MOms in REcovery (MORE) Study: Defining Optimal Care

NCT04251208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 444

Last updated 2024-04-09

No results posted yet for this study

Summary

Northern New England has among the highest rates of opioid dependence in the U.S, with prevalence highest and growing among those of between the ages of 18-35 years. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with opioid use disorder. In northern New England (Maine, New Hampshire, \& Vermont), 5-8% of newborns have mothers with an opioid use disorder (OUD), greatly increasing the risk of poor outcomes, including preterm birth and long hospitalization for neonatal withdrawal and other newborn complications. For pregnant women with OUD, medication assisted treatment (MAT) significantly reduces these risks. However, it is sometimes difficult for pregnant women to find MAT providers. As a result, many maternity care providers have begun to prescribe MAT in their own practices. Other practices have maintained the longstanding evidence-based standard of care, referral of patients with OUD to specialty MAT treatment program. Most pregnant women with OUD have other psychosocial needs, ranging from lack of housing and untreated mental health conditions, to need for parenting education and support. There is variability among practices in terms of types of other services provided to patients, whether the practice has integrated MAT or relies on referral. Although pregnancy is a time when women are highly motivated to start MAT, many women are also likely to discontinue MAT postpartum due to loss of insurance coverage, difficulty transitioning to another provider, loss of motivation for treatment, or competing demands on time and resources as a new parent.

The challenge for patients, providers, and other stakeholders is to understand the relative advantage of the two MAT models (receiving MAT as part of maternity care or at a specialty program) for improving key outcomes for baby \& mother. A second challenge is to understand the relative contributions of onsite services such as mental health care, care coordination, \& parenting education to improved outcomes. This question is important to patients \& families who may have a choice of where they receive their maternity care. It is even more important in rural areas, such as northern New England, where obstetric practices \& specialty care services are limited. Patients, providers \& other stakeholders need guidance in choosing the optimal models for building new programs to provide maternity care for women with OUD.

Conditions

Interventions

OTHER

Observational Study

No intervention will be administered.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Trustees of Dartmouth College

    lead OTHER

Principal Investigators

  • Sarah E Lord, PhD · Dartmouth College

  • Daisy Goodman, DNP, MPH · Dartmouth-Hitchcock Medical Center

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04251208 on ClinicalTrials.gov