Clinical trial NCT04510896: Inherited Risk Evaluation Tool (InheRET): Identifying Patients at Increased Risk for Hereditary Disease
Official title: InheRET: A Software-as-a-Service (SaaS) Solution to Identifying Patients at Increased Risk for Hereditary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hereditary Cancer-Predisposing Syndrome
Lead sponsor: InheRET, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2020-08-12
Enrollment: 2232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient is requested to take the InheRET personal and family health history form. If consented patients fail to complete the form within one week of consenting, they may receive up to three (3) weekly reminder emails. The survey will take less than 10 minutes for low-risk patients. Completion time for higher risk patients depends on the size of the family, the number of conditions to report, and the patient's skill level with completing online forms. The InheRET form can be completed from any web-enabled device at the patient's convenience. Follow-up surveys will be sent as follows:

1. Consented participants fail to complete the InheRET health history for 2 months after consent to determine reason(s) for not completing.
2. Consented participants who complete the InheRET health history - 6 and 12 months after completion to identify actions taken since completion including genetic counseling, genetic testing, screening, lifestyle changes, and prophylaxis.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Pre- and Post-Rate of Referrals of Patients to Genetic Counseling from Primary Care Clinics,
timeFrame: 6 months prior to InheRET as compared to post implementation.
Secondary outcomes:
measure: Physician Acceptance and Impact
timeFrame: Physicians will be surveyed within 3 months and again upon completion of enrollment, approximately 1 year.
measure: Patient Acceptance of InheRET
timeFrame: Immediately upon completion of the personal and family health history form.
measure: Qualitative Impact on Patients
timeFrame: Follow up surveys 12- to 18-months following completion of the InheRET program.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: InheRET, Inc.
state: Michigan
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: Flint
country: United States
facility: Hamilton Community Health Network - withdrew from study
state: Michigan
city: Saginaw
country: United States
facility: Ascension St. Mary's Hospital - withdrew from study
state: Michigan
Study officials:
affiliation: InheRET, Inc
name: David Keren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Elena Stoffel, MD
role: PRINCIPAL_INVESTIGATOR
References: