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Moms in Recovery (MORE): defining optimal care for pregnant women and infants
Investigator (PI): Lord, Sarah
Performing Organization (PO): (Current): Dartmouth College, Geisel School of Medicine, Department of Psychiatry, Center for Technology and Behavioral Health / (603) 646-7000
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2023
Record Source/Award ID: PCORI/MAT-2017C2-7717
Funding: Total Award Amount: $5,298,872
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Description of the problem our project seeks to solve: Northern New England has among the highest rates of opioid dependence in the U.S, with prevalence highest and growing among those 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, and 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 programs. 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 the 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 and mother. A second challenge is to understand the relative contributions of onsite services such as mental health care, care coordination, and parenting education to improved outcomes. This question is important to patients and 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 and specialty care services are limited. Patients, providers, and other stakeholders need guidance in choosing the optimal models for building new programs to provide maternity care for women with OUD. Intended outcomes: We will focus on outcomes identified by pregnant and parenting women with opioid use disorder and their maternity care providers as important. The study will compare the outcomes of women receiving prenatal care in practices that provide MAT with those of women receiving care in practices that refer MAT to specialty care. We will study the following outcomes important to women and their care team: experience of care, depression and anxiety, quality of life, pregnancy and complications, maintenance of child custody, infant treatment for neonatal withdrawal, and illicit opioid and other substance use abstinence, and maternal MAT treatment engagement during pregnancy and early postpartum. As a result of our study we hope to answer two key questions for pregnant women with opioid use disorder: (1) Is there a clear benefit to me and my baby from receiving prenatal services in practices that provide MAT rather than practices that refer patients to specialty providers? (2) What services will help most to support my long-term recovery? Why this project is important to patients: Maternity care providers are striving to identify the most effective ways to provide the best care and support to their patients with opioid use disorder, to improve outcomes for both mothers and their infant children. Payers are looking to identify the best ways to use resources to address the growing opioid epidemic that is ravaging the northern New England region and other rural regions throughout the country. Women are looking for ways to get the care they need to promote the health of their infants, and ways to maintain recovery to maintain custody of their infants. Through the comparison of real-world experiences of these two models of MAT within maternity care practices, we will gain insight into what types of services are associated with the best outcomes for mothers and babies. This knowledge will help patients, providers, policy makers, state Medicaid officials, and other stakeholders work together to co-design effective programs. How patients and stakeholders will make this project successful: Patients and stakeholders will be the drivers of success in this study. We are partnering with patients and providers in 21 practices providing maternity care in rural, semi-rural, and semi-urban areas across the three northern New England states to ensure that our study reflects the diversity of our region. We are using a patient-centered, participatory approach to the study whereby patients and stakeholder partners will be active collaborators in all phases of the study, including pre-study planning, conducting the study, assisting in analysis and interpretation of study results, and finally, in production of dissemination materials and participation in sharing of study results to their networks. Our patient and stakeholder partners, along with a study advisory committee, will ensure that the study produces results that are relevant, meaningful, and actionable in terms of impacting practice and policy related to the effective care of women with opioid use disorders and their infants.
Abstract Archived: Lay Abstract: PCORI has identified treatment for opioid use disorder among pregnant women, with a focus on maternal and neonatal outcomes, as an important research topic. To compare the effectiveness of different treatment approaches, PCORI launched an initiative in 2017 on Medication-Assisted Treatment (MAT) Delivery for Pregnant Women with Substance Use Disorders Involving Prescription Opioids and/or Heroin. The initiative funded this research project. This research project is in progress. PCORI will post the research findings on the PCORI website within 90 days after the results are final. What is the research about? Opioid use disorder, or OUD, increases health risks for pregnant women and their babies. Babies born to women with OUD may be born early, be underweight, or have withdrawal from opioids. In Maine, New Hampshire, and Vermont, between 5 and 8 percent of newborns have mothers with OUD. Medication-assisted treatment, or MAT, can reduce the risk of complications for women with OUD and their babies. But it can be hard for pregnant women to find doctors who offer MAT. This study is comparing two ways for pregnant women to receive MAT for OUD. One way is for clinics that care for pregnant women to provide MAT during patient visits. A second way is for these clinics to refer women to clinics that specialize in treating OUD. The study is also looking at what other types of services, such as mental health treatment, are most useful in helping women continue treatment for OUD. Who can this research help? Clinics, doctors, nurses, and others can use results from this study when considering the best ways to provide MAT to pregnant women with OUD. What is the research team doing? The research team is recruiting 2,000 pregnant women with OUD who get care at 21 maternity clinics in rural and suburban areas across Maine, New Hampshire, and Vermont. Some of the maternity clinics provide MAT for OUD on site. Others refer patients to different clinics to get MAT for OUD. The research team is checking the women's health records to see if they have problems with their pregnancies and whether their babies have opioid withdrawal. In addition, the team is collecting data about services the clinics offer, like parenting classes or mental health care. Finally, the team is using surveys and interviews to ask doctors at the 21 clinics about their views on the two ways of offering MAT to pregnant women with OUD. The research team is using the data they collect to compare the health results for women and their babies. The team is talking to a smaller group of women six months after their babies are born about (1) depression, anxiety, quality of life, and their experience with the care they received; (2) their pregnancy and any complications; (3) whether they are in treatment for OUD during pregnancy and shortly after giving birth; (4) whether they keep custody of their babies; and (5) whether they bring their babies in for the recommended visits. The research team is also looking at what makes a difference in whether pregnant women continue OUD treatment. These things may include mental health concerns, the medicine used for treatment, and the severity of OUD. They are also looking at what other maternity clinic services, like counseling, care coordination, or parenting education may improve health results for pregnant women. Finally, the team is looking at how maternity care doctors' views about treating OUD with medicine affect pregnant women's health results. Women who have had OUD during pregnancy, clinicians, insurers, and addiction recovery counselors are working with the research team to plan and conduct the study. Research methods. Design: The study design is observational: mixed-methods study. Population: The study population is pregnant adults who receive prenatal care from a participating clinic and meet DSM-5 diagnostic criteria for OUD. Interventions/comparators are integrated MAT and referral-based MAT. Outcomes: Outcomes are (a) primary: illicit opioid use, MAT treatment engagement and retention during pregnancy and early postpartum, pregnancy and complications, depression and anxiety, and experience of care; and (b) secondary: other illicit substance use, neonatal complications, infant treatment for neonatal withdrawal, maintenance of child custody, quality of life, and adherence to recommended infant care visits. The timeframe is 6-month follow-up for primary outcomes.

MeSH Terms:
  • Adolescent
  • Female
  • Health Policy
  • Humans
  • Infant, Newborn
  • Maine
  • Medicaid
  • * Mothers
  • New Hampshire
  • Opiate Substitution Treatment /methods
  • Opioid-Related Disorders /*complications
  • /*rehabilitation
  • Postpartum Period
  • Pregnancy
  • Pregnancy Complications
  • Prenatal Care /*organization & administration
  • Prevalence
  • United States
  • Vermont
  • Young Adult
Country: United States
State: New Hampshire
Zip Code: 03766
UI: 20191407
CTgovId: NCT04251208
Project Status: Ongoing
Record History: ('2020: Included Lay Abstract in Abstract Archived 1 field. Alternate Title: Comparing two ways to provide treatment for pregnant women with opioid use disorder',)