Risk Score Alerts for Chest Pain Care
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|ClinicalTrials.gov Identifier: NCT00674375|
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : March 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Acute Myocardial Infarction||Other: Electronic risk alerts||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Can Risk Score Alerts Improve Office Care for Chest Pain?|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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.
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%.
No Intervention: 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.
- Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%. [ Time Frame: During office visit ]
- Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10% [ Time Frame: During office visit ]
- Performance of exercise stress testing for patients with Framingham Risk Score less than 10% [ Time Frame: Within 2 months of office visit ]
- 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. [ Time Frame: During office visit ]
- 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. [ Time Frame: Within 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674375
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Harvard Vanguard Medical Associates|
|Newton, Massachusetts, United States, 02466|
|Principal Investigator:||Thomas D Sequist, MD, MPH||Brigham and Women's Hospital|