Mental Health Conditions, Opioid-use Disorder
Conditions
Keywords
Opioid-use disorder, Depression, Anxiety, Post-traumatic stress disorder, Collaborative Care
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.
Interventions
BEHAVIORALCollaborative 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.
BEHAVIORALAugmented 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.
BEHAVIORALCollaborative 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
University of Pennsylvania
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in opioid use based on self-reported | Baseline and monthly for 6 months | Modified Timeline Followback |
| Change in opioid use based on toxicology | Baseline and monthly for 6 months | Urine Drug Screens |
| Change in psychiatric symptoms - Depression | Baseline and monthly for 6 months | Patient Health Questionnaire (PHQ-9); range is 0-27 with higher scores demonstrating worse outcomes |
| Change in psychiatric symptoms - Anxiety | Baseline and monthly for 6 months | Generalized Anxiety Disorder Screener (GAD-7); range is 0-21 with higher scores demonstrating worse outcomes |
| Change in psychiatric symptoms - Post-traumatic Stress Disorder | Baseline and monthly for 6 months | Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); range is 0-80 with higher scores demonstrating worse outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine) | Baseline and monthly for 6 months | Modified Timeline Followback |
| Change in medication adherence | Baseline and monthly for 6 months | Self-report |
| Treatment retention | 6 months | Measured as the time to dropout (from both OUD and mental health treatment using clinic records) |
| Rate of Mortality | 6 months | Assessed through death records |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Mandell, ScD
University of Pennsylvania
Outcome results
None listed