Million Veteran Program Return of Actionable Results

NCT ID: NCT04178122

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2024-09-08

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)

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Immediate Results

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

Group Type: EXPERIMENTAL

Result disclosure

Intervention Type: GENETIC

Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

Delayed Results

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

Group Type: EXPERIMENTAL

Result disclosure

Intervention Type: GENETIC

Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

Interventions

Result disclosure

Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason L Vassy, MD MPH

Role: STUDY_CHAIR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Countries

United States

References

Vassy JL, Brunette CA, Yi T, Harrison A, Cardellino MP, Assimes TL, Christensen KD, Devineni P, Gaziano JM, Gong X, Hui Q, Knowles JW, Muralidhar S, Natarajan P, Pyarajan S, Sears MG, Shi Y, Sturm AC, Whitbourne SB, Sun YV, Danowski ME; Million Veteran Program. Design and pilot results from the Million Veteran Program Return Of Actionable Results (MVP-ROAR) Study. Am Heart J. 2024 Oct;276:99-109. doi: 10.1016/j.ahj.2024.04.021. Epub 2024 May 17.

Reference Type: DERIVED

PMID: 38762090 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MVP030

Identifier Type: -

Identifier Source: org_study_id