Clinical trial NCT04491045: Implementation Strategies for Task-Shifting Depression Care Depression Care in Vietnam
Official title: Randomized Control Trial on Implementation Strategies for Task-Shifting Depression Care in Vietnam
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Behavior Activation
Problem solving therapy
Depression Treatment
Depression care integration
Implementation research
Task shifting
Collaborative care
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
Collaborators: name: Hanoi University of Public Health
First posted: 2020-07-29
Enrollment: 918
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Patient Participants:

* Psychosis
* Mania
* 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.

Primary outcomes:
measure: Provider Adoption of Project Dep and Depression Care- Count
timeFrame: 24 months
measure: Provider Adoption of LIFE-DM and Depression Care - Percentage
timeFrame: 24 months
measure: Change in Provider Competence Scores
timeFrame: 24 months
measure: Patient Depression Scores (PHQ) Change from Baseline to 6 month
timeFrame: 6 months
Secondary outcomes:
measure: Provider Participation
timeFrame: 12 months
measure: Provider Implementation Quality
timeFrame: 24 months
measure: Implementation Barriers and Facilitators
timeFrame: 24 months
measure: Change in Patient Functioning
timeFrame: 6 months
measure: Change in Patient Family Functioning
timeFrame: 6 months
Other outcomes:
Locations:
city: Bắc Giang
country: Vietnam
facility: Commune Health Stations
city: Phú Thọ
country: Vietnam
facility: Commune Health Stations
Study officials:
affiliation: City University of New York
name: Victoria Ngo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanoi University of Public Health
name: Minh V Hoang, MD
role: STUDY_DIRECTOR
References: