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

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245423
• Other study ID #: UF1MH121944
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Donna M Coviello, PhD
• Phone: 215-746-6713
• Email: coviello[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1185
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years and older;

2. a diagnosis of opioid use disorder using DSM-5 criteria within the last 12 months OR have taken medication for opioid use disorder (MOUD) within the last 12 months;

3. agree to receive medication for opioid use disorder at the primary care site (the first line pharmacotherapy is buprenorphine-naloxone and the second line pharmacotherapy will include extended-release injectable naltrexone);

4. meet criteria for depression, anxiety (panic disorder, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder), or PTSD;

5. able to communicate in English; and

6. willing to give informed consent.

Exclusion Criteria:

1. acutely suicidal and needs immediate hospitalization, manic or psychotic (patients will not be randomized and PI or study physician covering for PI will be notified immediately); and

2. lack of a phone.

Related Conditions & MeSH terms

• Disease
• Mental Health Conditions
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Penn Center for Primary Care	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in opioid use based on self-reported	Modified Timeline Followback	Baseline and monthly for 6 months
Primary	Change in opioid use based on toxicology	Urine Drug Screens	Baseline and monthly for 6 months
Primary	Change in psychiatric symptoms - Depression	Patient Health Questionnaire (PHQ-9); range is 0-27 with higher scores demonstrating worse outcomes	Baseline and monthly for 6 months
Primary	Change in psychiatric symptoms - Anxiety	Generalized Anxiety Disorder Screener (GAD-7); range is 0-21 with higher scores demonstrating worse outcomes	Baseline and monthly for 6 months
Primary	Change in psychiatric symptoms - Post-traumatic Stress Disorder	Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); range is 0-80 with higher scores demonstrating worse outcomes	Baseline and monthly for 6 months
Secondary	Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine)	Modified Timeline Followback	Baseline and monthly for 6 months
Secondary	Change in medication adherence	Self-report	Baseline and monthly for 6 months
Secondary	Treatment retention	Measured as the time to dropout (from both OUD and mental health treatment using clinic records)	6 months
Secondary	Rate of Mortality	Assessed through death records	6 months