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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Canadian VIGOUR Centre
- 전화번호: (800) 707-9098
- 이메일: ehlocale@ualberta.ca
연구 장소
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Alberta
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Edmonton, Alberta, 캐나다, T6G2B7
- 모병
- University of Alberta Hospital / Mazankowski Alberta Heart Institute
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연락하다:
- Pishoy Gouda, MD
- 전화번호: 17804072098
- 이메일: gouda@ualberta.ca
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Edmonton, Alberta, 캐나다, T6G3B7
- 모병
- University of Alberta Hospital / Mazankowski Alberta Heart Institute
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 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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활성 비교기: 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.
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Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
기간: 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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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Proportion of individuals with repeat lipid panel testing at 3-months and 6-months
기간: 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
기간: 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
기간: 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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Composite of all-cause mortality, hospitalization for myocardial infarction, hospitalization for stroke and unplanned coronary revascularization at one-year and five-years
기간: From enrollment to 1 year and 5 years
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From enrollment to 1 year and 5 years
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Pishoy Gouda, MD, University of Alberta
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Pro00161129
- Canadian VIGOUR Centre (기타 식별자: University of Alberta)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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