HyperlipidemiaMEA ResearchNCT02742545
Impact of MayoExpertAdvisor on Provider Adherence
A study testing MayoExpertAdvisor in people with Hyperlipidemia and Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Atrial Fibrillation, Heart Failure
- What is being tested?
- MayoExpertAdvisor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,248 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperlipidemia, Atrial Fibrillation, Heart Failure
- Being tested
- MayoExpertAdvisor
- Medical subject headings
- Hyperlipidemias, Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MayoExpertAdvisorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MayoExpertAdvisor | Experimental | 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. Receives: Behavioral: MayoExpertAdvisor |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pre-visit recommendations for hyperlipidemia acted upon by providers
Measured: Baseline to 6 months
Percentage of pre-visit recommendations for atrial fibrillation acted upon by providers
Measured: Baseline to 6 months
Percentage of pre-visit recommendations for heart failure acted upon by providers
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 2,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul M. McKie, M.D., Mayo Clinic
- Investigators
- Paul M McKie, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742545
- Sponsor's protocol ID
- 15-008444
- Acronym
- MEA Research
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Patient identifiers will be removed from the data prior to submission to the researchers.
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.
PubMed 31862329Kessler 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.
PubMed 29208620
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of MayoExpertAdvisor (MEA) on Provider Adherence to Guideline Recommended Treatment for Hyperlipidemia, Atrial Fibrillation, and Heart Failure
- ClinicalTrials.gov ID
- NCT02742545
- Acronym / sponsor ID
- MEA Research / 15-008444
- Conditions
- Hyperlipidemia, Atrial Fibrillation, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,248 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MayoExpertAdvisor | Experimental | Behavioral: MayoExpertAdvisorClinicians 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MayoExpertAdvisorAccess 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. | Behavioural | MayoExpertAdvisor |
Primary outcome
Percentage of pre-visit recommendations for hyperlipidemia acted upon by providers
Time frame: Baseline to 6 months
Percentage of pre-visit recommendations for atrial fibrillation acted upon by providers
Time frame: Baseline to 6 months
Percentage of pre-visit recommendations for heart failure acted upon by providers
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 31862329McKie 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.
- Derived from this study: PubMed 29208620Kessler 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Patient identifiers will be removed from the data prior to submission to the researchers.
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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.
Paul M McKie, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MayoExpertAdvisor in people with Hyperlipidemia and Atrial Fibrillation, run by Mayo Clinic 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?
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 18 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of pre-visit recommendations for hyperlipidemia acted upon by providers (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. 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 NCT02742545, which also lists 2 linked publications.
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 18 Apr 2019.