Enhancing Veteran-Clinical Collaboration in VA PRRCs (EVCC VPRRC)

VA Office of Research and Development

Status: Begins enrollment in 7 months

Conditions: Major Depressive Disorder; Schizophrenia; Bipolar Disorder; Schizoaffective Disorder; Delusional Disorder

Treatments: Behavioral: Collaborative Decision Skills Training; Behavioral: Leveling Up

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06898879

D5052-R

RX005052 (Other Grant/Funding Number)

Details and patient eligibility

About

Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.

Full description

Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that supports meaningful involvement for patients across all aspects of decision- making, thereby empowering patients and facilitating better decision-making based on patient values, preferences, and cultural context. CDM is associated with several important outcomes including improved personal recovery, treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low. Collaborative Decision Skills Training (CDST) is a promising 10-session group intervention that support Veterans to gain knowledge, skills, comfort, and confidence to collaborate with their clinicians and other members of their treatment teams. CDST has undergone initial testing in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) and demonstrated feasibility for use among Veterans participating in PRRC care. This initial tests demonstrated preliminary evidence that CDST is effective at increasing Veteran-clinician collaboration, personal recovery, empowerment, treatment engagement, and social functioning.

Therefore, the proposed study will examine CDST's effectiveness among 119 Veterans with SMI participating in three PRRCs in the Southwestern United States (San Diego, Los Angeles, and Albuquerque). Veterans will be randomized to either CDST or active control (AC). The primary outcome measure will be functioning within the rehabilitation context, meaning Veteran CDM behavior during usual care VA mental health appointments. Secondary outcomes are treatment attendance, engagement, and satisfaction, along with functioning outside of the rehabilitation context (i.e., rehabilitation goal attainment, sense of personal recovery, empowerment symptom severity, and social functioning). Given that CDM is fundamentally an interaction between Veterans and their clinicians, the team will also assess whether clinician factors (i.e., engagement in CDST training or delivery; therapeutic alliance; work satisfaction; burnout; perceptions of self-efficacy; organizational climate; attitudes about recovery and CDM) moderate Veteran outcomes. Veterans in both groups will attend 10 hour- long group sessions held over 10 weeks.

All Veterans will complete an assessment battery at baseline, post-intervention, at three-month post- intervention follow-up, and at six-month follow-up. This will allow the team to assess durability of CDST's hypothesized benefits. Veterans who leave PRRC care and then return while the study is still active will complete one final assessment to further assess whether benefits are durable to re-entry to care. Additionally, the team will assess equity of benefits by assessing subgroup differences in benefits by race/ethnicity, gender, and sexual orientation. A team of Veterans and clinicians will be recruited to co-create consensus equity guidelines to support effective and equitable delivery of CDST in PRRCs.

The results of the proposed study will confirm CDST's benefits for Veterans in PRRC care and inform the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing a large, diverse sample to 1) assess CDST's overall benefits; 2) durability and equity of those potential benefits; 3) whether and how clinician factors impact those potential benefits; and 4) identify how to deliver CDST and related interventions effectively and equitably.

Enrollment: 119 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• be a Veteran currently receiving PRRC, MHICM and/or BHIP services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)
• meet SAMHSA criteria of serious mental illness; i.e., "having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities," based on chart review and clinician consultation if needed
• Be age 18 or above
• Be fluent and literate in English.
• Agree to have a subset of VA mental health treatment appointments audiotaped

Exclusion criteria

• primary substance use or organic neurological disorder diagnosis determined by chart review
• are determined by clinician and/or study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation
• have a history and/or current risk of violence that clinicians and/or study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

119 participants in 2 patient groups

Collaborative Decision Skills Training

Experimental group

Description:

Collaborative Decision Skills Training (CDST) is the intervention group (experimental arm).

Treatment:

Behavioral: Collaborative Decision Skills Training

Leveling Up

Active Comparator group

Description:

Leveling Up is the active control arm.

Treatment:

Behavioral: Leveling Up