Quality Improvement and Personalization for Statins

NCT02820870 | Completed Results

• 2 other identifiers: QUX 16-002QUE 15-286
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular Disease; Quality Improvement; Decision Support Tool; Performance Measurement; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated

  3 months

• Percent of Provider Response Forms Returned

  3 months

• Responses on Provider Response Forms

  3 months

Study Arms (2)

Primary Care Intervention Group

EXPERIMENTAL

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

Usual Care Group

NO INTERVENTION

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.

Interventions

Statin Decision Support Intervention BEHAVIORAL

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.

Primary Care Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

• B Sussman J, Holleman RG, Youles B, Lowery JC. Quality Improvement and Personalization for Statins: the QUIPS Quality Improvement Randomized Trial of Veterans' Primary Care Statin Use. J Gen Intern Med. 2018 Dec;33(12):2132-2137. doi: 10.1007/s11606-018-4681-6. Epub 2018 Oct 3.

  PMID: 30284172 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

In our submitted publication we chose not to publish the fidelity evaluation, because we think it distracts from the findings of the paper.

Results Point of Contact

• Title: Jeremy Sussman, MD, MS - Principal Investigator
• Organization: VA Center for Clinical Management Research

jeremysu@med.umich.edu

(734) 845-5200

Study Officials

• Jeremy B. Sussman, MD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: July 1, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 20, 2019
• Results First Posted: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)