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Support models for addiction-related treatment
Investigator (PI): Yonkers, Kimberly
Performing Organization (PO): (Current): Yale University, Yale School of Medicine, Department of Psychiatry / (203) 785-6396
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2024
Record Source/Award ID: PCORI/ MAT-2018C2-12891
Funding: Total Award Amount: $5,572,916
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Description: The opioid crisis has had a devastating impact in the U.S. Over 90 people die of an overdose each day. Pregnant women have not been spared. The likelihood that a pregnant mom will struggle with an opioid use disorder (OUD) has increased by more than 300% in the past 15 years. Unfortunately, there is a shortage of doctors who can help pregnant women with an OUD. Some research shows that pregnant women are less likely to receive treatment for an OUD than non-pregnant women. If obstetrical providers were trained to provide outpatient treatment for opioid misuse, and provide this treatment alongside prenatal care, many benefits are possible. Treatment may be 1) more available, 2) more accessible, and 3) fit a pregnant woman's needs and concerns. We will compare two ways to support obstetricians and nurses who would like to offer both prenatal care and addiction treatment for pregnant and postpartum women with an OUD. Study description: We will recruit 12 obstetrical centers and match their characteristics. We will randomly assign one center in each pair to one condition or the other. We will enroll 480 women in total, half in each treatment condition. The models being compared include (1) a collaborative care (CC), which provides onsite training and support to obstetricians through a care manager who would a) help women with barriers to prenatal care visits, b) provide recovery coaching, and c) measure emotional symptoms and substance misuse. The other condition (2) would provide obstetrical practices education, training, and assistance but only via videoconferencing. These 6 practices would learn how to care for pregnant women with opioid misuse by holding videoconference classes that educate doctors and nurses, and by review of real-life examples. The project would include input from a patient stakeholder group (PSG) that would meet at least 4 times each year. Outcomes: We would try and determine whether there are differences between women who are cared for in the CC condition versus the ECHO condition in starting and remaining in OUD treatment in pregnancy. A second aim would determine whether there are differences between the two groups in the likelihood that women will 1) feel empowered to control their illness; 2) partner with her doctors and nurses in making medical decisions; 3) experience improvement in depression and anxiety; and 4) feel able to fulfill her roles as mother, daughter, partner, etc. Further, we would explore differences in birth complications such as delivering a baby early. It is essential that we have guidance from women with lived experience. The PSG is critical in that it would help researchers understand and include treatment outcomes that are most important to pregnant women as well as find the best ways to recruit, respect, and retain patients in the program. We seek to make the project women centered and to have it reflect the voices and concerns of those struggling to recover from its effects.
MeSH Terms:
  • Access to Health Care
  • Anxiety /complications
  • Depression /complications
  • Drug Addiction /*therapy
  • Drug Overdose /prevention & control
  • Emotions
  • Female
  • Humans
  • Mental Health Services /*organization & administration
  • Multicenter Studies as Topic
  • Nurses
  • Obstetrics /*methods
  • Opioid-Related Disorders /*complications
  • /*therapy
  • Patient Participation
  • Patient Recruitment
  • Physicians
  • Postpartum Period
  • Pregnancy
  • Pregnancy Complications
  • Prenatal Care /organization & administration
  • Preterm Birth
  • Program Development
  • Randomized Controlled Trials as Topic
  • Telemedicine /organization & administration
  • United States
Country: United States
State: Connecticut
Zip Code: 06511
UI: 20202319
CTgovId: NCT04240392
Project Status: Ongoing