Implementation Science Approach to Enhancing Depression Treatment in Collaborative Depression Care Settings ( DepCare )

NCT ID: NCT05085886

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2023-06-30

Brief Summary

The purpose of this study is to examine the effectiveness of a multi-level intervention - centered around a web-application that facilitates depression screening, automated shared decision making (SDM), patient activation, and psychoeducation - on mental health treatment optimization among patients with elevated depressive symptoms with or without co-morbid anxiety receiving care in primary care clinics that offer collaborative care. The objectives of the study include: Leveraging user centered design to refine a strategy centered around an electronic SDM (eSDM) tool (aim 1), and assessing the effect of the strategy on provider behavior (aim 2) and on patient enrollment in depression treatment (aim 3).

Detailed Description

Collaborative care, a team-based approach to integrating primary and behavioral health, is effective in reducing depressive and anxiety symptoms and improving clinical outcomes. However, attempts to optimize collaborative care in real world settings have been hindered by patient (stigma, low self-efficacy, low perceived treatment efficacy), provider (suboptimal symptom recognition and communication at referral), and system (limited resources, lack of screening) level barriers. Few if any prior studies have focused on assessing the effectiveness of multi-level strategies to optimize treatment engagement in primary care settings in the sustainability phase of collaborative care.

Using the behavior change wheel (BCW) framework, we created a multi-level strategy for optimizing treatment in primary care settings with collaborative care programs. The strategy involves system/staff-level problem solving, patient-level electronic screening, patient activation, and an automated shared decision-making tool in addition to primary care provider-level behavioral health education with automated decisional support.

The investigators now aim to test this multifaceted implementation strategy for optimizing treatment amongst patients with elevated depressive symptoms (with or without co-morbid anxiety) in the ambulatory care network (ACN) clinics of New York Presbyterian Hospital (NYPH) with established/mature collaborative care programs that predominantly care for socioeconomically disadvantaged and minority patients. We will randomize providers to either the multicomponent strategy or enhanced usual care. The investigators aim to assess the effectiveness of this intervention on patient engagement in mental health treatment (primary outcome) as well as on provider action to optimize/manage treatment (secondary outcome).

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

DepCare Intervention

The clinic (administrators, staff, care managers) will receive quality improvement support and education around depression screening as well as local technical assistance for mental health treatment optimization. The cluster of primary care providers in the intervention arm will receive education and decisional support for optimizing mental health treatment and access to quality improvement/implementation meetings. When feasible, eligible patients will receive a tool that facilitates enhanced screening, diagnosis recognition, treatment selection support, psychoeducation, and activation.

Group Type: EXPERIMENTAL

DepCare

Intervention Type: BEHAVIORAL

Primary Care Provider (1) One-time presentation or video with education and motivational messaging around collaborative care, functionality of the DepCare patient tool and optimal management of depression and comorbid anxiety (2) Quality improvement/ implementation team meetings on optimizing mental health treatment in primary care and DepCare (i.e., multi-level, multi-component intervention) implementation (3) Automatically-generated decisional support on individual patient treatment preferences (i.e., for every patient who receives the DepCare patient tool) Patient: Tool comprised of enhanced depression and anxiety screening (includes option for voice-over questions, point-and-click responses), and for those who screen positive for depressive symptoms (with or without comorbid anxiety), diagnosis recognition support, psycho-education, videos promoting patient engagement in treatment, and personalized medication selection support.

Enhanced Usual Care

Intervention Type: BEHAVIORAL

Clinic-level (1) Quality Improvement Support and education around valid depression screening (2) Local technical support for mental health treatment optimization

Enhanced Usual Care

The clinic (administrators, staff, care managers) will receive quality improvement support and education around depression screening as well as local technical assistance for mental health treatment optimization. The cluster of primary care providers and patients in the active comparator arm will have access to this clinic-level strategy (i.e., the same clinic level intervention as in the DepCare group), but will not receive any provider or patient-level interventions.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

Clinic-level (1) Quality Improvement Support and education around valid depression screening (2) Local technical support for mental health treatment optimization

Interventions

DepCare

Primary Care Provider (1) One-time presentation or video with education and motivational messaging around collaborative care, functionality of the DepCare patient tool and optimal management of depression and comorbid anxiety (2) Quality improvement/ implementation team meetings on optimizing mental health treatment in primary care and DepCare (i.e., multi-level, multi-component intervention) implementation (3) Automatically-generated decisional support on individual patient treatment preferences (i.e., for every patient who receives the DepCare patient tool) Patient: Tool comprised of enhanced depression and anxiety screening (includes option for voice-over questions, point-and-click responses), and for those who screen positive for depressive symptoms (with or without comorbid anxiety), diagnosis recognition support, psycho-education, videos promoting patient engagement in treatment, and personalized medication selection support.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

Clinic-level (1) Quality Improvement Support and education around valid depression screening (2) Local technical support for mental health treatment optimization

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English or Spanish Speaking
• ≥ 18 years of age
• Elevated depressive symptoms Elevated Patient Health Questionnaire (PHQ)-9 >=10 Elevated PHQ-9 >=5 and Generalized Anxiety Disorder (GAD)-7 >= 10

Exclusion Criteria

• Under the care of a psychiatrist or depression collaborative care manager in the prior 3 months
• Diagnosis of psychosis or schizophrenia
• Diagnosis of bipolar disorder
• Dementia or severe cognitive impairment
• History of coronary heart disease
• Pregnancy
• Dementia or severe cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Nathalie Moise

Associate Professor of Medicine, Dept of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathalie Moise, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Florence Assistant Professor of Medicine

Locations

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States

Countries

United States

Other Identifiers

R01HS025198

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

AAAT6753

Identifier Type: -

Identifier Source: org_study_id