跳至主要内容
临床试验/NCT05833555
NCT05833555招募中不适用

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

City University of New York, School of Public Health2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2023年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
700
试验地点
2
主要终点
Depression - PHQ-9

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Multisector Collaborative Care

Experimental

Multisector Collaborative Care (MCC) Model will consist of all resources offered in E&R and additional trainings on skills related to working in a multisectoral team, care navigation, syndemic risks and coordination of services related to MH, social services, and health care.

干预措施: Supervision (Behavioral)

Education and Resources

Active Comparator

Education and Resources (E&R) involves online training through the E-Hub on delivery of basic MH task-shifting skills, such as screening, psychoeducation, and referral to MH care. A community directory along with training on community resources will be made available to all participants. Specifically, we will recommend that those identified to have common MH problems (PHQ-4≥3) are offered a single two-hour zoom-based group psychoeducation session about depression and anxiety, COVID-19 impact on MH, wellness and self-care skills, and directory of Harlem-based MH services and other community resources. Participants exhibiting higher level needs are referred to MH specialists.

干预措施: MH task-sharing training (Behavioral)

Multisector Collaborative Care

Experimental

Multisector Collaborative Care (MCC) Model will consist of all resources offered in E&R and additional trainings on skills related to working in a multisectoral team, care navigation, syndemic risks and coordination of services related to MH, social services, and health care.

干预措施: MH task-sharing training (Behavioral)

Multisector Collaborative Care

Experimental

Multisector Collaborative Care (MCC) Model will consist of all resources offered in E&R and additional trainings on skills related to working in a multisectoral team, care navigation, syndemic risks and coordination of services related to MH, social services, and health care.

干预措施: Learning Collaborative (Behavioral)

Multisector Collaborative Care and Technology

Experimental

MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.

干预措施: MH task-sharing training (Behavioral)

Multisector Collaborative Care and Technology

Experimental

MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.

干预措施: Supervision (Behavioral)

Multisector Collaborative Care and Technology

Experimental

MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.

干预措施: Learning Collaborative (Behavioral)

Multisector Collaborative Care and Technology

Experimental

MCC sites will be randomized to receive an additional technology-based implementation tool to evaluate impact on implementation and consumer outcomes.

干预措施: Technology Intervention (Other)

结局指标

主要结局

Depression - PHQ-9

时间窗: 6-12 months

Depression symptom severity is assessed using the Patient Health Questionnaire (PHQ-9), which includes nine items on a scale ranging from "0" (Not at all) to "3" (Nearly every day). PHQ-9 scores range from 0 to 27, with higher scores indicating greater severity of depression. The scores are categorized into five levels: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).

Reach of Screening

时间窗: 0-24 months

Number of new consumers screened for depression using the Patient Health Questionnaire (PHQ-4) relative to the total number of low-income housing residents or patients seen at the sites will be used.

Anxiety - GAD-7

时间窗: 6-12 months

Anxiety symptom severity is assessed using the General Anxiety Disorder (GAD-7) scale, which consists of seven items designed to screen and evaluate anxiety symptom severity on a scale ranging from "0" (Not at all) to "3" (Nearly every day). GAD-7 scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Scores are classified into four levels: minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).

Mental Health Service Linkage

时间窗: 0-24 months

% of successful MH linkages (connecting with MH navigator or MH referrals).

次要结局

  • Employment Security(6-12 months)
  • Program Sustainment(24 months)
  • Implementation Barriers and Facilitators(12, 24 months)
  • Food Insecurity(6-12 months)
  • Program Adoption(0-12 months)
  • Provider Attitude towards Adopting Evidence-Based Practices (EBPAS)(0, 6, 12, 24 months)
  • Partnerships with Coalition Members(0, 6, 12, 24 months)
  • Housing Security(6-12 months)

研究者

发起方
City University of New York, School of Public Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria Ngo

Associate Professor

City University of New York, School of Public Health

研究点 (2)

Loading locations...

相似试验

Harlem Strong Mental Health Coalition | 临床试验