Standardizing Emergency Work-ups Around Risk Data

Acute Coronary Syndrome Clinical Trial

— STEWARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286179
• Other study ID #: CN-16-2648
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: August 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13419
• Est. completion date: June 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Emergency department chief complaint of chest pain or chest discomfort

• Clinical concern for possible cardiac ischemia

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Emergencies
• Risk Reduction

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Antioch Emergency Department	Antioch	California
United States	Kaiser Permanente Fremont Emergency Department	Fremont	California
United States	Kaiser Permanente Oakland Emergency Department	Oakland	California
United States	Kaiser Permanente Richmond Emergency Department	Richmond	California
United States	Kaiser Permanente Roseville Emergency Department	Roseville	California
United States	Kaiser Permanente Sacramento Emergency Department	Sacramento	California
United States	Kaiser Permanente South Sacramento Emergency Department	Sacramento	California
United States	Kaiser Permanente San Francisco Emergency Department	San Francisco	California
United States	Kaiser Permanente San Leandro Emergency Department	San Leandro	California
United States	Kaiser Permanente San Rafael Emergency Department	San Rafael	California
United States	Kaiser Permanente South San Francisco Emergency Department	South San Francisco	California
United States	Kaiser Permanente Walnut Creek Emergency Department	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac event (MACE)	A composite outcome of either acute myocardial infarction, cardiac arrest, malignant arrhythmia, cardiac-related mortality	12 months
Secondary	Provocative and anatomic cardiac testing rates	Treadmill stress test, myocardial perfusion imaging, stress echocardiography, CT coronary angiography, catheter-based coronary angiography	12 months
Secondary	Emergency department length of stay	Total hours spent in the emergency department among study eligible patients	12 months
Secondary	Hospital admission rate	Percentage of hospital admissions among study eligible patients	12 months