Quality Improvement and Personalization for Statins

Cardiovascular Disease Clinical Trial

— QUIPS  

Official title:

Quality Improvement and Personalization for Statins (QUIPS) (QUE 15-286)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820870
• Other study ID #: QUX 16-002
• Secondary ID: QUE 15-286
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 1, 2016

Study information

• Verified date: December 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 1, 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria: This was a clustered study. The investigators randomized five patient-aligned care teams (PACTS), intervened upon the physicians within each PACT, and evaluated the effect on individual patient visits.

• Eligible physicians were practicing PACT primary care physicians in the Ann Arbor VA Healthcare System.

• Eligible patients those who were seen in primary care during the period of analysis who were under 75 and who would be recommended a moderate-or-high-strength statin according to the VA/DoD guidelines, but were not on one at the time of the visit according to the electronic health record

Exclusion Criteria:

• Patient exclusion criteria included patients over the age of 75, or those who had an ICD-9 or ICD-10 codes for ESRD, muscle pain, pregnancy, or in-vitro fertilization in the 2 years prior to the study visit, those who were on moderate-or-high-strength statins, and those who were not eligible according to the guidelines.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated	For a given visit during the study period for a patient who is guideline-appropriate for a moderate-to-high-strength statin but is not on one, the primary outcome is met if that patient is started on a moderate-or-high-strength statin within 30 days from the time of the visit, according to EHR medication data. The analysis was based on visits, not patients. It is possible that patients were included in more than one visit, as long as they were still guideline discordant.	30 days
Secondary	Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated	To test the continued impact of the intervention, after the intervention was complete and both arms were receiving usual care we measured if a statin was started in the 30 days from the time of the visit among patients who are recommended moderate-to-high strength statins by the VA/DoD clinical practice guidelines, but were not on them at the time of their visit. This secondary outcome looks at the stability of the results after the intervention was stopped, not during the intervention. It is a different set of visits and has a different set of numbers from the intervention. During this period both groups received usual care.	3 months
Secondary	Percent of Provider Response Forms Returned	As a fidelity evaluation, the investigators will assess the rates at which providers return the provider response forms, which are given to understand why intervention providers did or did not alter care.	3 months
Secondary	Responses on Provider Response Forms	As a fidelity evaluation, the investigators will assess the reasons providers give for making or not making a clinical change during an intervention visit. We provided forms with check boxes for each of the outcomes listed.	3 months