Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

Depression Clinical Trial

— WBCBHP  

Official title:

Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04321876
• Other study ID #: STU00208338
• Status: Active, not recruiting
• Start date: September 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 778
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PHQ-9 score > 10

Exclusion Criteria:

• Current suicidality

• Bipolar disorder

• Substance abuse disorder

• Psychosis

• Other severe mental health condition

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Northwestern Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Acceptability of CBHP	Self-report of key stakeholders and CBHP utilization (referral, engagement, completion)	2 years
Primary	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
Primary	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