Rebecca Arden Harris1, David S Mandell2, Kyle M Kampman2, Yuhua Bao3, Kristen Campbell2, Zuleyha Cidav2, Donna M Coviello2, Rachel French4, Cecilia Livesey2, Margaret Lowenstein5, Kevin G Lynch2, James R McKay6, David W Oslin6, Courtney Benjamin Wolk7, Hillary R Bogner8. 1. Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: Rebecca.Harris@pennmedicine.upenn.edu. 2. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. 3. Department of Population Health Sciences, Weill Cornell Medicine, New York, NY 10065, USA. 4. School of Nursing, University of Pennsylvania, Philadelphia, PA 19104, USA. 5. Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. 6. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA 19104, USA. 7. Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. 8. Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA.
Abstract
BACKGROUND:People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown. METHODS: The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders. DISCUSSION: The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov registration: NCT04245423.
RCT Entities:
BACKGROUND:People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown. METHODS: The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders. DISCUSSION: The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov registration: NCT04245423.