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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people in subsidized housing adopt smoke-free policies in their homes and access smoking cessation services. Participants will receive coaching from trained staff (Lay Health Worker coaching) and a pamphlet detailing the harms of smoking and strategies to maintain a smoke-free home. The trial includes an intervention group receiving this assistance and a waitlist control group who will receive it later. Ideal participants are those currently smoking at least five cigarettes daily, who smoke at home, and plan to stay in subsidized housing for at least a year.

As an unphased trial, this study offers participants the chance to engage in innovative research that could improve their health and living environment.

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 prior data suggests that this smoke-free home intervention is safe?

Research has shown that coaching by Lay Health Workers is generally well-received and safe. Previous studies indicate that participants handle these sessions well, with no major side effects reported. Trained workers provide support and advice to help people quit smoking.

The smoke-free home resident intervention aims to reduce exposure to secondhand smoke. Studies have found strong support for smoke-free policies among residents. Although data on safety is limited, the focus on education and support makes it a low-risk approach.

Both treatments aim to promote healthier living environments and have been positively received in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's tackling tobacco addiction at home in a fresh way. Traditional methods often focus on individual cessation programs or nicotine replacement therapies, but this intervention empowers residents with bilingual coaching and practical tools to establish smoke-free homes. The unique approach includes personalized cost assessments of tobacco use and motivational support, aiming to shift the entire household's environment towards a healthier lifestyle. By involving lay health workers for one-on-one coaching, the trial also creates a supportive community network, which could enhance long-term success in maintaining smoke-free homes.

What evidence suggests that this trial's interventions could be effective for promoting smoke-free homes?

In this trial, participants in the intervention arm will receive coaching from Lay Health Workers. Research shows that this support can help people make their homes smoke-free. Studies have found that these programs are generally well-received and lead to more homes remaining smoke-free for at least 90 days. Additionally, the smoke-free home program, another component of the intervention arm, has reduced smoking among low-income groups by encouraging more people to attempt quitting and decreasing the chances of relapse. Combining these efforts with smoke-free home rules has also helped people quit smoking. These strategies can support individuals in subsidized housing to live healthier, smoke-free lives. ^{1 3 6 7 8}

Who Is on the Research Team?

Maya Vijayaraghavan, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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 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]

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 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]

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 '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]

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]

Citations

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The Healthy Homes Study: Protocol for a cluster randomized ... The primary resident outcome is voluntary adoption of a smoke-free home for 90 days or more at 6 months. The secondary outcome is carbon monoxide–verified point ...

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Smoke-Free Home Intervention for Tobacco Addiction The studies involving Lay Health Workers (LHWs) and Lay Health Advisors (LHAs) suggest that these interventions are generally well-received and safe, as ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12306785/

The Healthy Homes Study: Protocol for a cluster ... The Healthy Homes study is a multilevel intervention that (a) provides coaching to residents on how to adopt a smoke-free home and (b) trains ...

5. researchgate.net researchgate.net/publication/394091273_The_Healthy_Homes_Study_Protocol_for_a_cluster_randomized_trial_of_a_place-based_smoke-free_home_intervention_in_affordable_housing

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Smoke-free Home Intervention in Permanent Supportive ... The training will address nicotine addiction, tobacco use among PSH residents, pilot data, brief cessation counseling (ask, advise, and refer), and local ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04427839

Interventions to Help More Low-income Smokers Quit (SFH) In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4083360/

Types of Lay Health Influencers in Tobacco Cessation To identify types of health influencers in tobacco cessation based on the frequency and characteristics of brief intervention activities.