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Risk Score Alerts for Chest Pain Care

This study is not yet open for participant recruitment.
Verified by Harvard Vanguard Medical Associates, May 2008

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
Phase III

MedlinePlus related topics:   Chest Pain    Exercise and Physical Fitness    Heart Attack    Stress   

Drug Information available for:   Acetylsalicylic acid   

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:   September 2008
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   October 2009 (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.

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:

  • All adults 30 years and older presenting to one of 14 ambulatory health centers with a complaint of non-traumatic chest pain and their evaluating primary care clinician will be eligible for this study.

Exclusion Criteria:

  • Prior history of coronary heart disease
  • Age <30 years
  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    
      Newton, Massachusetts, United States, 02466
Brigham and Women's Hospital    
      Boston, Massachusetts, United States, 02115

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


Harvard Vanguard Medical Associates  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   Brigham and Women's Hospital ( Thomas Sequist )
Study ID Numbers:   1 R18 HS017075-01
First Received:   May 6, 2008
Last Updated:   May 7, 2008
ClinicalTrials.gov Identifier:   NCT00674375
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:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2008




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