A Randomized Control Trial of a Multi-level Theoretical Approach to Enhancing Patient Engagement in Primary Care Settings Sustaining Collaborative Depression Care (Transform DepCare)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Depressive Symptoms
- Sponsor
- Columbia University
- Enrollment
- 605
- Locations
- 1
- Primary Endpoint
- Total proportion of patients who initiate or optimize depression treatment
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Nathalie Moise
Associate Professor of Medicine, Dept of Medicine
Columbia University
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
Outcomes
Primary Outcomes
Total proportion of patients who initiate or optimize depression treatment
Time Frame: During 4 months post-index visit
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
Secondary Outcomes
- 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 antidepressant fills(During 6 months post-index visit)
- Proportion of patients with at least 2 mental health visits(During 6 months post-index visit)
- Mean decisional conflict scale(Baseline)