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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Genetic: Result disclosure

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 Type: Interventional
• Enrollment (Estimated): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130-4817
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Results; Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.	Genetic: Result disclosure; Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.
Experimental: Delayed Results; Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.	Genetic: Result disclosure; Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C change	Change in LDL-C after 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Pharmacotherapy	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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	Medication adherence at 6 months, measured by the Beliefs About Medicines Questionnaire (BMQ). Statements are scored on a scale from 1 to 5, with higher scores indicating stronger beliefs in the concept.	6 months
Cascade testing	The number of first-degree relatives having undergone genetic testing at 6 months.	6 months
Lifestyle behaviors	Proportion of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses.	6 months
Healthcare costs	Healthcare costs at 6 months, determined by budget impact analysis using administrative data.	6 months
Quality of life (Veterans RAND Survey)	Quality of life, measured by the Veterans RAND (distributed by RAND Corporation) 12-item Health Survey (VR-12). Items are scored using an algorithm and summarized into two scores, a Physical Component Score and a Mental Component Score. Outcomes are compared to standardized scores and may be reported as z-scores.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Study Chair: Jason L Vassy, MD MPH, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: MVP030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified individual-level trial data through a data repository housed on a secure VA server and accessible only to outside investigators with IRB and other regulatory approvals. MVP ROAR Study data will also be stored in the VA MVP Central Database.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No