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The PATH Home Trial: a comparative effectiveness study of peripartum opioid use disorder in rural Kentucky
Investigator (PI): Hansen, Wendy
Past Investigator: Critchfield, Agatha
Performing Organization (PO): (Current): University of Kentucky, College of Medicine, Department of Obstetrics and Gynecology / (859) 323-6582
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2023
Record Source/Award ID: PCORI/MAT-2017C2-7842
Funding: Total Award Amount: $5,316,906
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Comparing Two Methods to Deliver a Health Education Program for Pregnant Women Treated for Opioid Use Disorder in Rural Kentucky. 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 this page (the PCORI website) within 90 days after the results are final. What is the research about? Opioid use disorder is a major health problem in the United States, especially in rural areas. Pregnant women with this disorder may have babies who are born early, are underweight, and who have withdrawal from opioids. Medical treatment can help women stop using opioids during and after pregnancy. Extra services and education can also improve health for women and babies. In this study, the research team is comparing two different ways of providing that education, called comprehensive care, to pregnant women and women who recently gave birth. Who can this research help? Health care organizations can use results from this study when considering ways to treat pregnant women in rural settings who have opioid use disorder. What is the research team doing? The research team is recruiting 1,620 women who receive treatment at 12 prenatal clinics in rural Kentucky. All women in the study are between weeks 6 and 32 of their pregnancy and are taking medicine to treat opioid use disorder. The team is assigning clinics to one of two groups by chance. In the first group of clinics, a nurse and peer support specialist lead group care sessions at the clinics. Peer support specialists are women who are in long-term recovery from a substance use disorder. They help other people with these disorders learn how to care for themselves. In the second group of clinics, specialists in substance use and in mother and child health meet with mothers online. In both groups, the sessions cover the same topics: treating opioid use disorder, quitting smoking, avoiding taking opioids again, keeping the baby safe from exposure to opioids, breastfeeding, learning about signs of domestic violence, watching for signs of depression after birth, and learning about birth control. Women in both groups receive the education every two weeks from the time they join the study until six months after they give birth. The research team is looking at medical records to see how often babies have symptoms of opioid withdrawal after they are born. In addition, the team is tracking mothers' smoking, mental health, and opioid use, and whether they are breastfeeding their baby. Finally, the team is tracking how often mothers and babies use health care services and how often babies are placed in foster care. Patients, clinicians, government and insurance agencies, and community members are helping plan and conduct the study. Research methods at a glance. Design: The study design is a randomized controlled trial. Population: The study population is pregnant women in rural Kentucky receiving medication-assisted therapy for opioid use disorder. Interventions/comparators are (a) biweekly group sessions on substance use and maternal-infant health and (b) biweekly telemedicine calls on substance use and maternal-infant health. Outcomes: Outcomes are (a) primary: rate of neonatal abstinence syndrome requiring treatment; and (b) secondary: smoking cessation, foster care placement, depression, anxiety, maternal and infant health service utilization, maternal relapse, and breastfeeding. Timeframe: The timeframe is follow-up at delivery for primary outcome.
Abstract Archived: Opioid addiction can result in significant health problems and have devastating effects on people, families, and communities. Pregnant women are of special concern since untreated opioid addiction is associated with many poor outcomes including preterm birth, low birth weight, and neonatal withdrawal (called neonatal abstinence syndrome, NAS). Opioid addiction has become a major problem in all areas of the US, but especially in rural areas such as the Appalachian region (1) NAS rates continue to rise (2). We know that patients in rural areas have a very hard time accessing care for their opioid addictions (3), often because of transportation issues and long distances to travel. One way to treat opioid addiction that has been shown to improve outcomes for pregnant mothers and infants (4) is with medication-assisted therapy (MAT) (i.e., buprenorphine or methadone). However, how to best care for pregnant mothers in rural areas on MAT is yet to be determined. At the University of Kentucky, we have a developed a multidisciplinary comprehensive treatment program for pregnant and early parenting women who have opioid addiction. This program is called PATHways. We have seen significant success with this program, including fewer babies being diagnosed with NAS, more babies going home with their mothers, and more mothers staying off of illicit opioids (5-7). In this study, we are comparing two different elements of the PATHways program in rural areas of Kentucky. Pregnant women who have an opioid addiction and are on MAT will be invited to participate. In one arm of the study, women will attend pregnancy/parenting support and education groups led by a trained nurse (called a nurse facilitator) and peer support specialist every other week. In the other arm of the study, women will have monthly meetings with specialists in high-risk pregnancy, addiction care, pediatrics, or substance counseling via telemedicine. Women will stay in the study until six months after delivery. The goal is for women to receive enhanced substance abuse care in their home communities. This is something we know is very important to patients living in rural areas. The outcomes that we are looking at are of direct interest to patients and their care providers: namely the long-term success of women in their recovery, the health of their babies, and the continuation of the maternal/infant dyad--that is: are mothers more stable, and are more infants leaving the hospital on time and in the care of their mothers? For this study, the input of patients and other stakeholders is essential to its successful completion. We have assembled a team of partners who will meet regularly to contribute to the design, conduct, and aid in the dissemination of study results. The members of this team include two current PATHways patients who live in rural areas of the state and are currently undergoing their peer support specialist training. Their input in this process has been and will continue to be vital. The other members of the stakeholder team include representatives from government, clinical fields, community action groups, and payers. Overall, the engagement of this team is instrumental to achieving the project's goals of improving the health of pregnant women with opioid addiction and their newborns in rural areas. References: 1. Yao N, Matthews SA, Hillemeier MM. White infant mortality in Appalachian states, 1976-1980 and 1996-2000: changing patterns and persistent disparities. J Rural Health 2012;28:174-82. 2. Talbert JC. Kentucky Hospital Discharge Data: 2016 Office of Health Policy, Kentucky Cabinet for Health and Family Services 2017. 3. Brown JD, Goodin AJ, Talbert JC. Rural and Appalachian Disparities in Neonatal Abstinence Syndrome Incidence and Access to Opioid Abuse Treatment. J Rural Health 2017. 4.?Jones HE, Kaltenbach K, Heil SH, et al. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med 2010;363:2320-31. 5.?Ashford K, Chavan N, Fallin-Bennett A, Lofwall M, Jennings N, Sayre M, Critchfield A. Perinatal Nurse Leader: An Effective Role in Integrated Medication Assisted Treatment Programs for Pregnant Women with Opioid Use Disorder. Journal of Obstetric, Gynecologic & Neonatal Nursing (submitted, awaiting review) 2017. 6.?Chavan NR, Ashford KB, Wiggins AT, Lofwall MR, Critchfield AS. Buprenorphine for Medication Assisted Treatment (MAT) of Opioid Use Disorder in Pregnancy: Relationship to Neonatal Opioid Withdrawal Syndrome. AJP Rep. 2017 Oct;7(4):e215-e222. doi: 10.1055/s-0037-1608783. 7.?Chavan NA, Kristin H; Wiggins, Amanda C; Critchfield, Agatha S. Perinatal Assistance and Treatment Homes for Opioid Use Disorders in Pregnancy: Impact on Perinatal Outcomes The Society for Maternal Fetal Medicine--The Pregnancy Meeting (abstract) 2016.

MeSH Terms:
  • Appalachian Region
  • Comparative Effectiveness Research
  • Female
  • Humans
  • Kentucky /epidemiology
  • Neonatal Abstinence Syndrome /*prevention & control
  • Opioid Dependence /complications
  • /*epidemiology /therapy
  • Peripartum Period
  • Pregnancy
  • Rural Health Services
  • Rural Population
  • Social Support
  • Telemedicine
  • Universities
Country: United States
State: Kentucky
Zip Code: 40536
UI: 20192353
CTgovId: NCT03725332
Project Status: Ongoing
Record History: ('2020: PI changed, and abstract archived to Abstract Archived 1 field and added new abstract.',)