Clinical trial NCT04321876: Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care
Official title: Evaluation of a Collaborative Behavioral Health Program Implementation in Primary Care
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Depression
Keywords: primary care
collaborative care model
implementation
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Medicine
First posted: 2020-03-25
Enrollment: 778
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients attending primary care appointments within the Northwestern Medicine health system's central region.

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.

Eligibility criteria: Inclusion Criteria:

• PHQ-9 score \> 10

Exclusion Criteria:

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

Primary outcomes:
measure: Impact of implementation strategies on the speed of CBHP implementation (time, in days)
timeFrame: 2 years
measure: Impact of implementation strategies on the quantity of CBHP implementation (number of CBHP participants)
timeFrame: 2 years
measure: Acceptability of CBHP
timeFrame: 2 years
measure: Effectiveness of CBHP on depressive symptoms (PHQ-9 scores)
timeFrame: 2 years
measure: Effectiveness of CBHP on behavioral health service utilization (antidepressant medication prescription, CBHP treatment engagement, and external referrals for behavioral health)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
References:
citation: 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.