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Acute Coronary SyndromeSTEWARDNCT03286179

Standardizing Emergency Work-ups Around Risk Data

An observational study of Acute Coronary Syndrome and Chest Pain, run by Kaiser Permanente at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)
How many people
13,419 participants
Where
12 sitesUnited States
Study dates
1 Jul 2018to 1 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult patients presenting to KPNC emergency departments with above elgibilty criteria

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Kaiser Permanente Antioch Emergency Department

    Antioch, California, 94531

  • Kaiser Permanente Fremont Emergency Department

    Fremont, California, 94538

  • Kaiser Permanente Oakland Emergency Department

    Oakland, California, 94611

  • Kaiser Permanente Richmond Emergency Department

    Richmond, California, 94801

  • Kaiser Permanente Roseville Emergency Department

    Roseville, California, 95661

  • Kaiser Permanente South Sacramento Emergency Department

    Sacramento, California, 95823

  • Kaiser Permanente Sacramento Emergency Department

    Sacramento, California, 95825

  • Kaiser Permanente San Francisco Emergency Department

    San Francisco, California, 94115

  • Kaiser Permanente San Leandro Emergency Department

    San Leandro, California, 94577

  • Kaiser Permanente San Rafael Emergency Department

    San Rafael, California, 94903

  • Kaiser Permanente South San Francisco Emergency Department

    South San Francisco, California, 94080

  • Kaiser Permanente Walnut Creek Emergency Department

    Walnut Creek, California, 94596

Other trials in United States

About this study

Official title: 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.

Being tested
modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)
Medical subject headings
Acute Coronary Syndrome, Chest Pain, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse cardiac event (MACE)

    A composite outcome of either acute myocardial infarction, cardiac arrest, malignant arrhythmia, cardiac-related mortality

    Measured: 12 months

Secondary outcomes (3)

  1. Provocative and anatomic cardiac testing rates

    Treadmill stress test, myocardial perfusion imaging, stress echocardiography, CT coronary angiography, catheter-based coronary angiography

    Measured: 12 months

  2. Emergency department length of stay

    Total hours spent in the emergency department among study eligible patients

    Measured: 12 months

  3. Hospital admission rate

    Percentage of hospital admissions among study eligible patients

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2017
  2. Study start1 Jul 2018
  3. Primary completion31 Dec 2019
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
13,419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03286179
Sponsor's protocol ID
CN-16-2648
Acronym
STEWARD
Status last verified
Aug 2020
First submitted
13 Sep 2017
Last updated
12 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sabbatini AK, Nallamothu BK, Kocher KE. Reducing variation in hospital admissions from the emergency department for low-mortality conditions may produce savings. Health Aff (Millwood). 2014 Sep;33(9):1655-63. doi: 10.1377/hlthaff.2013.1318.

    PubMed 25201672

  • Venkatesh AK, Dai Y, Ross JS, Schuur JD, Capp R, Krumholz HM. Variation in US hospital emergency department admission rates by clinical condition. Med Care. 2015 Mar;53(3):237-44. doi: 10.1097/MLR.0000000000000261.

    PubMed 25397965

  • Newman DH, Ackerman B, Kraushar ML, Lederhandler MH, Masri A, Starikov A, Tsao DT, Meyers HP, Shah KH. Quantifying Patient-Physician Communication and Perceptions of Risk During Admissions for Possible Acute Coronary Syndromes. Ann Emerg Med. 2015 Jul;66(1):13-8, 18.e1. doi: 10.1016/j.annemergmed.2015.01.027. Epub 2015 Mar 4.

    PubMed 25748480

  • Than MP, Pickering JW, Aldous SJ, Cullen L, Frampton CM, Peacock WF, Jaffe AS, Goodacre SW, Richards AM, Ardagh MW, Deely JM, Florkowski CM, George P, Hamilton GJ, Jardine DL, Troughton RW, van Wyk P, Young JM, Bannister L, Lord SJ. Effectiveness of EDACS Versus ADAPT Accelerated Diagnostic Pathways for Chest Pain: A Pragmatic Randomized Controlled Trial Embedded Within Practice. Ann Emerg Med. 2016 Jul;68(1):93-102.e1. doi: 10.1016/j.annemergmed.2016.01.001.

    PubMed 26947800

  • Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3.

    PubMed 25737484

  • Mark DG, Huang J, Ballard DW, Kene MV, Sax DR, Chettipally UK, Lin JS, Bouvet SC, Cotton DM, Anderson ML, McLachlan ID, Simon LE, Shan J, Rauchwerger AS, Vinson DR, Reed ME; Kaiser Permanente CREST Network Investigators [Link]. Graded Coronary Risk Stratification for Emergency Department Patients With Chest Pain: A Controlled Cohort Study. J Am Heart Assoc. 2021 Nov 16;10(22):e022539. doi: 10.1161/JAHA.121.022539. Epub 2021 Nov 6.

    PubMed 34743565

  • Mark DG, Huang J, Kene MV, Sax DR, Cotton DM, Lin JS, Bouvet SC, Chettipally UK, Anderson ML, McLachlan ID, Simon LE, Shan J, Rauchwerger AS, Vinson DR, Ballard DW, Reed ME; Kaiser Permanente CREST Network Investigators. Prospective Validation and Comparative Analysis of Coronary Risk Stratification Strategies Among Emergency Department Patients With Chest Pain. J Am Heart Assoc. 2021 Apr 6;10(7):e020082. doi: 10.1161/JAHA.120.020082. Epub 2021 Mar 31.

    PubMed 33787290

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Chest Pain, run by Kaiser Permanente at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiac event (MACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03286179, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.

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