Using Behavioral Economics and Implementation Science to Advance the Use of Genomic Medicine Utilizing an EHR Infrastructure Across a Diverse Health System

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• diagnosed with one of the study conditions

Locations
United States
Pennsylvania
Penn Medicine
RECRUITING
Philadelphia
Contact Information
Primary
Benita Weathers, MPH
weathers@upenn.edu
2155738860
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 1000
Treatments
Active_comparator: Generic BPA; no nudge
Usual care
Active_comparator: Clinician nudge, order
Clinician will receive a nudge to order genetic testing for the patient.
Active_comparator: Clinician nudge, refer
Clinician will receive a nudge to refer the patient for genetic testing.
Active_comparator: Patient nudge
The patient will receive a text message encouraging them to speak with their clinician about genetic testing.
Active_comparator: Clinician BPA order plus patient nudge
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.
Active_comparator: Clinician BPA refer plus patient nudge
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.
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov