Empowering Conversations for Postpartum Care
(DECORUM Trial)
Recruiting in Palo Alto (17 mi)
Overseen bySamuel DeMaria Jr., MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Anticoagulants
Disqualifiers: Severe labor pain, Coagulopathy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Racial and ethnic disparities in obstetric anesthesia care remains persistent despite studies documenting its existence and calling for action. The goal of this study is to share disparity data with underserved minority groups being admitted to the labor and delivery unit for obstetric care, to reduce mistrust and misconceptions regarding obstetric anesthesia care, and to bridge the cultural gap between patient beliefs and safe anesthetic care and to empower patients through transparency and provide them with the information necessary to make informed decisions about their care, to improve health literacy, and to ultimately improve patient outcomes and satisfaction.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation medications, you may not be eligible for the labor epidural.
What data supports the effectiveness of the treatment Disparities Conversation for postpartum care?
Research suggests that improving communication between healthcare providers and Black patients during the perinatal period can enhance care quality and outcomes. Effective communication, mutual respect, and shared decision-making are key factors that can be addressed through clinician education to improve perinatal care for Black individuals.12345
How does the treatment in the 'Empowering Conversations for Postpartum Care' trial differ from other postpartum care treatments?
The 'Empowering Conversations for Postpartum Care' treatment is unique because it focuses on improving communication between healthcare providers and postpartum women, particularly addressing racial disparities and enhancing patient experience. Unlike traditional treatments that may focus solely on medical interventions, this approach emphasizes the importance of effective communication and support to improve health outcomes for postpartum women.13678
Eligibility Criteria
This trial is for pregnant individuals, 18 or older, with a single baby at least 37 weeks along and in the first stage of labor. They must be admitted to The Mount Sinai Hospital's labor unit and agree to an epidural. It excludes those in severe pain, having a cesarean after trying labor, with blood clotting issues or on certain medications.Inclusion Criteria
Parturient patients being admitted to the labor and delivery unit at The Mount Sinai Hospital
Patients in the first stage of labor and who have consented for placement of a labor epidural
I am 18 or older, pregnant with one baby at least 37 weeks along, and in labor or about to be induced.
Exclusion Criteria
I cannot have an epidural due to a bleeding disorder or because I'm on blood thinners.
Patients who do not consent to labor epidural placement, or if they are on a mid-wife service
Patients who are in severe labor pain following verbal informed consent prohibiting them from participating in the discussion
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Treatment
Participants receive routine care with or without a disparities discussion following epidural placement
Labor and delivery period
Follow-up
Participants are monitored for outcomes and patient satisfaction using an 18-point questionnaire
1 day postpartum
Treatment Details
Interventions
- Disparities Conversation (Behavioural Intervention)
Trial OverviewThe study aims to improve understanding and trust in obstetric anesthesia care among underserved minorities by sharing information about disparities. It seeks to empower these patients through education during their admission for childbirth.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ConversationExperimental Treatment1 Intervention
Scripted interaction
Group II: No ConversationActive Control1 Intervention
Control Group
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Mount Sinai HospitalNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
America's Racial Reckoning Within Perinatal Communication: A Rapid Review Using Sociotechnical Systems Theory to Compare Publications Before and After 2020. [2023]Perinatal communication is one factor driving racial disparities in maternal and infant morbidity. The murder of George Floyd in May 2020, in addition to the disproportionate impacts of the Covid-19 pandemic on communities of color, was a catalyst for American society to address racial injustices with a renewed sense of urgency. Drawing upon sociotechnical systems (STS) theory, this rapid review describes changes in the literature regarding the organizational, social, technical, and external subsystems that affect communication between perinatal providers and their Black patients. The goal of this work is to support health system optimization of health communication initiatives and, as a result, improve patient experience and parent and child outcomes. As part of a multi-year project designed to improve health communications about safe fish consumption during pregnancy, and in response to racial disparities among our health system's patient population related to receipt of nutrition messages during prenatal visits, we conducted a rapid review of literature on Black parents' experience of all communication while receiving perinatal care. A search of PubMed identified relevant articles published in English since 2000. Articles were screened to include articles that focused on Black people receiving perinatal care. Article content was then coded using deductive content analysis guided by STS theory to inform healthcare system improvement efforts. Differences in the prevalence of codes pre- and post-2020 are compared using chi-square statistics. The search in PubMed yielded 2419 articles. After screening, 172 articles were included in the rapid review. There was an increased recognition of communication as a key component of quality perinatal care after 2020 (P = .012) and of the limitations of standardized technical communication (P = .002) after 2020. Emerging literature suggests improving perinatal health communication and relationships with Black parents would address disparities in perinatal patient and baby outcomes. Healthcare systems must address the racial disparities in maternal and child outcomes. Since 2020, public attention and published research on this issue has increased. Understanding perinatal communication using STS theory aligns subsystems in service of racial justice.
Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]The postpartum period represents a critical window of opportunity to improve maternal short- and long-term health, including optimizing postpartum recovery, providing effective contraception, caring for mood disorders, managing weight, supporting lactation, initiating preventive care, and promoting cardiometabolic health. However, inadequate postpartum care, especially for individuals facing social and structural barriers, is common in the United States and contributes to suboptimal health outcomes with lasting consequences. Patient navigation is a patient-centered intervention that uses trained personnel to identify financial, cultural, logistical, and educational obstacles to effective healthcare and to mitigate these barriers to facilitate comprehensive and timely access to needed health services. Given the emerging evidence suggesting that patient navigation may be a promising method to improve health among postpartum individuals, our team developed a postpartum patient navigator training guide to be used in the Navigating New Motherhood 2 and other obstetrical navigation programs. Navigating New Motherhood 2 is a randomized trial exploring whether patient navigation by a trained, lay postpartum navigator for individuals with a low income can improve health and patient-reported outcomes during and after the postpartum period. Hiring and training patient navigators without health professional degrees are integral components of initiating a navigation program. However, patient navigator training is highly variable, and no guideline regarding key elements in such a training program exists for obstetrics specifically. Thus, this paper aimed to describe the core principles, content, and rationale for each element in a comprehensive postpartum patient navigator training program. Training should be centered around the following 6 core elements: (1) principles of patient navigation; (2) knowledge of pregnancy and postpartum care; (3) health education and health promotion principles; (4) cultural sensitivity and health equity; (5) care coordination and community resources; and (6) electronic medical record systems. These core elements can serve as a basis for the development of adaptable curricula for several institutions and contexts. In addition, we offer recommendations for the implementation of a navigator training program. A curriculum with built-in flexibility to meet community and institutional needs may promote the effective and sustainable use of patient navigation in the postpartum context.
Delivery and Payment Redesign to Reduce Disparities in High Risk Postpartum Care. [2018]Purpose This paper describes the implementation of an innovative program that aims to improve postpartum care through a set of coordinated delivery and payment system changes designed to use postpartum care as an opportunity to impact the current and future health of vulnerable women and reduce disparities in health outcomes among minority women. Description A large health care system, a Medicaid managed care organization, and a multidisciplinary team of experts in obstetrics, health economics, and health disparities designed an intervention to improve postpartum care for women identified as high-risk. The program includes a social work/care management component and a payment system redesign with a cost-sharing arrangement between the health system and the Medicaid managed care plan to cover the cost of staff, clinician education, performance feedback, and clinic/clinician financial incentives. The goal is to enroll 510 high-risk postpartum mothers. Assessment The primary outcome of interest is a timely postpartum visit in accordance with NCQA healthcare effectiveness data and information set guidelines. Secondary outcomes include care process measures for women with specific high-risk conditions, emergency room visits, postpartum readmissions, depression screens, and health care costs. Conclusion Our evidence-based program focuses on an important area of maternal health, targets racial/ethnic disparities in postpartum care, utilizes an innovative payment reform strategy, and brings together insurers, researchers, clinicians, and policy experts to work together to foster health and wellness for postpartum women and reduce disparities.
Integrative Review of Black Birthing People's Interactions With Clinicians During the Perinatal Period. [2023]Maternal morbidity and mortality disproportionately affect Black birthing people. Multiple factors contribute to these disparities, including variations in quality health care, structural racism, and implicit bias. Interactions between Black patients and perinatal clinicians could further affect perinatal care use and subsequent perinatal outcomes. This integrative review aims to synthesize quantitative and qualitative literature published in peer-reviewed journals in English within the past 10 years that address patient-clinician interactions during the perinatal period for Black birthing people in the United States. A systematic search of CINAHL, PubMed, PsycINFO, MEDLINE, and Embase recovered 24 articles that met the eligibility criteria for inclusion in this review. The following themes emerged from synthesizing Black patients' interactions with perinatal clinicians: Care Quality, Communication, Power Dynamic, and Established Relationships. Mutual respect, effective communication, and shared decision-making may be key modifiable factors to address through clinician education to improve perinatal care for many Black persons.
Standardized Order Sets Do Not Eliminate Racial or Ethnic Inequities in Postpartum Pain Management. [2023]To quantify the extent to which a standardized pain management order set reduced racial and ethnic inequities in post-cesarean pain evaluation and management.
Evaluating the use of text message communication in a postpartum patient navigation program for publicly insured women. [2020]To compare communication between navigators and women according to follow-up status in a postpartum patient navigation program ("Navigating New Motherhood" [NNM]).
Communication technologies and maternal interest in health-promotion information about postpartum weight and parenting practices. [2021]To describe postpartum women's access, perceived skill, confidence, and use of Internet and mobile technologies; their views about receiving health information about postpartum weight and parenting; and whether these factors varied by race/ethnicity or income level.
Strategies for Recruiting a Diverse Postpartum Survey Sample. [2023]Data from diverse populations are needed to inform interventions for maternal health equity. However, research recruitment of postpartum individuals is challenging, especially in minoritized and structurally marginalized populations.