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Sponsors and Collaborators: |
Harvard Vanguard Medical Associates Brigham and Women's Hospital |
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Information provided by: | Harvard Vanguard Medical Associates |
ClinicalTrials.gov Identifier: | NCT00674375 |
The evaluation of chest pain in the primary care office is a challenging problem, with many patients suffering from missed diagnoses of acute myocardial infarction and many other low risk patients receiving unnecessary evaluations. This project will provide primary care physicians evaluating patients complaining of chest pain with computerized alerts that differentiate high-risk patients from low risk patients, and provide individualized evaluation and treatment recommendations.
Condition | Intervention | Phase |
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Chest Pain Acute Myocardial Infarction |
Other: Electronic risk alerts Other: Usual care |
Phase III |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Can Risk Score Alerts Improve Office Care for Chest Pain? |
Estimated Enrollment: | 6100 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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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Other: Electronic risk alerts
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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2: No Intervention
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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Other: Usual care
No electronic risk alerts are delivered during office visits
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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:
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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy Marston, BA | 617-559-8085 | Amy_Marston@vmed.org |
Contact: Thomas Sequist, MD | 617-525-7509 | tsequist@partners.org |
United States, Massachusetts | |
Harvard Vanguard Medical Associates | Recruiting |
Newton, Massachusetts, United States, 02466 | |
Contact: Amy Marston, BA 617-559-8085 Amy_Marston@vmed.org | |
Contact: Thomas Sequist, MD, MPH 617-525-7509 tsequist@partners.org | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Carol Keohane, BSN 617-525-6660 ckeohane@partners.org | |
Sub-Investigator: Thomas Lee, MD | |
Sub-Investigator: Earl F Cook, ScD | |
Sub-Investigator: John Orav, PhD |
Principal Investigator: | Thomas D Sequist, MD, MPH | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Thomas Sequist ) |
Study ID Numbers: | 1 R18 HS017075-01 |
Study First Received: | May 6, 2008 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00674375 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chest Pain Acute Myocardial Infarction Patient Safety Misdiagnosis |
Signs and Symptoms Necrosis Heart Diseases Aspirin Myocardial Ischemia Vascular Diseases |
Pain Ischemia Infarction Myocardial Infarction Chest Pain |
Signs and Symptoms Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Pain Ischemia Infarction Myocardial Infarction Chest Pain |