NCT04245423

The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 567 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Collaborative care for mental health is increasingly common, but most primary care practices have not embraced similar models for opioid use disorder (OUD). This study will refine and test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety or post-traumatic stress disorder (PTSD) in primary care. We also will examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models.

Detailed description

This research aims to refine and rigorously test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety disorder, or post-traumatic stress disorder (PTSD) in primary care. The investigators will also examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models. The primary aims of this proposal are: (1) Rapidly prototype and test our collaborative care models to optimize them for implementation at the University of Pennsylvania Health System (UPHS) primary care clinics for the treatment of individuals with co-occurring mental health problems and opioid use disorder (OUD); (2) Conduct a randomized clinical trial (RCT) among 1,185 primary care patients aged 18 years and older with OUD and depression, anxiety or PTSD. Patients will be randomized to one of three conditions: a) Augmented Usual Care (AUC), which consists of a primary care physician (PCP) waivered to prescribe buprenorphine, a mental health care manager, and an addiction psychiatrist to consult on Medication-Assisted Treatment (MAT); b) Collaborative Care (CC), which consists of a waivered PCP, a mental health care manager who receives OUD training, and a psychiatrist who provides telephonic consultation for OUD and mental health; or c) Collaborative Care Plus (CC+), which consists of all the elements of CC, plus a Certified Recovery Specialist (CRS) to help with patient engagement in treatment and retention in care; (3) Measure clinician- level factors associated with implementation of each component and metrics of fidelity and reach, our primary implementation outcomes of interest; and (4) Assess the costs to primary care practices of implementing and delivering AUC, CC and CC+ and the change in total healthcare costs associated with the implementation. Successful completion of the proposed study will provide definitive evidence regarding the most parsimonious set of elements of integrated collaborative care required to maximize outcomes for individuals with OUD and psychiatric disorders.

Conditions

• Opioid-use Disorder
• Mental Health Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Collaborative Care for Opioid Use Disorders and Mental Health Conditions	CC is delivered using the investigators' Foundations for Integrated Care model. The first line pharmacotherapy is buprenorphine-naloxone. The second line pharmacotherapy included is extended-release injectable naltrexone. Pharmacotherapy is accompanied by brief problem-solving therapy, cognitive-behavioral therapy, and/or motivational interviewing. The primary care physician, in consultation with the addictions psychiatrist and care manager, also will provide psychotropic medications for psychiatric disorders. In-person and telephone visits consist of the care manager carrying out intervention activities over 6 months. Visits are at baseline (90-minute intake appointment), home or office induction when in moderate opiate withdrawal if buprenorphine is prescribed, twice a week for two weeks with telephone calls in between visits, then weekly, and when stable once a month. There will be a final visit at 6 months. The intervention includes routine collection of urine drug screens.
BEHAVIORAL	Augmented Usual Care	If not already waivered, PCPs will be trained and waivered to treat OUD with medications. All practices will have mental health clinicians to treat mild psychiatric disorders. Other than that, the research team will provide no support to the PCP or practice staff. However, an addiction psychiatrist is available for consultation for OUD.
BEHAVIORAL	Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists	This intervention includes the Collaborative Care Intervention plus Certified Recovery Specialist to assist with treatment engagement and retention.

Timeline

• Start date: 2020-12-15
• Primary completion: 2025-03-28
• Completion: 2026-03-28
• First posted: 2020-01-28
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States