, many were homeless and most were dually diagnosed, in an intensive outpatient SATP that offered an accelerated dosing regimen for hepatitis A and B vaccination. Almost half (48%) of the vaccination-eligible patients began the accelerated regimen for hepatitis A/B vaccination. Moreover, 88% of those who started the vaccination regimen received the first 3 injections of the series, thus possibly conferring substantial immunity to hepatitis A and B and demonstrating the feasibility of an accelerated vaccination schedule in an intensive outpatient SATP.

It is especially important to demonstrate the successful integration of a hepatitis screening and immunization program within a SATP, given that many such programs do not offer screening or immunization for hepatitis, even though substance abusers are disproportionately affected by the disease and contribute greatly to the ongoing hepatitis epidemic.10,11 This study’s results were in line with another study of rapid vaccination for hepatitis B in IV drug users being treated in a methadone clinic, where 83% of the vaccination initiators completed the first 3 injections of the series.9

Unvaccinated Patients

The treatment team in the current study seemed to be less effective at reaching the subset of vaccination-eligible veterans with hepatitis C (almost one-quarter of the sample) in order to administer the accelerated vaccination schedule, as indicated by the lower rate of vaccination initiation as well as a lower rate of completion of the vaccination series among those patients. This replicates a finding from another study that also indicated a low rate of hepatitis A and B vaccination among patients with hepatitis C.23 Only 35% of the vaccination-eligible patients with hepatitis C in the current study initiated the vaccination series, compared with 51% of the patients without hepatitis C. However, the rate of completion of the first 3 injections of the series in the hepatitis C group was respectably high (77%), especially given the high relapse rate and psychosocial instability of individuals with addictive disorders. Initiation seems to be a bigger obstacle than completion of at least the first 3 injections of the vaccination series in both patients with and without hepatitis C.

The study investigators did not formally assess the reasons that more than half the patients in the study did not begin the vaccination series, but anecdotal evidence from the nurses indicated that many patients were afraid of needles. In addition, other patients felt that they simply did not need the vaccination. Some also insisted that they had already had the vaccination despite a blood test showing no evidence for either hepatitis A or B immunization.

Although the nursing team provided group and individual risk-based education as well as information about the effects of continued substance abuse on hepatitis C, it is possible that patients still underestimated their own risk of hepatitis infection and its consequences, or perhaps the information was simply not retained.24

 

 

Patient Education

A recent study showed that there is a positive relationship between the amount of hepatitis counseling received and knowledge of hepatitis.25 Possibly, increased intensity of education efforts may make an impact on initiation rates. Encouragingly, there is also evidence that prompting people to predict their future vaccination behavior may increase vaccination initiation rates despite a high-degree of short-term barriers, such as perceived pain or inconvenience.26 A brief intervention to induce people to formulate their future intentions would be relatively easy to incorporate into a vaccination program, and the study team is considering options for this to improve vaccination initiation rates.

Patients can expect to achieve substantial immunity from hepatitis A and, to a lesser degree, hepatitis B after completing the first 3 injections of the series, although the best seroprotection from both is obtained by completing the 12-month booster injection as well.17 Overall, about half of all patients who completed the first 3 injections returned for the booster shot, but only 35% of the patients with hepatitis C did so. The most common known cause of any patient not receiving the booster was movement out of the geographic area. However, much of the time the investigators were unable to determine the reasons patients did not return for the booster shot.

Medication adherence is a difficult problem with vaccination in high-risk samples, although Stitzer and colleagues found a significant improvement in follow-up for a 6-month vaccination protocol by using monetary incentives.27 In addition to ensuring medication adherence, it would also be of value for future immunization efforts to include testing to assess whether seroconversion has occurred once the vaccinations are complete, which is the ultimate measure of the success of a vaccination program. Most patients in the current study did not receive such testing at the completion of their vaccination schedules, and thus, seroconversion rates could not be determined. However, existing studies suggest high rates of seroprotection after the first 3 doses of the combined vaccine.10,17

Limitations

The retrospective nature of the study is its most significant limitation. Any conclusions about the results must be made with caution. However, this design allowed for a naturalistic and potentially generalizable investigation into the application of a vaccination program in a real-world treatment setting. As such, the investigators were able to demonstrate the feasibility of conducting a rapid vaccination program within a 3- to 6-week SATP.

The retrospective nature of the study also limited a full investigation into the reasons behind the lack of vaccination initiation and vaccination noncompletion among the study’s treatment population, especially with regard to the follow-up booster injection. Initial statistical comparisons of initiators and noninitiators and completers and noncompleters showed no significant statistical differences between the groups. Future prospective designs should take into account the need to successfully initiate and complete vaccinations for all eligible patients and include assessment measures to determine the specific reasons that patients did not initiate or complete their vaccinations.

Conclusions

Many patients began and completed the accelerated vaccination schedule for hepatitis A and B in the context of a 3- to 6-week SATP at JAHVH. The overall vaccination rate, including the 12-month booster injection, was one-fifth of the entire vaccination-eligible sample. Additionally, 88% of the vaccination-eligible patients who began the vaccination schedule (or 42% of the whole sample) completed at least the first 3 doses, which may confer substantial immunity from hepatitis A and B. For reasons not entirely clear, a little less than half the vaccination-eligible patients began the vaccination schedule, and only about 50% of those returned to receive their 12-month booster injection. Future prospective studies may be able to determine barriers to both the initiation of and adherence to the vaccination protocol.

The results of this study are also a testament to having primary care nursing staff available and actively involved in the care of patients in a SATP. It seems likely that additional interventions might be needed for outreach to and retention of patients in need of vaccination for hepatitis A and B, and particularly those patients with hepatitis C. It is important to find ways to increase the rates of 12-month booster vaccinations, both for veterans who continue to receive services at JAHVH and for those who transfer care to other VA facilities. Finally, testing to confirm serologic immunity to hepatitis A and hepatitis B would be the next step in the effort to eliminate the risk of hepatitis A and hepatitis B and minimize additional harm for those with hepatitis C in the population receiving treatment for addictive disorders.

 

 

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

References

1. Nyamathi A, Liu Y, Marfisee M, et al. Effects of a nurse-managed program on hepatitis A  and B vaccine completion among homeless adults. Nurs Res. 2009;58(1):13-22.

2. Center for Disease Control and Prevention (CDC). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. MMWR Morb Mortal Wkly Rep. 2006;55(RR16):1-25.

3. Advisory Committee on Immunization Practices (ACIP), Fiore AE, Wasley A, Bell BP. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2006;55(RR07):1-23.

4. Weltman MD, Brotodihardjo A, Crewe EB, et al. Coinfection with hepatitis B and C or B, C and delta viruses results in severe chronic liver disease and responds poorly to interferon-alpha treatment. J Viral Hepat. 1995;2(1):39-45.

5. Groessl EJ, Weingart KR, Kaplan RM, et al. Living with hepatitis C: qualitative interviews with hepatitis C-infected veterans. J Gen Intern Med. 2008;23(12):1959-1965.

6. Dominitz JA, Boyko EJ, Koepsell TD, et al. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Hepatology. 2005;41(1):88-96.

7. Himeloch S, McCarthy JF, Ganoczy D, et al. Understanding associations between serious mental illness and hepatitis C virus among veterans: a national multivariate analysis. Psychosomatics. 2009;50(1):30-37.

8. Hagedorn H, Dieperink E, Dingmann D, et al. Integrating hepatitis prevention services into a substance use disorder clinic. J Subst Abuse Treat. 2007;32(4):391-398.

9. Ramasamy P, Lintzeris N, Sutton Y, Taylor H, Day CA, Haber PS. The outcome of a rapid hepatitis B vaccination programme in a methadone treatment clinic. Addiction. 2010;105(2):329-334.

10. Bini EJ, Kritz S, Brown LS Jr, et al. Hepatitis B virus and hepatitis C virus services offered by substance abuse treatment programs in the United States. J Subst Abuse Treat. 2012;42(4):438-445.

11. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 1998;47(RR-19):1-39.

12. Francis E, Gonzales-Nolas CL, Markowitz J, Phillips S. Integration of preventive health screening into mental health clinics. Fed Pract. 2008;25(2):39-50.

13. Vreeland B. Bridging the gap between mental and physical health: a multidisciplinary approach. J Clin Psychiatry. 2007;68(suppl 4):26-33.

14. Brim N, Zaller N, Taylor LE, Feller E. Twinrix vaccination schedules among injecting drug users. Expert Opin Biol Ther. 2007;7(3):379-389.

15. Zuckerman J. The place of accelerated schedules for hepatitis A and B vaccinations. Drugs. 2003;63(17):1779-1784.

16. Connor BA, Blatter MM, Beran J, Zou B, Trofa AF. Rapid and sustained immune response against hepatitis A and B achieved with combined vaccine using an accelerated administration schedule. J Travel Med. 2007;14(1):9-15.

17. Nothdurft HD, Dietrich M, Zuckerman JN, et al. A new accelerated vaccination schedule for rapid protection against hepatitis A and B. Vaccine. 2002;20(7-8):1157-1162.

18. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association; 2000.

19. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86(9):1119-1127.

20. McLellan AT, Kushner H, Metzger D, et al. The Fifth Edition of the Addiction Severity Index. J Subst Abuse Treat. 1992;9(3):199-213.

21. Batki SL, Nathan KI. HIV/AIDS and Hepatitis C. In: Galanter M, Kleber HD, Brady KT, eds. The American Psychiatric Publishing Textbook of Substance Abuse Treatment. 5th ed. Arlington, VA: American Psychiatric Publishing; 2015.

22. Gelberg L, Robertson MJ, Leake B, et al. Hepatitis B among homeless and other impoverished US military veterans in residential care in Los Angeles. Public Health. 2001;115(4):286-291.

23. Felsen UR, Fishbein DA, Litwin AH. Low rates of hepatitis A and B vaccination in patients with chronic hepatitis C at an urban methadone maintenance program. J Addict Dis. 2010;29(4):461-465.

24. Brewer NT, Chapman GB, Gibbons FX, Gerrard M, McCaul KD, Weinstein ND. Meta-analysis of the relationship between risk perception and health behavior: the example of vaccination. Health Psychol. 2007;26(2):136-145.

25. Soto-Salgado M, Suárez E, Ortiz AP, et al. Knowledge of viral hepatitis among Puerto Rican adults: implications for prevention. J Community Health. 2011;36(4):565-573.

26. Cox AD, Cox D, Cyrier R, Graham-Dotson Y, Zimet GD. Can self-prediction overcome barriers to hepatitis B vaccination? A randomized controlled trial. Health Psychol. 2012;31(1):97-105.

27. Stitzer ML, Polk T, Bowles S, Kosten T. Drug users’ adherence to a 6-month vaccination protocol: effects of motivational incentives. Drug Alcohol Depend. 2010;107(1):76-79.

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Author and Disclosure Information

Dr. Winn is a clinical psychologist, Dr. Francis is an attending psychiatrist, Dr. Shealy is a clinical psychologist, Ms. Paton is a retired licensed practical nurse, Ms. Planner is a retired registered nurse, Ms. Kelly is a retired registered nurse, and Dr. Gonzales-Nolas is an attending psychiatrist, all at the James A. Haley Veterans’ Hospital in Tampa, Florida. Ms. Levarge is an advanced registered nurse practitioner at American Lake Division of the VA Puget Sound Healthcare System in Lakewood, Washington. Dr. Winn is an assistant professor, Dr. Francis is an associate professor, Dr. Shealy is an assistant professor, and Dr. Gonzales-Nolas is an assistant professor, all at the University of South Florida in Tampa.

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hepatitis A vaccine, hepatitis B vaccine, substance abuse treatment, hepatitis B and C, hepatitis A/B immunization series, dual immunization, Twinrix, addictive disorders and hepatitis, mental illness, vaccination, relapse rate, psychosocial instability, serologic immunity, Jamie L Winn, Elie M Francis, Suzanne E Shealy, Michelle Levarge, Stephanie Paton, Anne Planner, Karen Kelly, Cheryl Gonzales-Nolas
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Dr. Winn is a clinical psychologist, Dr. Francis is an attending psychiatrist, Dr. Shealy is a clinical psychologist, Ms. Paton is a retired licensed practical nurse, Ms. Planner is a retired registered nurse, Ms. Kelly is a retired registered nurse, and Dr. Gonzales-Nolas is an attending psychiatrist, all at the James A. Haley Veterans’ Hospital in Tampa, Florida. Ms. Levarge is an advanced registered nurse practitioner at American Lake Division of the VA Puget Sound Healthcare System in Lakewood, Washington. Dr. Winn is an assistant professor, Dr. Francis is an associate professor, Dr. Shealy is an assistant professor, and Dr. Gonzales-Nolas is an assistant professor, all at the University of South Florida in Tampa.

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Dr. Winn is a clinical psychologist, Dr. Francis is an attending psychiatrist, Dr. Shealy is a clinical psychologist, Ms. Paton is a retired licensed practical nurse, Ms. Planner is a retired registered nurse, Ms. Kelly is a retired registered nurse, and Dr. Gonzales-Nolas is an attending psychiatrist, all at the James A. Haley Veterans’ Hospital in Tampa, Florida. Ms. Levarge is an advanced registered nurse practitioner at American Lake Division of the VA Puget Sound Healthcare System in Lakewood, Washington. Dr. Winn is an assistant professor, Dr. Francis is an associate professor, Dr. Shealy is an assistant professor, and Dr. Gonzales-Nolas is an assistant professor, all at the University of South Florida in Tampa.

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An accelerated dosing program for hepatitis A and B vaccination among veterans receiving treatment for addictive disorders was successfully implemented, although many veterans with hepatitis C did not complete the immunization series.
An accelerated dosing program for hepatitis A and B vaccination among veterans receiving treatment for addictive disorders was successfully implemented, although many veterans with hepatitis C did not complete the immunization series.

Homeless individuals and IV drug users are susceptible to hepatitis A, B, and C infections, and co-infection with these diseases may complicate treatment and result in poor medical outcomes.1 Vaccination offers the best protection against hepatitis A and B, particularly among high-risk populations.2,3 Immunization against hepatitis A and B is of even greater importance for patients with hepatitis C, because there is no specific hepatitis C vaccine, and concomitant infections of B with C are damaging to the liver.4

Veterans have a rate of hepatitis C infection that is 3 times that of the general population.5 Some evidence exists that veterans with serious mental illness (SMI) have a higher rate of hepatitis C infection relative to patients without SMI. Co-occurring substance abuse may add another layer of vulnerability to hepatitis C infection, particularly for homeless veterans.5-7

Mental Health and Primary Care Integration

Substance abuse and dual-diagnosis treatment programs (ie, those programs that treat both substance abuse and co-occurring serious mental health problems, such as bipolar disorder, severe major depressive disorder, psychotic disorders, and posttraumatic stress disorder [PTSD]) that have integrated mental health and primary care into their treatment programs may offer a window of opportunity for risk-reducing interventions. These interventions include testing and education of patients regarding infectious diseases, such as viral hepatitis and HIV, and completion of the hepatitis A/B immunization series.

The James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, has demonstrated some limited success in the past with integrating a standard dosing schedule for hepatitis A/B vaccination into its substance abuse treatment program (SATP), though recent evidence points to more promising results using an accelerated regimen as indicated by a high completion rate for hepatitis B vaccination in a methadone clinic.8,9 A relatively low proportion of SATPs in the U.S. provide testing, education, or vaccination for hepatitis A and B, especially considering the public health importance of controlling these diseases in the substance abusing populations.10,11

Related: Combination Pill Approved for HCV

In 1999, a primary care team was added to the alcohol and drug abuse treatment program at JAHVH.In 2005, the nurses in the program began scheduling vaccinations and screening patients for medical and psychiatric issues, pain, hypertension, diabetes, hepatitis C, alcohol use, depression, PTSD, prostate and colorectal cancers.12 Such a multidisciplinary approach provides many treatment advantages for patients and may save lives.13

Even with a multidisciplinary approach, the nurses found it difficult to provide adequate hepatitis A/B immunization within the 3- to 6-week intensive SATP, because standard immunization dosing regimens are spread over 6 months.14 As with all types of immunizations, long dosing schedules may reduce patient adherence and result in inadequate seroprotection.15 Thus, there is a need to provide a completed immunization series in a more expeditious fashion, and an accelerated dosing regimen makes that possible.15,16

Hepatitis A/B Vaccination

Twinrix (GlaxoSmithKline, Brentford, United Kingdom) is a vaccine that provides dual immunization for hepatitis A and B. Whereas the standard vaccination schedule takes 6 months to complete, the accelerated dosing schedule can be used to complete the first 3 doses in less than a month. The accelerated dosing schedule was incorporated into the JAHVH clinic to capture as many patients as possible in the 3- to 6-week time frame: The first dose is administered and followed by a second dose 7 days later. The third dose is administered 21 to 30 days after the first dose. Twelve months after the first dose, a booster dose is given. 

After the first 3 accelerated doses, > 98% of patients show a sustained immune response to hepatitis A, and > 63% demonstrate immunity to hepatitis B. If a 12-month booster injection is given, 100% of patients may receive immunity to hepatitis A and > 96% may have immunity to hepatitis B.16 Another study of the combined vaccine showed even greater seroprotection for hepatitis A and B after only 1 month, 100% and 82%, respectively.17

Related: Viral Hepatitis Awareness

This JAHVH retrospective feasibility study describes a risk-reduction program for hepatitis A/B prevention that was implemented within a 3- to 4-week intensive outpatient SATP and a 6-week dual-diagnosis treatment program. The study includes the development and implementation of the program, designed to vaccinate patients using the accelerated Twinrix schedule. To ascertain the feasibility of this vaccination approach, historical medical records were used to describe and examine the vaccination initiation and follow-up rates of the treatment program participants who received the hepatitis A/B immunization series during their intensive SATP.

Study Design

A retrospective review of medical records was conducted for all participants who were admitted to the intensive JAHVH SATP between October 1, 2008, and September 30, 2009. This study was reviewed and approved by the JAHVH research and development committee and its associated University of South Florida institutional review board. Informed consent to participate was not obtained, because the study was retrospective.

 

 

Patient Identification and Education

All program participants were offered testing for HIV and hepatitis A, B, and C. Program participants were educated about hepatitis and HIV transmission, as well as about the long-term effects of continued substance abuse on the progression of hepatitis C. Education about hepatitis, HIV, and substance abuse was provided in a group setting by a member of the program’s nursing staff. One-on-one risk education counseling was also provided when requested or otherwise indicated.

Laboratory testing was performed following each participant’s initial physical examination (within 3 to 5 days of program admission), and the nursing staff reviewed the results before vaccination. Explanation of laboratory results and an individualized immunization regimen were provided to each participant. On review of participants’ laboratory results, those with seroconversion of both hepatitis A and B were not given the combined immunization. Participants who had seroconversion of hepatitis A were offered the hepatitis B vaccination series, and vice versa.

Immunization Process

Participants who lacked prior immunization for hepatitis A and B and had no seroconversion of either hepatitis A or B were offered vaccination. Some patients declined vaccination, even though they were eligible. Their reasons were not formally assessed.

Related: Nivolumab Approved for Expanded Indication

Patients who accepted the vaccination were given the accelerated regimen.16 Participants were educated on the importance of compliance with the vaccination series and provided with follow-up immunization dates and a reminder for the 1-year booster vaccine. The immunizations were ordered by the program’s primary care NP and administered by a licensed practical nurse. The nurse who administered the injections took responsibility for scheduling the patients for all their subsequent injections, including the 1-year booster.

Follow-up Care

If the third injection was not completed before discharge, patients were given a follow-up appointment with the nurse if they remained in the JAHVH service area. If they were leaving the area, they were given instructions on how to follow-up at another VA facility to continue their immunization schedule. A note was written in the electronic medical record documenting their abbreviated hepatitis A/B immunization schedule, which could be accessed by other providers at other VA facilities. Patients who did not show up for any follow-up appointments (third injection or the 1-year booster injection) were contacted and reminded about the importance of completing the immunization series and to schedule an appointment.

Statistical Analysis

All data were analyzed using IBM Statistical Package for the Social Sciences (IBM SPSS, Armonk, New York) with a focus on identifying differences between vaccination-eligible patients (n = 269) who did (n = 128) and did not (n = 141) initiate the immunization schedule during the treatment program. Chi-square and Fisher exact tests were used to assess statistical differences in initiation of the immunization schedule related to categoric variables (ie, marital status, race, history of IV drug abuse, cigarette smoking status, housing status, legal status, history of combat, having a psychiatric or medical diagnosis, and program track). Independent sample t tests were used to test for differences between these 2 groups on the continuous variables, including age, number of previous treatment programs, Global Assessment of Functioning score, severity of smoking dependence as measured by the Fagerström Test for Nicotine Dependence, and the Addiction Severity Index scales.18-20

Results

The sample consisted of 284 successive admissions to an intensive outpatient program for veterans with substance use disorders. About one-third of the patients were homeless at the time of admission to the treatment, and 87% required contracted housing while completing treatment for reasons related to lack of housing, transportation, clinical necessity, or a combination of those factors (Table 1). The most common substance problems were alcohol and cocaine dependence, and 21% (n = 59) of the patients acknowledged a history of IV drug use during their initial psychiatric evaluation. Seventy percent were dually diagnosed with some other Axis I disorder, and 40% had a history of serious mental illness. More than one-fourth (n = 77) of the patients admitted to the intensive outpatient SATP were seropositive for hepatitis A, B and/or C, and the most common hepatitis diagnosis was hepatitis C (n = 71).

Accelerated Immunization Regimen

Patients were eligible to receive the accelerated vaccination schedule only if they had no prior immunization for hepatitis A or B and if they had no seroconversion for either hepatitis A or B. Six people had hepatitis B alone, 7 had hepatitis B and C, 1 had hepatitis A and C, and 1 had all 3 (Table 2). Thus, 15 participants were ineligible to receive the accelerated hepatitis A/B immunization. Chi-square, Fisher exact, and independent sample t tests showed that among those who were vaccination-eligible (269), there were no significant differences in any of the demographic or clinical characteristics between those who initiated the vaccination schedule and those who did not. Among those who completed the first 3 vaccine injections, those who received the 1-year booster injection (54) did not differ (on any demographic or clinical variables) from those who did not (58).

 

 

Nearly half (48%) of all the eligible patients admitted to the program began the accelerated immunization schedule for hepatitis A and B.  Of those, 88% completed the first 3 injections in the series. Among the patients who received the first 3 injections, 48% received the 1-year booster injection—a 20% completion rate for the vaccination-eligible sample overall (Table 3).

Of the 74 patients who did not complete their vaccinations once initiating the accelerated schedule, the most common reason identified was that the patient moved away (37), or no reason could be identified (33). It was uncommon for a patient not to complete the vaccination schedule because of terminating treatment prematurely (4).

Compared with the vaccine-eligible patients without hepatitis C (207), patients with hepatitis C were less likely to receive any vaccination injections (Table 3). Specifically, 51% of the vaccination-eligible patients who did not have hepatitis C began the vaccination regimen. However, only 22 patients with hepatitis C, or
35% of all vaccination-eligible patients with hepatitis C, began the vaccination regimen. Patients with hepatitis C were also less likely than those without hepatitis C to complete the first 3 injections of the vaccination series once they had initiated it (77%, vs 90%, respectively). This difference continued to be apparent at the time of the 12-month booster injection. Only 35% of vaccine-eligible individuals with hepatitis C received the 12-month booster injection, whereas 51% of vaccination-eligible individuals without hepatitis C received the 12-month booster injection. As with the sample overall, the most common reason patients with hepatitis C did not complete the vaccination regimen was because they moved away (9), followed by no identified reason (5), and premature termination of treatment (2).

Discussion

Individuals abusing alcohol and drugs have an increased vulnerability for infectious diseases, and homeless veterans with substance use disorders may be at a particularly heightened risk.21,22 This study describes a sample of veterans, many were homeless and most were dually diagnosed, in an intensive outpatient SATP that offered an accelerated dosing regimen for hepatitis A and B vaccination. Almost half (48%) of the vaccination-eligible patients began the accelerated regimen for hepatitis A/B vaccination. Moreover, 88% of those who started the vaccination regimen received the first 3 injections of the series, thus possibly conferring substantial immunity to hepatitis A and B and demonstrating the feasibility of an accelerated vaccination schedule in an intensive outpatient SATP.

It is especially important to demonstrate the successful integration of a hepatitis screening and immunization program within a SATP, given that many such programs do not offer screening or immunization for hepatitis, even though substance abusers are disproportionately affected by the disease and contribute greatly to the ongoing hepatitis epidemic.10,11 This study’s results were in line with another study of rapid vaccination for hepatitis B in IV drug users being treated in a methadone clinic, where 83% of the vaccination initiators completed the first 3 injections of the series.9

Unvaccinated Patients

The treatment team in the current study seemed to be less effective at reaching the subset of vaccination-eligible veterans with hepatitis C (almost one-quarter of the sample) in order to administer the accelerated vaccination schedule, as indicated by the lower rate of vaccination initiation as well as a lower rate of completion of the vaccination series among those patients. This replicates a finding from another study that also indicated a low rate of hepatitis A and B vaccination among patients with hepatitis C.23 Only 35% of the vaccination-eligible patients with hepatitis C in the current study initiated the vaccination series, compared with 51% of the patients without hepatitis C. However, the rate of completion of the first 3 injections of the series in the hepatitis C group was respectably high (77%), especially given the high relapse rate and psychosocial instability of individuals with addictive disorders. Initiation seems to be a bigger obstacle than completion of at least the first 3 injections of the vaccination series in both patients with and without hepatitis C.

The study investigators did not formally assess the reasons that more than half the patients in the study did not begin the vaccination series, but anecdotal evidence from the nurses indicated that many patients were afraid of needles. In addition, other patients felt that they simply did not need the vaccination. Some also insisted that they had already had the vaccination despite a blood test showing no evidence for either hepatitis A or B immunization.

Although the nursing team provided group and individual risk-based education as well as information about the effects of continued substance abuse on hepatitis C, it is possible that patients still underestimated their own risk of hepatitis infection and its consequences, or perhaps the information was simply not retained.24

 

 

Patient Education

A recent study showed that there is a positive relationship between the amount of hepatitis counseling received and knowledge of hepatitis.25 Possibly, increased intensity of education efforts may make an impact on initiation rates. Encouragingly, there is also evidence that prompting people to predict their future vaccination behavior may increase vaccination initiation rates despite a high-degree of short-term barriers, such as perceived pain or inconvenience.26 A brief intervention to induce people to formulate their future intentions would be relatively easy to incorporate into a vaccination program, and the study team is considering options for this to improve vaccination initiation rates.

Patients can expect to achieve substantial immunity from hepatitis A and, to a lesser degree, hepatitis B after completing the first 3 injections of the series, although the best seroprotection from both is obtained by completing the 12-month booster injection as well.17 Overall, about half of all patients who completed the first 3 injections returned for the booster shot, but only 35% of the patients with hepatitis C did so. The most common known cause of any patient not receiving the booster was movement out of the geographic area. However, much of the time the investigators were unable to determine the reasons patients did not return for the booster shot.

Medication adherence is a difficult problem with vaccination in high-risk samples, although Stitzer and colleagues found a significant improvement in follow-up for a 6-month vaccination protocol by using monetary incentives.27 In addition to ensuring medication adherence, it would also be of value for future immunization efforts to include testing to assess whether seroconversion has occurred once the vaccinations are complete, which is the ultimate measure of the success of a vaccination program. Most patients in the current study did not receive such testing at the completion of their vaccination schedules, and thus, seroconversion rates could not be determined. However, existing studies suggest high rates of seroprotection after the first 3 doses of the combined vaccine.10,17

Limitations

The retrospective nature of the study is its most significant limitation. Any conclusions about the results must be made with caution. However, this design allowed for a naturalistic and potentially generalizable investigation into the application of a vaccination program in a real-world treatment setting. As such, the investigators were able to demonstrate the feasibility of conducting a rapid vaccination program within a 3- to 6-week SATP.

The retrospective nature of the study also limited a full investigation into the reasons behind the lack of vaccination initiation and vaccination noncompletion among the study’s treatment population, especially with regard to the follow-up booster injection. Initial statistical comparisons of initiators and noninitiators and completers and noncompleters showed no significant statistical differences between the groups. Future prospective designs should take into account the need to successfully initiate and complete vaccinations for all eligible patients and include assessment measures to determine the specific reasons that patients did not initiate or complete their vaccinations.

Conclusions

Many patients began and completed the accelerated vaccination schedule for hepatitis A and B in the context of a 3- to 6-week SATP at JAHVH. The overall vaccination rate, including the 12-month booster injection, was one-fifth of the entire vaccination-eligible sample. Additionally, 88% of the vaccination-eligible patients who began the vaccination schedule (or 42% of the whole sample) completed at least the first 3 doses, which may confer substantial immunity from hepatitis A and B. For reasons not entirely clear, a little less than half the vaccination-eligible patients began the vaccination schedule, and only about 50% of those returned to receive their 12-month booster injection. Future prospective studies may be able to determine barriers to both the initiation of and adherence to the vaccination protocol.

The results of this study are also a testament to having primary care nursing staff available and actively involved in the care of patients in a SATP. It seems likely that additional interventions might be needed for outreach to and retention of patients in need of vaccination for hepatitis A and B, and particularly those patients with hepatitis C. It is important to find ways to increase the rates of 12-month booster vaccinations, both for veterans who continue to receive services at JAHVH and for those who transfer care to other VA facilities. Finally, testing to confirm serologic immunity to hepatitis A and hepatitis B would be the next step in the effort to eliminate the risk of hepatitis A and hepatitis B and minimize additional harm for those with hepatitis C in the population receiving treatment for addictive disorders.

 

 

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Homeless individuals and IV drug users are susceptible to hepatitis A, B, and C infections, and co-infection with these diseases may complicate treatment and result in poor medical outcomes.1 Vaccination offers the best protection against hepatitis A and B, particularly among high-risk populations.2,3 Immunization against hepatitis A and B is of even greater importance for patients with hepatitis C, because there is no specific hepatitis C vaccine, and concomitant infections of B with C are damaging to the liver.4

Veterans have a rate of hepatitis C infection that is 3 times that of the general population.5 Some evidence exists that veterans with serious mental illness (SMI) have a higher rate of hepatitis C infection relative to patients without SMI. Co-occurring substance abuse may add another layer of vulnerability to hepatitis C infection, particularly for homeless veterans.5-7

Mental Health and Primary Care Integration

Substance abuse and dual-diagnosis treatment programs (ie, those programs that treat both substance abuse and co-occurring serious mental health problems, such as bipolar disorder, severe major depressive disorder, psychotic disorders, and posttraumatic stress disorder [PTSD]) that have integrated mental health and primary care into their treatment programs may offer a window of opportunity for risk-reducing interventions. These interventions include testing and education of patients regarding infectious diseases, such as viral hepatitis and HIV, and completion of the hepatitis A/B immunization series.

The James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, has demonstrated some limited success in the past with integrating a standard dosing schedule for hepatitis A/B vaccination into its substance abuse treatment program (SATP), though recent evidence points to more promising results using an accelerated regimen as indicated by a high completion rate for hepatitis B vaccination in a methadone clinic.8,9 A relatively low proportion of SATPs in the U.S. provide testing, education, or vaccination for hepatitis A and B, especially considering the public health importance of controlling these diseases in the substance abusing populations.10,11

Related: Combination Pill Approved for HCV

In 1999, a primary care team was added to the alcohol and drug abuse treatment program at JAHVH.In 2005, the nurses in the program began scheduling vaccinations and screening patients for medical and psychiatric issues, pain, hypertension, diabetes, hepatitis C, alcohol use, depression, PTSD, prostate and colorectal cancers.12 Such a multidisciplinary approach provides many treatment advantages for patients and may save lives.13

Even with a multidisciplinary approach, the nurses found it difficult to provide adequate hepatitis A/B immunization within the 3- to 6-week intensive SATP, because standard immunization dosing regimens are spread over 6 months.14 As with all types of immunizations, long dosing schedules may reduce patient adherence and result in inadequate seroprotection.15 Thus, there is a need to provide a completed immunization series in a more expeditious fashion, and an accelerated dosing regimen makes that possible.15,16

Hepatitis A/B Vaccination

Twinrix (GlaxoSmithKline, Brentford, United Kingdom) is a vaccine that provides dual immunization for hepatitis A and B. Whereas the standard vaccination schedule takes 6 months to complete, the accelerated dosing schedule can be used to complete the first 3 doses in less than a month. The accelerated dosing schedule was incorporated into the JAHVH clinic to capture as many patients as possible in the 3- to 6-week time frame: The first dose is administered and followed by a second dose 7 days later. The third dose is administered 21 to 30 days after the first dose. Twelve months after the first dose, a booster dose is given. 

After the first 3 accelerated doses, > 98% of patients show a sustained immune response to hepatitis A, and > 63% demonstrate immunity to hepatitis B. If a 12-month booster injection is given, 100% of patients may receive immunity to hepatitis A and > 96% may have immunity to hepatitis B.16 Another study of the combined vaccine showed even greater seroprotection for hepatitis A and B after only 1 month, 100% and 82%, respectively.17

Related: Viral Hepatitis Awareness

This JAHVH retrospective feasibility study describes a risk-reduction program for hepatitis A/B prevention that was implemented within a 3- to 4-week intensive outpatient SATP and a 6-week dual-diagnosis treatment program. The study includes the development and implementation of the program, designed to vaccinate patients using the accelerated Twinrix schedule. To ascertain the feasibility of this vaccination approach, historical medical records were used to describe and examine the vaccination initiation and follow-up rates of the treatment program participants who received the hepatitis A/B immunization series during their intensive SATP.

Study Design

A retrospective review of medical records was conducted for all participants who were admitted to the intensive JAHVH SATP between October 1, 2008, and September 30, 2009. This study was reviewed and approved by the JAHVH research and development committee and its associated University of South Florida institutional review board. Informed consent to participate was not obtained, because the study was retrospective.

 

 

Patient Identification and Education

All program participants were offered testing for HIV and hepatitis A, B, and C. Program participants were educated about hepatitis and HIV transmission, as well as about the long-term effects of continued substance abuse on the progression of hepatitis C. Education about hepatitis, HIV, and substance abuse was provided in a group setting by a member of the program’s nursing staff. One-on-one risk education counseling was also provided when requested or otherwise indicated.

Laboratory testing was performed following each participant’s initial physical examination (within 3 to 5 days of program admission), and the nursing staff reviewed the results before vaccination. Explanation of laboratory results and an individualized immunization regimen were provided to each participant. On review of participants’ laboratory results, those with seroconversion of both hepatitis A and B were not given the combined immunization. Participants who had seroconversion of hepatitis A were offered the hepatitis B vaccination series, and vice versa.

Immunization Process

Participants who lacked prior immunization for hepatitis A and B and had no seroconversion of either hepatitis A or B were offered vaccination. Some patients declined vaccination, even though they were eligible. Their reasons were not formally assessed.

Related: Nivolumab Approved for Expanded Indication

Patients who accepted the vaccination were given the accelerated regimen.16 Participants were educated on the importance of compliance with the vaccination series and provided with follow-up immunization dates and a reminder for the 1-year booster vaccine. The immunizations were ordered by the program’s primary care NP and administered by a licensed practical nurse. The nurse who administered the injections took responsibility for scheduling the patients for all their subsequent injections, including the 1-year booster.

Follow-up Care

If the third injection was not completed before discharge, patients were given a follow-up appointment with the nurse if they remained in the JAHVH service area. If they were leaving the area, they were given instructions on how to follow-up at another VA facility to continue their immunization schedule. A note was written in the electronic medical record documenting their abbreviated hepatitis A/B immunization schedule, which could be accessed by other providers at other VA facilities. Patients who did not show up for any follow-up appointments (third injection or the 1-year booster injection) were contacted and reminded about the importance of completing the immunization series and to schedule an appointment.

Statistical Analysis

All data were analyzed using IBM Statistical Package for the Social Sciences (IBM SPSS, Armonk, New York) with a focus on identifying differences between vaccination-eligible patients (n = 269) who did (n = 128) and did not (n = 141) initiate the immunization schedule during the treatment program. Chi-square and Fisher exact tests were used to assess statistical differences in initiation of the immunization schedule related to categoric variables (ie, marital status, race, history of IV drug abuse, cigarette smoking status, housing status, legal status, history of combat, having a psychiatric or medical diagnosis, and program track). Independent sample t tests were used to test for differences between these 2 groups on the continuous variables, including age, number of previous treatment programs, Global Assessment of Functioning score, severity of smoking dependence as measured by the Fagerström Test for Nicotine Dependence, and the Addiction Severity Index scales.18-20

Results

The sample consisted of 284 successive admissions to an intensive outpatient program for veterans with substance use disorders. About one-third of the patients were homeless at the time of admission to the treatment, and 87% required contracted housing while completing treatment for reasons related to lack of housing, transportation, clinical necessity, or a combination of those factors (Table 1). The most common substance problems were alcohol and cocaine dependence, and 21% (n = 59) of the patients acknowledged a history of IV drug use during their initial psychiatric evaluation. Seventy percent were dually diagnosed with some other Axis I disorder, and 40% had a history of serious mental illness. More than one-fourth (n = 77) of the patients admitted to the intensive outpatient SATP were seropositive for hepatitis A, B and/or C, and the most common hepatitis diagnosis was hepatitis C (n = 71).

Accelerated Immunization Regimen

Patients were eligible to receive the accelerated vaccination schedule only if they had no prior immunization for hepatitis A or B and if they had no seroconversion for either hepatitis A or B. Six people had hepatitis B alone, 7 had hepatitis B and C, 1 had hepatitis A and C, and 1 had all 3 (Table 2). Thus, 15 participants were ineligible to receive the accelerated hepatitis A/B immunization. Chi-square, Fisher exact, and independent sample t tests showed that among those who were vaccination-eligible (269), there were no significant differences in any of the demographic or clinical characteristics between those who initiated the vaccination schedule and those who did not. Among those who completed the first 3 vaccine injections, those who received the 1-year booster injection (54) did not differ (on any demographic or clinical variables) from those who did not (58).

 

 

Nearly half (48%) of all the eligible patients admitted to the program began the accelerated immunization schedule for hepatitis A and B.  Of those, 88% completed the first 3 injections in the series. Among the patients who received the first 3 injections, 48% received the 1-year booster injection—a 20% completion rate for the vaccination-eligible sample overall (Table 3).

Of the 74 patients who did not complete their vaccinations once initiating the accelerated schedule, the most common reason identified was that the patient moved away (37), or no reason could be identified (33). It was uncommon for a patient not to complete the vaccination schedule because of terminating treatment prematurely (4).

Compared with the vaccine-eligible patients without hepatitis C (207), patients with hepatitis C were less likely to receive any vaccination injections (Table 3). Specifically, 51% of the vaccination-eligible patients who did not have hepatitis C began the vaccination regimen. However, only 22 patients with hepatitis C, or
35% of all vaccination-eligible patients with hepatitis C, began the vaccination regimen. Patients with hepatitis C were also less likely than those without hepatitis C to complete the first 3 injections of the vaccination series once they had initiated it (77%, vs 90%, respectively). This difference continued to be apparent at the time of the 12-month booster injection. Only 35% of vaccine-eligible individuals with hepatitis C received the 12-month booster injection, whereas 51% of vaccination-eligible individuals without hepatitis C received the 12-month booster injection. As with the sample overall, the most common reason patients with hepatitis C did not complete the vaccination regimen was because they moved away (9), followed by no identified reason (5), and premature termination of treatment (2).

Discussion

Individuals abusing alcohol and drugs have an increased vulnerability for infectious diseases, and homeless veterans with substance use disorders may be at a particularly heightened risk.21,22 This study describes a sample of veterans, many were homeless and most were dually diagnosed, in an intensive outpatient SATP that offered an accelerated dosing regimen for hepatitis A and B vaccination. Almost half (48%) of the vaccination-eligible patients began the accelerated regimen for hepatitis A/B vaccination. Moreover, 88% of those who started the vaccination regimen received the first 3 injections of the series, thus possibly conferring substantial immunity to hepatitis A and B and demonstrating the feasibility of an accelerated vaccination schedule in an intensive outpatient SATP.

It is especially important to demonstrate the successful integration of a hepatitis screening and immunization program within a SATP, given that many such programs do not offer screening or immunization for hepatitis, even though substance abusers are disproportionately affected by the disease and contribute greatly to the ongoing hepatitis epidemic.10,11 This study’s results were in line with another study of rapid vaccination for hepatitis B in IV drug users being treated in a methadone clinic, where 83% of the vaccination initiators completed the first 3 injections of the series.9

Unvaccinated Patients

The treatment team in the current study seemed to be less effective at reaching the subset of vaccination-eligible veterans with hepatitis C (almost one-quarter of the sample) in order to administer the accelerated vaccination schedule, as indicated by the lower rate of vaccination initiation as well as a lower rate of completion of the vaccination series among those patients. This replicates a finding from another study that also indicated a low rate of hepatitis A and B vaccination among patients with hepatitis C.23 Only 35% of the vaccination-eligible patients with hepatitis C in the current study initiated the vaccination series, compared with 51% of the patients without hepatitis C. However, the rate of completion of the first 3 injections of the series in the hepatitis C group was respectably high (77%), especially given the high relapse rate and psychosocial instability of individuals with addictive disorders. Initiation seems to be a bigger obstacle than completion of at least the first 3 injections of the vaccination series in both patients with and without hepatitis C.

The study investigators did not formally assess the reasons that more than half the patients in the study did not begin the vaccination series, but anecdotal evidence from the nurses indicated that many patients were afraid of needles. In addition, other patients felt that they simply did not need the vaccination. Some also insisted that they had already had the vaccination despite a blood test showing no evidence for either hepatitis A or B immunization.

Although the nursing team provided group and individual risk-based education as well as information about the effects of continued substance abuse on hepatitis C, it is possible that patients still underestimated their own risk of hepatitis infection and its consequences, or perhaps the information was simply not retained.24

 

 

Patient Education

A recent study showed that there is a positive relationship between the amount of hepatitis counseling received and knowledge of hepatitis.25 Possibly, increased intensity of education efforts may make an impact on initiation rates. Encouragingly, there is also evidence that prompting people to predict their future vaccination behavior may increase vaccination initiation rates despite a high-degree of short-term barriers, such as perceived pain or inconvenience.26 A brief intervention to induce people to formulate their future intentions would be relatively easy to incorporate into a vaccination program, and the study team is considering options for this to improve vaccination initiation rates.

Patients can expect to achieve substantial immunity from hepatitis A and, to a lesser degree, hepatitis B after completing the first 3 injections of the series, although the best seroprotection from both is obtained by completing the 12-month booster injection as well.17 Overall, about half of all patients who completed the first 3 injections returned for the booster shot, but only 35% of the patients with hepatitis C did so. The most common known cause of any patient not receiving the booster was movement out of the geographic area. However, much of the time the investigators were unable to determine the reasons patients did not return for the booster shot.

Medication adherence is a difficult problem with vaccination in high-risk samples, although Stitzer and colleagues found a significant improvement in follow-up for a 6-month vaccination protocol by using monetary incentives.27 In addition to ensuring medication adherence, it would also be of value for future immunization efforts to include testing to assess whether seroconversion has occurred once the vaccinations are complete, which is the ultimate measure of the success of a vaccination program. Most patients in the current study did not receive such testing at the completion of their vaccination schedules, and thus, seroconversion rates could not be determined. However, existing studies suggest high rates of seroprotection after the first 3 doses of the combined vaccine.10,17

Limitations

The retrospective nature of the study is its most significant limitation. Any conclusions about the results must be made with caution. However, this design allowed for a naturalistic and potentially generalizable investigation into the application of a vaccination program in a real-world treatment setting. As such, the investigators were able to demonstrate the feasibility of conducting a rapid vaccination program within a 3- to 6-week SATP.

The retrospective nature of the study also limited a full investigation into the reasons behind the lack of vaccination initiation and vaccination noncompletion among the study’s treatment population, especially with regard to the follow-up booster injection. Initial statistical comparisons of initiators and noninitiators and completers and noncompleters showed no significant statistical differences between the groups. Future prospective designs should take into account the need to successfully initiate and complete vaccinations for all eligible patients and include assessment measures to determine the specific reasons that patients did not initiate or complete their vaccinations.

Conclusions

Many patients began and completed the accelerated vaccination schedule for hepatitis A and B in the context of a 3- to 6-week SATP at JAHVH. The overall vaccination rate, including the 12-month booster injection, was one-fifth of the entire vaccination-eligible sample. Additionally, 88% of the vaccination-eligible patients who began the vaccination schedule (or 42% of the whole sample) completed at least the first 3 doses, which may confer substantial immunity from hepatitis A and B. For reasons not entirely clear, a little less than half the vaccination-eligible patients began the vaccination schedule, and only about 50% of those returned to receive their 12-month booster injection. Future prospective studies may be able to determine barriers to both the initiation of and adherence to the vaccination protocol.

The results of this study are also a testament to having primary care nursing staff available and actively involved in the care of patients in a SATP. It seems likely that additional interventions might be needed for outreach to and retention of patients in need of vaccination for hepatitis A and B, and particularly those patients with hepatitis C. It is important to find ways to increase the rates of 12-month booster vaccinations, both for veterans who continue to receive services at JAHVH and for those who transfer care to other VA facilities. Finally, testing to confirm serologic immunity to hepatitis A and hepatitis B would be the next step in the effort to eliminate the risk of hepatitis A and hepatitis B and minimize additional harm for those with hepatitis C in the population receiving treatment for addictive disorders.

 

 

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

References

1. Nyamathi A, Liu Y, Marfisee M, et al. Effects of a nurse-managed program on hepatitis A  and B vaccine completion among homeless adults. Nurs Res. 2009;58(1):13-22.

2. Center for Disease Control and Prevention (CDC). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. MMWR Morb Mortal Wkly Rep. 2006;55(RR16):1-25.

3. Advisory Committee on Immunization Practices (ACIP), Fiore AE, Wasley A, Bell BP. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2006;55(RR07):1-23.

4. Weltman MD, Brotodihardjo A, Crewe EB, et al. Coinfection with hepatitis B and C or B, C and delta viruses results in severe chronic liver disease and responds poorly to interferon-alpha treatment. J Viral Hepat. 1995;2(1):39-45.

5. Groessl EJ, Weingart KR, Kaplan RM, et al. Living with hepatitis C: qualitative interviews with hepatitis C-infected veterans. J Gen Intern Med. 2008;23(12):1959-1965.

6. Dominitz JA, Boyko EJ, Koepsell TD, et al. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Hepatology. 2005;41(1):88-96.

7. Himeloch S, McCarthy JF, Ganoczy D, et al. Understanding associations between serious mental illness and hepatitis C virus among veterans: a national multivariate analysis. Psychosomatics. 2009;50(1):30-37.

8. Hagedorn H, Dieperink E, Dingmann D, et al. Integrating hepatitis prevention services into a substance use disorder clinic. J Subst Abuse Treat. 2007;32(4):391-398.

9. Ramasamy P, Lintzeris N, Sutton Y, Taylor H, Day CA, Haber PS. The outcome of a rapid hepatitis B vaccination programme in a methadone treatment clinic. Addiction. 2010;105(2):329-334.

10. Bini EJ, Kritz S, Brown LS Jr, et al. Hepatitis B virus and hepatitis C virus services offered by substance abuse treatment programs in the United States. J Subst Abuse Treat. 2012;42(4):438-445.

11. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 1998;47(RR-19):1-39.

12. Francis E, Gonzales-Nolas CL, Markowitz J, Phillips S. Integration of preventive health screening into mental health clinics. Fed Pract. 2008;25(2):39-50.

13. Vreeland B. Bridging the gap between mental and physical health: a multidisciplinary approach. J Clin Psychiatry. 2007;68(suppl 4):26-33.

14. Brim N, Zaller N, Taylor LE, Feller E. Twinrix vaccination schedules among injecting drug users. Expert Opin Biol Ther. 2007;7(3):379-389.

15. Zuckerman J. The place of accelerated schedules for hepatitis A and B vaccinations. Drugs. 2003;63(17):1779-1784.

16. Connor BA, Blatter MM, Beran J, Zou B, Trofa AF. Rapid and sustained immune response against hepatitis A and B achieved with combined vaccine using an accelerated administration schedule. J Travel Med. 2007;14(1):9-15.

17. Nothdurft HD, Dietrich M, Zuckerman JN, et al. A new accelerated vaccination schedule for rapid protection against hepatitis A and B. Vaccine. 2002;20(7-8):1157-1162.

18. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association; 2000.

19. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86(9):1119-1127.

20. McLellan AT, Kushner H, Metzger D, et al. The Fifth Edition of the Addiction Severity Index. J Subst Abuse Treat. 1992;9(3):199-213.

21. Batki SL, Nathan KI. HIV/AIDS and Hepatitis C. In: Galanter M, Kleber HD, Brady KT, eds. The American Psychiatric Publishing Textbook of Substance Abuse Treatment. 5th ed. Arlington, VA: American Psychiatric Publishing; 2015.

22. Gelberg L, Robertson MJ, Leake B, et al. Hepatitis B among homeless and other impoverished US military veterans in residential care in Los Angeles. Public Health. 2001;115(4):286-291.

23. Felsen UR, Fishbein DA, Litwin AH. Low rates of hepatitis A and B vaccination in patients with chronic hepatitis C at an urban methadone maintenance program. J Addict Dis. 2010;29(4):461-465.

24. Brewer NT, Chapman GB, Gibbons FX, Gerrard M, McCaul KD, Weinstein ND. Meta-analysis of the relationship between risk perception and health behavior: the example of vaccination. Health Psychol. 2007;26(2):136-145.

25. Soto-Salgado M, Suárez E, Ortiz AP, et al. Knowledge of viral hepatitis among Puerto Rican adults: implications for prevention. J Community Health. 2011;36(4):565-573.

26. Cox AD, Cox D, Cyrier R, Graham-Dotson Y, Zimet GD. Can self-prediction overcome barriers to hepatitis B vaccination? A randomized controlled trial. Health Psychol. 2012;31(1):97-105.

27. Stitzer ML, Polk T, Bowles S, Kosten T. Drug users’ adherence to a 6-month vaccination protocol: effects of motivational incentives. Drug Alcohol Depend. 2010;107(1):76-79.

References

1. Nyamathi A, Liu Y, Marfisee M, et al. Effects of a nurse-managed program on hepatitis A  and B vaccine completion among homeless adults. Nurs Res. 2009;58(1):13-22.

2. Center for Disease Control and Prevention (CDC). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. MMWR Morb Mortal Wkly Rep. 2006;55(RR16):1-25.

3. Advisory Committee on Immunization Practices (ACIP), Fiore AE, Wasley A, Bell BP. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2006;55(RR07):1-23.

4. Weltman MD, Brotodihardjo A, Crewe EB, et al. Coinfection with hepatitis B and C or B, C and delta viruses results in severe chronic liver disease and responds poorly to interferon-alpha treatment. J Viral Hepat. 1995;2(1):39-45.

5. Groessl EJ, Weingart KR, Kaplan RM, et al. Living with hepatitis C: qualitative interviews with hepatitis C-infected veterans. J Gen Intern Med. 2008;23(12):1959-1965.

6. Dominitz JA, Boyko EJ, Koepsell TD, et al. Elevated prevalence of hepatitis C infection in users of United States veterans medical centers. Hepatology. 2005;41(1):88-96.

7. Himeloch S, McCarthy JF, Ganoczy D, et al. Understanding associations between serious mental illness and hepatitis C virus among veterans: a national multivariate analysis. Psychosomatics. 2009;50(1):30-37.

8. Hagedorn H, Dieperink E, Dingmann D, et al. Integrating hepatitis prevention services into a substance use disorder clinic. J Subst Abuse Treat. 2007;32(4):391-398.

9. Ramasamy P, Lintzeris N, Sutton Y, Taylor H, Day CA, Haber PS. The outcome of a rapid hepatitis B vaccination programme in a methadone treatment clinic. Addiction. 2010;105(2):329-334.

10. Bini EJ, Kritz S, Brown LS Jr, et al. Hepatitis B virus and hepatitis C virus services offered by substance abuse treatment programs in the United States. J Subst Abuse Treat. 2012;42(4):438-445.

11. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 1998;47(RR-19):1-39.

12. Francis E, Gonzales-Nolas CL, Markowitz J, Phillips S. Integration of preventive health screening into mental health clinics. Fed Pract. 2008;25(2):39-50.

13. Vreeland B. Bridging the gap between mental and physical health: a multidisciplinary approach. J Clin Psychiatry. 2007;68(suppl 4):26-33.

14. Brim N, Zaller N, Taylor LE, Feller E. Twinrix vaccination schedules among injecting drug users. Expert Opin Biol Ther. 2007;7(3):379-389.

15. Zuckerman J. The place of accelerated schedules for hepatitis A and B vaccinations. Drugs. 2003;63(17):1779-1784.

16. Connor BA, Blatter MM, Beran J, Zou B, Trofa AF. Rapid and sustained immune response against hepatitis A and B achieved with combined vaccine using an accelerated administration schedule. J Travel Med. 2007;14(1):9-15.

17. Nothdurft HD, Dietrich M, Zuckerman JN, et al. A new accelerated vaccination schedule for rapid protection against hepatitis A and B. Vaccine. 2002;20(7-8):1157-1162.

18. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association; 2000.

19. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86(9):1119-1127.

20. McLellan AT, Kushner H, Metzger D, et al. The Fifth Edition of the Addiction Severity Index. J Subst Abuse Treat. 1992;9(3):199-213.

21. Batki SL, Nathan KI. HIV/AIDS and Hepatitis C. In: Galanter M, Kleber HD, Brady KT, eds. The American Psychiatric Publishing Textbook of Substance Abuse Treatment. 5th ed. Arlington, VA: American Psychiatric Publishing; 2015.

22. Gelberg L, Robertson MJ, Leake B, et al. Hepatitis B among homeless and other impoverished US military veterans in residential care in Los Angeles. Public Health. 2001;115(4):286-291.

23. Felsen UR, Fishbein DA, Litwin AH. Low rates of hepatitis A and B vaccination in patients with chronic hepatitis C at an urban methadone maintenance program. J Addict Dis. 2010;29(4):461-465.

24. Brewer NT, Chapman GB, Gibbons FX, Gerrard M, McCaul KD, Weinstein ND. Meta-analysis of the relationship between risk perception and health behavior: the example of vaccination. Health Psychol. 2007;26(2):136-145.

25. Soto-Salgado M, Suárez E, Ortiz AP, et al. Knowledge of viral hepatitis among Puerto Rican adults: implications for prevention. J Community Health. 2011;36(4):565-573.

26. Cox AD, Cox D, Cyrier R, Graham-Dotson Y, Zimet GD. Can self-prediction overcome barriers to hepatitis B vaccination? A randomized controlled trial. Health Psychol. 2012;31(1):97-105.

27. Stitzer ML, Polk T, Bowles S, Kosten T. Drug users’ adherence to a 6-month vaccination protocol: effects of motivational incentives. Drug Alcohol Depend. 2010;107(1):76-79.

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Accelerated Hepatitis A and B Immunization in a Substance Abuse Treatment Program
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Accelerated Hepatitis A and B Immunization in a Substance Abuse Treatment Program
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hepatitis A vaccine, hepatitis B vaccine, substance abuse treatment, hepatitis B and C, hepatitis A/B immunization series, dual immunization, Twinrix, addictive disorders and hepatitis, mental illness, vaccination, relapse rate, psychosocial instability, serologic immunity, Jamie L Winn, Elie M Francis, Suzanne E Shealy, Michelle Levarge, Stephanie Paton, Anne Planner, Karen Kelly, Cheryl Gonzales-Nolas
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hepatitis A vaccine, hepatitis B vaccine, substance abuse treatment, hepatitis B and C, hepatitis A/B immunization series, dual immunization, Twinrix, addictive disorders and hepatitis, mental illness, vaccination, relapse rate, psychosocial instability, serologic immunity, Jamie L Winn, Elie M Francis, Suzanne E Shealy, Michelle Levarge, Stephanie Paton, Anne Planner, Karen Kelly, Cheryl Gonzales-Nolas
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