Million Veteran Program Return of Actionable Results (MVP-ROAR)

VA Office of Research and Development

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Genetic: Result disclosure

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04178122

MVP030

Details and patient eligibility

About

The purpose of the Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study is to develop a process to return medically actionable genetic results to living MVP participants nationwide and to determine the impact of doing so on medical management and outcomes and Veteran quality of life.

Full description

The Million Veteran Program - Return of Actionable Results (MVP-ROAR) Study is a randomized controlled trial of immediate vs. delayed (after 6 months) return of medically actionable, clinically confirmed genetic testing results. MVP participants with a medically actionable variant in their MVP chip genotype data will be contacted and offered the opportunity to receive clinical confirmation of this result through a research protocol. First, a non-randomized pilot trial will be conducted among 10 eligible MVP participants, followed by a randomized controlled trial of immediate vs. delayed clinical confirmation and reporting, delivered to participants nationwide via telegenetic counseling.

Three hypotheses will be tested:

Hypothesis 1 (LDL-C change): LDL-C reduction after 6 months will be greater in the Immediate Results arm compared to the Delayed Results arm (primary outcome) Hypothesis 2 (LDL-C target): The proportion of participants meeting clinically significant LDL-C targets (<100mg/dL for primary prevention and <70 mg/dL for secondary prevention) at 6 months will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome) Hypothesis 3 (Pharmacotherapy): the proportion of participants with an intensification of lipid-lowering pharmacotherapy will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome)

Enrollment: 112 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Living enrollee in MVP
• Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data

Exclusion criteria

• Previously underwent genetic testing for the condition of interest
• Is incarcerated
• Is pregnant

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Immediate Results

Experimental group

Description:

Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.

Treatment:

Genetic: Result disclosure

Delayed Results

Experimental group

Description:

Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.

Treatment:

Genetic: Result disclosure