Inherited Risk Evaluation Tool (InheRET): Identifying Patients at Increased Risk for Hereditary Disease

Summary

This study will evaluate the impact InheRET™, an online family history gathering and risk assessment reporting tool, has on facilitating National Comprehensive Cancer Network(NCCN) guideline compliant referrals for cancer genetic counseling/genetic evaluation by decreasing and/or removing the barriers of 1) time-consuming in-clinic 3-generation family history collection, and 2) interpretation of the family and personal history in light of current NCCN guidelines.

Identifying individuals at increased risk for cancer has been shown to decrease morbidity and mortality in multiple clinical settings. Investigators hypothesize that InheRET will prove to be accurate, efficient, and accessible, and that its use will improve identification of individuals at risk for inherited susceptibility to cancer. The investigators propose also that using this tool will result in a reduction of inappropriate genetic counseling referrals and reduce unnecessary genetic testing in both primary and specialty care settings. InheRET will allow health care providers to focus resources on individuals at higher risk for developing cancer.

Conditions

• Hereditary Cancer-Predisposing Syndrome

Interventions

OTHER

InheRET

Primary Appropriate Referral Rates 6-months pre-intervention vs post-intervention Compare appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the pre-intervention vs post- intervention period. Only referrals to Michigan Medicine genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals.

OTHER

Patient Acceptance

Acceptance by Patients Over the course of the study Acceptance measures will include completion rates and levels of ease of use of InheRET by the patient. Impact measures will include uptake of advised risk management interventions. We will qualitatively describe why patients do not follow up with their referral. We will explore patterns of acceptance and impact levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents.

OTHER

Physician Acceptance Survey

Secondary Acceptance by Physicians Over the course of the study Acceptance by physicians will measure the physician effort required to deploy and use InheRET in their respective clinics, and overall satisfaction. Impact measures will include appropriate referral rates and rates of genetic testing. We will qualitatively describe why patients are not referred for genetic counseling if indicated. We will explore patterns in acceptance and impact levels by demographic and clinical data using correlations, t-tests, ANOVA, or their non-parametric equivalents.

Sponsors & Collaborators

• University of Michigan

  collaborator OTHER

• InheRET, Inc

  lead INDUSTRY

Principal Investigators

• David Keren, MD · InheRET, Inc

• Elena Stoffel, MD · University of Michigan

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2022-06-30

Completion

2022-08-31

Countries

• United States

Study Locations