Clinical trial NCT04245423: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Mental Health Conditions
Keywords: Opioid-use disorder
Depression
Anxiety
Post-traumatic stress disorder
Collaborative Care
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2020-01-28
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in opioid use based on self-reported
timeFrame: Baseline and monthly for 6 months
measure: Change in opioid use based on toxicology
timeFrame: Baseline and monthly for 6 months
measure: Change in psychiatric symptoms - Depression
timeFrame: Baseline and monthly for 6 months
measure: Change in psychiatric symptoms - Anxiety
timeFrame: Baseline and monthly for 6 months
measure: Change in psychiatric symptoms - Post-traumatic Stress Disorder
timeFrame: Baseline and monthly for 6 months
Secondary outcomes:
measure: Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine)
timeFrame: Baseline and monthly for 6 months
measure: Change in medication adherence
timeFrame: Baseline and monthly for 6 months
measure: Treatment retention
timeFrame: 6 months
measure: Rate of Mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Center for Primary Care
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Mandell, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.