Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study (EHR-LOCALE)

June 29, 2026 updated by: University of Alberta

The purpose of this study is to determine whether a proactive, EHR-guided approach helps more individuals reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care.

The main question it aims to answer is:

• Does the EHR-LOCALE pathway increases the proportion of patients who reach the LDL-cholesterol target of <1.8 mmol/L at 6 months?

Participants in the interventional group receive:

  • Pharmacist contact
  • Repeat lipid requisitions
  • Review of medications, adherence, and side effects
  • Treatment escalation according to national dyslipidemia guidelines

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

After a heart event, such as a heart attack, many people never reach the cholesterol levels needed to lower their risk of experiencing another heart event even with good care. This research study is evaluating a new way to better support patients in reaching those targets. The EHR-LOCALE study uses Alberta's electronic health record (EHR) to automatically identify these individuals and offer them extra support. Those who are not at their cholesterol target are contacted by a pharmacist, who can order blood tests, review medications, and adjust treatment according to national guidelines.

This project tests whether this proactive, EHR-guided approach helps more patients reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care. Ultimately, it aims to make cholesterol management after a heart event more consistent, equitable, and effective.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults over the age of 18
  2. Resident of Alberta
  3. Individuals hospitalized with an acute coronary syndrome and have undergone coronary angiography.
  4. Able to participate in follow-up contact if randomized to the intervention arm

Exclusion Criteria:

1. In-hospital mortality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Participants in the usual care arm will have data collected (baseline demographics, medical history, laboratory values, medication usage and clinical outcomes) from their health record. Usual care will include follow-up with their primary cardiologist, primary care physician, cardiac rehabilitation team and community pharmacy as per standards of care across Canada and the CCS Dyslipidemia Guidelines. This data will include information regarding their cholesterol levels and cholesterol treatments received as per standard of care practices.
Active Comparator: Quality-improvement intervention
Participants in the intervention will provide verbal consent to participate. In addition to data collection, Pharmacist contact will occur monthly until their cholesterol levels at target or if they no longer wish to participate in the study, no further changes in medications will occur and no further follow-up is required. Participation in the interventional arm can last up to 6 months.
Other: Pharmacist-led lipid optimization pathway
Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of individuals with repeat lipid panel testing at 3-months and 6-months
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Proportion of individuals who undergo escalation or addition of new of lipid lowering therapies
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Absolute difference in lipid values (LDL-C, high-density lipoprotein-cholesterol [HDL-C], non-HDL cholesterol, triglycerides) at six-months
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months
Composite of all-cause mortality, hospitalization for myocardial infarction, hospitalization for stroke and unplanned coronary revascularization at one-year and five-years
Time Frame: From enrollment to 1 year and 5 years
From enrollment to 1 year and 5 years

Other Outcome Measures

Outcome Measure
Time Frame
Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS
Time Frame: From enrollment to the end of intervention at 6 months
From enrollment to the end of intervention at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Pishoy Gouda, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00161129
  • Canadian VIGOUR Centre (Other Identifier: University of Alberta)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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