Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder

Official title

A Digitally Enhanced Model of Peer Doula Support for Substance Use Disorder and Peripartum Care

Overview

The goal of this pilot study is to learn if a digitally enhanced peer doula program for people with perinatal substance use disorders (PSUD) is feasible and acceptable to patients and staff at two clinics. Participants will include staff members, such as healthcare providers, recovery support doulas, and administrators, who work at one of the two clinics. It will also include PSUD patients receiving care through the digitally enhanced peer doula program. Participants will be asked to complete short surveys and take part in a one-time interview with research staff. This study will also explore engagement in perinatal substance use disorder treatment and prenatal and postpartum visits.

Detailed description

Over the past two decades, rates of substance use during pregnancy have increased fourfold. Overdose is a leading cause of mortality among patients with perinatal substance use disorders (PSUD). Interventions to address SUD during pregnancy and postpartum are critical to reduce mortality and the impact of SUD-related harms for parents and their infants.

Engagement in SUD and perinatal care can improve outcomes for PSUD and their infants, including reducing the risks of preterm delivery and low birthweight. Rates of adequate prenatal care receipt are low for PSUDs, with one recent study estimating that only an estimated 50% of PSUDs in the United States (US) receive adequate prenatal care. These healthcare disparities also extend to the postpartum period, where PSUDs have a 53% decrease in the odds of attending at least one postpartum obstetric visit, compared to patients without an SUD. PSUDs are also less likely to receive SUD treatment during the year postpartum due to lapses in health insurance. Stigma from health professionals and lack of trust in healthcare providers can prevent PSUD from seeking perinatal health services and SUD treatment. PSUD also report numerous barriers to effectively communicating with healthcare providers and want more evidence-based information about delivery, postpartum health, breastfeeding, and the impact of medication for opioid use disorder (MOUD) from their healthcare team. Lack of access to healthcare can have devastating consequences, including a return to substance use and increased risk of fatal overdose. Interventions improving engagement with prenatal and postpartum care and SUD treatment are urgently needed.

A growing body of research suggests that doula care may improve engagement in healthcare for patients with behavioral health conditions. A doula is a trained professional who provides comprehensive physical, emotional, and informational support to patients before, during, and/or after childbirth. Doula care has been widely studied, with reviews suggesting that doula support can decrease rates of preterm birth, Cesarean birth, and low birth weight babies.

Doula care promises to directly improve outcomes and care experiences for PSUD. A growing body of literature has studied how doula support may improve outcomes for patients with behavioral health conditions including postpartum depression and SUD. The Illinois Department of Health/Division of Substance Use Prevention and Recovery pilot specifically use peer doulas, who have dual certifications as certified peer support specialists and doulas. Peer doulas with experience in both SUD and perinatal care could be especially beneficial for PSUD and provide guidance in navigating both SUD and perinatal healthcare systems.

Only one known study has enrolled PSUD to examine their experiences with doula care during pregnancy and postpartum. Twenty-three patients with OUD who had engaged with the Philadelphia doula care model were enrolled in a mixed-methods study examining perceptions of engaging with a doula. Participants overwhelmingly reported positive experiences with the doula program, finding the program acceptable and helpful. They appreciated the ability to engage with the doulas through phone, text, video, or in-person in the community. Participants noted that the doulas helped manage their stress and anxiety, while providing critical assistance navigating the healthcare system. Importantly, participants and staff both agreed that doula involvement reduced perceptions of stigma from healthcare providers.

Interventions

• Other Digitally Enhanced Peer Doula Model of Care
  In the digitally enhanced peer doula model of care, patients with perinatal substance use disorder are partnered with a recovery support peer doula who is able to provide synchronous or asynchronous support. This support can include in-person and text-based and/or telehealth support, in addition to assistance scheduling and arranging transport to appointments for both SUD and peripartum care, and assisting with access to food, transportation and housing. Additionally, these patients are offered

Primary outcome measures

• Feasibility of Intervention Measure (FIM) [Time frame: At enrollment]
• Acceptability of Intervention Measures (AIM) [Time frame: At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)]

Secondary outcome measures (4)

• Number of Prenatal Obstetric Visits [Time frame: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum]
• Number of Postpartum Obstetric Visits [Time frame: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum]
• Engagement in substance use disorder (SUD) treatment [Time frame: At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)]
• Engagement in Peer Doula Support [Time frame: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum]

Eligibility criteria

Staff Participant

Inclusion criteria

• 18 years of age or older.
• Employed by the participating clinic site and identified as care providers and/or administrative staff. Clinic roles may include:

• Provider (including MD, CNM, DO, PA, NP, nurse, medical assistant, behavioral health clinician, social worker, lactation consultant and/or other clinical roles that provide care to patients).
• Peer doulas.
• Administrator (including front desk staff, scheduler, clinic and/or team manager).
• Site leadership.
• Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.

Exclusion criteria

• Unwilling or unable to provide consent
• Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law; or have pending legal action that could prevent participating in study activities

Patient Participant (Cohort 1 \& Cohort 2)

Inclusion criteria

• 18 years of age or older
• Patient of the participating site who is eligible to receive prenatal, postpartum, or delivery services

•Either

• Not currently engaged in the digitally enhanced peer doula model and no prior exposure to the model or less than 30 days exposure to the model if newly enrolled, AND currently pregnant or up to 6 weeks postpartum.

OR

• Currently engaged in the digitally enhanced peer doula model for more than 30 days, AND currently pregnant or up to one year postpartum
• Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.

Exclusion criteria

• Unable or unwilling to provide consent to participate in study activities
• Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law; or have pending legal action that could prevent participating in study activities
• Currently unable to engage in the digitally enhanced peer doula model or attend research visits

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• Dartmouth Hitchcock Medical Center — Lebanon
• The OHSU MEADOWLARK Program (MEntal health and ADdiction integrated for Obstetric Wellness — Portland

Publications

• Ruiz MG, Dronamraju R. Utilizing doula care to support substance use disorder in the postpartum period. Association of State and Territorial Health Officials,, 2023.
• Gannon M, Hand D, Short VL, Carrubba T, Thiele G, Pancoe S, Lawson S, Haerizadeh-Yazdi N, Keith SW, Abatemarco D. "Someone is there with you through this [pregnancy] that isn't seeing you through a negative lens": Considerations for integrating doula referrals into opioid treatment programs. J Subst Use Addict Treat. 2025 Feb;169:209585. doi: 10.1016/j.josat.2024.209585. Epub 2024 Nov 17. PMID 39551148
• Metz TD, Rovner P, Hoffman MC, Allshouse AA, Beckwith KM, Binswanger IA. Maternal Deaths From Suicide and Overdose in Colorado, 2004-2012. Obstet Gynecol. 2016 Dec;128(6):1233-1240. doi: 10.1097/AOG.0000000000001695. PMID 27824771
• Haight SC, Ko JY, Tong VT, Bohm MK, Callaghan WM. Opioid Use Disorder Documented at Delivery Hospitalization - United States, 1999-2014. MMWR Morb Mortal Wkly Rep. 2018 Aug 10;67(31):845-849. doi: 10.15585/mmwr.mm6731a1. PMID 30091969
• Nidey N, Kair LR, Wilder C, Froehlich TE, Weber S, Folger A, Marcotte M, Tabb K, Bowers K. Substance Use and Utilization of Prenatal and Postpartum Care. J Addict Med. 2022 Jan-Feb 01;16(1):84-92. doi: 10.1097/ADM.0000000000000843. PMID 33758116
• Han B, Compton WM, Einstein EB, Elder E, Volkow ND. Pregnancy and Postpartum Drug Overdose Deaths in the US Before and During the COVID-19 Pandemic. JAMA Psychiatry. 2024 Mar 1;81(3):270-283. doi: 10.1001/jamapsychiatry.2023.4523. PMID 37991773
• Mazel S, Alexander K, Cioffi C, Terplan M. Interventions to Support Engagement in Addiction Care Postpartum: Principles and Pitfalls. Subst Abuse Rehabil. 2023 Jul 3;14:49-59. doi: 10.2147/SAR.S375652. eCollection 2023. PMID 37424702
• Goldman-Mellor S, Margerison CE. Maternal drug-related death and suicide are leading causes of postpartum death in California. Am J Obstet Gynecol. 2019 Nov;221(5):489.e1-489.e9. doi: 10.1016/j.ajog.2019.05.045. Epub 2019 Jun 4. PMID 31173749

Identifiers

NCT: NCT07642947 · CTN-0157 · UG1DA040309

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗