Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study (EHR-LOCALE)
2 september 2026 uppdaterad av: 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
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
2000
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Canadian VIGOUR Centre
- Telefonnummer: (800) 707-9098
- E-post: ehlocale@ualberta.ca
Studieorter
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G2B7
- Rekrytering
- University of Alberta Hospital / Mazankowski Alberta Heart Institute
-
Kontakt:
- Pishoy Gouda, MD
- Telefonnummer: 17804072098
- E-post: gouda@ualberta.ca
-
Edmonton, Alberta, Kanada, T6G3B7
- Rekrytering
- University of Alberta Hospital / Mazankowski Alberta Heart Institute
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
1. In-hospital mortality
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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.
|
|
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Aktiv komparator: 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.
|
Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
Tidsram: From enrollment to the end of intervention at 6 months
|
From enrollment to the end of intervention at 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Proportion of individuals with repeat lipid panel testing at 3-months and 6-months
Tidsram: From enrollment to the end of intervention at 6 months
|
From enrollment to the end of intervention at 6 months
|
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Proportion of individuals who undergo escalation or addition of new of lipid lowering therapies
Tidsram: 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
Tidsram: From enrollment to the end of intervention at 6 months
|
From enrollment to the end of intervention at 6 months
|
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Composite of all-cause mortality, hospitalization for myocardial infarction, hospitalization for stroke and unplanned coronary revascularization at one-year and five-years
Tidsram: From enrollment to 1 year and 5 years
|
From enrollment to 1 year and 5 years
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS
Tidsram: From enrollment to the end of intervention at 6 months
|
From enrollment to the end of intervention at 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Pishoy Gouda, MD, University of Alberta
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 augusti 2026
Primärt slutförande (Beräknad)
1 september 2027
Avslutad studie (Beräknad)
1 september 2027
Studieregistreringsdatum
Först inskickad
29 juni 2026
Först inskickad som uppfyllde QC-kriterierna
29 juni 2026
Första postat (Faktisk)
6 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00161129
- Canadian VIGOUR Centre (Annan identifierare: University of Alberta)
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