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

NCT07685639 | Not Yet Recruiting

• 2 other identifiers: Pro00161129Canadian VIGOUR Centre
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hyperlipidemia; Dyslipidemia; Low-Density-Lipoprotein-cholesterol Level; ACS (Acute Coronary Syndrome)

Keywords

Dyslipidemia; Canadian VIGOUR Centre; LDL; ACS; triglycerides; lipid

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months

  From enrollment to the end of intervention at 6 months

Secondary Outcomes (4)

• Proportion of individuals with repeat lipid panel testing at 3-months and 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

  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

  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

  From enrollment to 1 year and 5 years

Other Outcomes (1)

• Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS

  From enrollment to the end of intervention at 6 months

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Quality-improvement intervention

ACTIVE COMPARATOR

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

Interventions

Pharmacist-led lipid optimization pathway OTHER

Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management

Quality-improvement intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. In-hospital mortality

Sponsors & Collaborators

• University of Alberta: lead

Related Publications (4)

• Pearson GJ, Thanassoulis G, Anderson TJ, Barry AR, Couture P, Dayan N, Francis GA, Genest J, Gregoire J, Grover SA, Gupta M, Hegele RA, Lau D, Leiter LA, Leung AA, Lonn E, Mancini GBJ, Manjoo P, McPherson R, Ngui D, Piche ME, Poirier P, Sievenpiper J, Stone J, Ward R, Wray W. 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in Adults. Can J Cardiol. 2021 Aug;37(8):1129-1150. doi: 10.1016/j.cjca.2021.03.016. Epub 2021 Mar 26.

  PMID: 33781847 BACKGROUND

• Claessen BE, Guedeney P, Gibson CM, Angiolillo DJ, Cao D, Lepor N, Mehran R. Lipid Management in Patients Presenting With Acute Coronary Syndromes: A Review. J Am Heart Assoc. 2020 Dec 15;9(24):e018897. doi: 10.1161/JAHA.120.018897. Epub 2020 Dec 8.

  PMID: 33289416 BACKGROUND

• Gouda P, Savu A, Bainey KR, Kaul P, Welsh RC. Long-term risk of death and recurrent cardiovascular events following acute coronary syndromes. PLoS One. 2021 Jul 1;16(7):e0254008. doi: 10.1371/journal.pone.0254008. eCollection 2021.

  PMID: 34197547 BACKGROUND

• Welsh RC, Gouda P, Dover D, Bainey KR, McAlister FA, Kaul P. Applicability and impact of the COMPASS trial in a Canadian population of patients with atherosclerotic disease. Atherosclerosis. 2024 Jun;393:117486. doi: 10.1016/j.atherosclerosis.2024.117486. Epub 2024 Mar 16.

  PMID: 38582637 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Hyperlipidemias; Dyslipidemias

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pishoy Gouda, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Canadian VIGOUR Centre

CONTACT

(800) 707-9098; ehlocale@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06