Standardizing Emergency Work-ups Around Risk Data (STEWARD)

August 11, 2020 updated by: Kaiser Permanente

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13419

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients presenting to KPNC emergency departments with above elgibilty criteria

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac event (MACE)
Time Frame: 12 months
A composite outcome of either acute myocardial infarction, cardiac arrest, malignant arrhythmia, cardiac-related mortality
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Emergency department length of stay
Time Frame: 12 months
Total hours spent in the emergency department among study eligible patients
12 months
Hospital admission rate
Time Frame: 12 months
Percentage of hospital admissions among study eligible patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN-16-2648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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