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临床试验/NCT07642947
NCT07642947尚未招募不适用

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

Trustees of Dartmouth College2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • 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.
  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa A. Marsch

Principal Investigator of the Northeast Node of the National Drug Abuse Treatment Clinical Trials Network (CTN)

Trustees of Dartmouth College

研究点 (2)

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