Cardiovascular DiseaseQUIPSNCT02820870
Quality Improvement and Personalization for Statins
A study testing Statin Decision Support Intervention in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Statin Decision Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 1 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
Official title: Quality Improvement and Personalization for Statins (QUIPS) (QUE 15-286)
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Statin Decision Support Intervention
- Keywords
- Cardiovascular Disease, Quality Improvement, Decision Support Tool, Performance Measurement, Primary Prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin Decision Support InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeremy B. Sussman, MD MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820870
- Sponsor's protocol ID
- QUX 16-002
- Other IDs
- QUE 15-286
- Acronym
- QUIPS
- Status last verified
- Dec 2019
- First submitted
- 23 May 2016
- Last updated
- 20 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Information security limitations would make it very difficult to share this data. Please contact the authors with any questions.
Publications
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.
PubMed 30284172
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement and Personalization for Statins (QUIPS) (QUE 15-286)
- ClinicalTrials.gov ID
- NCT02820870
- Acronym / sponsor ID
- QUIPS / QUX 16-002
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular Disease, Quality Improvement, Decision Support Tool, Performance Measurement, Primary Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Posted 20 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Care Intervention Group | Experimental | Behavioral: Statin Decision Support InterventionPrimary 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin Decision Support InterventionThe 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. | Behavioural | Primary Care Intervention Group |
Primary outcome
Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated
Time frame: 30 days
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.
3 secondary outcomes
Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated
Time frame: 3 months
Percent of Provider Response Forms Returned
Time frame: 3 months
Responses on Provider Response Forms
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30284172B 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.
- Individual participant dataSharing planned: No. Information security limitations would make it very difficult to share this data. Please contact the authors with any questions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy B. Sussman, MD MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statin Decision Support Intervention in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.