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

Columbia University

Status: Completed

Conditions: Depressive Symptoms

Treatments: Behavioral: Enhanced Usual Care; Behavioral: DepCare

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05085886

AAAT6753

R01HS025198 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 605 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

605 participants in 2 patient groups

DepCare Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: DepCare

Behavioral: Enhanced Usual Care

Enhanced Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care