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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The investigators are trying to understand the impact of the new VA/DoD cholesterol guidelines on primary care clinics and what the VA or the clinic could do to help clinicians and teamlets improve their statin use. To do this, the investigators will talk to providers about these guidelines and perform a brief intervention to help providers meet the guidelines' recommendations.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: Statin Decision Support Intervention Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Practicing PACT primary care physician in the Ann Arbor VA Healthcare System.

Exclusion Criteria:


Information from the National Library of Medicine

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


Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jeremy B. Sussman, MD MS VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02820870     History of Changes
Other Study ID Numbers: QUX 16-002
QUE 15-286 ( Other Grant/Funding Number: VA )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Cardiovascular Disease
Quality Improvement
Decision Support Tool
Performance Measurement
Primary Prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents