The opioid crisis has had a devastating impact in the US. On average, more than 90 people die of an overdose each day. Pregnant women have not been spared. The likelihood that a pregnant woman will struggle with an opioid use disorder (OUD) has increased by more than 300 percent 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 could be more available, more accessible, and 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 collaborative care (CC), which provides onsite training and support to obstetricians through a care manager who would help women overcome barriers to prenatal care visits, provide recovery coaching, and measure emotional symptoms and substance misuse. These practices would also have assistance from a psychiatrist via video conferencing. The other condition would provide obstetrical practices education, training and assistance but only via videoconferencing. These six 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 will include input from a patient stakeholder group (PSG) that would meet at least four times each year.
Outcomes: We will examine whether there are differences between women who are cared for in the CC condition vs the ECHO condition in starting and remaining in OUD treatment in pregnancy. A second aim would determine whether there are differences between the two group in the likelihood that women will feel empowered to control their illness, partner with her doctors and nurses in making medical decisions, experience improvement in depression and anxiety, and 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 who 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.
Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.