- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07742722
Honest, Open, Proud (HOP): A Peer Delivered, Co-occurring Disorders Intervention for Justice-involved Veterans (HOP)
Honest, Open, Proud (HOP) (QUE 25-014)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: David A Smelson, PsyD
- Telefonnummer: (781) 687-7778
- E-post: david.smelson@va.gov
Studer Kontakt Backup
- Navn: Michael A Andre, MPH
- Telefonnummer: (781) 382-5554
- E-post: michael.andre2@va.gov
Studiesteder
-
-
Massachusetts
-
Bedford, Massachusetts, Forente stater, 01730-1114
- Rekruttering
- VA Bedford HealthCare System, Bedford, MA
-
Hovedetterforsker:
- David A. Smelson, PsyD
-
Ta kontakt med:
- David A Smelson, PsyD
- Telefonnummer: (781) 687-7778
- E-post: david.smelson@va.gov
-
Ta kontakt med:
- Michael A Andre, MPH
- Telefonnummer: (781) 382-5554
- E-post: michael.andre2@va.gov
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
Andre navn:
|
|
Eksperimentell: 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.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of VA-HOP Sessions delivered
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dose Fidelity Adherence to HOP Model
Tidsramme: 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
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Effectiveness-Mental Health Outpatient Care encounters
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: David A. Smelson, PsyD, VA Bedford HealthCare System, Bedford, MA
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- QUX 26-005
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