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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if reminders, called "nudges," can encourage HIV patients who smoke to engage more in quitting programs. Participants will receive either no extra help, a nudge to their doctor (Clinician Nudge), a nudge to themselves (Patient Nudge), or nudges to both. The study seeks to assess whether these nudges increase referrals and engagement in smoking cessation services compared to usual care. Eligible participants are HIV patients who have smoked daily for at least six months. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative strategies that could enhance smoking cessation support for HIV patients.

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 prior data suggests that these nudge strategies are safe for increasing tobacco use treatment engagement?

Research has shown that using nudges—simple reminders—can help doctors and patients improve healthcare outcomes. However, the research does not specifically address the safety of these nudges in individuals.

Nudges are generally safe because they involve reminders, not medicine or medical procedures. For example, one study used reminders in electronic health records to enhance healthcare quality without any safety issues. Similarly, reminders like text messages have helped patients take their medication on time without causing harm.

In summary, while specific safety data for these nudges is lacking, they are non-invasive and have been used in healthcare without known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nudges for Smoking trial because it explores innovative behavioral techniques to encourage smoking cessation. Unlike traditional smoking cessation methods such as nicotine replacement therapy or prescription medications, this trial uses digital communication to nudge both clinicians and patients. The Clinician Nudge involves sending a Best Practice Alert within electronic medical records, while the Patient Nudge uses messages sent directly through patient portals or texts. These methods aim to seamlessly integrate into existing healthcare practices, potentially enhancing the effectiveness of current treatments by promoting healthier choices through subtle reminders. The trial's approach is promising as it leverages technology to facilitate behavior change without introducing new medications or complex interventions.

What evidence suggests that this trial's nudge strategies could be effective for increasing tobacco use treatment engagement in HIV patients?

Research shows that reminders to doctors, such as the Clinician Nudge in this trial, can significantly increase their involvement in helping patients quit smoking. One study found that these reminders boosted doctor participation in tobacco use treatment from 13.5% to 35.6%.

For patients, reminders like the Patient Nudge being tested in this trial can effectively encourage healthy actions, such as quitting smoking. A review found that personalized digital reminders helped more people quit compared to standard care.

This trial will also explore the Combined Nudge approach, using reminders for both doctors and patients. Research suggests that when both groups receive tailored reminders, the use of proven treatments improves in most cases. This combined approach could lead to increased use of tobacco use treatment services. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10552951/

Cluster Randomized Pragmatic Clinical Trial Testing ... Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% v 13.5 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8281481/

Rationale and protocol for a cluster randomized pragmatic ... This trial was designed to evaluate the additional effectiveness of patient and clinician “nudges”—messages informed by behavioral economics designed to ...

3. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.23.00355

Cluster Randomized Pragmatic Clinical Trial Testing ... Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% v 13.5 ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04737031

Improving Tobacco Treatment Rates for Outpatient Cancer ... The main purpose of this research study is to evaluate the effectiveness of "nudges" to clinicians, to patients, or to both in increasing Tobacco Use ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S277272462500037X?via%3Dihub

A formative study to develop nudges informed by ... There were significant differences in reported preference across the messages among PWH (χ2[3]=24.79, p < 0.001) and clinicians (χ2[3]=33.85, p < 0.001). The ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00355

Cluster Randomized Pragmatic Clinical Trial Testing ... Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% v 13.5 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9683998/

Improving Tobacco Cessation Rates Using Inline Clinical ... This study suggests a CDS intervention which respects the CDS Five Rights and incorporates user-centered design can affect tobacco use rates.

8. withpower.com withpower.com/trial/phase-tobacco-use-2024-cd36a

Nudges for Smoking · Info for Participants Is the nudge strategy generally safe for humans? The research does not provide specific safety data for nudge strategies, but these interventions are ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823608

Electronic Health Record Nudges and Health Care Quality ... This systematic review investigates whether there is an association between electronic health record (EHR) nudges and health care outcomes ...