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

NCT05085886 | Completed

• 2 other identifiers: AAAT6753R01HS025198
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 1

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).

Conditions

Depressive Symptoms

Keywords

collaborative care; implementation science; Elevated Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Total proportion of patients who initiate or optimize depression treatment

  The proportion of patients who initiate or optimize depression treatment, defined as those with at least 1 mental health visit or antidepressant fill during the 4 months following enrollment. Hypothesis 1: this proportion will be greater for patients of providers in the DepCare arm than for the Enhanced Usual Care arm

  During 4 months post-index visit

Secondary Outcomes (5)

• Proportion of patients whose providers take action to optimize depression treatment

  Baseline

• Change in proportion of patients receiving any depression treatment

  4 months pre-Index Visit, 4 months post-index visit

• Proportion of patients with at least 2 mental health visits

  During 6 months post-index visit

• Proportion of patients with at least 2 antidepressant fills

  During 6 months post-index visit

• Mean decisional conflict scale

  Baseline

Study Arms (2)

DepCare Intervention

EXPERIMENTAL

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.

Behavioral: DepCare; Behavioral: Enhanced Usual Care

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

DepCare 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.

DepCare Intervention

Enhanced Usual Care BEHAVIORAL

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

DepCare Intervention; Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Nathalie Moise, MD, MS

  Florence Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Treatment optimization assessor will be blinded to intervention vs. control start arm of the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Dept of Medicine

Model Details: 2 arm design with provider being the unit of randomization and patients being nested within provider

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 20, 2021
• Study Start: August 3, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 1 year of publication of trial primary outcome results
• Access Criteria: de-identified database

Locations

US (1)