Smoke-Free Home Program for Smoking Cessation

Overseen By Jessica Alway

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Contraindication to procedures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The focus of this proposal 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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on smoking cessation and smoke-free homes, so it's best to consult with the trial coordinators for specific guidance.

What data supports the idea that Smoke-Free Home Program for Smoking Cessation is an effective treatment?

The available research shows that smoking cessation programs, especially those implemented in hospitals, can be effective. For example, one study found that multiple counseling sessions in hospitals increased the number of people who quit smoking after six months. Another study highlighted that improving the quality of care for hospitalized smokers led to better documentation and counseling rates, with 82-96% of patients receiving tobacco cessation counseling. These findings suggest that structured programs, like the Smoke-Free Home Program, can be effective in helping people quit smoking. ^{1 2 3 4 5}

What safety data exists for the Smoke-Free Home Program for Smoking Cessation?

The provided research does not directly address safety data for the Smoke-Free Home Program or its related interventions. The studies focus on the effectiveness of various smoking cessation counseling methods, including tobacco cessation counseling, resident training, and cognitive behavioral therapy, but do not specifically mention safety outcomes. Further research specifically evaluating the safety of these interventions would be needed to provide a comprehensive answer. ^{6 7 8 9 10}

Is the Smoke-Free Home Program for Smoking Cessation a promising treatment?

Yes, the Smoke-Free Home Program for Smoking Cessation is a promising treatment. Research shows that counseling and support programs can help people quit smoking. Programs that involve counseling, like the Smoke-Free Home Program, have been effective in helping people stop smoking, especially when combined with other support methods. ^{2 6 7 8 11}

Research Team

Maya Vijayaraghavan, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for English-speaking adults who currently smoke in their homes, have smoked at least 100 cigarettes in their lifetime, and are living in permanent supportive housing. They should expect to stay there for at least a year and be able to follow the study's procedures.

Inclusion Criteria

Expect to live in the PSH site for at least 12 months

Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it

English proficient

Exclusion Criteria

I have no health issues preventing me from undergoing study procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Recruitment and Enrollment

Participants are recruited and enrolled into the study across multiple housing sites

6-8 months

Multiple visits (in-person)

Intervention

Participants receive a one-hour, one-on-one counseling session on adopting a smoke-free home

6 months

1 visit (in-person), follow-up assessments

Follow-up

Participants are monitored for voluntary adoption of smoke-free homes and abstinence

6 months

Follow-up assessments

Crossover Intervention for Wait-list Control

Wait-list control participants receive the smoke-free home intervention after the initial intervention group completes follow-up

6 months

Treatment Details

Interventions

• Resident counselling
• Staff Training

Trial Overview The study tests a smoke-free home intervention that includes resident counseling and staff training. It aims to encourage voluntary adoption of smoke-free homes among residents of permanent supportive housing sites across the San Francisco Bay Area.

Participant Groups

Group I: Wait-List Control (Usual Care) then crossover to Smoke-free home PSH resident intervention Experimental Treatment 1 Intervention

The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group receives Smoke-Free Home (SFH) intervention after intervention group complete 6-month follow-up

Group II: Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention Experimental Treatment 2 Interventions

Study staff will deliver a one hour, one-on-one counseling to PSH residents 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. At follow-up assessments, the study team will ask participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The 'Staying Free' program is a research-based smoking cessation model specifically designed for hospitalized patients, highlighting the importance of utilizing hospital stays as a chance to promote quitting smoking.

Insights gained from implementing this program suggest a systematic approach is essential for effectively integrating smoking cessation interventions into clinical practice and training for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating smoking cessation research findings into clinical practice: the "staying free" program. Miller, NH.[2019]

A study of 1943 hospitalized smokers showed that multiple in-hospital counseling sessions significantly increased the likelihood of achieving sustained smoking abstinence at 6 months, with odds ratios of 1.44 for two sessions and 2.02 for three or more sessions.

The effectiveness of this approach remained strong even when accounting for participants who did not continue with post-discharge cessation programs, suggesting that in-hospital counseling is a valuable strategy for reducing smoking prevalence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple in-hospital counseling increases six-month smoking abstinence among individuals participating in a hospital-initiated smoking cessation program. Kuo, CW., Chen, CY., Wu, CH., et al.[2023]

The inpatient tobacco treatment consult program at the University of North Carolina Hospital has shown high provider satisfaction, with 44.5% of surveyed providers reporting that the program effectively facilitated evidence-based tobacco treatment for patients.

The program significantly increased the likelihood of providers prescribing tobacco cessation medications at discharge and improved follow-up care, highlighting its positive impact on patient treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider satisfaction with an inpatient tobacco treatment program: results from an inpatient provider survey. Trout, S., Ripley-Moffitt, C., Meernik, C., et al.[2023]

A dedicated improvement team successfully increased the documentation of tobacco use status in hospitalized patients to 80-90%, ensuring better identification of those who need cessation support.

Counseling rates for tobacco cessation among patients admitted with heart failure or pneumonia improved significantly to 82-96%, highlighting the effectiveness of standardized processes and community resources in supporting hospitalized tobacco users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the quality of care for the hospitalized tobacco user--one institution's transformational journey. Liu, SK., Prior, E., Warren, C., et al.[2021]

In a study of 4,553 smokers, those who underwent intensive 8-day residential treatment for tobacco dependence had a significantly higher 6-month smoking abstinence rate (52%) compared to those receiving comprehensive outpatient treatment (27%).

Residential patients had more severe nicotine dependence and higher rates of co-occurring issues like alcoholism and depression, yet they still showed a threefold increase in the likelihood of quitting smoking compared to outpatient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Residential treatment compared with outpatient treatment for tobacco use and dependence. Hays, JT., Croghan, IT., Schroeder, DR., et al.[2021]

A study involving 100 tobacco users showed that standardized tobacco cessation counselling (TCC) significantly improved behavior change scores over 12 weeks, indicating its effectiveness in helping individuals quit smoking.

The mean behavior change score increased from 32.78 at baseline to 48.7 by the end of the study, demonstrating sustained positive behavioral changes among participants after receiving TCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of tobacco cessation counselling and behavioural changes Using Multi Theory Model (MTM): A follow-up study. Kumar, V., Sabbarwal, B., Jaggi, A., et al.[2022]

In a study involving 274 hospitalized smokers, those who received nicotine replacement therapy (NRT) combined with counseling had significantly higher smoking abstinence rates at discharge (55%) and at 12 months (17%) compared to those receiving counseling alone (43% and 6%) or usual care (37% and 8%).

The results suggest that providing NRT alongside brief counseling is an effective smoking cessation strategy for hospitalized patients, while counseling alone did not show significant benefits over usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients. Molyneux, A., Lewis, S., Leivers, U., et al.[2019]

A training program for 28 residents on smoking cessation counseling led to an initial increase in counseling frequency at 3 months, but this improvement regressed to baseline levels by 6 months, indicating that the changes were not sustained over time.

The implementation of a chart-prompting system improved counseling behaviors at certain clinics, but overall, the study suggests that systemic factors are crucial for achieving lasting changes in resident counseling practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving smoking cessation counseling by family practice residents. McIlvain, HE., Susman, JL., Manners, MA., et al.[2010]

The cognitive behavioral therapy (CBT) program called Smoke_less significantly helped smokers reduce their smoking by at least 50% compared to a waiting group, both at 1 week and 6 months after the intervention, indicating its short-term efficacy.

While Smoke_less was more effective than brief counseling in the short term, it did not show significant long-term benefits in terms of smoking reduction or abstinence rates, suggesting the need for further research to enhance its effectiveness for sustained smoking reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial. Rüther, T., Kiss, A., Eberhardt, K., et al.[2019]

Implementing new smoking cessation counseling strategies in clinical settings can significantly improve long-term quit rates among smokers, including young people, even if these methods were primarily validated for adults.

Clinicians should recognize that smoking cessation is often a long-term process requiring multiple attempts, and they can enhance their effectiveness by identifying smokers, involving support staff, and ensuring follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation counseling in adults and children: the clinician's role. Adams, JA.[2006]

A nontraditional tobacco cessation program led by a pharmacist at a Coast Guard facility showed that out of 20 participants who completed counseling, 4 successfully quit tobacco after one year, indicating a 20% success rate.

This approach provides an alternative to traditional group behavioral modification classes, which may not be suitable for everyone, highlighting the potential effectiveness of pharmacist-led interventions in tobacco cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMOKED: a pharmacist-monitored tobacco cessation program. Huntzinger, PE.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Translating smoking cessation research findings into clinical practice: the "staying free" program. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Multiple in-hospital counseling increases six-month smoking abstinence among individuals participating in a hospital-initiated smoking cessation program. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Provider satisfaction with an inpatient tobacco treatment program: results from an inpatient provider survey. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Improving the quality of care for the hospitalized tobacco user--one institution's transformational journey. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Residential treatment compared with outpatient treatment for tobacco use and dependence. [2021]

6. India pubmed.ncbi.nlm.nih.gov

Effectiveness of tobacco cessation counselling and behavioural changes Using Multi Theory Model (MTM): A follow-up study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Improving smoking cessation counseling by family practice residents. [2010]

9. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation counseling in adults and children: the clinician's role. [2006]

11. England pubmed.ncbi.nlm.nih.gov

SMOKED: a pharmacist-monitored tobacco cessation program. [2017]