Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned

Olamide Ojo-Fati^{1

2}, Anne M Joseph^{3

4}, Jed Ig-Izevbekhai^{5

3}, Janet L Thomas^{3

4}, Susan A Everson-Rose^{3

4}, Rebekah Pratt^{5

3}, Nancy Raymond^{5

3

6}, Ned L Cooney⁷, Xianghua Luo^{8

9}, Kolawole S Okuyemi^{3

10}

Affiliations

¹ Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA. oojofati@umn.edu.
² Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA. oojofati@umn.edu.
³ Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA.
⁴ Department of Medicine, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA.
⁵ Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA.
⁶ Department of Psychiatry, University of Minnesota Medical School, 2450 Riverside Ave., F282/2AW, Minneapolis, MN, 55454, USA.
⁷ Department of Psychiatry, Yale University School of Medicine, 300 George St., Suite 901, New Haven, CT, 06511, USA.
⁸ Division of Biostatistics, School of Public Health, University of Minnesota, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.
⁹ Biostatistics Core, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, 55455, USA.
¹⁰ Department of Family & Preventive Medicine, University of Utah, 375 Chipeta, Suite A, Salt Lake, UT, 84108, USA.

PMID: 28679430
PMCID: PMC5498931
DOI: 10.1186/s13063-017-2046-9

Randomized Controlled Trial

Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned

Olamide Ojo-Fati et al. Trials. 2017.

. 2017 Jul 5;18(1):305.

doi: 10.1186/s13063-017-2046-9.

Authors

Affiliations

¹ Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA. oojofati@umn.edu.
² Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA. oojofati@umn.edu.
³ Program in Health Disparities Research, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA.
⁴ Department of Medicine, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA.
⁵ Department of Family Medicine and Community Health, University of Minnesota Medical School, 717 Delaware St. SE, Suite 166, Minneapolis, MN, 55414, USA.
⁶ Department of Psychiatry, University of Minnesota Medical School, 2450 Riverside Ave., F282/2AW, Minneapolis, MN, 55454, USA.
⁷ Department of Psychiatry, Yale University School of Medicine, 300 George St., Suite 901, New Haven, CT, 06511, USA.
⁸ Division of Biostatistics, School of Public Health, University of Minnesota, 420 Delaware Street SE, Minneapolis, MN, 55455, USA.
⁹ Biostatistics Core, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, 55455, USA.
¹⁰ Department of Family & Preventive Medicine, University of Utah, 375 Chipeta, Suite A, Salt Lake, UT, 84108, USA.

PMID: 28679430
PMCID: PMC5498931
DOI: 10.1186/s13063-017-2046-9

Abstract

There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons learned while conducting two large NIH-funded randomized controlled trials targeting smoking cessation among persons who are homeless. The current report also addresses challenges when conducting clinical trials among homeless populations and offers potential solutions. Homeless individuals face several challenges including the need to negotiate daily access to food, clothing, and shelter. Some of the critical issues investigators encounter include recruitment and retention obstacles; cognitive impairment, mental health and substance abuse disorders; transportation and scheduling challenges; issues pertaining to adequate study compensation; the need for safety protocols for study staff; and issues related to protecting the wellbeing of these potentially vulnerable adults. Anticipating realistic conditions in which to conduct studies with participants who are homeless will help investigators to design efficient protocols and may improve the feasibility of conducting clinical trials involving homeless populations and the quality of the data collected by the researchers.

Trial registration: ClinicalTrials.gov, ID: NCT00786149 . Registered on 5 November 2008; ClinicalTrials.gov, ID: NCT01932996 . Registered on 20 November 2014.

Keywords: Attrition; Clinical trials; Community-based; Homeless adults; Retention; Smoking cessation.

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Figures

**Fig. 1**
Target versus actual recruitment. Note: Among the 238 subjects, 156 are randomized to Usual Care and Integrated Smoking + Alcohol

See this image and copyright information in PMC

References

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Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned

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Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned

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