ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Score Alerts for Chest Pain Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00674375
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : March 18, 2015
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Thomas Dean Sequist, Harvard Vanguard Medical Associates

Brief 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.

Condition or disease Intervention/treatment Phase
Chest Pain Acute Myocardial Infarction Other: Electronic risk alerts Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8000 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.



Primary Outcome Measures :
  1. Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%. [ Time Frame: During office visit ]
  2. Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10% [ Time Frame: During office visit ]
  3. Performance of exercise stress testing for patients with Framingham Risk Score less than 10% [ Time Frame: Within 2 months of office visit ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Harvard Vanguard Medical Associates
Newton, Massachusetts, United States, 02466
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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Dean Sequist, Principal Investigator, Harvard Vanguard Medical Associates
ClinicalTrials.gov Identifier: NCT00674375     History of Changes
Other Study ID Numbers: 1R18HS017075-01 ( U.S. AHRQ Grant/Contract )
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

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

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