Standardizing Emergency Work-ups Around Risk Data

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13419 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Chest Pain Risk Reduction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaiser Permanente Antioch Emergency Department

Antioch, California, United States

Site Status

Kaiser Permanente Fremont Emergency Department

Fremont, California, United States

Site Status

Kaiser Permanente Oakland Emergency Department

Oakland, California, United States

Site Status

Kaiser Permanente Richmond Emergency Department

Richmond, California, United States

Site Status

Kaiser Permanente Roseville Emergency Department

Roseville, California, United States

Site Status

Kaiser Permanente South Sacramento Emergency Department

Sacramento, California, United States

Site Status

Kaiser Permanente Sacramento Emergency Department

Sacramento, California, United States

Site Status

Kaiser Permanente San Francisco Emergency Department

San Francisco, California, United States

Site Status

Kaiser Permanente San Leandro Emergency Department

San Leandro, California, United States

Site Status

Kaiser Permanente San Rafael Emergency Department

San Rafael, California, United States

Site Status

Kaiser Permanente South San Francisco Emergency Department

South San Francisco, California, United States

Site Status

Kaiser Permanente Walnut Creek Emergency Department

Walnut Creek, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 25201672 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 25397965 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 25748480 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 26947800 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 25737484 (View on PubMed)

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.

Reference Type DERIVED

PMID: 34743565 (View on PubMed)

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.

Reference Type DERIVED

PMID: 33787290 (View on PubMed)

Other Identifiers

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CN-16-2648

Identifier Type: -

Identifier Source: org_study_id

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain

Developing a Brief Intervention to Communicate Cardiovascular Risk to Patients Presenting to the Emergency Department With Chest Pain: a Co-Production Approach. Phase 2.

Individual Patient Data Meta-analysis on Prehospital Risk Assessment in Patients Suspected of Non-ST-segment Elevation Acute Coronary Syndrome

Early Risk Stratification in ED Chest Pain Patients

Biomarkers in Acute Cardiac Care

Detailed Description

Conditions

Study Design

Interventions

modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)

Eligibility Criteria

Inclusion Criteria

Sponsors

Kaiser Permanente

Responsible Party

Locations

Kaiser Permanente Antioch Emergency Department

Kaiser Permanente Fremont Emergency Department

Kaiser Permanente Oakland Emergency Department

Kaiser Permanente Richmond Emergency Department

Kaiser Permanente Roseville Emergency Department

Kaiser Permanente South Sacramento Emergency Department

Kaiser Permanente Sacramento Emergency Department

Kaiser Permanente San Francisco Emergency Department

Kaiser Permanente San Leandro Emergency Department

Kaiser Permanente San Rafael Emergency Department

Kaiser Permanente South San Francisco Emergency Department

Kaiser Permanente Walnut Creek Emergency Department

Countries

References

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.

Other Identifiers

CN-16-2648

More Related Trials