Randomized Control Trial on Implementation Strategies for Task-Shifting Depression Care in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,382
- 试验地点
- 2
- 主要终点
- Provider Adoption of LIFE-DM and Depression Care - Percentage
研究概览
简要总结
The study is a Hybrid Implementation-Effectiveness study that will primarily test the implementation strategies on provider adoption and implementation quality in three Vietnam provinces. Secondarily, the effectiveness of the multicomponent collaborative care model for depression intervention on patient outcomes will be tested. A cluster randomized control trial design, with a mixed-methods approach, will be used to assess the effectiveness of the three implementation strategies on both organizational and provider implementation outcomes and patient effectiveness outcomes.
详细描述
Depression is a prevalent and debilitating mental health condition that is relatively common in almost all countries around the world, including Vietnam, and is one of the largest burdens of health. Although effective treatments exist, many with depression do not receive appropriate care. In Vietnam, numerous barriers exist to implementation of evidence-based mental health services but recently there has been growing recognition of the need to address the treatment gap. In order to close the treatment gap for depression, within the health care system, effective depression care needs to be scaled up to a wider network of community health stations that are supported by the local psychiatric hospitals. However, it is unclear what the best implementation model is for supporting depression care in primary care settings.
The aim of this project is to compare three different models of implementation support for depression care in two Vietnam provinces: 1) Supported Implementation when implementation support is provided and 2) Sustainment Phases, when study funded implementation supports are withdrawn. The providers in select community health stations (CHSs) within these two provinces) will receive training workshops and varying levels of implementation support based on the implementation models (described below) to provide depression care to their patients. The three models are : 1) Usual Implementation (UI) - a basic depression workshop, limited technical assistance to set up the program, and implementation toolkits 2) Enhanced Supervision (ES) - UI + ongoing structured supportive supervision; and 3) Community Engaged Learning Collaborative (CELC) - ES + community collaborative learning.
The three models will be evaluated based on the RE-AIM framework, which will be assessed using implementation and patient outcomes across supported implementation phase and sustainment phase. Both implementation and patient outcomes will be assessed during the sustainment phase after resources are withdrawn to evaluate the sustainability of the program. Knowledge gained from this project will be used to inform implementation of depression care services across Vietnam, and help increase access and quality of depression care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
All participants are offered depression care services at the CHS, therefore participants are not aware of the different implementation supports provided to the supervisors.
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
- 否
入选标准
- •Patient Participants:
- •18-65 years of age
- •PHQ-9 score of 10 or above
- •Planning to receive care at an eligible community health station
- •Able to provide written informed consent
- •Provider Participants:
- •General practitioners, nurses, social workers, and other qualified health care providers at a selected community health station selected by CHS Directors for depression care project.
排除标准
- •Patient Participants:
- •Psychosis
- •Substance Abuse
- •High suicide risk
- •Provider Participants: Cannot commit to full participation for the two year project period. Examples of reasons for potential barriers to commitment include leaving due to pursuit of advanced formal training at universities, anticipation of promotion or change in job status, anticipation of relocation.
结局指标
主要结局
Provider Adoption of LIFE-DM and Depression Care - Percentage
时间窗: 24 months
Delivery of Project Dep and depression care components (% of depression care components delivered - screening, assessment, individual therapy, medication).
Provider Adoption of Project Dep and Depression Care- Count
时间窗: 24 months
Delivery of Project Dep and depression care components (Counts of depression care components delivered - # of screening, assessment, individual therapy, medication).
Patient Depression Scores (PHQ) Change from Baseline to 6 month
时间窗: 6 months
Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Change in Provider Competence Scores
时间窗: 24 months
Providers will be assessed by their supervisors for their overall competence in delivering the components of depression care every 6 months for 24 months. There are 18 items related to depression care skills (e.g., screening, psychoeducation, behavior activation, problem solving, medication management, etc.), Each item is scored on a 3 point scale from 1 to 3 (1-needs improvement, 2-satisfactory, 3-excellent). A total of 54 points can be obtained, with higher score indicating higher competence. N/A is used when a particular skill is not expected of that provider (i.e., community health workers are not expected to assess or manage medication). These ratings are conducted by supervisors at 0, 6, 12, and 24 months.
次要结局
- Change in Patient Family Functioning(6 months)
- Implementation Barriers and Facilitators(24 months)
- Provider Implementation Quality(24 months)
- Provider Participation(12 months)
- Change in Patient Functioning(6 months)
研究者
Victoria Ngo
Director of the Center for Innovation in Mental Health
City University of New York, School of Public Health