Designing a smoking cessation intervention for the unique needs of homeless persons: A community-based randomized clinical trial

Kate Goldade, Guy Lucien Whembolua, Janet Thomas, Sara Eischen, Hongfei Guo, John Connett, Don Des Jarlais, Ken Resnicow, Lillian Gelberg, Greg Owen, Jon Grant, Jasjit S. Ahluwalia, Kolawole S. Okuyemi

Research output: Contribution to journalArticle

Abstract

Background Although smoking prevalence remains strikingly high in homeless populations (∼70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers.Purpose To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes.Methods Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders.Results Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication.Limitations The study's limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable.Conclusions Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.

Original languageEnglish (US)
Pages (from-to)744-754
Number of pages11
JournalClinical Trials
Volume8
Issue number6
DOIs
StatePublished - Dec 1 2011

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Homeless Persons
Smoking Cessation
Tobacco Use Cessation Products
Randomized Controlled Trials
Motivational Interviewing
Smoking
Vulnerable Populations
Psychiatry
Clinical Trials
Cotinine
Cell Phones
Nicotine
Population
Substance-Related Disorders
Motivation
Appointments and Schedules
Communication
Observation

ASJC Scopus subject areas

  • Pharmacology

Cite this

Goldade, K., Whembolua, G. L., Thomas, J., Eischen, S., Guo, H., Connett, J., ... Okuyemi, K. S. (2011). Designing a smoking cessation intervention for the unique needs of homeless persons: A community-based randomized clinical trial. Clinical Trials, 8(6), 744-754. https://doi.org/10.1177/1740774511423947

Designing a smoking cessation intervention for the unique needs of homeless persons : A community-based randomized clinical trial. / Goldade, Kate; Whembolua, Guy Lucien; Thomas, Janet; Eischen, Sara; Guo, Hongfei; Connett, John; Des Jarlais, Don; Resnicow, Ken; Gelberg, Lillian; Owen, Greg; Grant, Jon; Ahluwalia, Jasjit S.; Okuyemi, Kolawole S.

In: Clinical Trials, Vol. 8, No. 6, 01.12.2011, p. 744-754.

Research output: Contribution to journalArticle

Goldade, K, Whembolua, GL, Thomas, J, Eischen, S, Guo, H, Connett, J, Des Jarlais, D, Resnicow, K, Gelberg, L, Owen, G, Grant, J, Ahluwalia, JS & Okuyemi, KS 2011, 'Designing a smoking cessation intervention for the unique needs of homeless persons: A community-based randomized clinical trial', Clinical Trials, vol. 8, no. 6, pp. 744-754. https://doi.org/10.1177/1740774511423947
Goldade, Kate ; Whembolua, Guy Lucien ; Thomas, Janet ; Eischen, Sara ; Guo, Hongfei ; Connett, John ; Des Jarlais, Don ; Resnicow, Ken ; Gelberg, Lillian ; Owen, Greg ; Grant, Jon ; Ahluwalia, Jasjit S. ; Okuyemi, Kolawole S. / Designing a smoking cessation intervention for the unique needs of homeless persons : A community-based randomized clinical trial. In: Clinical Trials. 2011 ; Vol. 8, No. 6. pp. 744-754.
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N2 - Background Although smoking prevalence remains strikingly high in homeless populations (∼70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers.Purpose To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes.Methods Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders.Results Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication.Limitations The study's limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable.Conclusions Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.

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