Risk Score Alerts for Chest Pain Care

NCT00674375 | Completed Phase 3 DMC

• 1 other identifier: 1R18HS017075-01
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Chest Pain; Acute Myocardial Infarction

Keywords

Chest Pain; Acute Myocardial Infarction; Patient Safety; Misdiagnosis

Outcome Measures

Primary Outcomes (3)

• Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.

  During office visit

• Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%

  During office visit

• Performance of exercise stress testing for patients with Framingham Risk Score less than 10%

  Within 2 months of office visit

Secondary Outcomes (2)

• 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.

  During office visit

• 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.

  Within 2 months

Study Arms (2)

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

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.

Interventions

Electronic risk alerts 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%.

1

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Vanguard Medical Associates: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Harvard Vanguard Medical Associates

Newton, Massachusetts, 02466, United States

Location

Related Publications (2)

• 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.

  PMID: 17101942 BACKGROUND

• 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.

  PMID: 21993999 DERIVED

Related Links

• Harvard Vanguard Medical Associates

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas D Sequist, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

US (2)