Behavioral Nudge for Genetic Predisposition

Recruiting in Palo Alto (17 mi)

Overseen by Katherine L Nathanson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Under 18, not diagnosed, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place. Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.

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 data supports the effectiveness of the treatment Behavioral nudge for genetic predisposition?

Research shows that behavioral nudges, like text message reminders, can increase vaccination rates and help manage depression by encouraging healthier behaviors. These findings suggest that similar nudges could be effective in addressing genetic predispositions by promoting beneficial health behaviors. ^{1 2 3 4 5}

Is the Behavioral Nudge for Genetic Predisposition generally safe for humans?

The research does not provide specific safety data for the Behavioral Nudge for Genetic Predisposition, but it highlights the importance of understanding genetic risk information and its potential psychological effects, such as influencing behavior in ways that might not always be beneficial. ^{2 6 7 8 9}

How does the 'Behavioral Nudge for Genetic Predisposition' treatment differ from other treatments?

This treatment is unique because it uses 'nudges', which are subtle changes in the environment to influence behavior without using force or financial incentives. Unlike traditional treatments that may involve medication or therapy, nudges aim to alter decision-making processes by leveraging cognitive biases, making them a cost-effective and non-intrusive option. ^{4 10 11 12 13}

Research Team

Robert Schnoll, PhD

Principal Investigator

University of Pennsylva

Marylyn Ritchie, PhD

Principal Investigator

University of Pennsylva

Katherine L Nathanson, MD

Principal Investigator

University of Pennsylva

Eligibility Criteria

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 am 18 years old or older.

I have been diagnosed with a condition being studied.

Trial Timeline

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

Treatment Details

Interventions

• Behavioral nudge (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States 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. [2018]

3. 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]

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

"Nudges" to Prevent Behavioral Risk Factors Associated With Major Depressive Disorder. [2018]

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

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

6. England pubmed.ncbi.nlm.nih.gov

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

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

The impact of communicating genetic risks of disease on risk-reducing health behaviour: systematic review with meta-analysis. [2022]

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

Does genomic risk information motivate people to change their behavior? [2022]

9. England pubmed.ncbi.nlm.nih.gov

Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. [2023]

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

Should Governments Invest More in Nudging? [2018]

11. England 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. [2021]

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

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

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

Impact of Nudge Strategies on Nutrition Education Participation in Child Care: Randomized Controlled Trial. [2021]