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Successful Strategies for Practice-Based Recruitment of Racial and Ethnic Minority Pregnant Women in a Randomized Controlled Trial: the IDEAS for a Healthy Baby Study

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Abstract

Background

Racial/ethnic minority patients are often underrepresented in clinical trials. Efforts to address barriers to participation may improve representation, thus enhancing our understanding of how research findings apply to more diverse populations.

Methods

The IDEAS (Information, Description, Education, Assistance, and Support) for a Healthy Baby study was a randomized controlled trial (RCT) of an intervention to reduce barriers to using publicly reported quality data for low-income, racial/ethnic minority women. We used strategies grounded in a health equity framework to address barriers to recruitment and retention in three domains: preparation, process, and patient-centeredness. “Preparation” included teaching study staff about health inequities, role-playing skills to develop rapport and trust, and partnering with clinic staff. “Processes” included use of electronic registration systems to pre-screen potential candidates and determine when eligible participants were in clinic and an electronic database to track patients through the study. Use of a flexible protocol, stipends, and consideration of literacy levels promoted “patient-centeredness.”

Results

We anticipated needing to recruit 800 women over 18 months to achieve a completion goal of 650. Using the recruitment and retention strategies outlined above, we recruited 746 women in 15 months, achieving higher recruitment (87.1 %) and retention rates (97.3 %) than we had anticipated.

Discussion

These successful recruitment and retention strategies used for a large RCT promoted inclusivity and accessibility. Researchers seeking to recruit racial and ethnic minority pregnant women in similar settings may find the preparation, process, and patient-centered strategies used in this study applicable for their own studies.

Trial Registration

ClinicalTrials.gov NCT01784575, 1R21HS021864-01

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Acknowledgments

We would like to thank the staff at the Wesson Women’s Clinic for the major supportive role they played in this study’s recruitment and retention successes.

Funding

This study was support by a grant from the Agency for Healthcare Research and Quality (R21 HS021879).

Author information

Authors and Affiliations

  1. Department of Medicine, Tufts University/Baystate Medical Center, 759 Chestnut St, Springfield, MA, 01199, USA

    Sarah L. Goff, Haley Guhn-Knight, Tara Lagu & Peter K. Lindenauer

  2. Center for Quality of Care Research, Baystate Medical Center, 759 Chestnut St, Springfield, MA, 01199, USA

    Sarah L. Goff, Penelope S. Pekow, Haley Guhn-Knight, Tara Lagu & Peter K. Lindenauer

  3. School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, USA

    Yara Youssef & Penelope S. Pekow

  4. Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA

    Yara Youssef

  5. Department of Obstetrics and Gynecology, Boston University Medical Center, 72 East Concord St., Boston, MA, 02118, USA

    Katharine O. White

  6. Meyers Primary Care Institute, 630 Plantation St., Worcester, MA, USA

    Kathleen M. Mazor

  7. Department of Internal Medicine, University of Massachusetts Medical School, 55 Lake Ave N., Worcester, MA, USA

    Kathleen M. Mazor

Authors
  1. Sarah L. Goff
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Corresponding author

Correspondence to Sarah L. Goff.

Ethics declarations

Conflict of interest

Sarah Goff declares that she has no conflict of interest. Yara Youssef declares that she has no conflict of interest. Kathleen Mazor declares that she has no conflict of interest. Penelope Pekow declares that she has no conflict of interest. Katharine White consults for Actavis. Peter Lindenauer declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Dr. White and Ms. Youssef were employed by Baystate Medical Center while the study was conducted.

The authors have no conflicts to disclose. The study involved human subjects. Approval was obtained from the Baystate Medical Center Institutional Review Board and participants completed informed written consent.

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Goff, S.L., Youssef, Y., Pekow, P.S. et al. Successful Strategies for Practice-Based Recruitment of Racial and Ethnic Minority Pregnant Women in a Randomized Controlled Trial: the IDEAS for a Healthy Baby Study. J. Racial and Ethnic Health Disparities 3, 731–737 (2016). https://doi.org/10.1007/s40615-015-0192-x

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