Improving Mental Healthcare Outcomes for Minoritized Veterans Through a Peer-led, Patient Navigation Program (PARTNER-MH 2.0)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: PARTNER-MH, Educational Brochure.
- Кому может быть актуально
- Состояния в реестре: Diagnoses of Depression, Anxiety, PTSD. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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/orient - Поведенческое 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.
Первичные конечные точки
- The Veterans RAND 12 Item Health Survey (VR-12), mental health composition score (6-items, MCS) [Срок оценки: baseline, 3 and 6 months]
Вторичные конечные точки (5)
- Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: baseline, 3 and 6 months]
- Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: baseline, 3 and 6 months]
- PTSD symptoms -Life Event Checklist (PCL-5) [Срок оценки: baseline, 3 and 6 months]
- Altarum Consumer Engagement (ACE) scale [Срок оценки: baseline, 3 and 6 months]
- Perceived Efficacy in Patient-Physician Interaction scale (PEPPI-5) [Срок оценки: baseline, 3 and 6 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 2 центра
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh
Идентификаторы
NCT: NCT07645274 · HSR2-001-24W · I01RD000506-01A2