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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References
Martin JA, Hamilton BE, Osterman MJK, Curtain SC, and Matthews TJ. CDC National Vital Statistics; 64(1). Total fertility rate by race and Hispanic origin. http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_01.pdf. Accessed October 8, 2015.
Women with births in the past 12 months by citizenship status, educational attainment, and poverty status, by state. http://www.census.gov/compendia/statab/2012/tables/12s0094.pdf. Accessed October 8, 2015.
Martin JA, Hamilton BE, Osterman MJK, Curtain SC, and Matthews TJ. CDC. National Vital Statistics; 62(9). Births: final data for 2012. http://www.cdc.gov/nchs/data/nvsr/nvsr62/nvsr62_09.pdf
Martin JA, Hamilton BE, Osterman MJK, Curtain SC, and Matthews TJ. CDC. National Vital Statistics; 62(8). Infant mortality statistics from the 2010 period linked birth/death data set. http://www.cdc.gov/nchs/ data/nvsr/nvsr62/nvsr62_08.pdf
Flores G, Snowden-Bridon C, Torres S, Perez R, Walter T, Brotanek J, et al. Urban minority children with asthma: substantial morbidity, compromised quality and access to specialists, and the importance of poverty and specialty care. J Asthma Off J Assoc Care Asthma. 2009;46:392–8.
Mangione-Smith R, DeCristofaro AH, Setodji CM, Keesey J, Klein DJ, Adams JL, et al. The quality of ambulatory care delivered to children in the United States. N Engl J Med. 2007;357:1515–23.
Flores G, Lin H. Trends in racial/ethnic disparities in medical and oral health, access to care, and use of services in US children: has anything changed over the years? Int J Equity Health. 2013;12:10.
Flores G. Devising, implementing, and evaluating interventions to eliminate health care disparities in minority children. Pediatrics. 2009;124 Suppl 3:S214–223.
NIH guidelines on the inclusion of women and minorities as subjects in clinical research—amended, October, 2001 [http://grants1.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm]
Link MW, Mokdad AH, Stackhouse HF, Flowers NT. Race, ethnicity, and linguistic isolation as determinants of participation in public health surveillance surveys. Prev Chronic Dis. 2006;3:A09.
Brown SD, Lee K, Schoffman DE, King AC, Crawley LM, Kiernan M. Minority recruitment into clinical trials: experimental findings and practical implications. Contemp Clin Trials. 2012;33:620–3.
Coleman-Phox K, Laraia BA, Adler N, Vieten C, Thomas M, Epel E: Recruitment and retention of pregnant women for a behavioral intervention: lessons from the maternal adiposity, metabolism, and stress (MAMAS) study. Prev Chronic Dis 2013, 10. doi: 10.5888/pcd10.120096
George S, Duran N, Norris K. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. Am J Public Health. 2014;104:e16–31.
Leung BM, McDonald SW, Kaplan BJ, Giesbrecht GF, Tough SC. Comparison of sample characteristics in two pregnancy cohorts: community-based versus population-based recruitment methods. BMC Med Res Methodol. 2013;13:149.
Phillips AK, Fischer BA, Baxter RJ, Shafranski SA, Coe CL, Kling PJ. Recruiting Latina families in a study of infant iron deficiency: a description of barriers, study adjustments and review of the literature. WMJ Off Publ State Med Soc Wis. 2011;110:26–31.
Shavers VL, Lynch CF, Burmeister LF. Racial differences in factors that influence the willingness to participate in medical research studies. Ann Epidemiol. 2002;12:248–56.
Shavers-Hornaday VL, Lynch CF, Burmeister LF, Torner JC. Why are African Americans under-represented in medical research studies? Impediments to participation. Ethn Health. 1997;2:31–45.
Warner ET, Glasgow RE, Emmons KM, Bennett GG, Askew S, Rosner B, et al. Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: results and lessons learned. BMC Public Health. 2013;13:192.
Webster GM, Teschke K, Janssen PA. Recruitment of healthy first-trimester pregnant women: lessons from the Chemicals, Health & Pregnancy study (CHirP). Matern Child Health J. 2012;16:430–8.
Sweeney C, Edwards SL, Baumgartner KB, Herrick JS, Palmer LE, Murtaugh MA, et al. Recruiting Hispanic women for a population-based study: validity of surname search and characteristics of nonparticipants. Am J Epidemiol. 2007;166:1210–9.
Williams IC, Corbie-Smith G. Investigator beliefs and reported success in recruiting minority participants. Contemp Clin Trials. 2006;27:580–6.
Margitić S, Sevick MA, Miller M, Albright C, Banton J, Callahan K, et al. Challenges faced in recruiting patients from primary care practices into a physical activity intervention trial. Activity Counseling Trial Research Group. Prev Med. 1999;29:277–86.
Newington L, Metcalfe A. Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams. BMC Med Res Methodol. 2014;14:10.
Ruggiero L, Webster K, Peipert JF, Wood C. Identification and recruitment of low-income pregnant smokers: who are we missing? Addict Behav. 2003;28:1497–505.
Nicholson LM, Schwirian PM, Klein EG, Skybo T, Murray-Johnson L, Eneli I, et al. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemp Clin Trials. 2011;32:353–62.
Goff SL, Pekow PS, White KO, Lagu T, Mazor KM, Lindenauer PK. IDEAS for a healthy baby—reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial. Trials. 2013;14:244.
Users of public reports of hospital quality: who, what, why, and how? http://archive.ahrq.gov/professionals/quality-patient-safety/qualityresources/value/pubreportusers/index.html. Accessed March 24, 2016.
Massachusetts Health Quality Partners, quality insights [http://www.mhqp.org/default.asp?nav=010000]
Chasan-Taber L, Fortner RT, Hastings V, Markenson G. Strategies for recruiting Hispanic women into a prospective cohort study of modifiable risk factors for gestational diabetes mellitus. BMC Pregnancy Childbirth. 2009;9:57.
Take a test [https://implicit.harvard.edu/implicit/takeatest.html]
El-Khorazaty MN, Johnson AA, Kiely M, El-Mohandes AAE, Subramanian S, Laryea HA, et al. Recruitment and retention of low-income minority women in a behavioral intervention to reduce smoking, depression, and intimate partner violence during pregnancy. BMC Public Health. 2007;7:233.
Manca DP, O’Beirne M, Lightbody T, Johnston DW, Dymianiw D-L, Nastalska K, et al. The most effective strategy for recruiting a pregnancy cohort: a tale of two cities. BMC Pregnancy Childbirth. 2013;13:75.
Webb DA, Coyne JC, Goldenberg RL, Hogan VK, Elo IT, Bloch JR, et al. Recruitment and retention of women in a large randomized control trial to reduce repeat preterm births: the Philadelphia Collaborative Preterm Prevention Project. BMC Med Res Methodol. 2010;10:88.
Barnett J, Aguilar S, Brittner M, Bonuck K. Recruiting and retaining low-income, multi-ethnic women into randomized controlled trials: successful strategies and staffing. Contemp Clin Trials. 2012;33:925–32.
Durant RW, Wenzel JA, Scarinci IC, Paterniti DA, Fouad MN, Hurd TC, et al. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT). Cancer. 2014;120 Suppl 7:1097–105.
Martin A, Negron R, Balbierz A, Bickell N, Howell EA. Recruitment of black and Latina women to a randomized controlled trial. J Health Care Poor Underserved. 2013;24:1102–14.
Brown G, Marshall M, Bower P, Woodham A, Waheed W. Barriers to recruiting ethnic minorities to mental health research: a systematic review. Int J Methods Psychiatr Res. 2014;23:36–48.
Corbie-Smith G, Odeneye E, Banks B, Shandor Miles M, Roman Isler M. Development of a multilevel intervention to increase HIV clinical trial participation among rural minorities. Health Educ Behav Off Publ Soc Public Health Educ. 2013;40:274–85.
Corbie-Smith G. The continuing legacy of the Tuskegee Syphilis study: considerations for clinical investigation. Am J Med Sci. 1999;317:5–8.
Handler A, Rosenberg D, Johnson T, Raube K, Kelley MA. Prospective recruitment of women receiving prenatal care from diverse provider arrangements: a potential strategy. Matern Child Health J. 1997;1:173–7.
Kost K, Landry DJ, Darroch JE. Predicting maternal behaviors during pregnancy: does intention status matter? Fam Plann Perspect. 1998;30:79–88.
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).
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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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DOI: https://doi.org/10.1007/s40615-015-0192-x