Risk Score Alerts for Chest Pain Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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:

* 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.

Conditions

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Chest Pain Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Electronic risk alerts

Intervention Type OTHER

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%.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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%.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No