Genetic Counseling Sequence for Heart Disease
(RESEQUENCEGC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byCynthia James

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Although pre-test genetic counseling is widely recommended and has come to dominate genetic counseling practice, tailored results-focused genetic counseling could both increase genetic counseling efficiency and improve genetic counseling outcomes for the growing number of patients seeking genetic testing for recommended genome-guided medical management. This study will test that hypothesis in adults referred for cardiovascular genetic counseling and testing at the Johns Hopkins Center for Inherited Heart Diseases. This study is a three-arm randomized clinical trial to evaluate two complementary approaches to shifting the primary genetic counseling session to post-test for 510 adults with two broad cardiovascular genetic counseling indications: diagnostic panel testing and family-specific variant testing. The investigators will compare usual care (pre-test genetic counseling appointment, results returned by phone / electronic health record) with online video-based pre-test tailored genetic education with an optional (efficiency arm) or required (flipped arm) phone call with a genetic counselor followed by a post-test genetic counseling appointment. The investigators hypothesize that post-test genetic counseling will: 1) increase efficiency, 2) promote patient empowerment and adherence, and 3) have similar genetic test-associated psychosocial impact.

Research Team

Cynthia James

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Adults over 18 with suspected or diagnosed inherited heart conditions, including various cardiomyopathies, arrhythmias, lipid disorders, or early-onset coronary artery disease. They must be scheduled for genetic counseling at the Johns Hopkins Center and have not had previous genetic counseling/testing for their condition there.

Inclusion Criteria

I am referred for genetic testing due to family heart disease history.

You need a specific test for heart-related issues.

I may have a genetic heart condition or early heart disease.

See 2 more

Exclusion Criteria

You do not need a specific genetic test.

My condition's genetic cause has been identified through testing.

Previous genetic counseling at Johns Hopkins for this clinical indication

See 2 more

Treatment Details

Interventions

optional phone call with genetic counselor pre-test (Behavioural Intervention)
post-test cardiovascular genetic counseling with pre-test education by video (Behavioural Intervention)
required phone call with genetic counselor pre-test (Behavioural Intervention)

Trial OverviewThe trial is testing a new approach to cardiovascular genetic counseling by providing pre-test education via video and post-test counseling sessions. It compares usual care with two other methods: one where a call with a counselor before testing is optional and another where it's required.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: FlippedExperimental Treatment2 Interventions

Pre-test genetics education by educational video with a REQUIRED call with a genetic counselor to address questions. Pre-test appointment available by request. Post-test genetic counseling appointment.

Group II: EfficiencyExperimental Treatment2 Interventions

Pre-test genetics education by educational video with an OPTIONAL call with a genetic counselor to address questions. Pre-test appointment available by request. Post-test genetic counseling appointment.

Group III: Standard of careActive Control1 Intervention

Pre-test genetic counseling appointment with results returned by phone or EHR. Post-test appointment available upon request.