Smoke-free Home Intervention in Permanent Supportive Housing

University of California San Francisco (UCSF)

Status: Completed

Conditions: Second Hand Tobacco Smoke; Smoking Cessation

Treatments: Behavioral: Staff Training; Behavioral: Resident counselling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04855357

1R37CA248448-01A1 (U.S. NIH Grant/Contract)

21631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 452 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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452 participants in 2 patient groups

Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention

Experimental group

Description:

Study staff will deliver a one hour, one-on-one counseling to PSH resident-participants that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.

Treatment:

Behavioral: Resident counselling

Behavioral: Staff Training

Wait-List Control (Usual Care)

Other group

Description:

The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation.

Treatment:

Behavioral: Staff Training