Quality Improvement and Personalization for Statins (QUIPS)
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|ClinicalTrials.gov Identifier: NCT02820870|
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Behavioral: Statin Decision Support Intervention||Not Applicable|
The VA/DoD Committee on Clinical Practice Guidelines for the Management of Dyslipidemia for Cardiovascular Risk Reduction has created clinical practice guidelines that have been officially adopted by VA. The new guidelines are substantially different than previous guidelines, and arguably somewhat more complicated. Complicating matters somewhat, the American Heart Association and American College of Cardiology passed similar, but not identical, guidelines one year earlier and VA is also planning to adopt HEDIS (Healthcare Effectiveness Data and Information Set) performance measures for managing dyslipidemia, which are also similar, but not identical to the VA guidelines. Changing recommendations plus this misalignment - two guidelines, one performance measure, none identical or perfectly-understood - could create confusion and unclear guidance for practitioners.
The investigators are proposing a partnership with CAR and VA Ann Arbor Primary Care on a QI project to improve the adoption of these guidelines with a time and resource-efficient implementation strategy that will be tested in ten PACT teamlets.
As part of the larger project, the investigators have designed an efficient, multi-pronged intervention to improve statin use. The investigators first developed a preliminary intervention. The investigators then already conducted an assessment of the barriers and facilitators to implementation to obtain provider feedback to improve the planned intervention and develop ideas to make it better.
The intervention will have two parts. First, all clinicians at VA Ann Arbor received an educational session about the new guidelines. Second, the investigators have randomly divided the PACT teamlets in half. One half, "usual care," will receive all changes that VA in planning for the new guidelines.
The providers in the "intervention" group will receive the full intervention. This includes a personalized decision support tool for every guideline-discordant patient during the time of the intervention based on the VA guidelines. They will also receive automated personalized audit and feedback reports based on the guidelines that the investigators have developed together with VA's Center for Analytics and Reporting (CAR). Providers will also receive a poster in their clinical rooms alerting patients that the guidelines have changed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Quality Improvement and Personalization for Statins (QUIPS) (QUE 15-286)|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||October 1, 2016|
Experimental: Primary Care Intervention Group
Primary care providers will receive a generated print-out of statin recommendations for patient whose current medication therapy is not consistent with the new guidelines (i.e., are "guideline discordant"). Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the teamlets for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guidelines.
Behavioral: Statin Decision Support Intervention
The investigators have developed a "mock" medical record decision support tool for this project. Each week the investigators will pull a list of patients scheduled for a primary care visit at the Ann Arbor VAMC then calculate each patient's risk based on the clinical guidelines algorithm and compare the statin recommendation against their current prescriptions. For each patient whose current medication therapy is not consistent with the new guidelines (i.e., are "guideline discordant"), a brief recommendation will be generated. Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the providers for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guideline.
No Intervention: Usual Care Group
PACT teams that were not randomized to the intervention will serve as a usual care group and will be expected to follow the VA guidelines and HEDIS measures as part of the VA national roll-out.
- Pre/post change in the % of patients meeting the VA/DoD Cholesterol Guidelines [ Time Frame: Up to 10 months ]The investigators will assess the impact the decision support tool intervention has in the percentage of patients who meet the VA/DoD Cholesterol Guidelines.
- Percentage of providers who adopt the VA/DoD Cholesterol Guidelines [ Time Frame: Up to 10 months ]Providers will be surveyed pre/post about their willingness to adopt the cholesterol guidelines.
- Change in provider knowledge of the VA/DoD Guidelines [ Time Frame: One month prior to and one month after the intervention ]Providers will be surveyed pre/post about their knowledge of the cholesterol guidelines.
- Change in provider satisfaction with the VA/DoD Guidelines [ Time Frame: One month prior to and one month after the intervention ]Providers will be surveyed pre/post about their satisfaction with the the cholesterol guidelines.
- Frequency of statin discussions between providers and patients [ Time Frame: Up to 10 months ]Following each appointment, patients whose providers are in the intervention will be surveyed about whether they discussed statins with their primary care provider. A medical record chart review will also be conducted to assess whether a conversation took place between the patient and provider.
- Quality and consistency with which the guidelines were followed [ Time Frame: Start of the intervention to 2 months after the intervention ]The investigators will conduct chart reviews, survey providers and conduct ad-hoc interviews to determine on why statin changes were not made per the VA/DoD Cholesterol recommendations.
- Provider assessment form return [ Time Frame: Start of the intervention to 2 months after the intervention ]As a fidelity evaluation, the investigators will assess the rates at which providers return the forms assessing why their guideline-discordant patients did or did not have their statin treatment changed.
- Patient assessment form return [ Time Frame: Start of the intervention to 2 months after the intervention ]As a fidelity evaluation, the investigators will assess the rates at which patients return the forms assessing why they did or did not have their statin treatment changed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820870
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Jeremy B. Sussman, MD MS||VA Ann Arbor Healthcare System, Ann Arbor, MI|