Support Models for Addiction Related Treatment (SMART) for pregnant women: Study protocol of a cluster randomized trial of two treatment models for opioid use disorder in prenatal clinics

Abstract

Introduction: The prevalence of opioid use disorder (OUD) in pregnancy increased nearly five-fold over the past decade. Despite this, obstetric providers are less likely to treat pregnant women with medication for OUD than non-obstetric providers (75% vs 91%). A major reason is many obstetricians feel unprepared to prescribe medication for opioid use disorder (MOUD). Education and support may increase prescribing and overall comfort in delivering care for pregnant women with OUD, but optimal models of education and support are yet to be determined.

Methods and analysis: We describe the rationale and conduct of a matched-pair cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with OUD. The primary outcomes of this trial are patient treatment engagement and retention in OUD treatment. This study compares two support models: 1) a collaborative care approach, based upon the Massachusetts Office-Based-Opioid Treatment Model, that provides practice-level training and support to providers and patients through the use of care managers, versus 2) a telesupport approach based on the Project Extension for Community Healthcare Outcomes, a remote education model that provides mentorship, guided practice, and participation in a learning community, via video conferencing.

Discussion: This clustered randomized clinical trial aims to test the effectiveness of two approaches to support practitioners who care for pregnant women with an OUD. The results of this trial will help determine the best model to improve the capacity of obstetrical providers to deliver treatment for OUD in prenatal clinics.

Trial registration: Clinicaltrials.gov trial registration number: NCT0424039.

Trial registration: ClinicalTrials.gov NCT04240392.

Conflict of interest statement

I have read the journals policy and the authors of this manuscript have the following competing interests: Dr. Nancy Byatt has received salary and/or funding support from Massachusetts Department of Mental Health via the Massachusetts Child Psychiatry Access Program for Moms (MCPAP for Moms). She is also the statewide Medical Director of MCPAP for Moms and the Executive Director of Lifeline4Moms. She has served on the Medscape Steering Committee on Clinical Advances in Postpartum Depression. She received honoraria from Medscape, Miller Medical Communications and Mathematica. She has served on the Perinatal Depression Advisory Board for the Janssen Disease Interception Accelerator Program, Advisory Boards for Sage Therapeutics. She has also served as a consultant Ovia Health, Sage Therapeutics or their agents, and has received speaking honoraria from Sage Therapeutics. Dr. Kimberly Yonkers has consulted to Athenen Pharmaceuticals. Dr. Leena Mittal consulted to Sage Therapeutics. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. SPIRIT schedule of enrollment, interventions and assessments.

1. Participant will enter the study at different point of pregnancy. Therefore, it is likely that participants will complete varying numbers of visits between screening and the 26-week visit, and the 36-week visit and birth. This is expected and is not considered a protocol deviation. Visit 1 will follow immediately after the consenting process. 2. All participating centers will administer a validated substance use screening tool, such as the NIDA Quick Screen, 4Ps Plus or equivalent validated instrument as standard of care. The tool utilized is determined by the clinical site. 3. The DSM-5 OUD Checklist will be administered to any patients who have a positive substance use screen as part of the standard of care. 4. The Timeline Followback (TLFB) will be conducted monthly during the length of the study. The number of TLFB assessments will vary depending on when the patient enters the study and when they give birth. 5. Birth outcomes include: Low birth weight, resuscitation at delivery, fetal demise, preterm birth, duration of hospitalization. 6. Provider measures: The Substance Abuse Attitude Scale, the Physicians Worklife Survey and the Qualitative Interviews will be completed by providers and done prior to the first participant being enrolled at the site and after the last participant is enrolled at the site. 7. 3-mo PP: 3-months postpartum.

Fig 2. Participant flow through study procedures.

Note: If a patient-participant is enrolled after 26 weeks’ gestation and before 36 weeks’ gestation, the items from the 26-week visit are added to the baseline assessment.