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Standardizing Emergency Work-ups Around Risk Data (STEWARD)

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: NCT03286179
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
Chest pain is the second leading reason for emergency department (ED) visits in the United States. Resource utilization for this ED subpopulation is particularly high, in part due to a dearth of accepted standardized clinical approaches and general overestimation of risk on the part of both providers and patients. This prospective observational cohort study seeks to address this issue by providing externally validated risk scores for major adverse cardiac events using a web-based clinical decision support platform (RISTRA) embedded within the electronic health record at 13 Kaiser Permanente Northern California (KPNC) EDs over a 12-month period. The decision support will provide risk estimates specific to the KPNC patient population. This studies hypothesis is that the provision of more accurate risk estimation for major adverse cardiac events will improve informed decision making by both providers and patients, resulting in less provocative testing and lower ED lengths of stay amongst low risk patients, as well as improving medical management among non-low risk patients and decreasing future rates of major adverse cardiac events.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Chest Pain Risk Reduction Other: modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Standardizing Emergency Work-ups Around Risk Data (STEWARD): The CREST Network Chest Pain Project
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain


Intervention Details:
  • Other: modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)
    Provision of estimated risk for major cardiac events at 60 days based on the modified HEART and/or EDACS, using KPNC specific estimates derived from an internal validation study


Primary Outcome Measures :
  1. Major adverse cardiac event (MACE) [ Time Frame: 12 months ]
    A composite outcome of either acute myocardial infarction, cardiac arrest, malignant arrhythmia, cardiac-related mortality


Secondary Outcome Measures :
  1. Provocative and anatomic cardiac testing rates [ Time Frame: 12 months ]
    Treadmill stress test, myocardial perfusion imaging, stress echocardiography, CT coronary angiography, catheter-based coronary angiography

  2. Emergency department length of stay [ Time Frame: 12 months ]
    Total hours spent in the emergency department among study eligible patients

  3. Hospital admission rate [ Time Frame: 12 months ]
    Percentage of hospital admissions among study eligible patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients presenting to KPNC emergency departments with above elgibilty criteria
Criteria

Inclusion Criteria:

  • Emergency department chief complaint of chest pain or chest discomfort
  • Clinical concern for possible cardiac ischemia

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): NCT03286179


Locations
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United States, California
Kaiser Permanente Antioch Emergency Department
Antioch, California, United States, 94531
Kaiser Permanente Fremont Emergency Department
Fremont, California, United States, 94538
Kaiser Permanente Oakland Emergency Department
Oakland, California, United States, 94611
Kaiser Permanente Richmond Emergency Department
Richmond, California, United States, 94801
Kaiser Permanente Roseville Emergency Department
Roseville, California, United States, 95661
Kaiser Permanente South Sacramento Emergency Department
Sacramento, California, United States, 95823
Kaiser Permanente Sacramento Emergency Department
Sacramento, California, United States, 95825
Kaiser Permanente San Francisco Emergency Department
San Francisco, California, United States, 94115
Kaiser Permanente San Leandro Emergency Department
San Leandro, California, United States, 94577
Kaiser Permanente San Rafael Emergency Department
San Rafael, California, United States, 94903
Kaiser Permanente South San Francisco Emergency Department
South San Francisco, California, United States, 94080
Kaiser Permanente Walnut Creek Emergency Department
Walnut Creek, California, United States, 94596
Sponsors and Collaborators
Kaiser Permanente

Publications:

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03286179    
Other Study ID Numbers: CN-16-2648
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Emergencies
Chest Pain
Disease Attributes
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms