Improving Mental Healthcare Outcomes for Minoritized Veterans Through a Peer-led, Patient Navigation Program (PARTNER-MH 2.0) (PARTNER-MH)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Despite expanded availability of mental health services within the Veterans Health Administration (VHA), many Veterans-particularly those from varied cultural backgrounds and communities-continue to face significant barriers to accessing and fully engaging in care. Effective strategies to address these issues remain limited, leaving under-supported and vulnerable Veterans at risk for inadequate care experiences and poorer mental health outcomes. If these persistent and often overlooked challenges remain unresolved, they will continue to contribute to long-term disability, societal burden, and costly, inefficient care.
To address these challenges, the investigators will test the effectiveness of the Pro-Active, Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH) intervention. PARTNER-MH integrates two existing evidence-based care models: peer services and patient navigation and offers multiple services to address key drivers of healthcare disparities. These include (a) peer support, (b) assessment of unmet social needs to address barriers to care, (c) patient navigation to facilitate access to and engagement in mental health services, d) and psychoeducation to increase self-efficacy to communicate with providers. The intervention will be delivered via telehealth over 3 months by VHA peer specialists.
Specific Aims: This study is a multisite, randomized controlled clinical trial comparing PARTNER-MH to an educational brochure control group. Aim1: Test the effects of PARTNER-MH on mental health functioning (primary outcome), measured by the Veterans RAND-12 Mental Health Summary Score (VR-12 MCS), and secondary outcomes (e.g., depression, anxiety, PTSD, and healthcare utilization) at 3 months (primary endpoint) and 6 months (sustained effects) from baseline compared to the control group. Aim2: Test the effects of PARTNER-MH on mental healthcare process outcomes (patient engagement, communication self-efficacy) at 3 and 6 months. Aim3: To inform PARTNER-MH's future implementation, maintenance, and tailoring to different patient characteristics, we will conduct a formative process evaluation, guided by the Consolidated Framework for Implementation Research (CFIR), using mixed methods and input from Veteran, provider, and operational partners.
Methodology: Aims 1 and 2 involve delivering the intervention to (N=268) minoritized Veterans in outpatient mental health clinics at the Richard L. Roudebush VA Medical Center and the VA Pittsburgh Healthcare System. Data from Aims 1 and 2 will be analyzed using linear mixed models. In Aim 3, the investigators will describe Veterans' (n=30) and providers' experiences (N=10) with the intervention using semi-structured interviews to identify barriers and facilitators to PARTNER-MH's future implementation. The investigators will explore sex and post-traumatic stress disorder (PTSD) diagnosis as potential moderators. Communication's self-efficacy and patient engagement will be examined as mediators. The investigators will conduct Coincidence Analysis to explore which patients benefits the most from the intervention and which sets of intervention conditions are sufficient or necessary to lead to study outcomes. Qualitative data will be analyzed using an inductive/deductive approach. Mixed methods data will be integrated using joint displays.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Johanne Eliacin, PhD
- Número de teléfono: (317) 988-5298
- Correo electrónico: johanne.eliacin@va.gov
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Contacto:
- Jasma Adams, BA MPH
- Correo electrónico: jasma.adams2@va.gov
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Investigador principal:
- Johanne Eliacin, PhD
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Contacto:
- Angela L Rollins, PhD MS
- Número de teléfono: (317) 771-4023
- Correo electrónico: Angela.Rollins@va.gov
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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Contacto:
- Matthew Chinman, PhD
- Correo electrónico: matthew.chinman@va.gov
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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
Eligible participants must be:
- 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
- Have a diagnosis of depression, anxiety, or PTSD
- Not currently receiving peer services in the outpatient clinic
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention condition
Arm 1 involves delivery of the study intervention, PARTNER-MH program.
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PARTNER-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.
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Comparador activo: Control condition
Participants in this arm will receive the control condition, which consists of informational/education materials.
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The 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Veterans RAND 12 Item Health Survey (VR-12), mental health composition score (6-items, MCS)
Periodo de tiempo: baseline, 3 and 6 months
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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.
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baseline, 3 and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: baseline, 3 and 6 months
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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.
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baseline, 3 and 6 months
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Generalized Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: baseline, 3 and 6 months
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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.
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baseline, 3 and 6 months
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PTSD symptoms -Life Event Checklist (PCL-5)
Periodo de tiempo: baseline, 3 and 6 months
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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.
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baseline, 3 and 6 months
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Altarum Consumer Engagement (ACE) scale
Periodo de tiempo: baseline, 3 and 6 months
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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.
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baseline, 3 and 6 months
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Perceived Efficacy in Patient-Physician Interaction scale (PEPPI-5)
Periodo de tiempo: baseline, 3 and 6 months
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Communication self-efficacy will be measured with the Perceived Efficacy in Patient-Physician Interaction scale (PEPPI-5), a 5-item scale scored on a 5-point Likert scale ranging from 1 (not confident at all) to 5 (very confident).
Higher scores indicate higher levels of communication self-efficacy.
The PEPPI-5 has demonstrated high internal consistency (α= 0.92) and adequate test-retest reliability.
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baseline, 3 and 6 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Working Alliance Inventory Short-Revised (WAI-SR)
Periodo de tiempo: baseline, 3 and 6 months
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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.
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baseline, 3 and 6 months
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Multi-Dimensional Treatment Satisfaction Measure (MDSTM)
Periodo de tiempo: baseline, 3 and 6 months
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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).
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baseline, 3 and 6 months
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Assessing Circumstances and Offering Resources for Needs (ACORN)
Periodo de tiempo: baseline, 3 and 6 months
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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."
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baseline, 3 and 6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Johanne Eliacin, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSR2-001-24W
- I01RD000506-01A2 (Otro identificador: Veterans Health Administration)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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