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

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

Challenges and Opportunities to Meet the Mental Health Needs of Underserved and Disenfranchised Populations in the United States

“…Many factors affect the higher mortality rates among homeless adults: increased risk for mental illness, trauma, suicide, and medical comorbidities, as well as excessive alcohol and substance use. Approximately 33% of adults who are homeless suffer from some form of severe and persistent mental illness (41).…”

The implementation of a smoking cessation and alcohol abstinence intervention for people experiencing homelessness

“…A full explanation of the design and methods can be found elsewhere. (34,35) During the RCT consent process, PTQ2 participants were informed that they might be invited to participate in an interview portion of the study. Research study staff approached potential participants just prior to the nal study visit (week 26).…”

“…Power to Quit 2 (PTQ2) was a randomized controlled trial, built on the ndings from the rst PTQ study, aimed to investigate concurrent smoking cessation and alcohol treatment among people experiencing homelessness. (34,35) In this study, we present ndings from semi-structured interviews with participants completing PTQ2, where the experience of participating in a smoking and alcohol intervention were explored in order to provide insight into the challenges faced by participants when trying to quit smoking. Additionally, the analysis drew on the CFIR framework (14) to inform future learning on the intervention implementation process.…”

Evaluating a specialist primary care service for patients experiencing homelessness: a qualitative study

“…The major strength of this study is the sample of patients, who are very often excluded from research 22 and thus provide unique insight into the nature of exclusion. Trying to capture the experience and insights of both staff and patients adds an interesting and valuable dimension to the research, which has not been shown before.…”