Clinical Trial of the Sequence of Cardiovascular Genetic Counseling and Testing

Summary

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.

Conditions

• Genetic Counseling
• Inherited Cardiac Disease

Interventions

BEHAVIORAL

post-test cardiovascular genetic counseling with pre-test education by video

post-test cardiovascular genetic counseling with pre-test education by video

BEHAVIORAL

required phone call with genetic counselor pre-test

REQUIRED phone call with genetic counselor pre-test.

BEHAVIORAL

optional phone call with genetic counselor pre-test

OPTIONAL phone call with genetic counselor pre-test

Sponsors & Collaborators

• Johns Hopkins University

  lead OTHER

• National Human Genome Research Institute (NHGRI)

  collaborator NIH

Principal Investigators

• Cynthia James · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-20

Primary Completion

2026-05-31

Completion

2026-09-30

Countries

• United States

Study Locations