Clinical trial NCT05085886: Implementation Science Approach to Enhancing Depression Treatment in Collaborative Depression Care Settings ( DepCare )
Official title: A Randomized Control Trial of a Multi-level Theoretical Approach to Enhancing Patient Engagement in Primary Care Settings Sustaining Collaborative Depression Care (Transform DepCare)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: collaborative care
implementation science
Elevated Depressive Symptoms
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-10-20
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm design with provider being the unit of randomization and patients being nested within provider
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Total proportion of patients who initiate or optimize depression treatment
timeFrame: During 4 months post-index visit
Secondary outcomes:
measure: Proportion of patients whose providers take action to optimize depression treatment
timeFrame: Baseline
measure: Change in proportion of patients receiving any depression treatment
timeFrame: 4 months pre-Index Visit, 4 months post-index visit
measure: Proportion of patients with at least 2 mental health visits
timeFrame: During 6 months post-index visit
measure: Proportion of patients with at least 2 antidepressant fills
timeFrame: During 6 months post-index visit
measure: Mean decisional conflict scale
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center/New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Florence Assistant Professor of Medicine
name: Nathalie Moise, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: