Peer Recovery Support for Opioid Use Disorder Treatment Retention
Reducing OUD Treatment Dropout: Development and Pilot Test of a Peer Recovery Support Intervention in Primary Care
The goal of this clinical trial is to learn whether adding peer recovery support services to standard opioid use disorder (OUD) treatment in primary care helps patients stay in treatment longer. The main question it seeks to answer is whether it is feasible to deliver a peer recovery support intervention alongside medication-assisted treatment (buprenorphine) in a Philadelphia primary care clinic.
Participants will receive standard OUD treatment (buprenorphine) combined with peer recovery support services for 180 days. They will attend study visits at baseline, weekly for the first 2 weeks, then every 2 weeks, then monthly, and complete assessments about substance use, medication adherence, self-efficacy, resilience, and coping. Participants will also take part in brief periodic interviews about their experience with peer support.
調査の概要
詳細な説明
Opioid use disorder (OUD) is a chronic, relapsing condition associated with substantial morbidity, mortality, and social burden. Buprenorphine, delivered in primary care settings, is an evidence-based treatment for OUD, yet treatment dropout remains a critical barrier to recovery. Many patients disengage during the early weeks following induction, before buprenorphine has had the opportunity to stabilize their condition. Peer recovery support (PRS) services, provided by individuals with lived experience of addiction and recovery, represent a promising strategy to improve retention, but the evidence base for optimized peer interventions in primary care OUD treatment remains limited.
The peer intervention evaluated in this study was developed through a systematic optimization process conducted in partnership with OUD, peer, and implementation experts, with extensive input from patients, practitioners, and community stakeholders. Intervention design drew on surveys and qualitative studies of Philadelphia-region OUD treatment programs with existing peer support services, as well as best practices from community health worker models in other chronic disease settings. Component elements, including peer qualifications, supervision structure, training curriculum, caseload size, scope of services, and care team integration, were systematically evaluated and refined prior to the pilot.
The resulting intervention is organized around five core structural elements: (1) clinically integrated supervision with structured case review; (2) standardized recruitment and hiring practices emphasizing empathy, problem-solving capacity, and community engagement; (3) a competency-based training curriculum covering psychosocial support, crisis response, stigma, interprofessional ethics, social determinants of health, and system navigation; (4) stage-tailored peer-patient contact, with intensive engagement during the high-dropout early induction period transitioning to stabilization-focused support as treatment progresses; and (5) active peer wellness practices to mitigate compassion fatigue and burnout.
This pilot study will evaluate the feasibility, acceptability, and operational implementation of the intervention within primary care-based buprenorphine treatment programs and generate data to inform a future randomized controlled trial.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Penn Family Medicine
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of opioid use disorder (OUD)
- Currently receiving or initiating buprenorphine treatment from a primary care physician
- Able to communicate in English
- Access to a phone
- Able and willing to provide written informed consent
Exclusion Criteria:
- Acute suicidal ideation or intent
- Active mania or psychotic episode
- Significant cognitive impairment
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Peer Support
|
Peer recovery support services delivered by trained, certified peers with lived experience of opioid use disorder, added to standard medication-assisted treatment (buprenorphine) in a primary care setting.
Peer services are structured around three stages of OUD treatment (initial engagement, early treatment, and stable treatment) with contact intensity tailored to dropout risk at each stage (approximately 2 contact hours/week during initial engagement).
Contact modalities include in-office meetings, phone calls, texts, and appointment reminders.
Peers are supervised and integrated as full members of the clinical care team.
The intervention was developed with input from OUD, peer, and implementation experts and informed by qualitative and survey data from Philadelphia-region OUD treatment programs.
Caseload: approximately 15 patients per peer.
Duration: 180 days.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
OUD treatment retention
時間枠：180 days
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Retention in OUD treatment measured as time in days from treatment initiation (buprenorphine induction) to dropout (unplanned treatment termination) or treatment completion over the 180-day study period.
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180 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-report opioid use
時間枠：180 days
|
Assessed using an abbreviated 30-day Time-Line Follow-Back (TLFB) instrument capturing self-reported opioid use at each study visit.
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180 days
|
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Buprenorphine adherence
時間枠：180 days
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Assessed using the Brief Medication Questionnaire (self-report).
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180 days
|
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Resilience, coping, and self-efficacy
時間枠：180 days
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A 30-item composite questionnaire combining three patient-centered outcome domains to minimize participant burden.
Section 1 (Resilience, 10 items) uses a 5-point Likert scale rating the past month, with 4 items reverse-scored; scores range from 10 to 50, with higher scores indicating greater resilience.
Section 2 (Coping Strategies, 10 items adapted from the Brief COPE) uses a 4-point scale rating frequency of coping strategy use, including a substance use item; scores range from 10 to 40, with higher scores indicating greater frequency of coping strategy use.
Section 3 (Abstinence Self-Efficacy, 10 items adapted from the Alcohol Abstinence Self-Efficacy Scale) uses a 5-point confidence scale assessing ability to remain opioid-free across situational triggers over the past week; scores range from 10 to 50, with higher scores indicating greater confidence in maintaining opioid abstinence.
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180 days
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Opioid urine drug screen positivity
時間枠：180 days
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Proportion of urine drug screens positive for opioids, obtained at routine clinical visits throughout the study period.
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180 days
|
協力者と研究者
捜査官
- 主任研究者：Rebecca A Harris, MD、University of Pennsylvania
出版物と役立つリンク
一般刊行物
- Bao Y, Zhang H, Hutchings K, Harris RA, Calderbank T, Schackman BR. Medicaid-Covered Peer Support Services Used by Enrollees With Opioid Use Disorder. JAMA Netw Open. 2024 Jul 1;7(7):e2420737. doi: 10.1001/jamanetworkopen.2024.20737.
- Harris RA, Campbell K, Calderbank T, Dooley P, Aspero H, Maginnis J, O'Donnell N, Coviello D, French R, Bao Y, Mandell DS, Bogner HR, Lowenstein M. Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model. Healthc (Amst). 2022 Sep;10(3):100641. doi: 10.1016/j.hjdsi.2022.100641. Epub 2022 Jul 2.
- Harris RA, Mandell DS, Kampman KM, Bao Y, Campbell K, Cidav Z, Coviello DM, French R, Livesey C, Lowenstein M, Lynch KG, McKay JR, Oslin DW, Wolk CB, Bogner HR. Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol. Contemp Clin Trials. 2021 Apr;103:106325. doi: 10.1016/j.cct.2021.106325. Epub 2021 Feb 22.
- Harris RA, Kearney M, Keddem S, Calderbank T, Tomczuk L, Clapp J, Perrone J, Kranzler HR, Long JA, Mandell DS. Organization of primary care and early MOUD discontinuation. Addict Sci Clin Pract. 2024 Dec 19;19(1):96. doi: 10.1186/s13722-024-00527-w.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 858768
- K23DA054157 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
オピオイド使用障害の臨床試験
Peer Supportの臨床試験
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center積極的、募集していない
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Potomac Health FoundationsNational Institutes of Health (NIH); National Institute of Drug Abuse積極的、募集していない
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MYnd AnalyticsUniversity of Ottawa; Canadian Forces Health Services Centre Ottawaわからない
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Monash University MalaysiaMinistry of Higher Education, Malaysia完了
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Medical University of South CarolinaNational Institutes of Health (NIH)募集
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完了
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Amager HospitalThe Peer partnership association完了
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了