Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568601
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Pharmacogenomic Informed Statin Prescribing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reducing Veterans Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease CVD risk However many patients at high-risk for CVD do not accept or adhere to statins This gap in patients use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk The main barriers to using statins are patients perceived lack of benefit excess risk of statin toxicity as well as their misperceptions of their CVD risk Statin pharmacogenomic testing - an application of precision medicine - is a readily available feasible and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit andor reduced risk of statin toxicity or increased risk for CVD By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy the investigators aim to improve patients perceptions of their risk of CVD and statins and in turn their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk
Detailed Description:
Background Despite the proven efficacy and safety of statins nearly 250000 Veterans at high-risk for cardiovascular disease CVD seen annually in primary care are not taking them leading to higher cholesterol levels cardiovascular risk and health care costs Primary care providers and health systems have a critical and unmet need for pragmatic scalable interventions to address gaps in their patients perceptions of the risks and benefits of statin therapy to improve appropriate statin utilization and to lower CVD risk Important prior work by the investigators group demonstrates that pharmacogenomic testing for statin toxicity is feasible improves patients perceptions of statin therapy leads to a doubling in appropriate statin prescribing and lowers cholesterol levels The central hypothesis of this proposal is that disclosure of statin pharmacogenomic test results for statin efficacytoxicity and CVD risk to patients at high-risk for CVD will improve their perceptions of their CVD risk and statins risksbenefits and in turn the proportion of Veterans accepting and adhering to statin therapy to achieve a clinically significant low-density lipoprotein cholesterol LDL reduction
Significance By using a feasible and inexpensive approach of pharmacogenomic testing for common genetic variants reporting on statin efficacy and toxicity and CVD risk the work is significant as it will lead to more patients at high-risk for CVD accepting and adhering to statins This work addresses HSRD research priorities of quality and safety of health care and health care value ORD priorities of increasing substantial real-world impact of VA research and VHA quality measures around statin prescribing and controlling cholesterol levels in patients at high-risk for CVD
Innovation and Impact This proposal uses an innovative approach of pharmacogenomic testing to address patients perceptions of the risks and benefits of statin therapy and their risk of CVD which are known barriers to statin acceptance and adherence The investigators expect a positive impact on reducing CVD risk in Veterans
Specific Aims
1 Reduce cholesterol levels through a precision medicine approach of statin pharmacogenomic testing
2 Improve acceptance of guideline-directed statin therapy through delivery of statin pharmacogenomic test results that communicates statin efficacy and toxicity
3 Identify contextual and economic factors salient for implementing statin pharmacogenomic testing
Methodology A randomized controlled trial focused on effectiveness while secondarily gathering implementation data will enroll 408 primary care patients who are at high-risk for CVD and recommended for statins based on guidelines but not prescribed them Participants will be randomized 11 to intervention guideline-based statin recommendations - guidelines - plus statin pharmacogenomic test results vs control guidelines stratified by prior statin use The primary outcome is change in 12-month LDL Secondary outcomes are new statin prescriptions and patients perceptions of risks and benefits of statins Exploratory analyses will assess statin prescriptions and fills as potential mediators of the intervention Qualitative data from trial participants and their providers will illuminate key factors to consider for future implementation If effective the cost-effectiveness and budget impact of the intervention on LDL during the trial period projected over 10-year and lifetime CVD risk horizons will be measured
Next stepsImplementation An embedded primary care patient-powered caucus and a VA operational stakeholder board representing primary care cardiology pharmacy and the VA Pharmacogenomics Testing for Veterans PHASER clinical program will work with the investigative team to create an implementation blueprint package consisting of patientprovider educational portfolios electronic medical record tools Corporate Data Warehouse queries and laboratory protocols for dissemination to Veterans and VHA facilities
Significance By using a feasible and inexpensive approach of pharmacogenomic testing for common genetic variants reporting on statin efficacy and toxicity and CVD risk the work is significant as it will lead to more patients at high-risk for CVD accepting and adhering to statins This work addresses HSRD research priorities of quality and safety of health care and health care value ORD priorities of increasing substantial real-world impact of VA research and VHA quality measures around statin prescribing and controlling cholesterol levels in patients at high-risk for CVD
Innovation and Impact This proposal uses an innovative approach of pharmacogenomic testing to address patients perceptions of the risks and benefits of statin therapy and their risk of CVD which are known barriers to statin acceptance and adherence The investigators expect a positive impact on reducing CVD risk in Veterans
Specific Aims
1 Reduce cholesterol levels through a precision medicine approach of statin pharmacogenomic testing
2 Improve acceptance of guideline-directed statin therapy through delivery of statin pharmacogenomic test results that communicates statin efficacy and toxicity
3 Identify contextual and economic factors salient for implementing statin pharmacogenomic testing
Methodology A randomized controlled trial focused on effectiveness while secondarily gathering implementation data will enroll 408 primary care patients who are at high-risk for CVD and recommended for statins based on guidelines but not prescribed them Participants will be randomized 11 to intervention guideline-based statin recommendations - guidelines - plus statin pharmacogenomic test results vs control guidelines stratified by prior statin use The primary outcome is change in 12-month LDL Secondary outcomes are new statin prescriptions and patients perceptions of risks and benefits of statins Exploratory analyses will assess statin prescriptions and fills as potential mediators of the intervention Qualitative data from trial participants and their providers will illuminate key factors to consider for future implementation If effective the cost-effectiveness and budget impact of the intervention on LDL during the trial period projected over 10-year and lifetime CVD risk horizons will be measured
Next stepsImplementation An embedded primary care patient-powered caucus and a VA operational stakeholder board representing primary care cardiology pharmacy and the VA Pharmacogenomics Testing for Veterans PHASER clinical program will work with the investigative team to create an implementation blueprint package consisting of patientprovider educational portfolios electronic medical record tools Corporate Data Warehouse queries and laboratory protocols for dissemination to Veterans and VHA facilities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None