Clinical trial NCT03286179: Standardizing Emergency Work-ups Around Risk Data
Official title: Standardizing Emergency Work-ups Around Risk Data (STEWARD): The CREST Network Chest Pain Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Chest Pain
Risk Reduction
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 13419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting to KPNC emergency departments with above elgibilty criteria

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Major adverse cardiac event (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Provocative and anatomic cardiac testing rates
timeFrame: 12 months
measure: Emergency department length of stay
timeFrame: 12 months
measure: Hospital admission rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Antioch
country: United States
facility: Kaiser Permanente Antioch Emergency Department
state: California
city: Fremont
country: United States
facility: Kaiser Permanente Fremont Emergency Department
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Emergency Department
state: California
city: Richmond
country: United States
facility: Kaiser Permanente Richmond Emergency Department
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville Emergency Department
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento Emergency Department
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Emergency Department
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Emergency Department
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro Emergency Department
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente San Rafael Emergency Department
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente South San Francisco Emergency Department
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek Emergency Department
state: California
Study officials:
References:
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.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.