Trial Outcomes & Findings for Quality Improvement and Personalization for Statins (NCT NCT02820870)
NCT ID: NCT02820870
Last Updated: 2019-12-20
Results Overview
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.
COMPLETED
NA
43 participants
30 days
2019-12-20
Participant Flow
All primary care providers at one VA Medical Center clinic were randomized prior to the start of the intervention. Eligible visits were those with patients who were recommended statins by VA/DoD guidelines, but were not receiving them. The intervention was only performed on intervention arm visits during the 3-month intervention duration.
The unit of analysis was the visit during the 3-month intervention, with clustering for provider. Patients who met VA/DoD statin recommendations were excluded from the project. Each time-period (pre-intervention, intervention, post-intervention) are visits, and hence should have different sample sizes.
Unit of analysis: Visits
Participant milestones
| Measure |
Primary Care Intervention Group
Primary care providers received a personalized decision support tool, an educational program, and an audit and feedback system that evaluated appropriate patients. The intervention lasted 3 months. Providers results for the 3 months prior to the intervention and the 3 months after it ended were also analyzed as controls.
|
Usual Care Group
PACT teams that were not randomized to the intervention also received the educational intervention, but otherwise engaged in usual care.
|
|---|---|---|
|
Before Intervention
STARTED
|
15 538
|
28 672
|
|
Before Intervention
COMPLETED
|
15 538
|
28 672
|
|
Before Intervention
NOT COMPLETED
|
0 0
|
0 0
|
|
Intervention
STARTED
|
15 573
|
28 673
|
|
Intervention
COMPLETED
|
15 573
|
28 673
|
|
Intervention
NOT COMPLETED
|
0 0
|
0 0
|
|
Post Intervention
STARTED
|
15 603
|
28 728
|
|
Post Intervention
COMPLETED
|
15 603
|
28 728
|
|
Post Intervention
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quality Improvement and Personalization for Statins
Baseline characteristics by cohort
| Measure |
Primary Care Intervention Group
n=15 Participants
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.
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.
|
Usual Care Group
n=28 Participants
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.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
28 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Five care teams were randomized. Two with 15 total providers received the intervention. Three, with 28 providers, were the control arm. During the QI period, the intervention arm had 573 eligible visits and the control arm had 673. Our outcome was the chance an appropriate statin would be started at a visit.
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.
Outcome measures
| Measure |
Primary Care Intervention Group
n=573 Visits
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.
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"),
|
Usual Care Group
n=673 Visits
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.
|
|---|---|---|
|
Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated
|
102 Visits
|
95 Visits
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Patient visits in the 3 months following the intervention with the same inclusion criteria used for the intervention. 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.
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.
Outcome measures
| Measure |
Primary Care Intervention Group
n=603 Visits
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.
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"),
|
Usual Care Group
n=728 Visits
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.
|
|---|---|---|
|
Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated
|
57 Visits
|
95 Visits
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Whenever an intervention arm provider received a decision support reminder, they were also given a provider response form.
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.
Outcome measures
| Measure |
Primary Care Intervention Group
n=573 Response forms
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.
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"),
|
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.
|
|---|---|---|
|
Percent of Provider Response Forms Returned
|
211 Response forms
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Data represents the responses on the forms returned. The survey asked respondents if they made changes to their statins and to provide reasoning behind their decisions. Some selected more than one answer and some returned the survey that denoted yes/no but did not answer follow-up question elaborating on their decision.
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.
Outcome measures
| Measure |
Primary Care Intervention Group
n=211 Response forms
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.
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"),
|
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.
|
|---|---|---|
|
Responses on Provider Response Forms
Provider changed statin prescription
|
45 Response forms
|
—
|
|
Responses on Provider Response Forms
Did not change due to: patient allergy
|
26 Response forms
|
—
|
|
Responses on Provider Response Forms
Did not change due to: no time during visit
|
16 Response forms
|
—
|
|
Responses on Provider Response Forms
Did not change due to: Already on statin
|
25 Response forms
|
—
|
|
Responses on Provider Response Forms
Did not change due to: status incorrect
|
8 Response forms
|
—
|
|
Responses on Provider Response Forms
Did not change due to: do not need statin
|
8 Response forms
|
—
|
|
Responses on Provider Response Forms
Did not change due to: patient refusal
|
45 Response forms
|
—
|
Adverse Events
Primary Care Intervention Group
Usual Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeremy Sussman, MD, MS - Principal Investigator
VA Center for Clinical Management Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place