Risk Score Alerts for Chest Pain Care

Acute Myocardial Infarction Clinical Trial

Official title:

Can Risk Score Alerts Improve Office Care for Chest Pain?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674375
• Other study ID #: 1R18HS017075-01
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2008
• Last updated: March 17, 2015
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2015
• Source: Harvard Vanguard Medical Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Chest Pain
• Infarction
• Myocardial Infarction

Intervention

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%.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Harvard Vanguard Medical Associates	Newton	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Vanguard Medical Associates	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.		During office visit	No
Primary	Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%		During office visit	No
Primary	Performance of exercise stress testing for patients with Framingham Risk Score less than 10%		Within 2 months of office visit	No
Secondary	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.		During office visit	No
Secondary	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.		Within 2 months	No

External Links

•   Harvard Vanguard Medical Associates