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

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04321876

Collaborator

Northwestern Medicine (Other)

1,900

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1900 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

• PHQ-9 score > 10

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University
Northwestern Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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. Review.

Responsible Party:

Justin D. Smith, Associate Professor, Northwestern University

ClinicalTrials.gov Identifier:

NCT04321876

Other Study ID Numbers:

STU00208338

First Posted:

Mar 25, 2020

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Justin D. Smith, Associate Professor, Northwestern University

primary care

collaborative care model

implementation

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of May 6, 2022