Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of Intervention Measure (FIM)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Prenatal Obstetric Visits
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Lisa A. Marsch, PhD, Dartmouth College

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. januar 2027

Studieafslutning (Anslået)

28. februar 2027

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CTN-0157
  • UG1DA040309 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

The NIDA data share website is public

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Perinatal stofbrug

Kliniske forsøg med Digitally Enhanced Peer Doula Model of Care

Abonner