Clinical trial NCT06898879: Enhancing Veteran-Clinical Collaboration in VA PRRCs
Official title: Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Delusional Disorder
Bipolar Disorder
Major Depressive Disorder
Keywords: serious mental illness
psychosis
collaborative decision-making
shared decision-making
veterans
recovery
personal recovery
empowerment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-03-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental design for this study is a 2-group randomized effectiveness trial, with assessments at baseline (month 0), post-intervention (month 3), and 3- and 6- post-intervention follow-ups (months 6 and 9). Veterans will be randomly assigned to either the CDST condition or to LU after completing baseline assessments. To maximize power for between-group comparisons, randomization will be 1:1 resulting in \~60 participants per group. Stratification may be introduced if necessary due to uneven or statistically different groups in key demographic domains (e.g., age, gender). Quantitative analyses will compare improvements in primary, secondary, and exploratory outcomes between the two groups, as described elsewhere. There are also qualitative outcomes associated with this study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Shared Decision-Making Coding System
timeFrame: Baseline to 3-month follow-up
measure: Shared Decision-Making Coding System
timeFrame: Baseline to 6-month follow-up
measure: Consumer-Created Opportunities for Active Involvement Coding System
timeFrame: Baseline to 3-month follow-up
measure: Consumer-Created Opportunities for Active Involvement Coding System
timeFrame: Baseline to 6-month follow-up
Secondary outcomes:
measure: Singh O'Brien Level of Engagement Scale
timeFrame: Baseline to 3-month follow-up
measure: Singh O'Brien Level of Engagement Scale
timeFrame: Baseline to 6-month follow-up
measure: Client Satisfaction Questionnaire
timeFrame: Baseline to 3-month follow-up
measure: Client Satisfaction Questionnaire
timeFrame: Baseline to 6-month follow-up
measure: Canadian Occupational Performance Measure- Performance subscale
timeFrame: Baseline to 3-month follow-up
measure: Canadian Occupational Performance Measure- Performance subscale
timeFrame: Baseline to 6-month follow-up
measure: Goal Attainment Scaling
timeFrame: Baseline to 3-month follow-up
measure: Goal Attainment Scaling
timeFrame: Baseline to 6-month follow-up
measure: Maryland Assessment of Recovery in Serious Mental Illness
timeFrame: Baseline to 3-month follow-up
measure: Maryland Assessment of Recovery in Serious Mental Illness
timeFrame: Baseline to 6-month follow-up
measure: Personal and Social Performance scale
timeFrame: Baseline to 3-month follow-up
measure: Personal and Social Performance scale
timeFrame: Baseline to 6-month follow-up
measure: Shared Decision Making Questionnaire for Mental Health
timeFrame: Baseline to 3-month follow-up
measure: Shared Decision Making Questionnaire for Mental Health
timeFrame: Baseline to 6-month follow-up
measure: Problem-Solving Decision-Making Scale for Mental Health
timeFrame: Baseline to 3-month follow-up
measure: Problem-Solving Decision-Making Scale for Mental Health
timeFrame: Baseline to 6-month follow-up
measure: Patient Perceived Involved in Care Scale
timeFrame: Baseline to 3-month follow-up
measure: Patient Perceived Involved in Care Scale
timeFrame: Baseline to 6-month follow-up
measure: Empowerment Scale
timeFrame: Baseline to 3-month follow-up
measure: Empowerment Scale
timeFrame: Baseline to 6-month follow-up
measure: Behaviour and Symptom Identification Scale (BASIS)
timeFrame: Baseline to 3-month follow-up
measure: Behaviour and Symptom Identification Scale (BASIS)
timeFrame: Baseline to 6-month follow-up
measure: Clinical Global Impression
timeFrame: Baseline to 3-month follow-up
measure: Clinical Global Impression
timeFrame: Baseline to 6-month follow-up
measure: Brief Inventory of Psychosocial Functioning
timeFrame: Baseline to 3-month follow-up
measure: Brief Inventory of Psychosocial Functioning
timeFrame: Baseline to 6-month follow-up
Other outcomes:
measure: Scale to Assess Therapeutic Relationship (patient and clinician versions)
timeFrame: Baseline to 3-month follow-up
measure: Scale to Assess Therapeutic Relationship (patient and clinician versions)
timeFrame: Baseline to 6-month follow-up
measure: Maslach Burnout Inventory
timeFrame: Every three months for 2.5 year clinical trial duration
measure: General Self-Efficacy Scale
timeFrame: Every three months for 2.5 year clinical trial duration
measure: Recovery Knowledge Inventory
timeFrame: Every three months for 2.5 year clinical trial duration
measure: Task and Relational Climate Scale
timeFrame: Every three months for 2.5 year clinical trial duration
measure: Collaborative Decision Making Attitudes Measure
timeFrame: Every three months for 2.5 year clinical trial duration
measure: Work satisfaction
timeFrame: Every three months for 2.5 year clinical trial duration
measure: Perceived Cultural Competency
timeFrame: Baseline to 3-month follow-up
measure: Perceived Cultural Competency
timeFrame: Baseline to 6-month follow-up
measure: Qualitative interviews
timeFrame: Baseline to six month follow up
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque, NM
state: New Mexico
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Emily Treichler, PhD
role: PRINCIPAL_INVESTIGATOR
References: