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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL166680-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Carelon Research | OTHER |
| Harvard Pilgrim Health Care | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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ACHIEVE aims to increase statin usage among patients with ASCVD by having a pharmacist talk to patients and providers.
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the United States (U.S.) Statins reduce the risk of cardiovascular events by 30% in those with prior history of ASCVD. Despite being inexpensive and well-tolerated, however, statins are underused in clinical practice, particularly in patients who identify as Black. A large-scale intervention to improve evidence-based statin initiation among individuals with ASCVD is needed, particularly for the Black population. To meet this need, we aim to conduct a multi-center, pragmatic, cluster randomized, controlled trial to assess the impact of a provider- and patient-directed intervention to increase the prescription of, and adherence to, appropriate statin therapy among those with ASCVD (ACHIEVE: A Controlled trial to improve use of High IntEnsity statins for Vascular protEction). The intervention will be pharmacist-led, embedded in commercial payer systems, partnering with the National Committee for Quality Assurance (NCQA), and with a particular emphasis on improving statin use in the Black population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No statin | Patients who are identified with ASCVD who do not take a statin or do not take the recommended dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist call | Other | Pharmacists will call patients and their providers to discuss benefits of statin use |
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| Measure | Description | Time Frame |
|---|---|---|
| Provider engagement as measured by recruitment | The goal is recruiting at least 25% of identified providers. | 2 years |
| Patient engagement as measured by recruitment | The goal is to recruit at least 30% of identified patients overall and within the black population | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes patients who have an ASCVD diagnosis but are currently not treated with a moderate-high intensity statin.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Granger, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carelon Research | Wilmington | Delaware | 19801 | United States | ||
| Duke Clinical Research Institute |
We will provide requested unrestricted data to parties who sign a data sharing agreement which stipulates that data must be: 1) used solely for research purposes, 2) properly acknowledged in resulting publications, 3) kept confidential and inaccessible to third parties, and 4) destroyed or returned after analyses are completed. Additionally, users must agree not to use data to identify individual participants. Letters of agreement will be executed so that research materials can be provided to not-for-profit institutions. The study team further agrees that all resource sharing agreements comply with the Bayh-Dole Act of 1980 and the Technology Transfer Commercialization Act of 2000. We will not be using model organisms.
Data will be shared after publication of the final manuscript and will continue until the data from the main study is available for sharing.
Unrestricted access will be provided to parties who sign a standard data sharing agreement.
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| Durham |
| North Carolina |
| 27701 |
| United States |