Clinical trial NCT04178122: Million Veteran Program Return of Actionable Results
Official title: Million Veteran Program Return of Actionable Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-11-26
Enrollment: 121
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

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

Primary outcomes:
measure: LDL-C change
timeFrame: 6 months
Secondary outcomes:
measure: LDL-C target
timeFrame: 6 months
measure: Pharmacotherapy
timeFrame: 6 months
Other outcomes:
measure: Medication adherence
timeFrame: 6 months
measure: Cascade testing
timeFrame: 6 months
measure: Lifestyle behaviors
timeFrame: 6 months
measure: Healthcare costs
timeFrame: 6 months
measure: Quality of life (Veterans RAND Survey)
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Jason L Vassy, MD MPH
role: STUDY_CHAIR
References: