The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions
Opioid-use Disorder, Mental Health Conditions
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
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.
Sites / Locations
- Penn Center for Primary CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Augmented Usual Care (AUC)
Collaborative Care (CC)
Collaborative Care + Certified Recovery Specialist (CC+)
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.