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Improving Mental Healthcare Outcomes for Minoritized Veterans Through a Peer-led, Patient Navigation Program (PARTNER-MH 2.0) (PARTNER-MH)

8. června 2026 aktualizováno: VA Office of Research and Development
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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 plan to 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 is delivered via telehealth over 3 months by VHA peer specialists.

Specific Aims: The investigators aim for 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: 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, to inform PARTNER-MH's future implementation, maintenance, and tailoring to different patient characteristics.

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

268

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Johanne Eliacin, PhD
        • Kontakt:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention condition
Arm 1 involves delivery of the study intervention, PARTNER-MH program.
Behaviorální: PARTNER-MH
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.
Aktivní komparátor: Control condition
Participants in this arm will receive the control condition, which consists of informational/education materials.
Behaviorální: Educational Brochure
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The Veterans RAND 12 Item Health Survey (VR-12), mental health composition score (6-items, MCS)
Časové okno: baseline, 3 and 6 months
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.
baseline, 3 and 6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient Health Questionnaire-9 (PHQ-9)
Časové okno: baseline, 3 and 6 months
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.
baseline, 3 and 6 months
Generalized Anxiety Disorder-7 (GAD-7)
Časové okno: baseline, 3 and 6 months
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.
baseline, 3 and 6 months
PTSD symptoms -Life Event Checklist (PCL-5)
Časové okno: baseline, 3 and 6 months
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.
baseline, 3 and 6 months
Altarum Consumer Engagement (ACE) scale
Časové okno: baseline, 3 and 6 months
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.
baseline, 3 and 6 months
Perceived Efficacy in Patient-Physician Interaction scale (PEPPI-5)
Časové okno: baseline, 3 and 6 months
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.
baseline, 3 and 6 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Working Alliance Inventory Short-Revised (WAI-SR)
Časové okno: baseline, 3 and 6 months
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.
baseline, 3 and 6 months
Multi-Dimensional Treatment Satisfaction Measure (MDSTM)
Časové okno: baseline, 3 and 6 months
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).
baseline, 3 and 6 months
Assessing Circumstances and Offering Resources for Needs (ACORN)
Časové okno: baseline, 3 and 6 months
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."
baseline, 3 and 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

VA Office of Research and Development

Spolupracovníci

Minneapolis Veterans Affairs Medical Center
Indiana University
White River Junction Veterans Affairs Medical Center
VA Pittsburgh Healthcare System

Vyšetřovatelé

  • Vrchní vyšetřovatel: Johanne Eliacin, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

4. ledna 2027

Primární dokončení (Odhadovaný)

28. září 2029

Dokončení studie (Odhadovaný)

31. prosince 2031

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

8. června 2026

První zveřejněno (Aktuální)

12. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HSR2-001-24W
  • I01RD000506-01A2 (Jiný identifikátor: Veterans Health Administration)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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