Behavioral Nudge for Genetic Predisposition

Overseen By Benita Weathers, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under 18, not diagnosed, others

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

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help patients and doctors use genetic testing to improve medical care. Simple reminders, or "behavioral nudges," encourage doctors to refer or order genetic tests and prompt patients to discuss these tests with their doctors. The trial includes different groups, each receiving various combinations of these nudges to determine which is most effective. Individuals diagnosed with certain conditions and interested in genetic testing might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future healthcare practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that this behavioral nudge is safe for patients?

Research shows that simple reminders, such as text messages or prompts to doctors, are generally well-received by patients and healthcare providers. A review of 39 studies found that these reminders are safe and help improve medical decisions. Most studies reported no negative effects from using these reminders.

Although specific safety data for the Behavioral Nudge for Genetic Predisposition is unavailable, the nature of these reminders suggests they pose low risk. They primarily involve sending reminders or prompts, which are unlikely to cause harm. Therefore, based on existing research on similar methods, participants can feel confident that this approach is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how behavioral nudges can influence the decision-making process for genetic testing. Unlike traditional methods that rely solely on clinician discretion, this approach introduces gentle prompts for both clinicians and patients. By sending text messages to patients and reminders to clinicians, the trial aims to encourage more proactive conversations and decisions about genetic testing. This could lead to earlier identification of genetic predispositions, ultimately improving patient outcomes.

What evidence suggests that this trial's behavioral nudges could be effective for implementing genomic medicine?

Research shows that simple reminders, known as behavioral nudges, can help people make better health decisions. In this trial, participants will join different arms where they may receive various types of nudges. These nudges, such as prompts or alerts, have increased the use of genetic testing and other medical choices by changing how options are presented. Studies have found that reminders for both patients and doctors effectively encourage discussions about genetic testing. For instance, one study discovered that nudges made doctors more likely to order necessary tests. Additionally, nudges have improved decision-making in healthcare, leading to more treatments based on solid evidence. ^{1 6 7 8 9}

Who Is on the Research Team?

Marylyn Ritchie, PhD

Principal Investigator

University of Pennsylva

Katherine L Nathanson, MD

Principal Investigator

University of Pennsylva

Robert Schnoll, PhD

Principal Investigator

University of Pennsylva

Are You a Good Fit for This Trial?

Adults diagnosed with specific conditions like Alzheimer's, various heart diseases, and genetic predispositions that can change medical management based on genetic testing results. Participants must be over 18 years old.

Inclusion Criteria

I have been diagnosed with a condition being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nudge Design and Development

Development of clinician- and patient-directed nudges informed by behavioral economic theory within the EHR to address barriers to genetic testing.

6 months

Implementation Trial

Conduct a type 3 hybrid implementation cluster randomized clinical trial to evaluate the effect of clinician and patient nudges on the rate of genetic testing.

3 years

Follow-up

Participants are monitored for the effectiveness of nudges and genetic testing outcomes.

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral nudge

Trial Overview The trial is testing a new approach to genomic medicine using electronic health records (EHR) to nudge clinicians and patients towards the use of genetic testing. It involves direct test ordering, EHR algorithms for patient identification, and behavioral economics methods.

How Is the Trial Designed?

Group I: Clinician BPA refer plus patient nudge Active Control 1 Intervention

Clinician will receive a nudge to refer patient for genetic testing and the patient will receive a text message encouraging them to speak with their clinician about genetic testing.

Group II: Clinician nudge, refer Active Control 1 Intervention

Clinician will receive a nudge to refer the patient for genetic testing.

Group III: Generic BPA; no nudge Active Control 1 Intervention

Usual care

Group IV: Clinician nudge, order Active Control 1 Intervention

Clinician will receive a nudge to order genetic testing for the patient.

Group V: Patient nudge Active Control 1 Intervention

The patient will receive a text message encouraging them to speak with their clinician about genetic testing.

Group VI: Clinician BPA order plus patient nudge Active Control 1 Intervention

Clinician will receive a nudge to order genetic testing for the patient and the patient will receive a text message encouraging them to speak with their clinician about genetic testing.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A study involving 161 general practice trainees found that while residents generally accepted the idea of nudging their peers and patients towards vaccination, the specific nudge used (a reminder with a paper form for vaccine delivery) did not actually increase vaccination rates.

The results suggest that simply implementing a nudge is not enough; it must be tailored to the specific needs and preferences of the target population to be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging health care workers towards a flu shot: reminders are accepted but not necessarily effective. A randomized controlled study among residents in general practice in France. Barbaroux, A., Benoit, L., Raymondie, RA., et al.[2021]

In a study involving 88 early childhood education centers, incorporating nudge strategies into workshop invitations did not significantly increase registration rates compared to generic invitations, with only 25% of the intervention group registering versus 20% in the control group.

The study found no significant differences in invitation recall or acceptability between the two groups, suggesting that low-intensity behavioral nudges may not be effective in promoting participation in nutrition education workshops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Nudge Strategies on Nutrition Education Participation in Child Care: Randomized Controlled Trial. Grady, A., Barnes, C., Lum, M., et al.[2021]

In a study involving 2103 participants, it was found that individuals who tested negative for genetic predisposition to alcohol use disorder (AUD) often underestimated the risks associated with their drinking, potentially leading to increased consumption and avoidance of treatment.

Education on the Causal Markov condition helped participants understand that the presence of AUD symptoms carries the same risks regardless of genetic factors, effectively reducing their irrational discounting of AUD threats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The symptom discounting effect: what to do when negative genetic test results become risk factors for alcohol use disorder. Ahn, WK., Perricone, AM.[2022]

A systematic review of 18 studies involving over 10,000 participants found that communicating DNA-based disease risk estimates did not significantly influence risk-reducing health behaviors such as smoking cessation, diet, or physical activity.

The evidence suggests that genetic testing for common diseases does not motivate individuals to change their health behaviors, and there were no adverse effects reported, indicating that the approach may not be effective for promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of communicating genetic risks of disease on risk-reducing health behaviour: systematic review with meta-analysis. Hollands, GJ., French, DP., Griffin, SJ., et al.[2022]

Genetic risk information from genome-wide association studies has potential benefits for health, but it may not effectively motivate individuals to change their behaviors to reduce disease risk, highlighting the need for caution in its application.

Further research is essential to understand how genetic risk knowledge influences behavior and to identify which groups may respond positively, ensuring that policies regarding genetic susceptibility tests are well-informed and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does genomic risk information motivate people to change their behavior? Henrikson, NB., Bowen, D., Burke, W.[2022]

Nudges are simple and cost-effective interventions that can help reduce behavioral risk factors for depression, such as low physical activity, poor coping strategies, and weak social connections.

By leveraging cognitive biases, nudges can encourage healthier behaviors, making them a practical alternative to more expensive preventive therapies like problem-solving therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Nudges" to Prevent Behavioral Risk Factors Associated With Major Depressive Disorder. Woodend, A., Schölmerich, V., Denktaş, S.[2018]

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]

In a pilot study with 213 primary care patients, providing quantitative information about colorectal cancer screening significantly increased the likelihood of patients getting screened compared to those who did not receive this information.

While a nudge towards stool testing (FIT) increased perceived risk of colorectal cancer, it did not lead to a higher screening uptake, suggesting that simply nudging patients may not be as effective as providing clear quantitative data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial. Schwartz, PH., Perkins, SM., Schmidt, KK., et al.[2018]

A randomized controlled trial involving 74,811 adults showed that text message reminders before primary care visits significantly increased influenza vaccination rates by an average of 1.8 percentage points (6.1%).

The most effective message, which described the vaccine as 'reserved for you,' resulted in a notable 3.1 percentage point increase in vaccination rates, indicating that personalized messaging can enhance vaccine uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Behavioral Nudges Delivered Through Text Messages to Increase Influenza Vaccination Among Patients With an Upcoming Primary Care Visit. Patel, MS., Milkman, KL., Gandhi, L., et al.[2023]

Nudge interventions, which subtly influence people's decisions without coercion or major economic changes, have been found to be cost-effective compared to traditional policy tools like tax incentives.

The analysis suggests that nudging can be a valuable addition to policy strategies, but further research is necessary to fully understand its effectiveness relative to other methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Governments Invest More in Nudging? Benartzi, S., Beshears, J., Milkman, KL., et al.[2018]

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]

A nationwide trial in Denmark involving over 964,000 older adults showed that electronic letters emphasizing the cardiovascular benefits of influenza vaccination significantly increased vaccination rates compared to usual care, with a notable increase of 0.89 percentage points.

The use of repeated electronic reminders also improved vaccination uptake, demonstrating that simple, low-cost behavioral nudges can effectively enhance public health initiatives, especially among those who were previously unvaccinated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. Johansen, ND., Vaduganathan, M., Bhatt, AS., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-aortic-aneurysm-4-2024-52198

Behavioral Nudge for Genetic Predisposition This N/A medical study run by University of Pennsylvania is evaluating whether Behavioral nudge will have tolerable side effects & efficacy for patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11331805/

Protocol for a type 3 hybrid implementation cluster ... A type 3 hybrid implementation cluster randomized clinical trial to evaluate the effect of patient and clinician nudges to advance the use of genomic medicine.

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

Cluster Randomized Pragmatic Clinical Trial Testing ... We designed this pragmatic trial to test the effectiveness of patient- and clinician-directed implementation strategies, or nudges, informed ...

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

A formative study to develop nudges informed by ... This formative study tested nudges in the form of messages that target four behavioral economic biases – status quo, availability, omission, and focusing effect ...

5. researchgate.net researchgate.net/publication/341135088_Association_of_Behavioral_Nudges_With_High-Value_Evidence-Based_Prescribing_in_Oncology

(PDF) Association of Behavioral Nudges With High-Value ... ¹ By intentionally modifying the way choices are framed, behavioral nudges can lead to desirable changes in prescribing while preserving ...

6. reporter.nih.gov reporter.nih.gov/project-details/10877980

Project Details - NIH RePORTER We will examine patient (e.g., race), clinician (e.g., specialty), and system (e.g. , community vs. academic center) moderators of nudge effects on genetic ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/OP.24.00070

Electronic Medical Record–Based Nudge Intervention to ... These findings demonstrate that behavioral nudges can promote molecular testing ... Data and Patient-Reported Outcomes; 17/972,105. Erica L.

8. bmjopen.bmj.com bmjopen.bmj.com/content/11/7/e048801

Systematic review of clinician-directed nudges in ... This systematic review of 39 studies found that a variety of nudge interventions have been tested to improve clinical decisions. Thirty-three of the 48 (73%) ...

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0311442

Assessing a behavioral nudge on healthcare leaders ... This study examined whether a letter with peer comparison data and social norms messaging impacted healthcare leaders' decision to access a website with ...