Quality Improvement and Personalization for Statins
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators developed novel quality improvement intervention consisting of a
      personalized decision support tool, an educational program, a performance measure, and an
      audit and feedback system to encourage the adoption of the VA/DoD guidelines for the use of
      statin medicines. The investigators then performed a cluster randomized trial of the
      intervention in a single clinic.
    

Detailed description: 
      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.

      Post-study clarification: The analysis divided the study in to three time periods. There was
      a period before the intervention (pre-QI) from December 12, 2015 to March 20, 2016; during
      the intervention (QI) from March 29-June 30, 2016, and after the intervention (post-QI) from
      July 1, 2016 to September 30, 2016. Each period was divided by study arm. All analyses were
      compared to the pre-QI baseline. Analyses were at the level of the patient visit. Eligible
      patients were those recommended statins by the VA/DoD clinical practice guidelines, but not
      receiving them.
    

Intervention name(s): Statin Decision Support Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cardiovascular Disease; Quality Improvement; Decision Support Tool; Performance Measurement; Primary Prevention