MVP-ROAR: Million Veteran Program Return of Actionable Results
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- LDL-C change [6 months]
Change in LDL-C after 6 months.
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Medication adherence [6 months]
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.
- Cascade testing [6 months]
The number of first-degree relatives having undergone genetic testing at 6 months.
- Lifestyle behaviors [6 months]
Proportion of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses.
- Healthcare costs [6 months]
Healthcare costs at 6 months, determined by budget impact analysis using administrative data.
- Quality of life (Veterans RAND Survey) [6 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Living enrollee in MVP
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Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data
Exclusion Criteria:
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Previously underwent genetic testing for the condition of interest
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Is incarcerated
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Is pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | United States | 02130 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- MVP030