- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02742545
Impact of MayoExpertAdvisor on Provider Adherence (MEA Research)
Impact of MayoExpertAdvisor (MEA) on Provider Adherence to Guideline Recommended Treatment for Hyperlipidemia, Atrial Fibrillation, and Heart Failure
This study evaluates the efficacy of MayoExpertAdvisor (MEA), a knowledge delivery tool, to improve adherence to best practices for patients with hyperlipidemia, atrial fibrillation and heart failure. Half of the clinicians will receive MEA, while the other half will not receive MEA.
The investigators hypothesize care teams with access to MEA will act upon recommendations at a higher rate than those care teams in the standard of care arm without access to MEA.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
MEA is designed to increase adherence to consensus national guidelines and quality measures which are the standard of care for hyperlipidemia, atrial fibrillation, and heart failure. These diseases were selected based on national data which suggest there is less than optimal adherence to standard of care therapy and this non-adherence is associated with adverse cardiovascular outcomes.
There are 29 care teams in the Employee and Community Health (ECH) practice. Care teams are comprised of 4-8 clinicians who provide primary care to between 3,000 and 8000 patients. 8 care teams are resident/fellow led and will be excluded from the study. The remaining 21 care teams in the ECH practice will be stratified by clinic location and provider specialty (Internal Medicine, Family Medicine). 20 care teams will then be cluster-randomized to either the intervention arm or standard of care arm.
Prior to randomization, clinicians in both arms will receive the same educational module to the current guidelines for management of the atrial fibrillation, heart failure and hyperlipidemia. Clinicians in the intervention arm will receive training by the research team on the use of MEA. This training will clearly inform clinicians that they are always to use their best clinical judgment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Clinician Inclusion Criteria:
- Physicians
- Assistants
- Nurse Practitioners
Clinician Exclusion Criteria:
- Clinicians providing care to nursing home patients
- Pediatricians
- Residents and fellows
Patient Record Inclusion Criteria:
- Diagnosis of hyperlipidemia, atrial fibrillation, and/or heart failure
Patient Record Exclusion Criteria:
- Unscheduled visits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MayoExpertAdvisor
Clinicians in care teams assigned to the intervention arm will have access to MayoExpertAdvisor (MEA) in the electronic medical record (EMR).
MEA will provide patient-specific knowledge and treatment suggestions for patients with hyperlipidemia, atrial fibrillation, and/or heart failure via a clickable tab in the Mayo Clinic EMR.
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Access to MayoExpertAdvisor (MEA) in the electronic medical record (EMR).
MEA will provide patient-specific knowledge and treatment suggestions for patients with hyperlipidemia, atrial fibrillation, and/or heart failure via a clickable tab in the Mayo Clinic EMR.
|
|
No Intervention: Usual Care
Clinicians in care teams assigned to the standard of care arm will continue to provide up-to-date, patient-specific guideline-based treatment recommendations as is the standard of care at Mayo Clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of pre-visit recommendations for hyperlipidemia acted upon by providers
Time Frame: Baseline to 6 months
|
Baseline to 6 months
|
|
Percentage of pre-visit recommendations for atrial fibrillation acted upon by providers
Time Frame: Baseline to 6 months
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Baseline to 6 months
|
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Percentage of pre-visit recommendations for heart failure acted upon by providers
Time Frame: Baseline to 6 months
|
Baseline to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul M McKie, M.D., Mayo Clinic
Publications and helpful links
General Publications
- McKie PM, Kor DJ, Cook DA, Kessler ME, Carter RE, Wilson PM, Pencille LJ, Hickey BC, Chaudhry R. Computerized Advisory Decision Support for Cardiovascular Diseases in Primary Care: A Cluster Randomized Trial. Am J Med. 2020 Jun;133(6):750-756.e2. doi: 10.1016/j.amjmed.2019.10.039. Epub 2019 Dec 18.
- Kessler ME, Carter RE, Cook DA, Kor DJ, McKie PM, Pencille LJ, Scheitel MR, Chaudhry R. Impact of electronic clinical decision support on adherence to guideline-recommended treatment for hyperlipidaemia, atrial fibrillation and heart failure: protocol for a cluster randomised trial. BMJ Open. 2017 Dec 4;7(12):e019087. doi: 10.1136/bmjopen-2017-019087.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-008444
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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