Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care (WBCBHP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Collaborative Behavioral Health Program

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.

• Study Type: Observational
• Enrollment (Actual): 778

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients attending primary care appointments within the Northwestern Medicine health system's central region.

Description

Inclusion Criteria:

• PHQ-9 score > 10

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

11

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NMG IM 211 E Chicago Ave	Behavioral: 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.
NMG IM ARKES	Behavioral: 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.
NMG IM 1460 N Halsted St	Behavioral: 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.
NMG IM 201 E Huron St	Behavioral: 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.
NMG Integrative Medicine 150 E Huron St	Behavioral: 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.
NMG IM 1776 N Milwaukee Ave	Behavioral: 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.
NMG IM 20 S Clark St	Behavioral: 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.
NMG IM FM 1704 Maple Ave	Behavioral: 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.
NMG IM 259 E Erie St	Behavioral: 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.
NMG IM 1135 S Delano Ct	Behavioral: 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.
NMG IM 1333 W Belmont Ave	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of implementation strategies on the speed of CBHP implementation (time, in days)	Trends in the rate at which CBHP is implemented over successive practices, as assessed by the Universal Stages of Implementation Completion (USIC)	2 years
Impact of implementation strategies on the quantity of CBHP implementation (number of CBHP participants)	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	2 years
Acceptability of CBHP	Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)	2 years
Effectiveness of CBHP on depressive symptoms (PHQ-9 scores)	Pre- and post-treatment self-reported depressive symptoms (PHQ-9 scores), anti-depressant medication prescriptions and adherence, treatment engagement, psychiatry referrals	2 years
Effectiveness of CBHP on behavioral health service utilization (antidepressant medication prescription, CBHP treatment engagement, and external referrals for behavioral health)	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)	2 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Northwestern Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 31, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: primary care; implementation; collaborative care model
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: STU00208338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No