IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk.

Abstract

Introduction

Preterm birth is a major cause of neonatal morbidity and mortality rate. Non-Hispanic black patients disproportionately experience preterm birth and nonadherence to evidence-based preventive measures. Interventions tailored to non-Hispanic black birthing individuals (NHBBIs) that address barriers to preterm birth preventions are urgently needed.

Methods

Together with a community-engaged multidisciplinary stakeholder group, we developed an intervention to improve adherence to preterm birth preventions among black pregnant patients with prior preterm birth. The intervention included the following: (1) preterm birth prevention education, (2) an employment navigation toolkit, and (3) encouragement text messages. We piloted the intervention by recruiting self-identified non-Hispanic black patients at or before 20 weeks of gestation with a prior preterm birth and randomizing them to the intervention or an active control. The primary outcomes were feasibility and acceptability. Our secondary outcomes were preliminary efficacy based on birth outcomes, patient experience, and pregnancy-specific anxiety (PSA). Descriptive statistics, analysis of verbatim survey responses, Wilcoxon signed rank, and Fisher's exact were used to describe and compare quantitative and qualitative data.

Results

We identified 53 individuals who met the inclusion criteria, 35 were reachable remotely and 30 were enrolled and randomized. More than 80% (n=26) were retained throughout the study, and 100% of participants identified at least one intervention component as helpful. In this small pilot, there were no detectable differences in adherence to preterm birth preventive recommendations. No difference in preterm births, other pregnancy, or patient experience outcomes was detected between the intervention and active control participants.

Discussion

The intervention is feasible and acceptable. Larger, appropriately powered studies are needed to assess whether the intervention will decrease PSA and reduce preterm birth. This trial was registered with ClinicalTrials.gov (NCT04933812).

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1089/heq.2022.0089

Publication Info

Wheeler, Sarahn M, Kelley EC Massengale, Thelma A Fitzgerald, Tracy Truong, Truls Østbye, Amy Corneli and Geeta K Swamy (2022). IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk. Health equity, 6(1). pp. 922–932. 10.1089/heq.2022.0089 Retrieved from https://hdl.handle.net/10161/28286.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Wheeler

Sarahn M Wheeler

Associate Professor of Obstetrics and Gynecology

Dr. Sarahn M. Wheeler is a practicing maternal-fetal medicine specialist at Duke University Medical Center. Dr. Wheeler was born and raised in Mt. Laurel, NJ. She graduated magna cum laude from Harvard University. She completed medical school at the University of Chicago’s Pritzker School of Medicine. Dr. Wheeler went on to residency training in Obstetrics and Gynecology at the Johns Hopkins Hospital. Dr. Wheeler completed her maternal-fetal medicine sup-specialty training at Duke University in June of 2016.

Dr. Wheeler currently serves as Assistant Professor in the Duke University School of Medicine. In this role, Dr. Wheeler is both a practicing clinician and research faculty. in her clinical role, Dr. Wheeler is the director of Duke's Prematurity Prevention Program, a specialty clinic that is geared for women with risk factors for preterm birth.  In her research role, Dr. Wheeler has published several peer-reviewed articles on topics ranging from fetal brain injury to vaccination during pregnancy. Dr. Wheeler’s current research focus is on race disparities in preterm birth. She is actively involved in research to develop interventions to improve utilization of preterm birth prevention therapies.

Dr. Wheeler also serves as the Director of Diversity, Equity and Inclusion for the OB/GYN department.  In this role she leads efforts to ensure an inclusive environment for the diverse patients, faculty, staff and trainees within Duke OB/GYN.

Truong

Tracy Truong

Biostatistician, Principal

Tracy currently collaborates with clinicians, residents, and fellows in the Department of Obstetrics and Gynecology, Neurology, Pediatrics, and Center for Childhood Obesity Research. Her professional experience includes data management, observational studies, with an emphasis on reproducible research utilizing R markdown.

Corneli

Amy Lynn Corneli

Professor in Population Health Sciences

Dr. Amy Corneli, a social scientist by training, conducts qualitative, mixed-method, intervention, and implementation science research. Her work spans the U.S. and multiple countries in sub-Saharan Africa, the Middle East, and South and Southeast Asia. She has a history of collaborating with and learning from community organizations and representatives in conducting research with populations that face discrimination, bias, or unequal treatment within the healthcare system and society due to race, ethnicity, gender, sexual orientation, or socioeconomic status. Her collaborative research often focuses on generating synergies between the creativity of art and the analytical thinking of science. The findings from her research inform clinical trials and practice, socio-behavioral interventions, guideline development, and the practical dissemination of proven interventions.

Dr. Corneli's current research portfolio encompasses three areas:

  1. Leading, co-leading, mentoring, and supporting qualitative, mixed-methods, and implementation science research in HIV prevention.
  2. Serving as a methodological investigative partner on qualitative, mixed-methods, and intervention research on a variety of health conditions and topics with faculty in the School of Medicine at Duke University.
  3. Leading the social science team for the Clinical Trials Transformation Initiative, a public-private initiative between Duke University and the U.S. Food and Drug Administration.


Dr. Corneli is also the:

  1. Founder and Director of QualCore, a group of PhD- and master-level social scientists who partner with Duke faculty to provide scientific direction and interviewing and analysis expertise in qualitative research.
  2. Co-founder and Director of The BASE (Bioethics and Stakeholder Engagement) Lab, a group of faculty and staff that partner with clinical investigators at Duke to conduct research with key contributors to inform the planning, conduct, interpretation, and reporting of clinical research.
  3. Director of the Duke CFAR Social and Behavioral Sciences Core.


QualCore | https://populationhealth.duke.edu/research/qualcore

The BASE Lab | https://populationhealth.duke.edu/research/base-lab

Duke CFAR Social and Behavioral Sciences Core | https://cfar.duke.edu 

Clinical Trials Transformation Initiative | https://www.ctti-clinicaltrials.org 

Prior to joining Duke University, Dr. Corneli was engaged in biomedical HIV prevention research at FHI 360 for 10 years.

Swamy

Geeta Krishna Swamy

Haywood Brown, MD Distinguished Professor of Women's Health

Dr. Geeta Swamy, MD, is Professor of Obstetrics and Gynecology in the Division of Maternal-Fetal Medicine, having served as the director of the Duke Perinatal Research Center and Vice Chair for Research and Faculty Development in the Department of ObGyn. She has achieved international acclaim as a clinician researcher and expert in the field of maternal immunization and perinatal infection. As a consultant to the World Health Organization, Dr. Swamy contributes her knowledge to advance international work to evaluate the immunogenicity, safety, and efficacy of vaccines in pregnant women. The American College of ObGyn has grown to be the “collective voice” for women’s health, and Dr. Swamy has been a leader within that organization for the last two decades. She currently serves as the Co-Principal Investigator for the NIH-NIAID Vaccine Treatment and Evaluation (VTEU) and CDC Clinical Immunization Safety Assessment. In addition, she has been a leader at Duke and nationally in promoting a culture of scientific integrity and transparency in research. She has been instrumental in developing and leading the School of Medicine’s research initiatives in administration, regulatory oversight, and compliance. In 2018, she became Vice Dean for Scientific Integrity in the School of Medicine and Associate Vice President for Research for Duke University. In these roles she oversees the Duke Office of Scientific Integrity (DOSI) which houses the Advancing Scientific Integrity, Services, & Training (ASIST) initiative, conflict of interest, clinical quality management, incident response in research, and research misconduct. She also oversees the Duke Office of Research Initiatives, the Duke Health IRB, Office of Research Administration (ORA), and Office of Research Contracts (ORC). 





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