Million Veteran Program Return of Actionable Results

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Genetic: Result disclosure

• Registration Number: NCT04178122
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed 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)

Study Timeline

• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Start: 2019-12-30
• Primary Completion: 2024-09-08
• Study Completion: 2024-09-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Results	Result disclosure	Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
Immediate Results	Result disclosure	Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.

Primary Outcome Measures

Name	Time	Method
LDL-C change	6 months	Change in LDL-C after 6 months.

Secondary Outcome Measures

Name	Time	Method
LDL-C target	6 months	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.
Pharmacotherapy	6 months	The proportion of participants with an intensification of lipid-lowering pharmacotherapy, a composite outcome including prescription of new monotherapy, dose escalation of existing pharmacotherapy, and addition of one or more medications to existing pharmacotherapy.

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States