N/A
N=43
Quality Improvement and Personalization for Statins
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02820870 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated — 102; 95 Visits — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Statin Decision Support Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated |
102; 95 | <0.01 sig |
| SECONDARY Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated |
57; 95 | 0.06 |
| SECONDARY Percent of Provider Response Forms Returned |
211 | — |
| SECONDARY Responses on Provider Response Forms |
45; 26; 16; 25; 8; 8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02820870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.