Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Honest, Open, Proud (HOP): A Peer Delivered, Co-occurring Disorders Intervention for Justice-involved Veterans (HOP)

28 июля 2026 г. обновлено: VA Office of Research and Development

Honest, Open, Proud (HOP) (QUE 25-014)

As many as two-thirds of Justice-involved Veterans (JIVs) have a substance-use disorder (SUD), and up to 51% have a mental health (MH) condition; however, fewer than one-third of JIVs receive MH or SUD treatment, and addressing stigma is a recommended strategy for improving Veteran willingness to engage in treatment. Honest, Open, Proud (HOP) is an evidence-based stigma reduction intervention for justice-involved Veterans that is delivered by peers, which can ultimately increase access to and engagement in care, lower rates of criminal recidivism, and improve MH and SUD outcomes. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, stigma reduction intervention for justice-involved Veterans with co-occurring SUD and MH disorders.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

Background: Justice-involved Veterans (JIVs) are highlighted as a highly vulnerable Veteran subgroup, and as many as two-thirds of JIVs have SUD, and up to 51% have a MH condition. However, fewer than one-third of JIVs receive MH or SUD treatment and addressing stigma is a recommended strategy for improving Veteran willingness to engage in treatment. Moreover, self-stigma prevents Veterans from asking for help or engaging in ongoing care. The connection between internalized self-stigma and lack of accessing care or support services impairs Veterans recovery. Interventions grounded in evidence-based, peer-led practices are effective in increasing access to and engagement in care; however, implementation of such strategies are costly and intensive. This study protocol describes a Hybrid Type III effectiveness-implementation trial of Honest, Open, Proud (HOP) with high-need, justice-involved Veterans and will evaluate the impact and cost of a high intensity (vs. low-intensity) strategy on implementation, maintenance, and sustainment outcomes.

Methods: This quality improvement (QI) project involves a Hybrid Type III implementation effectiveness trial in six VA medical centers across the United States. Sites will begin with a 6-month pre-implementation period (e.g., orientation) to examine organizational readiness to adopt VA-HOP (Aim 1). A pre-post pragmatic trial with enhancements to accommodate possible growth trends with features of an interrupted time series in which VJP staff at each site will be offered 6-months of audit and feedback (lower-intensity implementation support) followed by 6-months of implementation facilitation (higher-intensity implementation support) for promoting VA-HOP implementation by VJP staff (Aim 2). The investigators will examine whether the Veterans served by staff who delivered VA-HOP with greater model fidelity will demonstrate an increase in outpatient specialty care days, reductions in emergency department use, and reductions in suicide risk compared to Veterans who received VA-HOP with lower fidelity (Aim 3). Finally, this study will examine implementation erosion and sustainment of VA-HOP following discontinuation of active implementation support (for 9-months after high intensity support ends) using quantitative implementation outcomes and post-implementation qualitative interviews (Aim 4).

Anticipated Impact: This study will provide information on the relative impacts and relative costs of strategies aimed at implementing a peer-led, stigma reduction intervention for justice-involved Veterans with co-occurring SUD and MH disorders. The findings will provide guidance to VA and other healthcare systems that serve justice-involved Veterans with co-occurring disorders.

Тип исследования

Интервенционный

Регистрация (Оцененный)

240

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: David A Smelson, PsyD
  • Номер телефона: (781) 687-7778
  • Электронная почта: david.smelson@va.gov

Учебное резервное копирование контактов

  • Имя: Michael A Andre, MPH
  • Номер телефона: (781) 382-5554
  • Электронная почта: michael.andre2@va.gov

Места учебы

  • Соединенные Штаты
    • Massachusetts
      • Bedford, Massachusetts, Соединенные Штаты, 01730-1114
        • Рекрутинг
        • VA Bedford HealthCare System, Bedford, MA
        • Главный следователь:
          • David A. Smelson, PsyD
        • Контакт:
          • David A Smelson, PsyD
          • Номер телефона: (781) 687-7778
          • Электронная почта: david.smelson@va.gov
        • Контакт:
          • Michael A Andre, MPH
          • Номер телефона: (781) 382-5554
          • Электронная почта: michael.andre2@va.gov

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • Veterans who are service-connected and enrolled in a VJP program within six VA Medical Centers:

    • Fresno, Palo Alto, Butler, Coatesville, Pittsburgh, Wilmington, and therefore have justice involvement
  • Veterans who meet DSM-5 criteria for a mental health and/or substance use disorder
  • Veterans who are willing to participate in VA-HOP

Exclusion Criteria:

  • Does not have a history of justice involvement and or not enrolled in a participating site VJP program
  • Do not have a mental health and/or substance use disorder diagnosis

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Нерандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Low Intensity
Audit and Feedback will be our low intensity implementation strategy. Peer specialists and key stakeholders will receive monthly data reports on VA-HOP delivery (e.g. number of sessions delivered, number of Veterans served) and fidelity data with written feedback. Peers will have the opportunity to join an optional, monthly virtual session to discuss their report with a quantitative expert.
Поведенческий: Veterans Affairs-Honest, Open, Proud
VA-HOP is an evidence-based, peer-delivered group intervention designed to help individuals navigate decisions about disclosure of behavioral health conditions. The intervention consists of three lessons comprising nine structured tasks that guide participants through decisions of disclosure aimed at reducing self-stigma. The goal of HOP is not to force disclosure; rather, it empowers participants to decide whether, when, and how disclosure may occur. VA-HOP is facilitated by a peer specialist with a group of 8-10 participants, and sessions can be broken down into a 45-minute weekly session for 9 weeks or 3 weekly 2 1/4-hour blocks. The first lesson covers the short- and long-term benefits and risks of disclosure and non-disclosure. The second lesson addresses the different levels of disclosure, emphasizing that disclosure exists on a continuum and can vary depending on the context and audience. The third lesson focuses on how to tell one's recovery story.
Другие имена:
  • VA-HOP
Экспериментальный: High Intensity
Implementation Facilitation will be our high intensity implementation strategy. Peer specialists and other key stakeholders will participate in biweekly virtual meetings with an external facilitator. Facilitation activities serve a range of functions spanning problem-solving, relationship-building, and goal setting and planning. Activities are selected based on site progress and needs.
Поведенческий: Veterans Affairs-Honest, Open, Proud
VA-HOP is an evidence-based, peer-delivered group intervention designed to help individuals navigate decisions about disclosure of behavioral health conditions. The intervention consists of three lessons comprising nine structured tasks that guide participants through decisions of disclosure aimed at reducing self-stigma. The goal of HOP is not to force disclosure; rather, it empowers participants to decide whether, when, and how disclosure may occur. VA-HOP is facilitated by a peer specialist with a group of 8-10 participants, and sessions can be broken down into a 45-minute weekly session for 9 weeks or 3 weekly 2 1/4-hour blocks. The first lesson covers the short- and long-term benefits and risks of disclosure and non-disclosure. The second lesson addresses the different levels of disclosure, emphasizing that disclosure exists on a continuum and can vary depending on the context and audience. The third lesson focuses on how to tell one's recovery story.
Другие имена:
  • VA-HOP

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of VA-HOP Sessions delivered
Временное ограничение: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Uptake is the study primary outcome and is defined as the number of VA-HOP sessions delivered to Veterans during each implementation period. Using EHR data submitted into the VA CDW, uptake statistics will be extracted for each implementation period, i.e. Audit and Feedback (6-months), Implementation Facilitation (6-months), and Sustainment Phase (9-months).
Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Dose Fidelity Adherence to HOP Model
Временное ограничение: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Dose Fidelity will be a secondary outcome. Dose fidelity is defined as a proportion of expected VA-HOP encounters completed by each Veteran. Fidelity will be assessed from standard documentation embedded within each participating sites EHR completed by VA HOP peer facilitators. This data will be extracted for each implementation period, i.e. Audit and Feedback (6-months), Implementation Facilitation (6-months), and Sustainment Phase (9-months).
Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Content Fidelity Adherence to HOP Model
Временное ограничение: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Content Fidelity will be a secondary outcome. Content fidelity is defined as the extent to which peer facilitators complete the three VA-HOP lessons and nine VA-HOP tasks. Content fidelity will be assessed from standard documentation embedded within each participating sites EHR completed by VA HOP peer facilitators. This documentation note tracks each VA-HOP Peer facilitator and their use of the VA-HOP lessons and associated tasks. This data will be extracted for each implementation period, i.e. Audit and Feedback (6-months), Implementation Facilitation (6-months), and Sustainment Phase (9-months).
Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Effectiveness-Mental Health Outpatient Care encounters
Временное ограничение: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Among Veterans who receive VA-HOP, the number of outpatient mental health treatment encounters they have in each implementation phase will be compared. These data will be collected using VA administrative data.
Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Effectiveness-Substance Use Disorder Outpatient Care encounters
Временное ограничение: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Among Veterans who receive VA-HOP, the number of outpatient substance use treatment encounters they have in each implementation phase will be compared. These data will be collected using VA administrative data.
Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Effectiveness-Emergency Department Hospitalizations
Временное ограничение: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Among Veterans who receive VA-HOP, the number of emergency department visits they have in each implementation phase will be compared. These data will be collected using VA administrative data.
Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Effectiveness-Suicide Prevention Coordinator Visits
Временное ограничение: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Among Veterans who receive VA-HOP, Suicide risk measured as the number of engagements with the Suicide Prevention Coordinator they have in each implementation phase will be compared. These data will be collected using VA administrative data.
Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

VA Office of Research and Development

Следователи

  • Главный следователь: David A. Smelson, PsyD, VA Bedford HealthCare System, Bedford, MA

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 июля 2026 г.

Первичное завершение (Оцененный)

30 июня 2030 г.

Завершение исследования (Оцененный)

30 сентября 2030 г.

Даты регистрации исследования

Первый отправленный

22 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

28 июля 2026 г.

Первый опубликованный (Действительный)

3 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • QUX 26-005

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться