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

NCT ID: NCT04510896

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-08-31

Brief 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.

Detailed Description

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.

This is a prospective study with a pre/post intervention analysis. The prior 6-months' genetic counseling referrals to Michigan Medicine will be collected for each site to serve as baseline data and compared to the intervention data to measure the difference made by InheRET utilization. Primary care sites are selected to offer the broadest range of patient populations to ensure the InheRET tool works well in diverse groups accessing varied clinical settings. The Cancer Genetics and MM Breast and Ovarian Cancer Risk Evaluation Clinics will allow us to measure the appropriateness of referrals and the impact of InheRET on genetic counseling workflows as patients from the primary care sites are referred for counseling from throughout the tri-state catchment areas and beyond. Similarly, investigators will review electronic health records for appropriateness of referrals to other counseling clinics at Michigan Medicine.

This will be accomplished by implementing InheRET in a variety of clinical settings to measure its acceptance by providers and patients as well as any changes made in referral patterns as a result of its use, compared to patterns of referral before it is implemented. Patients completing the InheRET online tool form will be followed longitudinally by surveys to discover their risk management actions (i.e. genetic counseling appointment, genetic testing, screenings, prophylaxis) and the reasons for or against undertaking such actions. Providers will also be surveyed to determine the impact InheRET has made to their workflow, the acceptability of this tool by their practice, and the usefulness of InheRET's features to accomplish its goals. This study has a goal enrollment of 2109 patients in Phase I (already enrolled) and at least 1023 patient subjects in Phase II (anticipated) to use the InheRET program for the purpose of this study and will also enroll six to twelve (6-12) physicians to obtain reflection on experience using InheRET for the purpose of this study.

Conditions

Hereditary Cancer-Predisposing Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pre-InheRET

Determine appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the pre-intervention 6-month period. Only referrals to Michigan Medicine (MM) 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Post-InheRET

Determine appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the 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.

Group Type: EXPERIMENTAL

InheRET

Intervention Type: OTHER

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.

Patient Acceptance

Intervention Type: OTHER

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.

Physician Acceptance Survey

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

InheRET 2.0 - Phase I; InheRET 3.0 - Phase II

Eligibility Criteria

Inclusion Criteria

• Primary Care sites:Adult patients with New and Health Maintenance Exam appointments at participating clinics
• Genetics sites: Adult patients with new referrals for genetic counseling

Exclusion Criteria

• Patients who were previously referred or who have an appointment for genetic counseling pending.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

InheRET, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Keren, MD

Role: PRINCIPAL_INVESTIGATOR

InheRET, Inc

Elena Stoffel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

InheRET, Inc.

Ann Arbor, Michigan, United States

Michigan Medicine

Ann Arbor, Michigan, United States

Hamilton Community Health Network - withdrew from study

Flint, Michigan, United States

Ascension St. Mary's Hospital - withdrew from study

Saginaw, Michigan, United States

Countries

United States

Other Identifiers

1R41CA239842-01

Identifier Type: NIH

Identifier Source: org_study_id

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