Suicide and drug overdose are leading causes of death during the year after having a baby. These deaths are due to a lack of identification and treatment of Perinatal Mood and Anxiety Disorders (PMADs), Perinatal Substance Use Disorders (PSUDs) and Intimate Partner Violence (IPV) and poor patient-provider, provider-provider communication and care coordination throughout pregnancy and the postpartum year. PMADs, PSUDs and IPV also have a negative impact on maternal health and a child development. To address each factor contributing to maternal deaths and poor maternal and child health due to undetected and/or untreated PMADs, PSUDs, and IPV and poor communication and care coordination we created Listening to Women and Pregnant and Postpartum People (LTWP). LTWP is a patient-and-provider-informed, technology-enhanced, intervention that aims to improve our healthcare system’s screening, referral to treatment and communication and care coordination among patients, providers, and health systems throughout pregnancy and the postpartum year (peripartum period).
The goal of this research is to reduce maternal deaths associated with undetected and untreated PMADs, PSUDs and IPV and improve PPP's health and well-being during pregnancy and the postpartum year. We will accomplish this goal by improving screening and referral to treatment for PMADs, PSUDs and IPV and communication and care coordination among patients, providers, and health systems throughout the peripartum period. The aims of this study are to compare LTWP to evidence-based in-person Screening, Brief Intervention, and Referral to Treatment (SBIRT) to determine group differences in outcomes that are important to patients and community partners such as attending treatment (primary outcome), continuing in treatment (other primary outcome) and Patient Reported Outcomes (PROs) such as depressive symptoms, suicidal ideation, substance use, and maternal functioning and well-being (secondary outcomes).
The study design is a stepped wedge cluster randomized trial where each clinic will initially continue their usual SBIRT procedures, and then be randomized to a time in which they stop using SBIRT and start using the LTWP system. This will allow comparison of LTWP to SBIRT on key outcomes. SBIRT includes 8 screening questions asked by a provider with all pregnant persons at their first clinic appointment. For those screening positive, a Brief Intervention (BI) using Motivational Interviewing (MI) is completed and a referral to treatment is provided, if appropriate. The Edinburgh Postnatal Depression Scale (EPDS) is completed at 20-24 weeks gestation and 6-8 weeks postpartum, and during newborn well-visits at months 1-and-6 postpartum. The EPDS results are discussed with the patient, and a referral is made, if appropriate. LTWP employs the same SBIRT and EPDS screening questions and delivers a BI using MI and referral to treatment identical to SBIRT. LTWP differs, and is hypothesized to increase rates of treatment attendance and retention by: i) delivering screening questions via text-message; ii) utilizing care coordinators (CCs) with a master’s in clinical social work to assess PMADs, PSUDs, IPV, social determinants of health and suicide and drug overdose risk necessary to facilitate appropriate referrals; iii) CCs employing a shared decision-making process to support patient-centered referrals; and iv) a CC to facilitate patient-provider, provider-provider communication and care coordination. LTWP screenings are completed in each trimester, 1, 4, 7 and 10 months postpartum. The study will include all pregnant persons, 16-45 years of age, and receiving prenatal care in 1 of 8 obstetric clinics. Screening, referral, and treatment data will be extracted from the Electronic Health Record. Among those referred to treatment, PROs will be completed via surveys and interviews at the time of referral, and 3, 6, 9 and 12 months postpartum.
Throughout all phases of the study, we will include patient partners, community organizations, clinicians, members of the research team, health care system representatives, payors, and policy makers with vested interests in this work. We will convene a Patient Stakeholder Group and Study Advisory Committee to seek input and all opinions about the research, research procedures and ensure that outcomes are meaningful to patients. We will determine the intervention that is best for patients, and groups of patients as well as characteristics that determine the likelihood that LTWP is successfully used. Results from the study will help patients, providers, clinics, payors, and health systems decide how to best screen and refer peripartum persons to treatment to reduce maternal deaths and improve maternal and child health.
*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.