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.
Is the treatment in the trial 'Behavioral Nudge for Genetic Predisposition' a promising treatment?Yes, behavioral nudges are promising because they can effectively change people's behavior without using force or money incentives. They are often cheaper and can work well alongside traditional methods. Research shows they can help with issues like depression by encouraging better habits, like staying active and keeping social connections.25678
Do I need to stop taking my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for more information.
What safety data exists for the Behavioral Nudge treatment?The provided research does not directly address safety data for the Behavioral Nudge treatment. However, it highlights potential psychological risks, such as the symptom discounting effect, where individuals may underestimate health risks after receiving negative genetic test results. This suggests a need for careful consideration of psychological impacts and effective communication strategies when implementing behavioral nudges in genetic predisposition contexts.1341013
What data supports the idea that Behavioral Nudge for Genetic Predisposition is an effective treatment?The available research shows that Behavioral Nudges can be effective in various contexts. For example, a study found that nudges delivered through text messages increased influenza vaccination rates among patients. Another study explored how nudges could help prevent depression by encouraging physical activity, better coping mechanisms, and maintaining social ties. Additionally, nudges have been used to improve completion rates of the herpes zoster vaccine series and to enhance communication between clinicians and cancer patients. These examples suggest that Behavioral Nudges can effectively influence positive health behaviors.2491112
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.
Treatment Details
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.
6Treatment groups
Active Control
Group I: Clinician BPA refer plus patient nudgeActive Control1 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, referActive Control1 Intervention
Clinician will receive a nudge to refer the patient for genetic testing.
Group III: Generic BPA; no nudgeActive Control1 Intervention
Usual care
Group IV: Clinician nudge, orderActive Control1 Intervention
Clinician will receive a nudge to order genetic testing for the patient.
Group V: Patient nudgeActive Control1 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 nudgeActive Control1 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Penn MedicinePhiladelphia, PA
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
References
Does genomic risk information motivate people to change their behavior? [2022]The recent flood of information about new gene variants associated with chronic disease risk from genome-wide association studies has understandably led to enthusiasm that genetic discoveries could reduce disease burdens and increase the availability of direct-to-consumer tests offering risk information. However, we suggest caution: if it is to be any benefit to health, genetic risk information needs to prompt individuals to pursue risk-reduction behaviors, yet early evidence suggests that genetic risk may not be an effective motivator of behavior change. It is not clear how genetic information will inform risk-based behavioral intervention, or what harms might occur. Research is needed that examines the behavioral consequences of genetic risk knowledge in the context of other motivators and social conditions, as well as research that determines the subgroups of people most likely to be motivated, in order to inform policy decisions about emerging genetic susceptibility tests. Without such research, it will not be possible to determine the appropriate health care uses for such tests, the impact on health care resources from consumer-initiated testing, or the criteria for truthful advertising of direct-to-consumer tests.
"Nudges" to Prevent Behavioral Risk Factors Associated With Major Depressive Disorder. [2018]Major depressive disorder-colloquially called "depression"-is a primary global cause of disability. Current preventive interventions, such as problem-solving therapy, are effective but also expensive. "Nudges" are easy and cheap interventions for altering behavior. We have explored how nudging can reduce three behavioral risk factors of depression: low levels of physical activity, inappropriate coping mechanisms, and inadequate maintenance of social ties. These nudges use cognitive biases associated with these behavioral risks, such as valuing the present more than the future, following the herd or the norm, making different choices in light of equivalent conditions, and deciding on the basis of salience or attachment to status quo.
The impact of communicating genetic risks of disease on risk-reducing health behaviour: systematic review with meta-analysis. [2022]To assess the impact of communicating DNA based disease risk estimates on risk-reducing health behaviours and motivation to engage in such behaviours.
Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial. [2018]Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a "nudge" towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge.
Should Governments Invest More in Nudging? [2018]Governments are increasingly adopting behavioral science techniques for changing individual behavior in pursuit of policy objectives. The types of "nudge" interventions that governments are now adopting alter people's decisions without coercion or significant changes to economic incentives. We calculated ratios of impact to cost for nudge interventions and for traditional policy tools, such as tax incentives and other financial inducements, and we found that nudge interventions often compare favorably with traditional interventions. We conclude that nudging is a valuable approach that should be used more often in conjunction with traditional policies, but more calculations are needed to determine the relative effectiveness of nudging.
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]A nudge corresponds to any procedure that influences choice architecture, without using persuasion or financial incentives. Nudges are effective in increasing vaccination with heterogeneous levels of acceptability.
Impact of Nudge Strategies on Nutrition Education Participation in Child Care: Randomized Controlled Trial. [2021]To assess the impact of incorporating nudge strategies in the design of a nutrition education workshop invitation on workshop registration among early childhood education and care centers.
Nudging: Progress to date and future directions. [2021]Nudges influence behavior by changing the environment in which decisions are made, without restricting the menu of options and without altering financial incentives. This paper assesses past empirical research on nudging and provides recommendations for future work in this area by discussing examples of successful and unsuccessful nudges and by analyzing 174 articles that estimate nudge treatment effects. Researchers in disciplines spanning the behavioral sciences, using varied data sources, have documented that many different types of nudges succeed in changing behavior in a wide range of domains. Nudges that automate some aspect of the decision-making process have an average effect size, measured by Cohen's d, that is 0.193 larger than that of other nudges. Our analyses point to the need for future research to pay greater attention to (1) determining which types of nudges tend to be most impactful; (2) using field and laboratory research approaches as complementary methods; (3) measuring long-run effects of nudges; (4) considering effects of nudges on non-targeted outcomes; and (5) examining interaction effects among nudges and other interventions.
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]Serious illness conversations (SICs) are an evidence-based approach to eliciting patients' values, goals, and care preferences that improve patient outcomes. However, most patients with cancer die without a documented SIC. Clinician-directed implementation strategies informed by behavioral economics ("nudges") that identify high-risk patients have shown promise in increasing SIC documentation among clinicians. It is unknown whether patient-directed nudges that normalize and prime patients towards SIC completion-either alone or in combination with clinician nudges that additionally compare performance relative to peers-may improve on this approach. Our objective is to test the effect of clinician- and patient-directed nudges as implementation strategies for increasing SIC completion among patients with cancer.
The symptom discounting effect: what to do when negative genetic test results become risk factors for alcohol use disorder. [2022]Most consumers of genetic testing for health conditions test negative, yet the psychological perils of this are hardly known. In three experiments (N = 2103) participants discounted repercussions of alcohol use disorder (AUD), after learning or imagining that they were not genetically predisposed to AUD. Such discounting can lead people to avoid treatment and to feel safe to continue or even increase their drinking, ironically turning the negative genetic feedback into a risk factor for AUD. Concerningly, the debriefing currently used by a direct-to-consumer genetic testing company failed to counteract this discounting among those already engaging in problematic drinking in all three studies. It was hypothesized that this discounting derives from not understanding the Causal Markov condition; once AUD symptoms are present, their ramifications remain the same regardless of whether genes or environmental factors caused the symptoms. Educating participants about this principle successfully mitigated the irrational discounting of threats of AUD.
A Randomized Trial of Behavioral Nudges Delivered Through Text Messages to Increase Influenza Vaccination Among Patients With an Upcoming Primary Care Visit. [2023]To evaluate if nudges delivered by text message prior to an upcoming primary care visit can increase influenza vaccination rates.
Impact of patient and provider nudges on addressing herpes zoster vaccine series completion. [2023]To determine the combined impact of provider-facing and text message-based, patient nudges on herpes zoster vaccine series completion.
Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. [2023]Influenza vaccination rates remain suboptimal despite effectiveness in preventing influenza infection and related complications. We investigated whether behavioural nudges, delivered via a governmental electronic letter system, would increase influenza vaccination uptake among older adults in Denmark.