RECRUITING

Using the EHR to Advance Genomic Medicine Across a Diverse Health System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-10
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06377033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * diagnosed with one of the study conditions
  1. * Under 18 years of age
  2. * not diagnosed with one of the study conditions

Contacts and Locations

Study Contact

Benita Weathers, MPH
CONTACT
2155738860
weathers@upenn.edu

Principal Investigator

Katherine L Nathanson, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylva
Robert Schnoll, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylva
Marylyn Ritchie, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylva

Study Locations (Sites)

Penn Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Katherine L Nathanson, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylva
  • Robert Schnoll, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylva
  • Marylyn Ritchie, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylva

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-06-10
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Genetic testing
  • Genomic medicine
  • Electronic health record

Additional Relevant MeSH Terms

  • Genetic Predisposition
  • Paraganglioma
  • Pheochromocytoma
  • ALS
  • Parkinson Disease
  • Polyneuropathies
  • Frontotemporal Dementia
  • Alzheimer Disease
  • Cardiomyopathy Non-ischemic
  • Thoracic Aortic Aneurysm