Risk Score Alerts for Chest Pain Care
Can Risk Score Alerts Improve Office Care for Chest Pain?
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Newton、Massachusetts、アメリカ、02466
- Harvard Vanguard Medical Associates
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
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:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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介入なし: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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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 |
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Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.
時間枠: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%
時間枠: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%
時間枠:Within 2 months of office visit
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Within 2 months of office visit
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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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.
時間枠: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.
時間枠:Within 2 months
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Within 2 months
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協力者と研究者
捜査官
- 主任研究者:Thomas D Sequist, MD, MPH、Brigham and Women's Hospital
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。