Smoke-Free Home Intervention for Tobacco Addiction

Overseen By Ana Martinez

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: 1

544 Participants Needed

Trial Summary

What is the purpose of this trial?

Comprehensive smoke-free policies have the potential to substantially reduce tobacco-related disparities among populations in subsidized housing. This study fills this gap by identifying approaches to increase the implementation of smoke-free policies in all types of subsidized housing by increasing the voluntary adoption of smoke-free homes and promoting access to smoking cessation services.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Smoke-Free Home Intervention for Tobacco Addiction treatment?

Research shows that hospital-based smoking cessation programs, like the 'Staying Free' program, have been successfully implemented in clinical settings, and interventions such as the Women's Initiative for Nonsmoking (WINS) have proven effective in helping women quit smoking. These programs highlight the potential success of structured interventions, education, and counseling in supporting tobacco cessation. ^{1 2 3 4 5}

Is the Smoke-Free Home Intervention safe for humans?

The studies involving Lay Health Workers (LHWs) and Lay Health Advisors (LHAs) suggest that these interventions are generally well-received and safe, as participants reported satisfaction and positive engagement with the programs. ^{6 7 8 9 10}

How does the Smoke-Free Home Intervention differ from other treatments for tobacco addiction?

The Smoke-Free Home Intervention is unique because it focuses on creating smoke-free environments in homes, particularly targeting low-income populations through 2-1-1 call centers. Unlike other treatments that may focus on individual cessation, this intervention emphasizes environmental change and community support to reduce tobacco exposure for both smokers and non-smokers. ^{11 12 13 14 15}

Research Team

Maya Vijayaraghavan, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals living in subsidized housing who are dealing with tobacco use disorder or addiction. It's aimed at those interested in adopting smoke-free home policies and seeking smoking cessation services.

Inclusion Criteria

I speak Chinese (Cantonese or Mandarin), English, or Spanish.

I am a current smoker and I smoke inside my home.

Eligible resident participants

Exclusion Criteria

Contraindication to any study-related procedures or assessment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the smoke-free home intervention, including in-person delivery and pamphlet distribution, with coaching from lay-health workers

6 months

Multiple visits (in-person)

Follow-up

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

6 months

1 visit (in-person)

Treatment Details

Interventions

• Lay Health Worker coaching
• Smoke-free home resident intervention

Trial Overview The study tests a smoke-free home intervention combined with coaching from Lay Health Workers to see if these strategies can help residents of subsidized housing reduce or quit smoking.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

The study's investigators will train bilingual study staff to deliver the intervention to residents using a script that matches the content in the smoke-free home intervention pamphlet. The in-person delivery of the intervention and pamphlet will be the primary modes of intervention delivery to residents. The pamphlet will include: (1) the harms of tobacco, e-cigarette use, cannabis use and exposure (secondhand and thirdhand), (2) an exercise to calculate personal cost of tobacco use, (3) benefits of a smoke-free home, (4) skill-building on how to adopt a smoke-free home, and (5) motivational language on smoke-free home adoption. The study staff will qualitatively assess participants' knowledge by prompting questions on the topics covered and will refer participants to lay-health workers (LHWs) for one-on-one coaching. Participants will receive a pledge to designate their homes smoke-free.

Group II: Waitlist Control Group Active Control 1 Intervention

The current standard of care does not include any interventions for smoke-free home adoption or referrals to tobacco treatment resources. At the end of the primary endpoint (6 months), control participants will be offered the intervention.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

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]

The Women's Initiative for Nonsmoking (WINS) trial tested a nurse-managed smoking cessation program specifically for women, showing it to be feasible and well-accepted by over 140 participants.

Rooted in social learning theory, the intervention combines education, counseling, and follow-up, making it adaptable for nurses in various healthcare settings to help women at risk for serious health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's initiative for nonsmoking (WINS) II: the intervention. Martin, K., Froelicher, ES., Miller, NH.[2019]

A pilot study at Georgetown University showed that a 6-hour training program for advanced practice nursing students significantly improved their knowledge and confidence in helping patients quit tobacco.

The 'Rx for Change' curriculum demonstrates the importance of targeted training for healthcare providers to effectively support tobacco cessation efforts among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Rx for Change tobacco curriculum in advanced practice nursing education. Kelley, FJ., Heath, J., Crowell, N.[2019]

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]

Implementing a tobacco order set in a computerized order-entry system significantly improved the identification of smoking status and increased referrals for smoking counseling and nicotine replacement therapy (NRT) among admitted patients, with usage rates of 76% and 81% respectively.

The intervention led to a notable increase in the percentage of patients receiving counseling (from 0.8% to 2.1%) and NRT orders (from 1.6% to 2.5%), which also enhanced the hospital's performance on smoking cessation quality measures, demonstrating its efficacy in promoting smoking cessation in a hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computerized aid to support smoking cessation treatment for hospital patients. Koplan, KE., Regan, S., Goldszer, RC., et al.[2021]

The implementation of lay health workers, known as Patient Attendant Service Aides (PASAs), in a community hospital's inpatient setting significantly reduced nursing turnover from 71.1% to 21.6%, indicating a positive impact on staff retention.

Nurses and nursing assistants reported that PASAs helped alleviate their workload, allowing them to concentrate on essential nursing tasks, which suggests that this role can effectively support clinical staff in managing staffing shortages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of lay health workers on quality of care in the inpatient setting. Basnight, R., Berry, P., Capes, K., et al.[2023]

This study highlights the effectiveness of Lay Health Workers (LHWs) in delivering family-based interventions for smoking cessation among Vietnamese American smokers, emphasizing their role in managing chronic health conditions.

LHWs employed various relational strategies, such as creating a supportive environment, using engaging teaching methods, and culturally specific approaches to build trust, which are crucial for effective health communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unpacking the 'black box' of lay health worker processes in a US-based intervention. Burke, NJ., Phung, K., Yu, F., et al.[2022]

This study highlights how Lay Health Workers (LHWs) effectively deliver family-based interventions for smoking cessation among Vietnamese American smokers, using culturally tailored strategies to build trust and engage participants.

The research provides insights into the mechanisms of LHW effectiveness, such as creating a supportive environment and employing recognized teaching methods, which can inform future interventions aimed at improving health in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unpacking the 'black box' of lay health worker processes in a US-based intervention. Burke, NJ., Phung, K., Yu, F., et al.[2019]

The lay health advisor (LHA) model was effective in enhancing participation in a smoking cessation clinical trial among college fraternity and sorority members, with 74% of chapter members screened and 73% completing three out of four motivational interviewing sessions.

Both trial participants and LHAs reported high satisfaction with the model, indicating that LHAs played a crucial role in facilitating recruitment and retention in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of a lay health advisor model as a recruitment and retention strategy in a clinical trial of college student smokers. Varvel, SJ., Cronk, NJ., Harris, KJ., et al.[2022]

A lay health promoter program effectively improved pesticide-related knowledge and practices among 610 families, primarily from Mexico, demonstrating the potential of community-based education in public health settings.

Significant gains in knowledge were observed across all lessons, and families showed improved practices regarding pesticide exposure and pest control, highlighting the importance of culturally appropriate health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of a lay health promoter-led, community-based participatory pesticide safety intervention with farmworker families. Quandt, SA., Grzywacz, JG., Talton, JW., et al.[2021]

A study involving 36 residents in permanent supportive housing revealed that while support for indoor smoking bans was modest (33.1%), a significant majority (77.8%) would not move due to a smoking ban, indicating potential feasibility for smoke-free policies.

Residents expressed interest in quitting smoking, but barriers such as co-use of tobacco with other substances and concerns about financial and housing stability need to be addressed to effectively implement smoke-free policies and cessation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoke-Free or Not: Attitudes Toward Indoor Smoke-Free Policies Among Permanent Supportive Housing Residents. Petersen, AB., Elser, H., Nguyen, T., et al.[2020]

Self-help and minimal intervention strategies for smoking cessation can be as effective as formal programs, offering lower costs and greater accessibility for smokers.

The National Cancer Institute's Expert Advisory Panel recommended essential elements for these strategies, including increasing motivation to quit, targeting specific populations, and providing widely available resources focused on health consequences and relapse prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of self-help/minimal intervention strategies for smoking cessation. Glynn, TJ., Boyd, GM., Gruman, JC.[2019]

The smoke-free home (SFH) program in rural Indonesia has shown promising results after one year, with 95% of smokers reporting they do not smoke near pregnant women, children, or non-smokers, indicating a strong awareness of the dangers of secondhand smoke.

Despite the positive changes in smoking behavior, the study highlights the need for increased political and resource support from policymakers to further enhance the effectiveness and sustainability of the SFH initiative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoke-free home initiative in Bantul, Indonesia: Development and preliminary evaluation. Trisnowati, H., Kusuma, D., Ahsan, A., et al.[2020]

This study will evaluate the effectiveness of an educational intervention aimed at 136 non-smoker women exposed to second-hand smoke at home, focusing on creating smoke-free environments through women's empowerment and education.

If successful, the intervention could lead to a significant reduction in second-hand smoke exposure at home, suggesting that integrating this educational program into routine care at primary health-care centers could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Study Protocol of Women's Education to Create Smoke-free Home on the Basis of Family Ties in Isfahan, Iran. Zamani, A., Golshiri, P., Moqtader, B.[2021]

The Smoke-Free Homes (SFH) Program was found to be acceptable and feasible for implementation across multiple 2-1-1 sites, with 70% of staff believing it contributed to more smoke-free homes in their communities.

Despite its perceived effectiveness, challenges such as sustainability, resource demands, and integration into existing workflows were significant barriers to successful implementation, highlighting the need for ongoing support and funding for future tobacco control initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an Evidence-based Tobacco Control Program at Five 2-1-1 Call Centers: An Evaluation Using the Consolidated Framework for Implementation Research. Thompson, T., Kreuter, MW., Caito, N., et al.[2023]

References

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

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

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

Women's initiative for nonsmoking (WINS) II: the intervention. [2019]

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

Using the Rx for Change tobacco curriculum in advanced practice nursing education. [2019]

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

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

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

A computerized aid to support smoking cessation treatment for hospital patients. [2021]

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

Evaluation of lay health workers on quality of care in the inpatient setting. [2023]

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

Unpacking the 'black box' of lay health worker processes in a US-based intervention. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Unpacking the 'black box' of lay health worker processes in a US-based intervention. [2019]

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

Adaptation of a lay health advisor model as a recruitment and retention strategy in a clinical trial of college student smokers. [2022]

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

Evaluating the effectiveness of a lay health promoter-led, community-based participatory pesticide safety intervention with farmworker families. [2021]

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

Smoke-Free or Not: Attitudes Toward Indoor Smoke-Free Policies Among Permanent Supportive Housing Residents. [2020]

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

Essential elements of self-help/minimal intervention strategies for smoking cessation. [2019]

13. Greece pubmed.ncbi.nlm.nih.gov

Smoke-free home initiative in Bantul, Indonesia: Development and preliminary evaluation. [2020]

14. Iran pubmed.ncbi.nlm.nih.gov

The Study Protocol of Women's Education to Create Smoke-free Home on the Basis of Family Ties in Isfahan, Iran. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Implementing an Evidence-based Tobacco Control Program at Five 2-1-1 Call Centers: An Evaluation Using the Consolidated Framework for Implementation Research. [2023]