Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

NCT ID: NCT04321876

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 778 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2025-09-01

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.

Conditions

Depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NMG IM 211 E Chicago Ave

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM ARKES

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1460 N Halsted St

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 201 E Huron St

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG Integrative Medicine 150 E Huron St

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1776 N Milwaukee Ave

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 20 S Clark St

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM FM 1704 Maple Ave

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 259 E Erie St

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1135 S Delano Ct

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

NMG IM 1333 W Belmont Ave

Collaborative Behavioral Health Program

Intervention Type: BEHAVIORAL

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

Interventions

Collaborative Behavioral Health Program

Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• PHQ-9 score > 10

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern Medicine

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Allison Carroll

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern Medicine

Chicago, Illinois, United States

Countries

United States

References

Smith JD, Hasan M. Quantitative approaches for the evaluation of implementation research studies. Psychiatry Res. 2020 Jan;283:112521. doi: 10.1016/j.psychres.2019.112521. Epub 2019 Aug 17.

Reference Type: BACKGROUND

PMID: 31473029 (View on PubMed)

Kordon A, Carroll AJ, Fu E, Rosenthal LJ, Rado JT, Jordan N, Brown CH, Smith JD. Multilevel perspectives on the implementation of the collaborative care model for depression and anxiety in primary care. BMC Psychiatry. 2024 Jul 22;24(1):519. doi: 10.1186/s12888-024-05930-w.

Reference Type: DERIVED

PMID: 39039458 (View on PubMed)

Other Identifiers

STU00208338

Identifier Type: -

Identifier Source: org_study_id