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Risk Score Alerts for Chest Pain Care

Primary Purpose

Chest Pain, Acute Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Electronic risk alerts
Sponsored by
Harvard Vanguard Medical Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chest Pain focused on measuring Chest Pain, Acute Myocardial Infarction, Patient Safety, Misdiagnosis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital
  • Harvard Vanguard Medical Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.
Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%
Performance of exercise stress testing for patients with Framingham Risk Score less than 10%

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.
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.

Full Information

First Posted
May 6, 2008
Last Updated
March 17, 2015
Sponsor
Harvard Vanguard Medical Associates
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00674375
Brief Title
Risk Score Alerts for Chest Pain Care
Official Title
Can Risk Score Alerts Improve Office Care for Chest Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Vanguard Medical Associates
Collaborators
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Acute Myocardial Infarction
Keywords
Chest Pain, Acute Myocardial Infarction, Patient Safety, Misdiagnosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electronic risk alerts
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.
Time Frame
During office visit
Title
Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%
Time Frame
During office visit
Title
Performance of exercise stress testing for patients with Framingham Risk Score less than 10%
Time Frame
Within 2 months of office visit
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas D Sequist, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Harvard Vanguard Medical Associates
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02466
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17101942
Citation
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. doi: 10.1001/archinte.166.20.2237.
Results Reference
background
PubMed Identifier
21993999
Citation
Sequist TD, Morong SM, Marston A, Keohane CA, Cook EF, Orav EJ, Lee TH. Electronic risk alerts to improve primary care management of chest pain: a randomized, controlled trial. J Gen Intern Med. 2012 Apr;27(4):438-44. doi: 10.1007/s11606-011-1911-6. Epub 2011 Oct 13.
Results Reference
derived
Links:
URL
http://www.harvardvanguard.org
Description
Harvard Vanguard Medical Associates

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Risk Score Alerts for Chest Pain Care

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