Recruitment and retention of women in a large randomized control trial to reduce repeat preterm births: the Philadelphia Collaborative Preterm Prevention Project

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  • Webb, David A
    • Other Affiliation: Department of Adolescent Medicine, Children’s Hospital of Philadelphia, 3535 Market Street, Philadelphia, Pa., 19104, USA
  • Coyne, James C
    • Other Affiliation: Department of Psychiatry, University of Pennsylvania School of Medicine, 3535 Market Street, Philadelphia, Pa.,19104, USA
  • Goldenberg, Robert L
    • Other Affiliation: Department of Obstetrics and Gynecology, Drexel University College of Medicine, 1525 Race Street, Philadelphia, Pa., 19104, USA
  • Hogan, Vijaya
    • Affiliation: Gillings School of Global Public Health, Department of Maternal and Child Health
  • Elo, Irma T
    • Other Affiliation: Department of Sociology, University of Pennsylvania, 3718 Locust Walk, Philadelphia, Pa., 19104
  • Bloch, Joan R
    • Other Affiliation: Department of Nursing, Drexel University College of Nursing and Health Professions, 1520 Race Street, Philadelphia, Pa 19102, USA
  • Mathew, Leny
    • Other Affiliation: Department of Adolescent Medicine, Children’s Hospital of Philadelphia, 3535 Market Street, Philadelphia, Pa., 19104, USA
  • Bennett, Ian M
    • Other Affiliation: Department of Family Practice and Community Medicine, University of Pennsylvania Health System 3400 Spruce Street, 19104, USA
  • Dennis, Erika F
    • Other Affiliation: Department of Neonatology, Children’s Hospital of Philadelphia, 3535 Market Street, Philadelphia, Pa., 19104, USA
  • Culhane, Jennifer F
    • Other Affiliation: Department of Pediatrics, University of Pennsylvania School of Medicine, 3535 Market Street, Philadelphia, Pa., 19104, USA
Abstract
  • Abstract Background Recruitment and retention of patients for randomized control trial (RCT) studies can provide formidable challenges, particularly with minority and underserved populations. Data are reported for the Philadelphia Collaborative Preterm Prevention Project (PCPPP), a large RCT targeting risk factors for repeat preterm births among women who previously delivered premature (< 35 weeks gestation) infants. Methods Design of the PCPPP incorporated strategies to maximize recruitment and retention. These included an advanced database system tracking follow-up status and assessment completion rates; cultural sensitivity training for staff; communication to the community and eligible women of the benefits of participation; financial incentives; assistance with transportation and supervised childcare services; and reminder calls for convenient, flexibly scheduled appointments. Analyses reported here: 1) compare recruitment projections to actual enrollment 2) explore recruitment bias; 3) validate the randomization process 4) document the extent to which contact was maintained and complete assessments achieved 5) determine if follow-up was conditioned upon socio-economic status, race/ethnicity, or other factors. Results Of eligible women approached, 1,126 (77.7%) agreed to participate fully. Of the 324 not agreeing, 118 (36.4%) completed a short survey. Consenting women were disproportionately from minority and low SES backgrounds: 71.5% consenting were African American, versus 38.8% not consenting. Consenting women were also more likely to report homelessness during their lifetime (14.6% vs. 0.87%) and to be unmarried at the time of delivery (81.6% versus 47.9%). First one-month postpartum assessment was completed for 83.5% (n = 472) of the intervention group (n = 565) and 76% (426) of the control group. Higher assessment completion rates were observed for the intervention group throughout the follow-up. Second, third, fourth and fifth postpartum assessments were 67.6% vs. 57.5%, 60.0% vs. 48.9%, 54.2% vs. 46.3% and 47.3% vs. 40.8%, for the intervention and control group women, respectively. There were no differences in follow-up rates according to race/ethnicity, SES or other factors. Greater retention of the intervention group may reflect the highly-valued nature of the medical and behavior services constituting the intervention arms of the Project. Conclusion Findings challenge beliefs that low income and minority women are averse to enrolling and continuing in clinical trials or community studies.
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  • Article
Rights statement
  • In Copyright
Rights holder
  • David A Webb et al.; licensee BioMed Central Ltd.
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Journal title
  • BMC Medical Research Methodology
Journal volume
  • 10
Journal issue
  • 1
Page start
  • 88
Language
  • English
Is the article or chapter peer-reviewed?
  • Yes
ISSN
  • 1471-2288
Bibliographic citation
  • BMC Medical Research Methodology. 2010 Sep 29;10(1):88
Publisher
  • BioMed Central Ltd
Access right
  • Open Access
Date uploaded
  • July 15, 2016

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