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

Depressive Symptoms Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05085886
• Other study ID #: AAAT6753
• Secondary ID: R01HS025198
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Jennifer Mizhquiri Barbecho
• Phone: 917-985-1926
• Email: cbch_depcarestudy[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 an electronic SDM (eSDM) tool (aim 1), and assessing the effect of the eSDM tool on provider behavior (aim 2) and on patient enrollment in depression treatment (aim 3).

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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• 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.
• Enhanced Usual Care
Clinic-level (1) Quality Improvement Support and education around valid depression screening (2) Local technical support for mental health treatment optimization

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center/New York Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients whose providers take action to optimize depression treatment	The proportion of patients whose providers take action to optimize their patients' depression treatment at the index visit (baseline), defined as placing a mental health referral for collaborative care or other mental health services; initiating, intensifying, switching and/or combining antidepressant medications; and/or providing depression management counseling [i.e., on adherence to treatment regimen]. Hypothesis 2: this proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.	Baseline
Secondary	Change in proportion of patients receiving any depression treatment	Change from baseline in the proportion of patients receiving any treatment for depression, defined as filling an antidepressant and/or attending one or more mental health visits during the 4 months following enrollment. Hypothesis 3: This proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.	4 months pre-Index Visit, 4 months post-index visit
Secondary	Proportion of patients with at least 2 mental health visits	The proportion of patients with at least 2 mental health visits (i.e., with a mental health specialist). Hypothesis 4: This proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.	During 6 months post-index visit
Secondary	Proportion of patients with at least 2 antidepressant fills	The proportion of patients with at least 2 antidepressant fills. Hypothesis 5: This proportion will be greater for the DepCare arm than for the Enhanced Usual Care arm.	During 6 months post-index visit
Secondary	Mean decisional conflict scale	Mean decisional conflict (measures personal perceptions of uncertainty around choosing among treatment option, 10 items, range 0-100, higher score indicates greater conflict) of patients. Hypothesis 5: the mean decisional conflict will be lower for the DepCare arm than for the Enhanced Usual Care arm.	Baseline