Digitally Enhanced Peer Doula Model for Perinatal Patients With Substance Use Disorder (EMBRACE)
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前:Elizabeth Saunders, PhD
- 電話番号:603-646-7006
- メール:Elizabeth.C.Saunders@dartmouth.edu
研究連絡先のバックアップ
- 名前:Kathleen Bell, MS
- 電話番号:603-646-7038
- メール:kathleen.bell@dartmouth.edu
研究場所
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03766
- Dartmouth Hitchcock Medical Center
-
コンタクト:
- Lisa Lamadriz
- 電話番号:603-308-9120
- メール:lisa.a.lamadriz@hitchcock.org
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Oregon
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Portland、Oregon、アメリカ、97239
- The OHSU MEADOWLARK Program (MEntal health and ADdiction integrated for Obstetric Wellness)
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コンタクト:
- Alisa Patten
- 電話番号:971-442-3625
- メール:pattena@ohsu.edu
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-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
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
|
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of Intervention Measure (FIM)
時間枠: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)
時間枠: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)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Prenatal Obstetric Visits
時間枠: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
時間枠: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
時間枠: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:
|
At enrollment, and 30 days post-enrollment (Cohort 1) At enrollment (Cohort 2)
|
|
Engagement in Peer Doula Support
時間枠: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:
|
Cohort 1 & Cohort 2: At start of pregnancy episode through one-year postpartum
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Lisa A. Marsch, PhD、Dartmouth College
出版物と役立つリンク
一般刊行物
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- 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.
- Ecker J, Abuhamad A, Hill W, Bailit J, Bateman BT, Berghella V, Blake-Lamb T, Guille C, Landau R, Minkoff H, Prabhu M, Rosenthal E, Terplan M, Wright TE, Yonkers KA. Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine. Am J Obstet Gynecol. 2019 Jul;221(1):B5-B28. doi: 10.1016/j.ajog.2019.03.022. Epub 2019 Mar 27. No abstract available.
- Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
- Gjerdingen DK, McGovern P, Pratt R, Johnson L, Crow S. Postpartum doula and peer telephone support for postpartum depression: a pilot randomized controlled trial. J Prim Care Community Health. 2013 Jan;4(1):36-43. doi: 10.1177/2150131912451598. Epub 2012 Jun 20.
- Ruiz MG, Dronamraju R. Utilizing doula care to support substance use disorder in the postpartum period. Association of State and Territorial Health Officials,, 2023.
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- 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.
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- 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.
- 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.
- 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.
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- Quiray J, Richards E, Navarro-Aguirre Y, Glazer D, Adachi J, Trujillo E, Perera D, Garcia EP, Bhat A. The role of doulas in supporting perinatal mental health - a qualitative study. Front Psychiatry. 2024 Feb 29;15:1272513. doi: 10.3389/fpsyt.2024.1272513. eCollection 2024.
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研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CTN-0157
- UG1DA040309 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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