Second Hand Tobacco Smoke, Smoking Cessation
Conditions
Keywords
Smoke-free home, Smoking cessation, Permanent supportive housing
Brief summary
The focus of this study is on expanding access to voluntary smoke-free homes to formerly homeless residents residing in permanent supportive housing and examining the impact of this intervention on reducing tobacco-caused disparities. In this study, the principal investigator will conduct a multi-site, community-based cluster-randomized wait-list controlled trial of the multi-faceted smoke-free home intervention among 400 permanent supportive housing residents residing in 20 permanent supportive housing sites across the San Francisco Bay Area with the goal of increasing voluntary adoption of smoke-free homes.
Detailed description
PSH resident-participants (200 each in the intervention and wait-list control arms) and within each site (\ 20 participants at each site). All resident-participants will be informed about the study and invited to participate. Participants will be recruited within blocks of four housing sites per month, with each block containing two intervention and two wait-list control sites and anticipating roll-out of one such block per month. Anticipated completion of recruitment and enrollment of all resident-participants and staff-participants at the locations should occur within 6 months, allowing for a one-to-two-month extension to complete these activities. The intervention will be offered to the wait-list control participants once all participants in the intervention sites from the same block have completed their 6-month follow-up. Within each site, study staff will advertise the study to residents the week prior to enrollment by placing flyers at the study site and making announcements at community meetings. After the informational meeting, study staff will be present at the recruitment sites during designated times to screen interested participants for eligibility and enroll eligible resident-participants into the study. These study procedures were successfully employed in the pilot study. Participants in the study may be invited to a one-time, voluntary, community advisory board (CAB) meeting. Primary Objective: I. Conduct a cluster randomized trial to estimate the effect of the smoke-free home intervention on resident-participants' voluntary adoption of smoke-free homes. Exploratory Objectives: II. Evaluate the cost-effectiveness of the smoke-free home intervention. III. Determine characteristics of high and low adopters at the individual level, and social and environmental barriers and enablers of adoption, scalability and sustainability of the intervention. It will take 6 months for the intervention group resident-participants to complete the study, and 1 year for the wait-list control participants to complete the study if resident-participants accept the option to cross over after 6 months and receive the intervention.
Interventions
One hour, one-on-one counseling for residents
A two-hour training for PSH staff-participants on how to provide referrals to smoking cessation programs using materials previously developed from UCSF's 'Rx for change' curriculum for service providers, directed toward empowering PSH staff-participants to provide referrals to local cessation services using the ask, advise, and refer approach. The training will address nicotine addiction, tobacco use among PSH resident-participants, pilot data, brief cessation counseling (ask, advise, and refer), and local resources for cessation. Because PSH resident-PSH staff encounters will take place as part of routine care, the study team will request permission from a random sample of staff-participants and resident dyads (n=40) to record these interactions to assess fidelity.
Sponsors
Study design
Intervention model description
A cluster-randomized, wait-list controlled designed trial where PSH sites will be randomized into intervention and wait-list control groups.
Eligibility
Inclusion criteria
1. Age 18 years or older 2. Ability to understand study procedures and to comply with them for the entire length of the study. 3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it. 4. Current smokers \[(smoked at least 100 cigarettes in lifetime, daily or non-daily smoking in the past 7 days and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO)\>= 8 parts per million (ppm) who smoke in their homes. 5. Expect to live in the PSH site for at least 12 months 6. English proficient.
Exclusion criteria
1\. Contraindication to any study-related procedure or assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Resident-participants Who Adopt a Smoke-free Home Voluntarily | 6 months | The proportion of resident-participants who self-reported a voluntary adoption of smoke-free homes for \>=90 days at 6 months follow-up will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Resident-participants Who Achieve Abstinence | 6 months | The proportion of resident-participants with 7-day point prevalence abstinence at 6 months follow-up, measured as self-report of abstinence and an expired carbon monoxide of \<= 5 parts per million (ppm) as abstinence will be reported. |
Countries
United States
Contacts
University of California, San Francisco
Participant flow
Pre-assignment details
This study is designed as an intent-to-treat model so all resident-participants who completed the baseline assessment will be included in the outcome measures. Trained location staff-participants who were enrolled in the study were not included in any analysis but were consented to participate in the study and included in Participant Flow, Baseline, and Adverse Event tables.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Resident-Participants | 54.53 Years STANDARD_DEVIATION 10.69 |
| Age, Continuous Staff-Participants | 43.29 Years STANDARD_DEVIATION 12.41 |
| Ethnicity (NIH/OMB) Resident-Participants Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Resident-Participants Not Hispanic or Latino | 179 Participants |
| Ethnicity (NIH/OMB) Resident-Participants Unknown or Not Reported | 4 Participants |
| Ethnicity (NIH/OMB) Staff-Participants Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Staff-Participants Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Staff-Participants Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Resident-Participants American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Resident-Participants Asian | 2 Participants |
| Race (NIH/OMB) Resident-Participants Black or African American | 73 Participants |
| Race (NIH/OMB) Resident-Participants More than one race | 79 Participants |
| Race (NIH/OMB) Resident-Participants Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Resident-Participants Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) Resident-Participants White | 62 Participants |
| Race (NIH/OMB) Staff-Participants American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Staff-Participants Asian | 3 Participants |
| Race (NIH/OMB) Staff-Participants Black or African American | 29 Participants |
| Race (NIH/OMB) Staff-Participants More than one race | 1 Participants |
| Race (NIH/OMB) Staff-Participants Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Staff-Participants Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) Staff-Participants White | 10 Participants |
| Region of Enrollment United States | 452 participants |
| Sex/Gender, Customized Resident-Participants Female | 68 Participants |
| Sex/Gender, Customized Resident-Participants Male | 111 Participants |
| Sex/Gender, Customized Resident-Participants Not Reported | 12 Participants |
| Sex/Gender, Customized Staff-Participants Female | 20 Participants |
| Sex/Gender, Customized Staff-Participants Male | 13 Participants |
| Sex/Gender, Customized Staff-Participants Not Reported | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 191 | 0 / 35 | 6 / 209 | 0 / 17 |
| other Total, other adverse events | 0 / 191 | 0 / 35 | 0 / 209 | 0 / 17 |
| serious Total, serious adverse events | 0 / 191 | 0 / 35 | 0 / 209 | 0 / 17 |