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Идёт набор NCT05833555

Harlem Strong Mental Health Coalition

Без фазы С лечением Stress-related Problem Depression, Anxiety Mental Health Wellness

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: MH task-sharing training, Supervision, Learning Collaborative, Technology Intervention.
Кому может быть актуально
Состояния в реестре: Stress-related Problem, Depression, Anxiety, Mental Health Wellness. Базовые параметры: 18 лет — 65 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 →
Официальное название

Harlem Strong Mental Health Coalition: A Multi-sector Community-Engaged Collaborative for System Transformation

Обзор

Addressing health disparities, especially in the face of coronavirus pandemic, requires an integrated multi-sector equity-focused, community-based approach. This study will examine the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with a network of community-based organizations, medical providers, and behavioral health providers to engage in a network-wide implementation planning process to: (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for mental health (MH) task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and a range of social services, including case management, housing supports, financial education, employment support, and other community resources to improve linkages to services, and (4) identify a set of common MH, social risk, and health metrics and strategies to integrate these metrics into data systems across the network for continuous quality improvement of the system. The long-term goal of our study is to develop sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services, including primary care, behavioral/MH, social services, and other community resources.

Подробное описание

This study examines the impact of Harlem Strong Community Mental Health Collaborative, a community-wide multi-sectoral coalition in which a health insurer works with community-based organizations and medical and behavioral health providers to (1) problem-solve financing, access, and quality of care barriers, (2) support capacity building for MH task-sharing for community health workers, (3) facilitate coordination and collaboration across MH/behavioral health, primary care, and social services, and (4) identify a set of common metrics and strategies for continuous system quality improvement. The research study will evaluate the impact using a Hybrid Implementation-Effectiveness design to assess the effects of the Harlem Strong Collaborative on implementation and consumer outcomes. The investigators will also describe implementation outcomes and key informant interviews to explore impact of community engagement, organization variables, and provider factors on model impact. The long-term goal of this study is to develop a sustainable model for task-sharing MH care that will be embedded in a coordinated comprehensive network of services.

The investigators will conduct a stepped-wedge clustered randomized control study evaluating the effectiveness of a MH task-sharing intervention, that involves randomization and sequenced exposure to three implementation conditions: (1) online education and resources (E\&R) about MH task-sharing (screening, education, and referral), (2) community-engaged multisector collaborative care model (MCC), where a neighborhood-based coalition will support implementation of MH task-sharing, and (3) community crowdsourced technology solution to support implementation (MCC+Tech).

Вмешательства

  • Поведенческое MH task-sharing training
    Providers will be trained to screen for MH, provide education, refer, and coordinate to range of social services. MH training typically consists of education and resources, such as one-time workshops and toolkits, provided with limited technical assistance.
  • Поведенческое Supervision
    Additionally, Community Health Workers (CHWs) will receive bi-weekly group supervision for the first 6-months, and monthly supervision for the remaining year on Zoom from a supervisor at Center for Innovation in Mental Health.
  • Поведенческое Learning Collaborative
    A learning collaborative with multidisciplinary teams from various healthcare organizations will support continuous quality improvement and develop develop structured approach to improve provision of care.
  • Другое Technology Intervention
    To be determined by community crowdsourcing after the first phase of implementation of the multisector collaborative care for MH task-sharing.

Первичные конечные точки

  • Depression - PHQ-9 [Срок оценки: 6-12 months]
  • Anxiety - GAD-7 [Срок оценки: 6-12 months]
  • Reach of Screening [Срок оценки: 0-24 months]
  • Mental Health Service Linkage [Срок оценки: 0-24 months]
Вторичные конечные точки (8)
  • Program Adoption [Срок оценки: 0-12 months]
  • Program Sustainment [Срок оценки: 24 months]
  • Implementation Barriers and Facilitators [Срок оценки: 12, 24 months]
  • Provider Attitude towards Adopting Evidence-Based Practices (EBPAS) [Срок оценки: 0, 6, 12, 24 months]
  • Partnerships with Coalition Members [Срок оценки: 0, 6, 12, 24 months]
  • Housing Security [Срок оценки: 6-12 months]
  • Employment Security [Срок оценки: 6-12 months]
  • Food Insecurity [Срок оценки: 6-12 months]

Критерии участия

Критерии включения

  • Black and Latino adults between 18 and 65 years
  • Harlem residents from low-income housing developments or receiving primary care services in Harlem
  • PHQ-4 Total Score ≥3, moderate risk for depression

Критерии исключения

  • Those with risk for depression or anxiety who screen positive for severe mental illness (e.g., psychosis, mania, substance abuse, and high suicide risk) using screening items from the Mini-International Neuropsychiatric Interview will be excluded from the study and referred to MH services at higher levels of care

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 2 центра
  • CUNY Graduate School of Public Health and Health Policy — New York
  • Harlem Congregation for Community Improvement — New York

Публикации

  • Ngo VK, Vu TT, Levine D, Punter MA, Beane SJ, Weiss MR, Wyka K, Florez-Arango JF, Zhou X. A multisector community-engaged collaborative for mental health integration in primary care and housing developments: Protocol for a stepped-wedge randomized controlled trial (the Harlem Strong Program). BMC Public Health. 2024 Sep 19;24(1):2554. doi: 10.1186/s12889-024-20026-6. PMID 39300414

Идентификаторы

NCT: NCT05833555 · U01OD033245

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗