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Risk Score Alerts for Chest Pain Care
This study is currently recruiting participants.
Verified by Harvard Vanguard Medical Associates, March 2009
First Received: May 6, 2008   Last Updated: March 20, 2009   History of Changes
Sponsors and Collaborators: Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Information provided by: Harvard Vanguard Medical Associates
ClinicalTrials.gov Identifier: NCT00674375
  Purpose

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
Chest Pain
Acute Myocardial Infarction
Other: Electronic risk alerts
Other: Usual care
Phase III

MedlinePlus related topics: Chest Pain Exercise and Physical Fitness Heart Attack
U.S. FDA Resources
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?

Further study details as provided by Harvard Vanguard Medical Associates:

Primary Outcome Measures:
  • Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%. [ Time Frame: During office visit ] [ Designated as safety issue: No ]
  • Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10% [ Time Frame: During office visit ] [ Designated as safety issue: No ]
  • Performance of exercise stress testing for patients with Framingham Risk Score less than 10% [ Time Frame: Within 2 months of office visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
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.
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%.
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.
Other: Usual care
No electronic risk alerts are delivered during office visits

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674375

Contacts
Contact: Amy Marston, BA 617-559-8085 Amy_Marston@vmed.org
Contact: Thomas Sequist, MD 617-525-7509 tsequist@partners.org

Locations
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            
Sponsors and Collaborators
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Investigators
Principal Investigator: Thomas D Sequist, MD, MPH Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
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

Keywords provided by Harvard Vanguard Medical Associates:
Chest Pain
Acute Myocardial Infarction
Patient Safety
Misdiagnosis

Study placed in the following topic categories:
Signs and Symptoms
Necrosis
Heart Diseases
Aspirin
Myocardial Ischemia
Vascular Diseases
Pain
Ischemia
Infarction
Myocardial Infarction
Chest Pain

Additional relevant MeSH terms:
Signs and Symptoms
Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Pain
Ischemia
Infarction
Myocardial Infarction
Chest Pain

ClinicalTrials.gov processed this record on May 07, 2009