About this trial
The proposed project is a randomized controlled trial that seeks to test the effectiveness of a peer-facilitated, patient navigation program to improve mental healthcare experiences and outcomes for under-supported Veterans from diverse cultural backgrounds and communities. PARTNER-MH is a structured, telehealth-based intervention delivered by VHA peer specialists over a three-month period. It integrates two evidence-based care delivery models, peer support and patient navigation, and addresses three primary contributors to healthcare disparities: unmet social needs, low patient engagement in care, and unproductive patient-clinician communication. Findings from this study will support ongoing efforts to improve mental health services for all Veterans in the VHA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Member of a racial or ethnic minoritized group
Veterans who are currently receiving or waiting to receive treatment in the outpatient mental health clinics or affiliated CBOCS at the study sites
waiting to start treatment (e.g., Veterans who were referred to treatment, assigned a provider, or recommended a treatment option that includes either pharmacotherapy, psychotherapy, or both but have not yet started treatment at time of enrollment)
Veterans who are already receiving ongoing treatment - pharmacotherapy, individual, and/or group psychotherapy, but initiated treatment within 9 months of study enrollment date
Disqualifiers
Patients needing emergency psychiatric services of hospitalization due to suicidal ideation or recent suicide attempt (within past 2 months), have severe psychiatric symptoms (e.g., active psychosis), or a diagnosis of severe mental illness (e.g., schizophrenia)
Severe cognitive, hearing, or speech impairment (e.g., dementia, severe TBI)
Severe physical illness that impedes study participation
Recent hospitalization for substance use disorder (SUD) for the past 2 months or severe SUD symptoms based on the screen tools (AUDIC-C, DAST-10) that may require higher level of care and peer support
Trial design
Parallel
Treatments tested in this trial
PARTNER-MH
BehavioralPARTNER-MH is a manualized, peer-facilitated, patient navigation intervention that involves the delivery of three services: 1) peer support to increase patient engagement in care, 2) patient navigation to address unmet social needs and increase access to services, and 3) psychoeducation to increase communication self-efficacy. PARTNER-MH consists of 10 sessions, lasting up to 60 minutes, that will be delivered over 12 weeks via videoconference or phone. It also includes a rapport building/orientation session that will be delivered in person or via videoconference to facilitate study engagement and two flex weeks with no scheduled lessons to accommodate rescheduling if needed.
Educational Brochure
BehavioralThe control condition consists of informational/educational materials that will be distributed to study participants after randomization and completion of baseline assessment. The content of the educational brochure includes 3-4 brief, healthy living articles about stress management, well-being, and navigation of health services.
Treatment groups
Trial outcomes
Primary outcomes
The Veterans RAND 12 Item Health Survey (VR-12), mental health composition score (6-items, MCS)
The Veterans RAND 12-item (VR-12) is a brief, multi-use, self-administered survey that is used primarily to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". VR-12 scores are standardized using a T-score metric ranging from 1-100, with a mean of 50 and a standard deviation of 10. Scores below 50 indicate worse mental health than the general population average.
Secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item self-administered questionnaire that assesses cases of depression and symptom severity. Each question is scored from 0 to 3, with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. Scores are categorized as: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). The questionnaire has high internal consistency, reliability (α = 0.89), good sensitivity, and specificity.
Generalized Anxiety Disorder-7 (GAD-7)
GAD-7 is a validated self-reported measure of anxiety. It has 7 items rated on a 4-point Likert scale, 0 (Not at all) to 3 (Nearly every day). The scale has a total summed score of 0 (minimum) to 21 (maximum). It has shown reliability, internal consistency (α = 0.89), and good sensitivity. A meaningful change is indicated by 5 or more points. A total score of 1-4 indicates minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, and 12-21 severe symptoms.
PTSD symptoms -Life Event Checklist (PCL-5)
The PCL-5 is a widely used, 20-item self-report questionnaire used to screen for and diagnose probable PTSD. It evaluates the presence and severity of PTSD symptoms over the past month. The scale has strong internal consistency α =.94, test-retest reliability, convergent and discriminant validity. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely). All items are summed to create a total score that ranges from 0 to 80. Higher scores reflect a greater degree of distress or severity of PTSD symptoms. The recommended optimal cut-off score of \>33 will be used to indicate probable PTSD.
Altarum Consumer Engagement (ACE) scale
Patient Engagement will be measured with the Altarum Consumer Engagement (ACE) scale, which has 12 items and 3 subscales to reflect patients' commitment to everyday health behaviors, navigation skills in using healthcare services, and informed choice in treatment decisions. The ACE is administered as a 5-point Likert scale, and scores range from 5 to 25. Higher scores represent higher patient engagement.
Other outcomes
Working Alliance Inventory Short-Revised (WAI-SR)
Working Alliance Inventory Short-Revised (WAI-SR) evaluates key aspects of the therapeutic alliance between patients and their providers. It includes 12 items rated on a 5-point Likert scale ranging from 1= never to 5= always. It showed high reliability (α\> 0.90). Higher scores correspond to higher working alliance.
Multi-Dimensional Treatment Satisfaction Measure (MDSTM)
Multi-Dimensional Treatment Satisfaction Measure (MDSTM) has 2 sections, 11 subscales, and comprehensively assesses satisfaction with treatment. For this study, the investigators will use 4 subscales (12-items) that include 1) suitability and 2) utility of treatment, 3) attitudes toward treatment, and 4) therapist interpersonal style. Response options are rated on a 5-point Likert scale ranging from not at all (0) to very much (4), with scores indicating higher satisfaction. The measure shows satisfactory reliability (Cronbach's alpha α ≥ .70 for subscales).
Assessing Circumstances and Offering Resources for Needs (ACORN)
ACORN a 15-item, self-administered screening tool for health related unmet social needs. Most items have a yes or no answer. Two items - loneliness/social isolation and experience of abuse have answer options of "never, rarely, sometimes, often, and always." One item related to employment has answer option of "yes, help finding work, yes, help keeping work, and I do not need or want help."
Sponsors and contacts
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VA Office of Research and Development
Lead sponsor
Minneapolis Veterans Affairs Medical Center
Collaborator
Indiana University
Collaborator
VA Pittsburgh Healthcare System
Collaborator
White River Junction Veterans Affairs Medical Center
Collaborator
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