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OpenTrials
Completed

NCT Number: NCT03286179

Standardizing Emergency Work-ups Around Risk Data

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Antioch Emergency Department, Antioch, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Standardizing Emergency Work-ups Around Risk Data (STEWARD): The CREST Network Chest Pain Project

Acronym: STEWARD

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 18, 2017
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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