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CompletedNCT03286179STEWARDUpdated Aug 12, 2020

Standardizing Emergency Work-ups Around Risk Data

An observational study in Acute Coronary Syndrome, Chest Pain and Risk Reduction, sponsored by Kaiser Permanente. Completed at 12 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by Kaiser Permanente · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13,419
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Coronary Syndrome
  • Chest Pain
  • Risk Reduction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult patients presenting to KPNC emergency departments with above elgibilty criteria

Eligibility criteria

Inclusion Criteria:

  • Emergency department chief complaint of chest pain or chest discomfort
  • Clinical concern for possible cardiac ischemia
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13,419 participants (actual)
Patient registry
No

Interventions

  • Othermodified 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

05

What researchers measure

Primary outcomes

  1. Major adverse cardiac event (MACE)

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

    Time frame: 12 months

Secondary outcomes

  1. Provocative and anatomic cardiac testing rates

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

    Time frame: 12 months

  2. Emergency department length of stay

    Total hours spent in the emergency department among study eligible patients

    Time frame: 12 months

  3. Hospital admission rate

    Percentage of hospital admissions among study eligible patients

    Time frame: 12 months

06

Study locations

12 sites
  • Kaiser Permanente Antioch Emergency Department
    Antioch, California 94531, United States
  • Kaiser Permanente Fremont Emergency Department
    Fremont, California 94538, United States
  • Kaiser Permanente Oakland Emergency Department
    Oakland, California 94611, United States
  • Kaiser Permanente Richmond Emergency Department
    Richmond, California 94801, United States
  • Kaiser Permanente Roseville Emergency Department
    Roseville, California 95661, United States
  • Kaiser Permanente South Sacramento Emergency Department
    Sacramento, California 95823, United States
  • Kaiser Permanente Sacramento Emergency Department
    Sacramento, California 95825, United States
  • Kaiser Permanente San Francisco Emergency Department
    San Francisco, California 94115, United States
  • Kaiser Permanente San Leandro Emergency Department
    San Leandro, California 94577, United States
  • Kaiser Permanente San Rafael Emergency Department
    San Rafael, California 94903, United States
  • Kaiser Permanente South San Francisco Emergency Department
    South San Francisco, California 94080, United States
  • Kaiser Permanente Walnut Creek Emergency Department
    Walnut Creek, California 94596, United States
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03286179
Lead sponsor
Kaiser Permanente
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Jul 1, 2018
Primary completion
Dec 31, 2019
Completion
Jun 1, 2020
Last update
Aug 12, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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