Use of suPAR Algorithm for the ED Decision Making (EDsuPAR)

Use of Algorithm for Safer and More Efficient Decision Making in the ED

Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Diagnostic test: suPAR algoritm

Detailed Description

Background Crowding and readmissions are common challenges in Emergency departments across Europe. The decision whether to admit or discharge the patient is challenging and is often based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen saturation and temperature. But some patients are unnecessarily admitted and may have been better off if sent home. Other patients may be discharged without - and one out of five patients are readmitted within a month raising the question whether the patient should have been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker measured routinely in acute medical patients in some emergency department (ED) settings.suPAR is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple interpretation of suPAR in clinical decisions for the study.

Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of improving discharge or admission decisions.

• Study Type: Observational
• Enrollment (Actual): 1800

Contacts and Locations

Study Locations

• Finland
  • Helsinki Usimaa
    • Helsinki, Helsinki Usimaa, Finland
      • Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 104 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients during the study period who signed the consent

Description

Inclusion Criteria:

• All patients above 18 years
• who are having blood taken for biochemical analysis when attending the ED

Exclusion Criteria:

• Acute medical patients that do not have blood drawn for routine biochemical testing.
• Pregnant
• Under 18 years old
• Terminally ill patients.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
suPAR algoritm control; Control arm (Meilahti hospital): Samples are collected and suPAR measured but no algorithm is implemented.	Diagnostic test: suPAR algoritm; All medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR > 6 ng/mL) the Intervention will be carried out
suPAR algoritm intervention; Intervention arm (Jorvi Hospital). According the algorithm when admitting a patient with suPAR below 3 ng/ml, physician should answer the following question "Are you sure it is the right decision to admit this patient? Please discuss this with a senior physician". If discharging a patient with suPAR above 6 ng/ml, physician should answer the following question "Are you sure it is the right decision to discharge this patient? Please discuss this with a senior physician".	Diagnostic test: suPAR algoritm; All medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR > 6 ng/mL) the Intervention will be carried out

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharges	Number of discharges from the ED within 24 hours	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admissions	Number of admissions to hospital	30 days
Length of stay	Length of stay during admission	30 days
Readmissions	Number of readmissions	1,7 and 30 days
Mortality	Number of Mortality	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economical savings	Amount of money	30 days

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Maaret Castrén, Docent, PROFESSOR

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: ED; Critical illness; Decision making; suPAR; POC test
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: §33, HUS/141/2020 14.4.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No