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

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.

Conditions

• Opioid-use Disorder
• Mental Health Conditions

Interventions

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• David Mandell, ScD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-15

Primary Completion

2025-03-28

Completion

2026-03-28

Countries

• United States

Study Locations