QUIPS: Quality Improvement and Personalization for Statins

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02820870
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Behavioral: Statin Decision Support Intervention	N/A

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

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Quality Improvement and Personalization for Statins (QUIPS) (QUE 15-286)
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primary Care Intervention Group 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; 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated [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.

Secondary Outcome Measures

1. Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated [3 months]

   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.

2. Percent of Provider Response Forms Returned [3 months]

   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. Responses on Provider Response Forms [3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Jeremy B. Sussman, MD MS, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02820870
• Other Study ID Numbers: QUX 16-002; QUE 15-286
• First Posted: Jul 1, 2016
• Last Update Posted: Dec 20, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: Cardiovascular Disease; Quality Improvement; Decision Support Tool; Performance Measurement; Primary Prevention
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Primary Care Intervention Group	Usual Care Group
Arm/Group Description	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.	PACT teams that were not randomized to the intervention also received the educational intervention, but otherwise engaged in usual care.
Period Title: Before Intervention
STARTED	15	28
COMPLETED	15	28
NOT COMPLETED	0	0
Period Title: Before Intervention
STARTED	15	28
COMPLETED	15	28
NOT COMPLETED	0	0
Period Title: Before Intervention
STARTED	15	28
COMPLETED	15	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Primary Care Intervention Group	Usual Care Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	15	28	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.2 (8.5)	43.2 (8.1)	44.6 (8.4)
Sex: Female, Male (Count of Participants)
Female	10 66.7%	13 46.4%	23 53.5%
Male	5 33.3%	15 53.6%	20 46.5%
Region of Enrollment (participants) [Number]
United States	15 100%	28 100%	43 100%

Outcome Measures

1. Primary Outcome

Title	Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Primary Care Intervention Group	Usual Care Group
Arm/Group Description	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"),	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.
Measure Participants	15	28
Measure Visits	573	673
Count of Units [Visits]	102	95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary Care Intervention Group, Usual Care Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Logistic
	Comments	With clustering by provider and team.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.00
	Confidence Interval	(2-Sided) 95%; 1.84 to 4.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Primary Care Intervention Group	Usual Care Group
Arm/Group Description	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.	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.
Measure Participants	15	28
Measure Visits	603	728
Count of Units [Visits]	57	95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary Care Intervention Group, Usual Care Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Regression, Logistic
	Comments	With cluster by provider and team.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.65
	Confidence Interval	(2-Sided) 95%; 0.99 to 2.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percent of Provider Response Forms Returned
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Whenever an intervention arm provider received a decision support reminder, they were also given a provider response form.

Arm/Group Title	Primary Care Intervention Group
Arm/Group Description	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.
Measure Participants	15
Measure Response forms	573
Count of Units [Response forms]	211

4. Secondary Outcome

Title	Responses on Provider Response Forms
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Primary Care Intervention Group
Arm/Group Description	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.
Measure Participants	15
Measure Response forms	211
Provider changed statin prescription	45
Did not change due to: patient allergy	26
Did not change due to: no time during visit	16
Did not change due to: Already on statin	25
Did not change due to: status incorrect	8
Did not change due to: do not need statin	8
Did not change due to: patient refusal	45

Adverse Events

Time Frame	The period during which adverse events could have occurred was 3 months.
Adverse Event Reporting Description	There were no adverse events.
Arm/Group Title	Primary Care Intervention Group		Usual Care Group
Arm/Group Description	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.		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.
All Cause Mortality
	Primary Care Intervention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Primary Care Intervention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Primary Care Intervention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/28 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.