High Risk Atherosclerotic Cardiovascular DiseaseNCT04394715
Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)
A study testing Electronic Alert in people with High Risk Atherosclerotic Cardiovascular Disease, run by Yale University at 4 sites in United States.
Trial summary
This study is designed to evaluate the efficacy of automated electronic alerts in the electronic health record to improve rates of best practices in the treatment of patients with hyperlipidemia who present in the setting of outpatient primary care and family medicine practices within the Yale New Haven Health System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Atherosclerotic Cardiovascular Disease
- What is being tested?
- Electronic Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,596 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2021to 9 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or greater
- Currently being seen as an outpatient of Internal Medicine or Cardiology within the Yale New Haven Health System
- At very high risk for ASCVD, defined by a history of a major ASCVD event, and most recent lipid profile with LDL-C greater than 70 mg/dL, with or without other high-risk features (diabetes, CKD, age >65 years)
- Practicing at an outpatient cardiology or internal medicine practice with the Yale New Haven Health System
- High frequency of eligible patients seen, based on retrospective review of outpatient records
Who cannot join
- Heart transplant recipient
- Left ventricular assist device recipient
- Hospital inpatient status
- Pregnancy
- Have opted out of clinical research in MyChart
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bridgeport Hospotal
Bridgeport, Connecticut, 06610
Greenwich Hospital
Greenwich, Connecticut, 06830
Yale New Haven Hospital
New Haven, Connecticut, 06510
St. Raphael's Hospital
New Haven, Connecticut, 06511
About this study
This study is designed to evaluate the efficacy of automated electronic alerts in the electronic health record to improve rates of best practices in the treatment of patients with hyperlipidemia who present in the setting of outpatient primary care and family medicine practices within the Yale New Haven Health System.
Read the detailed description
Cardiovascular disease (CVD) remains the leading cause of death in most developed countries, including the United States. A key risk factor for CVD is an elevation in low-density lipoprotein cholesterol, or LDL-C. Based on favorable results from large clinical trials, guidelines support the use of high intensity statin therapy for the reduction of LDL-C in very high risk patients and addition of non-statin therapies including ezetimibe and PCSK9 inhibitors if the LDL-C remains above 70 mg/dL. However, implementation of these guidelines is poor and there remains substantial underuse of evidence-based lipid lowering therapies across healthcare systems.
Real-time alerting to important clinical conditions, when fired in an appropriate and timely manner, can have positive impacts on patient outcomes through increased physician awareness and adherence to best practices. To this end, this study has been designed to evaluate whether automated electronic alerts built into the Epic electronic health record can improve the management of hyperlipidemia among patients of outpatient internal medicine and cardiology practices within the Yale New Haven Health System who are at very high risk for future atherosclerotic CVD (ASCVD) events.
One hundred physicians will undergo cluster randomization to either the alert group or the control (usual care) group. Upon opening the order entry screen of an eligible patient with hyperlipidemia, the alert group will receive an informational alert that informs the provider that the patient has hyperlipidemia and is at very high risk for future ASCVD events and provides ACC/AHA-guideline-directed actionable items, including a link to a hyperlipidemia "order set" to include both diagnostic and therapeutic options.
The primary outcome will be the proportion of patients who have intensification of their lipid lowering therapy (increase in statin dose or addition of ezetimibe or addition of a PCSK9 inhibitor) at 90-days. The secondary outcomes will be achieved LDL-C at 6-months and proportion of patients with LDL-C levels less than 70 mg/dL and less than 55 mg/dL. In an optional extension phase, long-term exploratory outcomes looking at the rate of major cardiovascular cardiac events (MACE), defined as hospitalization for myocardial infarction, stroke, unstable angina, or coronary or peripheral artery revascularization will be evaluated at 2 years.
- Being tested
- Electronic Alert
- Keywords
- electronic alerts, hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic AlertOther
Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. Receives: Other: Electronic Alert |
| Control | No intervention | Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Intensification of Lipid Lowering Therapy
Intensification of lipid lowering therapy is defined as an increase in statin dose, an addition of ezetimibe, or addition of PCSK9. Any one of the three will be sufficient to meet this endpoint. Proportion of patients who meet this endpoint will be compared between study arms.
Measured: 90 days from first alert for any given patient
Secondary outcomes (3)
Achieved LDL-C at 6 Months
LDL-C at 6 months as measured by medical record review
Measured: 6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 70 mg/dL
Number of patients with LDL-C levels less than 70 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.
Measured: 6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 55 mg/dL
Number of patients with LDL-C levels less than 55 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.
Measured: 6 months from first alert for any given patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jun 2021
- Primary completion9 Jun 2022
- Study completion9 Sep 2022
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 (2)Papers the sponsor has linked to this study.
- Other trials for High Risk Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nihar Desai, MD MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394715
- Sponsor's protocol ID
- 2000027852
- Status last verified
- Aug 2024
- First submitted
- 14 May 2020
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data underlying results for publication will be shared upon publication.
Publications
Shah NN, Ghazi L, Yamamoto Y, Kumar S, Martin M, Simonov M, Riello Iii RJ, Faridi KF, Ahmad T, Wilson FP, Desai NR. Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID): A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2024 May;17(5):e010335. doi: 10.1161/CIRCOUTCOMES.123.010335. Epub 2024 Apr 18.
PubMed 38634282Shah NN, Ghazi L, Yamamoto Y, Martin M, Simonov M, Riello RJ, Faridi KF, Ahmad T, Wilson FP, Desai NR. Rationale and design of a pragmatic trial aimed at improving treatment of hyperlipidemia in outpatients with very high risk atherosclerotic cardiovascular disease: A pragmatic trial of messaging to providers about treatment of hyperlipidemia (PROMPT-LIPID). Am Heart J. 2022 Nov;253:76-85. doi: 10.1016/j.ahj.2022.07.002. Epub 2022 Jul 14.
PubMed 35841944
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)
- ClinicalTrials.gov ID
- NCT04394715
- Acronym / sponsor ID
- 2000027852
- Keywords
- electronic alerts, hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,596 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the efficacy of automated electronic alerts in the electronic health record to improve rates of best practices in the treatment of patients with hyperlipidemia who present in the setting of outpatient primary care and family medicine practices within the Yale New Haven Health System.
Detailed description
Cardiovascular disease (CVD) remains the leading cause of death in most developed countries, including the United States. A key risk factor for CVD is an elevation in low-density lipoprotein cholesterol, or LDL-C. Based on favorable results from large clinical trials, guidelines support the use of high intensity statin therapy for the reduction of LDL-C in very high risk patients and addition of non-statin therapies including ezetimibe and PCSK9 inhibitors if the LDL-C remains above 70 mg/dL. However, implementation of these guidelines is poor and there remains substantial underuse of evidence-based lipid lowering therapies across healthcare systems.
Real-time alerting to important clinical conditions, when fired in an appropriate and timely manner, can have positive impacts on patient outcomes through increased physician awareness and adherence to best practices. To this end, this study has been designed to evaluate whether automated electronic alerts built into the Epic electronic health record can improve the management of hyperlipidemia among patients of outpatient internal medicine and cardiology practices within the Yale New Haven Health System who are at very high risk for future atherosclerotic CVD (ASCVD) events.
One hundred physicians will undergo cluster randomization to either the alert group or the control (usual care) group. Upon opening the order entry screen of an eligible patient with hyperlipidemia, the alert group will receive an informational alert that informs the provider that the patient has hyperlipidemia and is at very high risk for future ASCVD events and provides ACC/AHA-guideline-directed actionable items, including a link to a hyperlipidemia "order set" to include both diagnostic and therapeutic options.
The primary outcome will be the proportion of patients who have intensification of their lipid lowering therapy (increase in statin dose or addition of ezetimibe or addition of a PCSK9 inhibitor) at 90-days. The secondary outcomes will be achieved LDL-C at 6-months and proportion of patients with LDL-C levels less than 70 mg/dL and less than 55 mg/dL. In an optional extension phase, long-term exploratory outcomes looking at the rate of major cardiovascular cardiac events (MACE), defined as hospitalization for myocardial infarction, stroke, unstable angina, or coronary or peripheral artery revascularization will be evaluated at 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Electronic AlertProviders will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record. |
| Control | No intervention | –Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years of age or greater
- Currently being seen as an outpatient of Internal Medicine or Cardiology within the Yale New Haven Health System
- At very high risk for ASCVD, defined by a history of a major ASCVD event, and most recent lipid profile with LDL-C greater than 70 mg/dL, with or without other high-risk features (diabetes, CKD, age >65 years)
- Practicing at an outpatient cardiology or internal medicine practice with the Yale New Haven Health System
- High frequency of eligible patients seen, based on retrospective review of outpatient records
Key exclusion criteria (5 listed)
- Heart transplant recipient
- Left ventricular assist device recipient
- Hospital inpatient status
- Pregnancy
- Have opted out of clinical research in MyChart
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 |
|---|---|---|
| Electronic AlertProviders will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits. | Other | Intervention |
Primary outcome
Proportion of Patients With Intensification of Lipid Lowering Therapy
Time frame: 90 days from first alert for any given patient
Intensification of lipid lowering therapy is defined as an increase in statin dose, an addition of ezetimibe, or addition of PCSK9. Any one of the three will be sufficient to meet this endpoint. Proportion of patients who meet this endpoint will be compared between study arms.
3 secondary outcomes
Achieved LDL-C at 6 Months
Time frame: 6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 70 mg/dL
Time frame: 6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 55 mg/dL
Time frame: 6 months from first alert for any given patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38634282Shah NN, Ghazi L, Yamamoto Y, Kumar S, Martin M, Simonov M, Riello Iii RJ, Faridi KF, Ahmad T, Wilson FP, Desai NR. Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID): A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2024 May;17(5):e010335. doi: 10.1161/CIRCOUTCOMES.123.010335. Epub 2024 Apr 18.
- Derived from this study: PubMed 35841944Shah NN, Ghazi L, Yamamoto Y, Martin M, Simonov M, Riello RJ, Faridi KF, Ahmad T, Wilson FP, Desai NR. Rationale and design of a pragmatic trial aimed at improving treatment of hyperlipidemia in outpatients with very high risk atherosclerotic cardiovascular disease: A pragmatic trial of messaging to providers about treatment of hyperlipidemia (PROMPT-LIPID). Am Heart J. 2022 Nov;253:76-85. doi: 10.1016/j.ahj.2022.07.002. Epub 2022 Jul 14.
- Individual participant dataSharing planned: Yes. Deidentified data underlying results for publication will be shared upon publication.
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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.
Nihar Desai, MD MPH principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Alert in people with High Risk Atherosclerotic Cardiovascular Disease, run by Yale University at 4 sites 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 5 inclusion and 5 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 Sep 2024). 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?
Proportion of Patients With Intensification of Lipid Lowering Therapy (time frame: 90 days from first alert for any given patient). 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 NCT04394715, 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 3 Sep 2024.