Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05079334 |
| Other study ID # |
201202 |
| Secondary ID |
U01CA232829 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Vanderbilt University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Investigators from Vanderbilt University Medical Center (VUMC), Duke University, and Meharry
Medical College (MMC) are collaborating on a family health history study to deploy a family
health history (FHH) platform, MeTree. Recruited participants will complete surveys, the
MeTree questionnaire, and MeTree will determine the participant's cancer risk based on
current guidelines. The study team will offer genetic counseling to high-risk participants.
Investigators will track participant outcomes and behaviors from the use of MeTree to
determine the efficiency of the use of MeTree compared to completion of pedigrees in clinic.
Description:
From the earliest recognition of cancer-prone families over 100 years ago, clinicians have
depended on the family health history (FHH) to identify and treat patients and family members
who may have a cancer family syndrome. Once identified, patients can be offered lifesaving,
evidence-based management strategies for many of these conditions. To fully realize the
benefits of genetic healthcare, however, at risk individuals must be recognized, offered
genetic counseling and testing, and then referred for specialized therapy or enhanced
screening. While this is a promising time for these patients and families, there are
significant challenges to implement a modern and efficient care delivery model across the
many patients, provider, and health system stakeholders.
The practice of genetic medicine is changing as genetic discoveries are translated into new
tests for an increasing number of health indications. In fact, the prevalence of high-risk
individuals who are at risk for hereditary cancer has been rising due to new testing
strategies. This has placed enormous pressure on the hospitals and clinics providing care for
high-risk patients. Coupled with the healthcare systems need for greater efficiency, the
traditional genetic clinic-based practice has become untenable. Barriers and challenges
include low numbers of trained genetic workforce, lack of integrated FHH tools for patients
and physicians, and long wait times for available clinic appointments. Further, while cancer
syndromes are seen across all groups, gaps in care exist as underserved populations are often
not recognized and referred for care.
Investigators propose that these barriers can be overcome by using innovations in informatics
and telecommunications to develop a sustainable and scalable genomic care delivery model that
can be replicated by other health systems. Such a program would need to integrate FHH
applications that collect and analyze family data, SMART-on-FHIR capabilities that can link
third party apps with the electronic medical record (EMR), and clinical decision support
modules to assist providers and patients. MeTree is one such system with all these
capabilities -- a validated and flexible patient-facing FHH collection tool that supports
SMART-on-FHIR technology. This platform was the backbone of the Implementing Genomics in
Practice (IGNITE) network's FHH clinical utility study that showed clear improvements in the
quality and quantity of FHH collected in 5 geographically diverse primary care practices.
Furthermore, MeTree was highly acceptable to patients and providers, and was able to properly
identify participants at risk for 23 hereditary cancer syndromes for genetic counseling
referral.
Our re-submission for this Beau Biden Moonshot grant opportunity is based on the hypothesis
that an implementation science approach will improve the identification and management of
high-risk patients from diverse clinical setting by systematically integrating FHH driven
evidence-based guidelines into the EMR. Investigators plan to improve ascertainment of
high-risk patients by imbedding MeTree in the workflow of primary and cancer care clinics.
This will improve identification for genetic counseling, facilitate patient education about
genetic testing, and risk management for at risk patients, as well as facilitate engagement
of patients, family members, and providers with telegenetic and telephone counseling options.
This collaborative effort from genetic, genomic, biomedical informatic, and implementation
science researchers at Vanderbilt University Medical Center (VUMC), Meharry Medical Center
(MMC) and Duke University is highly responsive to the five required elements in
RFA-CA-19-017. The proposal has the following specific aims:
SA1. Deploy a care delivery model that will facilitate systematic risk assessment for
hereditary cancers in diverse clinical environments.
- 4000 participants will be enrolled and randomized to usual care or MeTree FHH risk
assessment
- Deploy in academic medical center (VUMC) and a medical center (MMC) that serves
underserved populations
- Assess participants perceptions using online survey and qualitative semi-structured
interviews
SA2. Improve access to genetic healthcare providers for participants at risk for hereditary
cancer syndromes.
- 300 high risk participants in the VUMC Hereditary Cancer Clinic will be enrolled and
randomized
- Extend clinic capacity by lessening the need for in-clinic family history collection and
basic counseling
- Expand reach of clinic by using telephone and video genetic counseling, referral to
specialists
SA3. Explore the feasibility of our care delivery model to improve family engagement for
cancer risk assessment
- Participants extend invitations to MeTree's family resource center to share results of
genetic tests
- Assist with education and referral needed for cascade testing for pathogenic variants
