Honest, Open, Proud (HOP) (QUE 25-014)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Number of VA-HOP Sessions delivered
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of VA-HOP Sessions delivered
Time Frame: 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).
Secondary Outcomes
- Dose Fidelity Adherence to HOP Model(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(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))