Nudges for Smoking

Overseen By Robert Schnoll, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Non-smokers, Non-HIV patients, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: up to 12 months

500 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to usual care and that the combination of nudges to clinicians and to patients will be the most effective.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Nudges for Smoking?

Research shows that involving clinicians in tobacco treatment and using strategies like reminders and adherence strategies can improve smoking cessation outcomes. Additionally, using conversational agents to support smokers who are not ready to quit can gradually promote behavior change and increase motivation to use evidence-based resources. ^{1 2 3 4 5}

Is the nudge strategy generally safe for humans?

The research does not provide specific safety data for nudge strategies, but these interventions are designed to subtly influence behavior without restricting choices or altering financial incentives, suggesting they are generally safe. ^{6 7 8 9 10}

How does the 'Nudges for Smoking' treatment differ from other smoking cessation treatments?

The 'Nudges for Smoking' treatment is unique because it focuses on using behavioral nudges and technology, such as gamification and conversational agents, to engage smokers who are not yet ready to quit. This approach aims to gradually build motivation and skills for quitting, making it different from traditional treatments that often target individuals already motivated to stop smoking. ^{3 5 11 12 13}

Eligibility Criteria

This trial is for healthcare providers with prescribing authority in Pennsylvania who oversee HIV patients, and for English-speaking HIV patients who currently smoke tobacco daily. Providers must have managed HIV care for the past six months.

Inclusion Criteria

Clinician participants must meet the following criteria for enrollment: Penn Division of Infectious Disease, Prescribing authority in Pennsylvania (i.e., physician, nurse practitioner, physician assistant), Clinical oversight of HIV patients for the past six months, English-speaking (messages will be in English), Patient participants must be diagnosed with HIV and report current tobacco smoking (self-report daily smoking for last 6 months)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nudges to increase referral and engagement with tobacco use treatment services

up to 12 months

Regular monitoring through electronic medical records

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Clinician Nudge
• Patient Nudge

Trial Overview The study tests if 'nudges' to clinicians, patients, or both can increase referrals and participation in tobacco use treatment services among HIV patients compared to usual care. It's a four-arm trial where participants are randomly assigned to different strategies.

Participant Groups

Group I: Patient Nudge Experimental Treatment 1 Intervention

Patients will receive a message sent through the patient portal or via text.

Group II: Combined Nudge: Clinician and Patient Nudge Experimental Treatment 2 Interventions

Both the clinician nudge and the patient nudge will be used.

Group III: Clinician Nudge Experimental Treatment 1 Intervention

Clinicians will receive a nudge via a Best Practice Alert within the electronic medical record.

Group IV: Usual Care Active Control 1 Intervention

Clinicians and patients will receive no further interventions beyond usual practice.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The study aims to develop a smoking cessation support chatbot specifically for ambivalent smokers, with a focus on understanding their preferences through a survey of 300 participants.

The chatbot's acceptability and feasibility will be tested with 25 individuals over a 2-week period, with the goal of creating a prototype that can eventually be tested for efficacy in promoting smoking behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Conversational Agent for Individuals Ambivalent About Quitting Smoking: Protocol for a Proof-of-Concept Study. Nair, US., Greene, K., Marhefka, S., et al.[2023]

Health professionals can significantly improve patient outcomes related to tobacco use by implementing ten practical recommendations that enhance the delivery of tobacco interventions in clinical settings.

These recommendations focus on integrating tobacco treatment into routine clinical workflows, emphasizing the importance of evidence-based treatments, and ensuring that every patient encounter is an opportunity for intervention, ultimately aiming to reduce social disparities among tobacco users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing consumer demand for tobacco treatments: Ten design recommendations for clinicians and healthcare systems. Woods, SS., Jaén, CR.[2010]

Nudges, which are small changes in the environment or information presentation, can significantly improve patient outcomes in healthcare by influencing behaviors.

To effectively implement nudges, it is crucial to systematically design them to fit clinical workflows, engage relevant stakeholders, and conduct rapid experimentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Nudges for Success in Health Care. Harrison, JD., Patel, MS.[2021]

A study involving over 220,000 adults showed that combining provider nudges with text message reminders significantly improved the completion rate of the herpes zoster vaccine series, with completion rates of 88.3% for those receiving both nudges compared to 85.3% for those who did not receive text messages.

Patients who received text message reminders not only completed their vaccine series at a higher rate but also received their second dose an average of 8.6 days sooner, highlighting the effectiveness of patient-focused nudges in enhancing vaccination adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient and provider nudges on addressing herpes zoster vaccine series completion. Gatwood, J., Brookhart, A., Kinney, O., et al.[2023]

This study will evaluate the effectiveness of both clinician- and patient-directed nudges to increase the completion of serious illness conversations (SICs) among high-risk cancer patients, involving 166 clinicians and approximately 5500 patients.

The primary outcome will be the time to SIC documentation, with secondary outcomes including palliative care referrals and the use of aggressive end-of-life care, aiming to improve patient outcomes and promote health equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. Takvorian, SU., Bekelman, J., Beidas, RS., et al.[2022]

Nudges can effectively change behavior by modifying the decision-making environment without limiting options or altering financial incentives, as shown in a review of 174 articles across various disciplines.

Nudges that automate decision-making processes have a greater average effect size (Cohen's d of 0.193) compared to other types of nudges, highlighting the importance of understanding which nudges are most effective for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging: Progress to date and future directions. Beshears, J., Kosowsky, H.[2021]

References

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

Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial. [2021]

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

A randomized controlled trial of financial incentives to low income pregnant women to engage in smoking cessation treatment: Effects on post-birth abstinence. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Development of a Conversational Agent for Individuals Ambivalent About Quitting Smoking: Protocol for a Proof-of-Concept Study. [2023]

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

Effects of the tobacco use cessation automated clinical practice guideline. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Increasing consumer demand for tobacco treatments: Ten design recommendations for clinicians and healthcare systems. [2010]

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

Designing Nudges for Success in Health Care. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of patient and provider nudges on addressing herpes zoster vaccine series completion. [2023]

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

Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. [2022]

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

Nudging: Progress to date and future directions. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Hospital doctors' attitudes to brief educational messages that aim to modify diagnostic test requests: a qualitative study. [2020]

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

The 'Take a Break' game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A pre-post pilot study of a brief, web-based intervention to engage disadvantaged smokers into cessation treatment. [2018]

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

Facilitating adherence to the tobacco use treatment guideline with computer-mediated decision support systems: physician and clinic office manager perspectives. [2015]