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

Hereditary Cancer-Predisposing Syndrome Clinical Trial

Official title:

InheRET: A Software-as-a-Service (SaaS) Solution to Identifying Patients at Increased Risk for Hereditary Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04510896
• Other study ID #: 1R41CA239842-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2021
• Source: InheRET, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2232
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Diseases, Inborn
• Hereditary Cancer-Predisposing Syndrome
• Neoplastic Syndromes, Hereditary

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
InheRET, Inc	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre- and Post-Rate of Referrals of Patients to Genetic Counseling from Primary Care Clinics,	Average number of patients per month referred to genetic counseling before and after InheRET's implementation in clinic.	6 months prior to InheRET as compared to post implementation.
Secondary	Physician Acceptance and Impact	Physicians will be consented and surveyed to determine acceptance, utility, and impact on clinical workflows. For discrete data elements, data will be reported as the number of physicians out of "n" responses. Qualitative data will be anonymized as needed, grouped thematically and reported. Responses from the two surveys will be compared to determine if perceptions have changed over time. Data will be reported as above with a % change added for discrete data elements.	Physicians will be surveyed within 3 months and again upon completion of enrollment, approximately 1 year.
Secondary	Patient Acceptance of InheRET	Acceptance measures will include InheRET program completion rates (%) and levels of ease of use of InheRET by the patient, via survey at completion of the form. Patients will rank, using a 5-point Likert Scale, Ease of Use, and Understandability. Yes/No answers with comments will collect data on Cancer Coverage, Increased Knowledge of Family History, and Problems Encountered.; Investigators will explore patterns of acceptance levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents.	Immediately upon completion of the personal and family health history form.
Secondary	Qualitative Impact on Patients	Impact measures will include uptake of advised risk management interventions (genetic counseling, testing, screening, lifestyle changes, therapeutics, and prophylaxis), collected by survey and through medical record exam. Investigators will also qualitatively describe why patients do not follow up with their referral, gathered through a survey sent 12 months after completion (Phase I) and every 6 months x 3 (Phase II). We will explore patterns of impact levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents.	Follow up surveys 12- to 18-months following completion of the InheRET program.