Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

Active, not recruiting

• Conditions: Depression
• Interventions: Behavioral: Collaborative Behavioral Health Program

• Registration Number: NCT04321876
• Lead Sponsor: Northwestern University

Brief Summary

This study will give researchers the opportunity to evaluate implementation of the Collaborative Behavioral Health Program (CBHP), based on the collaborative care model for depression, which aims to improve practice for physicians and staff; improve care for patients; and improve clinic operations through a model that allows for more efficient identification and referral for care for depression.

Detailed Description

This study used a hybrid Type 2 effectiveness-implementation design of a randomized roll-out trial of the Collaborative Care Model for depression (CoCM) in 11 primary care practices in a large healthcare system affiliated with an academic medical center. The Collaborative Behavioral Health Program (CBHP) is supported by leaders in the healthcare system and the primary care steering committee as a means of improving access to effective mental health services. Implementation strategies including hiring and training the necessary staff for CoCM, audit and feedback procedures, and health information technologies to assist with billing and the patient registry, will be provided for all practices. Using a sequential mixed methods measurement approach, we will assess key stakeholders' perspectives of CBHP roll-out, focused on barriers and facilitators of implementation and sustainability. The Stages of Implementation tool will be used to measure the speed and quantity of implementation activities completed across the stages of implementation preparation, implementation, and sustainment over a 30-month period for each practice. Effectiveness of CBHP for patient-level outcomes will be conducted on depressive symptoms, graduation rates for CBHP, and spillover effects on chronic health conditions.

With its focus on implementation processes and strategies, this study will elucidate the critical drivers of CoCM implementation that are understudied for a program with such a robust evidence base. This study will also be among the first to conduct economic analyses on a fee-for-service model with the new billing codes for CoCM and can inform ways to improve implementation efficiency with our optimization approach to successive practices in the roll-out design. Changes to the protocol and current status of the study are also discussed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Primary Completion: 2024-01-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 778

Inclusion Criteria

• PHQ-9 score > 10

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Exclusion Criteria

• Current suicidality
• Bipolar disorder
• Substance abuse disorder
• Psychosis
• Other severe mental health condition

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NMG IM ARKES	Collaborative Behavioral Health Program	-
NMG IM FM 1704 Maple Ave	Collaborative Behavioral Health Program	-
NMG IM 259 E Erie St	Collaborative Behavioral Health Program	-
NMG IM 211 E Chicago Ave	Collaborative Behavioral Health Program	-
NMG IM 1333 W Belmont Ave	Collaborative Behavioral Health Program	-
NMG IM 1460 N Halsted St	Collaborative Behavioral Health Program	-
NMG IM 201 E Huron St	Collaborative Behavioral Health Program	-
NMG IM 1776 N Milwaukee Ave	Collaborative Behavioral Health Program	-
NMG IM 1135 S Delano Ct	Collaborative Behavioral Health Program	-
NMG Integrative Medicine 150 E Huron St	Collaborative Behavioral Health Program	-
NMG IM 20 S Clark St	Collaborative Behavioral Health Program	-

Primary Outcome Measures

Name	Time	Method
Impact of implementation strategies on the speed of CBHP implementation (time, in days)	2 years	Trends in the rate at which CBHP is implemented over successive practices, as assessed by the Universal Stages of Implementation Completion (USIC)
Impact of implementation strategies on the quantity of CBHP implementation (number of CBHP participants)	2 years	Trends in the number of CBHP participants over successive practices, as assessed by CBHP referrals, engagement, and treatment completion derived from the electronic health record
Acceptability of CBHP	2 years	Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)
Effectiveness of CBHP on depressive symptoms (PHQ-9 scores)	2 years	Pre- and post-treatment self-reported depressive symptoms (PHQ-9 scores), anti-depressant medication prescriptions and adherence, treatment engagement, psychiatry referrals
Effectiveness of CBHP on behavioral health service utilization (antidepressant medication prescription, CBHP treatment engagement, and external referrals for behavioral health)	2 years	Proportion of patients who are eligible for CBHP who receive behavioral health services, including anti-depressant medication prescriptions, CBHP treatment sessions, and/or external referrals for behavioral health (e.g., psychiatry)

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States