Methods and Timeline
This is a four-year observational comparative effectiveness study, which means that we are rigorously evaluating what our maternity care practice partners are already doing to care for pregnant women with opioid use disorder. We are not asking practices to implement another intervention. We have partnered with over 20 maternity care practices throughout Maine, New Hampshire and Vermont for this study.
To answer our research questions, we will collect data in the following ways:
- Conduct a retrospective review of the medical records of pregnant women with identified opioid use disorder to collect data related to clinical outcomes, including opioid use and other substance use, MAT treatment adherence and retention, mental health conditions and treatment, and pregnancy and delivery complications.
- Recruit and consent a cohort of 525 pregnant women with identified opioid use order from partner practices to follow prospectively until 6 months postpartum. Participants will complete assessment surveys at 3 time points: in their 3rd trimester, 3 months postpartum, and 6 months postpartum.
- Conduct qualitative interviews with clinicians and other practice stakeholders to gather in-depth information about experiences of providing care for pregnant women with opioid use order.
- Conduct qualitative interviews with a subset of women participants to gather in-depth information about their experiences of care.
Data collection will begin in June 2019 and continue for approximately two years. We will focus on analyzing the data and summarizing the results in the last year of the study. The main activities in this last year of the study will be to disseminate findings to patient, practice, and state stakeholders with the goal of impacting practice and policy to promote the most effective care for women with OUD and their infants.
Governance for the MORE study includes a Study Advisory Committee (SAC) made up of representatives from many key stakeholder groups, including representatives of state Medicaid and policy initiatives, obstetric practitioners and MAT treatment providers, and women with lived experience. The SAC is co-chaired by a community partner, and has standing workgroups to foster engagement in all aspects of the study to ensure relevance. Click here (PDF) to see Study Governance Structure.