search
Back to results

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

Primary Purpose

Opioid-use Disorder, Mental Health Conditions

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care for Opioid Use Disorders and Mental Health Conditions
Augmented Usual Care
Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Opioid-use disorder, Depression, Anxiety, Post-traumatic stress disorder, Collaborative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn Center for Primary CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Augmented Usual Care (AUC)

Collaborative Care (CC)

Collaborative Care + Certified Recovery Specialist (CC+)

Arm Description

If not already waivered, PCPs will be trained and waivered to treat OUD with medications. Almost all practices have hired mental health clinicians, equivalent to the care managers in the investigators' collaborative care model, to treat mild and moderate depression and anxiety. These clinicians typically are licensed clinical social workers; a few are nurses or psychologists. No care managers have received systematic training in treating patients with OUD. The clinicians will retain their role and continue to treat and monitor patients with mental health conditions in these practices. 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. Patients are informed that the primary care practice provides both OUD and mental health treatment and are referred back to their provider for referral or to schedule care. A list of available community resources are available to the patient.

CC condition includes the following elements: Personnel trained to assist with scheduling, reminders and referrals; PCP trained and waivered to provide evidence-based pharmacotherapy for OUD; Addictions psychiatrist with collaborative care expertise to provide treatment consultation and supervision in both OUD and mental health issues; A care manager trained in evidence-based interventions for individuals with OUD and psychiatric disorders, who provides care in the primary care practice as part of the collaborative care team; Measurement-guided care and treat-to-target practices, using validated measures of substance use, depression, anxiety as well as measures of adherence and side effects; Electronic and in-person systematic communication regarding patient care among team members, facilitated by the electronic health record; and Shared patient-provider decision making.

In addition to the collaborative care model described above, patients in the CC+ condition will have access to a Certified Recovery Specialist (CRS) to assist with treatment engagement and retention. A CRS is a person in the community who is in recovery and may share similar experiences and barriers that participants have faced. They will work with participants as a peer to help them coordinate information and needs with their providers. The CRS will take participants to their PCP appointments and any other appointments that they may have to help them engage and stay in care to remain healthy. They will also provide education and help participants work on their recovery goals. They will identify and support linkages to community resources and help participants identify barriers to full participation in their recovery and develop strategies to overcome those barriers.

Outcomes

Primary Outcome Measures

Change in opioid use based on self-reported
Modified Timeline Followback
Change in opioid use based on toxicology
Urine Drug Screens
Change in psychiatric symptoms - Depression
Patient Health Questionnaire (PHQ-9); range is 0-27 with higher scores demonstrating worse outcomes
Change in psychiatric symptoms - Anxiety
Generalized Anxiety Disorder Screener (GAD-7); range is 0-21 with higher scores demonstrating worse outcomes
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

Secondary Outcome Measures

Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine)
Modified Timeline Followback
Change in medication adherence
Self-report
Treatment retention
Measured as the time to dropout (from both OUD and mental health treatment using clinic records)
Rate of Mortality
Assessed through death records

Full Information

First Posted
January 25, 2020
Last Updated
January 10, 2023
Sponsor
University of Pennsylvania
Collaborators
Weill Medical College of Cornell University
search

1. Study Identification

Unique Protocol Identification Number
NCT04245423
Brief Title
The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions
Official Title
The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Mental Health Conditions
Keywords
Opioid-use disorder, Depression, Anxiety, Post-traumatic stress disorder, Collaborative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1185 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Augmented Usual Care (AUC)
Arm Type
Active Comparator
Arm Description
If not already waivered, PCPs will be trained and waivered to treat OUD with medications. Almost all practices have hired mental health clinicians, equivalent to the care managers in the investigators' collaborative care model, to treat mild and moderate depression and anxiety. These clinicians typically are licensed clinical social workers; a few are nurses or psychologists. No care managers have received systematic training in treating patients with OUD. The clinicians will retain their role and continue to treat and monitor patients with mental health conditions in these practices. 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. Patients are informed that the primary care practice provides both OUD and mental health treatment and are referred back to their provider for referral or to schedule care. A list of available community resources are available to the patient.
Arm Title
Collaborative Care (CC)
Arm Type
Experimental
Arm Description
CC condition includes the following elements: Personnel trained to assist with scheduling, reminders and referrals; PCP trained and waivered to provide evidence-based pharmacotherapy for OUD; Addictions psychiatrist with collaborative care expertise to provide treatment consultation and supervision in both OUD and mental health issues; A care manager trained in evidence-based interventions for individuals with OUD and psychiatric disorders, who provides care in the primary care practice as part of the collaborative care team; Measurement-guided care and treat-to-target practices, using validated measures of substance use, depression, anxiety as well as measures of adherence and side effects; Electronic and in-person systematic communication regarding patient care among team members, facilitated by the electronic health record; and Shared patient-provider decision making.
Arm Title
Collaborative Care + Certified Recovery Specialist (CC+)
Arm Type
Experimental
Arm Description
In addition to the collaborative care model described above, patients in the CC+ condition will have access to a Certified Recovery Specialist (CRS) to assist with treatment engagement and retention. A CRS is a person in the community who is in recovery and may share similar experiences and barriers that participants have faced. They will work with participants as a peer to help them coordinate information and needs with their providers. The CRS will take participants to their PCP appointments and any other appointments that they may have to help them engage and stay in care to remain healthy. They will also provide education and help participants work on their recovery goals. They will identify and support linkages to community resources and help participants identify barriers to full participation in their recovery and develop strategies to overcome those barriers.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care for Opioid Use Disorders and Mental Health Conditions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Augmented Usual Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists
Intervention Description
This intervention includes the Collaborative Care Intervention plus Certified Recovery Specialist to assist with treatment engagement and retention.
Primary Outcome Measure Information:
Title
Change in opioid use based on self-reported
Description
Modified Timeline Followback
Time Frame
Baseline and monthly for 6 months
Title
Change in opioid use based on toxicology
Description
Urine Drug Screens
Time Frame
Baseline and monthly for 6 months
Title
Change in psychiatric symptoms - Depression
Description
Patient Health Questionnaire (PHQ-9); range is 0-27 with higher scores demonstrating worse outcomes
Time Frame
Baseline and monthly for 6 months
Title
Change in psychiatric symptoms - Anxiety
Description
Generalized Anxiety Disorder Screener (GAD-7); range is 0-21 with higher scores demonstrating worse outcomes
Time Frame
Baseline and monthly for 6 months
Title
Change in psychiatric symptoms - Post-traumatic Stress Disorder
Description
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); range is 0-80 with higher scores demonstrating worse outcomes
Time Frame
Baseline and monthly for 6 months
Secondary Outcome Measure Information:
Title
Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine)
Description
Modified Timeline Followback
Time Frame
Baseline and monthly for 6 months
Title
Change in medication adherence
Description
Self-report
Time Frame
Baseline and monthly for 6 months
Title
Treatment retention
Description
Measured as the time to dropout (from both OUD and mental health treatment using clinic records)
Time Frame
6 months
Title
Rate of Mortality
Description
Assessed through death records
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older; 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; 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); meet criteria for depression, anxiety (panic disorder, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder), or PTSD; able to communicate in English; and willing to give informed consent. Exclusion Criteria: 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 lack of a phone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna M Coviello, PhD
Phone
215-746-6713
Email
coviello@upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Campbell
Email
krcam@upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mandell, ScD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Center for Primary Care
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna M Coviello, PhD
Phone
215-510-6792
Email
coviello@upenn.edu
First Name & Middle Initial & Last Name & Degree
Kristen Campbell, MPH
Phone
267-670-1344
Email
krcam@upenn.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
35785613
Citation
Harris RA, Campbell K, Calderbank T, Dooley P, Aspero H, Maginnis J, O'Donnell N, Coviello D, French R, Bao Y, Mandell DS, Bogner HR, Lowenstein M. Integrating peer support services into primary care-based OUD treatment: Lessons from the Penn integrated model. Healthc (Amst). 2022 Sep;10(3):100641. doi: 10.1016/j.hjdsi.2022.100641. Epub 2022 Jul 2.
Results Reference
derived
PubMed Identifier
33631356
Citation
Harris RA, Mandell DS, Kampman KM, Bao Y, Campbell K, Cidav Z, Coviello DM, French R, Livesey C, Lowenstein M, Lynch KG, McKay JR, Oslin DW, Wolk CB, Bogner HR. Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol. Contemp Clin Trials. 2021 Apr;103:106325. doi: 10.1016/j.cct.2021.106325. Epub 2021 Feb 22.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs