Standardizing Emergency Work-ups Around Risk Data (STEWARD)

• ClinicalTrials.gov Identifier: NCT03286179
• Recruitment Status: Completed
• First Posted: September 18, 2017
• Last Update Posted: August 12, 2020
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): Kaiser Permanente

Study Description

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)

Study Design

• Study Type: Observational
• Actual Enrollment: 13419 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
• Actual Study Completion Date: June 1, 2020

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT03286179
• Other Study ID Numbers: CN-16-2648
• First Posted: September 18, 2017
• Last Update Posted: August 12, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acute Coronary Syndrome; Emergencies; Chest Pain; Disease Attributes; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations