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

9. Juni 2026 aktualisiert von: Lisa A. Marsch, Trustees of Dartmouth College

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

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.

Studienübersicht

Status

Noch keine Rekrutierung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03766
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • The OHSU MEADOWLARK Program (MEntal health and ADdiction integrated for Obstetric Wellness)
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Staff participants and patient participants will be selected from two participating clinical sites that have implemented the digitally enhanced peer doula model of care.

Beschreibung

Staff Participant

Inclusion Criteria:

  1. 18 years of age or older.
  2. Employed by the participating clinic site and identified as care providers and/or administrative staff. Clinic roles may include:

    1. 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).
    2. Peer doulas.
    3. Administrator (including front desk staff, scheduler, clinic and/or team manager).
    4. Site leadership.
  3. Able to speak English sufficiently to understand the study and, having understood, provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Unwilling or unable to provide consent
  2. 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

  1. 18 years of age or older
  2. Patient of the participating site who is eligible to receive prenatal, postpartum, or delivery services

    •Either

    1. 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

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

Exclusion Criteria:

  1. Unable or unwilling to provide consent to participate in study activities
  2. 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
  3. Currently unable to engage in the digitally enhanced peer doula model or attend research visits

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Patient Participants Cohort 1
Patient Participants who have not yet been exposed to the peer doula model of care or have been exposed for less than 30 days
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 a free smartphone and data plan for pregnancy and one-year postpartum.
Patient Participants Cohort 2
Patient Participants who have been exposed to the peer doula model of care for at least 30 days
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 a free smartphone and data plan for pregnancy and one-year postpartum.
Site Staff Participants
Site staff participants who have been exposed to the peer doula model of care at their clinical site

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility of Intervention Measure (FIM)
Zeitfenster: At enrollment

Site staff participants will complete the FIM, a 4-item survey, that examines the feasibility of implementing the digitally enhanced peer doula model in routine obstetric settings.

Using a five-point Likert scale, the FIM has 4 items examining whether an innovation is implementable, possible, doable, and easy to use. Items are scored using a Likert scale that ranges from 1 (Completely Disagree) to 5 (Completely Agree). Scales are created by averaging responses, with total score values ranging from 1 to 5. Higher scores indicate greater feasibility. Two versions of the FIM will be completed by Site staff participants. The first will collect data on the acceptability of providing smartphones to patients. The second version of the FIM will assess the acceptability of the peer doula component of the model.

At enrollment
Acceptability of Intervention Measures (AIM)
Zeitfenster: At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)

Site staff and patient participants will complete the AIM, a 4-item survey, that assesses the acceptability of the digitally enhanced peer doula model in routine obstetric settings. The survey asks participants to rate the acceptability of the model from completely disagree to completely agree.

Using a five-point Likert scale, the AIM has 4 items examining whether an innovation meets participant approval, is appealing, is welcomed, and is liked. Items are scored using a Likert scale that ranges from 1 (Completely Disagree) to 5 (Completely Agree). Scales are created by averaging responses, with total score values ranging from 1 to 5. Higher scores indicate greater acceptability. Two versions of the AIM will be completed by patient participants. The first will collect data on the acceptability of providing smartphones to patients. The second version of the AIM will assess the acceptability of the peer doula component of the model. Site staff will only complete the second version.

.

At enrollment (Site staff, Cohort 2), and 30 days post-enrollment (Cohort 1)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Prenatal Obstetric Visits
Zeitfenster: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

The number of prenatal visits will be abstracted from the EHR to explore the impact of the digitally enhanced peer doula model.

Depending on the distribution of the number of visits, either mean or median visits will be compared between patient participants and the historical control cohort.

Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
Number of Postpartum Obstetric Visits
Zeitfenster: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
The number of postpartum visits will be abstracted from the EHR to explore the impact of the digitally enhanced peer doula model. Depending on the distribution of the number of visits, either mean or median visits will be compared between patient participants and the historical control cohort.
Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
Engagement in substance use disorder (SUD) treatment
Zeitfenster: At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)

Engagement in substance use disorder (SUD) treatment will be assessed via the Oregon Hope Engagement in Addiction Treatment Survey (OR HOPE). This will be measured by evaluating the percentage of patients reporting participation in SUD services before and after exposure to the model.

Items measured will be the following:

  • Types of SUD treatment received
  • Frequency of SUD treatment
At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)
Engagement in Peer Doula Support
Zeitfenster: Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

Sites will abstract data from each peer doula contact with study participants. This data will include the following:

  1. Modality of each encounter (e.g., virtual, phone-based, or in-person)
  2. Location of contact (e.g., obstetric clinic, other healthcare setting, patient home, or community)
  3. Types of support provided (e.g., recovery, pregnancy, postpartum, housing, transportation, food, lactation, or other).
Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Lisa A. Marsch, PhD, Dartmouth College

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

31. Januar 2027

Studienabschluss (Geschätzt)

28. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • CTN-0157
  • UG1DA040309 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified participant level data will be posted to the NIDA data share website

IPD-Sharing-Zeitrahmen

IPD will be available on the NIDA data share website per NIH guidelines after publication of the primary outcomes with no end date

IPD-Sharing-Zugriffskriterien

The NIDA data share website is public

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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