- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00674375
Risk Score Alerts for Chest Pain Care
Can Risk Score Alerts Improve Office Care for Chest Pain?
연구 개요
상세 설명
The evaluation of ambulatory patients with chest pain is a challenging and serious problem, accounting for a significant proportion of all outpatient visits. High risk patients may go undetected, resulting in missed diagnoses of acute myocardial ischemia, while low risk patients may be subject to unnecessary evaluations. To substantially improve the evaluation and treatment of outpatients with acute chest pain syndromes, new strategies need to be developed in the primary care setting to risk stratify symptomatic patients and direct appropriate care. Our prior work demonstrates that an elevated Framingham Risk Score (at least 10%) reliably identifies patients with chest pain in the primary care setting who are at high risk for acute myocardial infarction.
This study will implement and evaluate electronic risk alerts to risk stratify outpatients with chest pain and present this information to primary care clinicians within the context of an electronic health record. The intervention will take place within Harvard Vanguard Medical Associates, a multispecialty integrated group practice with 140 primary care physicians caring for approximately 300,000 patients at 14 centers in eastern Massachusetts. With a randomized, controlled study design, the study has three specific aims:
- To identify predictors of risk-appropriate evaluation and treatment of patients presenting to primary care offices with acute chest pain, including race and sex.
- To determine whether rates of appropriate evaluation and treatment of patients with acute chest pain can be improved through the use of point-of-care electronic risk alerts that provide individual patient cardiac risk profiles and tailored evaluation and treatment recommendations to primary care clinicians.
- To perform a cost analysis for the provision of electronic decision support for patients with acute chest pain.
This study has important implications for determining how the treatment of outpatients with chest pain syndromes can be optimized through the innovative use of electronic decision support, while documenting the cost implications of such a strategy. This work will also provide a model for how ambulatory practices across the country can use electronic health records to present real-time patient risk information to clinicians with the goal of improving patient safety and quality, which has important implications for both acute and chronic care.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Newton, Massachusetts, 미국, 02466
- Harvard Vanguard Medical Associates
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults 30 years and older presenting to one of 14 ambulatory health centers and their evaluating primary care clinician will be eligible for this study.
Exclusion Criteria:
- Prior history of coronary heart disease
- Age <30 years
- Presentation for an annual physical examination
- Prior hospital admission or emergency department visit for evaluation of chest pain within 30 days of their presentation to primary care clinician
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
Primary care clinicians (physicians, nurse practitioners, and physician assistants) randomized to the intervention arm will receive electronic alerts within the electronic medical record system during office visits with patients complaining of chest pain.
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Electronic risk alerts within the electronic medical record system will automatically calculate a patient's Framingham Risk Score during office visits for chest pain.
These alerts will recommend electrocardiogram performance and aspirin therapy for patients with Framingham Risk Score at least 10%, and will recommend against exercise stress testing for patients with a Framingham Risk Score less than 10%.
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간섭 없음: 2
Primary care clinicians randomized to the 'no intervention' arm will evaluate and treat patients complaining of chest pain without the aid of electronic risk alerts.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.
기간: During office visit
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During office visit
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Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%
기간: During office visit
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During office visit
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Performance of exercise stress testing for patients with Framingham Risk Score less than 10%
기간: Within 2 months of office visit
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Within 2 months of office visit
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2차 결과 측정
결과 측정 |
기간 |
---|---|
EKG and aspirin therapy for patients with Framingham Risk Score at least 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with a high risk tolerance.
기간: During office visit
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During office visit
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Exercise stress testing for patients with Framingham Risk Score less than 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with lowest risk tolerance.
기간: Within 2 months
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Within 2 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas D Sequist, MD, MPH, Brigham and Women's Hospital
간행물 및 유용한 링크
일반 간행물
- Sequist TD, Marshall R, Lampert S, Buechler EJ, Lee TH. Missed opportunities in the primary care management of early acute ischemic heart disease. Arch Intern Med. 2006 Nov 13;166(20):2237-43. doi: 10.1001/archinte.166.20.2237.
- Sequist TD, Morong SM, Marston A, Keohane CA, Cook EF, Orav EJ, Lee TH. Electronic risk alerts to improve primary care management of chest pain: a randomized, controlled trial. J Gen Intern Med. 2012 Apr;27(4):438-44. doi: 10.1007/s11606-011-1911-6. Epub 2011 Oct 13.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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