Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study (EHR-LOCALE)
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Canadian VIGOUR Centre
- 電話番号：(800) 707-9098
- メール：ehlocale@ualberta.ca
研究場所
-
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Alberta
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Edmonton、Alberta、カナダ、T6G2B7
- 募集
- University of Alberta Hospital / Mazankowski Alberta Heart Institute
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コンタクト：
- Pishoy Gouda, MD
- 電話番号：17804072098
- メール：gouda@ualberta.ca
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Edmonton、Alberta、カナダ、T6G3B7
- 募集
- University of Alberta Hospital / Mazankowski Alberta Heart Institute
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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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アクティブコンパレータ：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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
時間枠：From enrollment to the end of intervention at 6 months
|
From enrollment to the end of intervention at 6 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of individuals with repeat lipid panel testing at 3-months and 6-months
時間枠：From enrollment to the end of intervention at 6 months
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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
時間枠：From enrollment to the end of intervention at 6 months
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From enrollment to the end of intervention at 6 months
|
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Absolute difference in lipid values (LDL-C, high-density lipoprotein-cholesterol [HDL-C], non-HDL cholesterol, triglycerides) at six-months
時間枠：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
時間枠：From enrollment to 1 year and 5 years
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From enrollment to 1 year and 5 years
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS
時間枠：From enrollment to the end of intervention at 6 months
|
From enrollment to the end of intervention at 6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Pishoy Gouda, MD、University of Alberta
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Pro00161129
- Canadian VIGOUR Centre (その他の識別子：University of Alberta)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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