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.
Get full access to this article
View all access options for this article.
References
1.
MokdadAMarksJStroupDGerberdingJ. Actual causes of death in the United States, 2000. JAMA2004; 291(10): 1238–45.
2.
The United States Conference of Mayors. Hunger and Homelessness Survey: A Status Report on Hunger and Homelessness in America’s Cities. A 27-City Survey. December2009.
3.
Wilder Research Center. Homelessness in Minnesota 2009: Results of the Wilder Statewide Survey. Wilder Research, St. Paul, Minnesota, 2010.
4.
Wilder Research Center. Homelessness in Minnesota 2003: Key Facts from the Survey of Minnesotans without Permanent Housing. Amherst H. Wilder Foundation, St. Paul, MN, 2004.
5.
BaggettTPRigottiNA. Cigarette smoking and advice to quit in a national sample of homeless adults. Am J Prev Med2010; 39(2): 164–72.
6.
KushelMBMiaskowskiC. End-of-life care for homeless patients: ‘She says she is there to help me in any situation’. JAMA2006; 296(24): 2959–66.
7.
SongJRatnerERBartelsDM. Experiences with and attitudes toward death and dying among homeless persons. J Gen Intern Med2007; 22(4): 427–34.
8.
KungH-CHoyertDXuJMurphySL. Deaths: Final data for 2005. National Vital Statistics Report2008; 56(10).
9.
HwangSW. Mortality among men using homeless shelters in Toronto, Ontario. JAMA2000; 283(16): 2152–57.
10.
HwangSWOravEJO’ConnellJJLebowJMBrennanTA. Causes of death in homeless adults in Boston. Ann Intern Med1997; 126(8): 625–28.
11.
MorrisonDS. Homelessness as an independent risk factor for mortality: Results from a retrospective cohort study. Int J Epidemiol2009; 38(3): 877–83.
12.
GelbergLGallagherTCAndersenRMKoegelP. Competing priorities as a barrier to medical care among homeless adults in Los Angeles. Am J Pub Health1997; 87(2): 217–20.
13.
GelbergLAndersenRMLeakeBD. The behavioral model for vulnerable populations: Application to medical care use and outcomes for homeless people. Health Serv Res2000; 34(6): 1273–302.
14.
TeeterT. Adherence: Working with homeless populations. Focus1999; 14(2): 5–6.
15.
OkuyemiKCaldwellAThomasJ. Homelessness and smoking cessation: Insights from focus groups. Nicotine Tob Res2006; 8(2): 287–96.
16.
ArnstenJHReidKBiererMRigottiN. Smoking behavior and interest in quitting among homeless smokers. Addict Behav2004; 29(6): 1155–61.
17.
ConnorSCookRHerbertMNealSWilliamsJ. Smoking cessation in a homeless population: There is a will, but is there a way?J Gen Intern Med2002; 17(5): 369–72.
18.
OkuyemiKSThomasJLHallS. Smoking cessation in homeless populations: A pilot clinical trial. Nicotine Tob Res2006; 8(5): 689–99.
19.
ShelleyDCantrellJWarnDWongS. Smoking cessation among sheltered homeless: A pilot. Am J Health Behav2010; 34(5): 544–52.
20.
MillerWRRollnickS. Motivational Interviewing: Preparing People to Change. Guildford Press, New York, 2002.
21.
ButlerCRollnickSCohenD. Motivational consulting versus brief advice for smokers in general practice: A randomised trial. Br J Gen Pract1999; 49: 611–16.
22.
ColbySMMontiPMBarnettNP. Brief motivational interviewing in a hospital setting for adolescent smoking: A preliminary study. J Consult Clin Psychol1998; 66(3): 574–78.
23.
HeckmanCJEglestonBLHofmannMT. Efficacy of motivational interviewing for smoking cessation: A systematic review and meta-analysis. Tob Control2010; 19(5): 410–16.
24.
SlamaKRedmanSPerkinsJReidASanson-FisherRW. The effectiveness of two smoking cessation programs for use in general practice: A randomized clinical trial. BMJ1990; 300: 1707–09.
25.
A clinical practice guideline for treating tobacco use and dependence: A US Public Health Service report. The Tobacco Use and Dependence Clinical Practice Guideline Panel, Staff, and Consortium Representatives. JAMA2000; 283(24): 3244–54.
MiddletonETMoriceAH. Breath carbon monoxide as an indication of smoking habit. Chest2000; 117(3): 758–63.
28.
Society for Research on Nicotine and Tobacco (SRNT). Biochemical verification of tobacco use and cessation. Nicotine Tob Res2002; 4(2): 149–59.
29.
TonnesenPNorregaardJMikkelsenKJorgensenSNilssonF. A double-blind trial of a nicotine inhaler for smoking cessation. JAMA1993; 269(10): 1268–71.
30.
SheehanDVLecrubierYSheehanKH. The Mini-International Neuropsychiatric Interview (M.I.N.I.): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry1998; 59(Suppl. 20): 22–33, quiz34–57.
31.
ButlerJOkuyemiKSJeanS. Smoking characteristics of a homeless population. Subst Abus2002; 23(4): 223–31.
32.
OkuyemiKSCaldwellARThomasJL. Homelessness and smoking cessation: Insights from focus groups. Nicotine Tob Res2006; 8(2): 287–96.
33.
MoriskyDEGreenLWLevineDM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care1986; 24(1): 67–74.
34.
EversonSAGoldbergDEKaplanGA. Hopelessness and risk of mortality and incidence of myocardial infarction and cancer. Psychosom Med1996; 58(2): 113–21.
35.
EversonSAKaplanGAGoldbergDESalonenJT. Hypertension incidence is predicted by high levels of hopelessness in Finnish men. Hypertension2000; 35(2): 561–67.
36.
EtterJFBergmanMMHumairJPPernegerTV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction2000; 95(6): 901–13.
37.
WilliamsGCCoxEMKouidesRDeciEL. Presenting the facts about smoking to adolescents: Effects of an autonomy-supportive style. Arch Pediatr Adolesc Med1999; 153(9): 959–64.
38.
CoxLSTiffanySTChristenAG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res2001; 3(1): 7–16.
39.
RostKBurnamMASmithGR. Development of screeners for depressive disorders and substance disorder history. Med Care1993; 31(3): 189–200.
40.
KroenkeKSpitzerRL. The PHQ-9: A new diagnostic and severity measure. Psychiatr Ann2002; 32(9): 509–15.
41.
CohenSKamarckTMermelsteinR. A global measure of perceived stress. J Health Soc Behav1983; 24(4): 385–96.
42.
VolminkJMatchabaPGarnerP. Directly observed therapy and treatment adherence. Lancet2000; 355(4): 1345–49.
