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Clinical Trials/NCT02180854
NCT02180854
Completed
Not Applicable

Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Bispebjerg Hospital1 site in 1 country600 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
In-hospital Deterioration
Sponsor
Bispebjerg Hospital
Enrollment
600
Locations
1
Primary Endpoint
Number of patients with an EWS >/= 2
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Acute deterioration among hospitalised patient can result in serious adverse events like cardiac arrest, unexpected death or unanticipated intensive care unit (ICU) admission. Most events are preceeded by deteriorating vital signs, and potentially avoidable.

To detect and treat hospitalised at-risk patients early an early warning score (EWS) was introduced at the investigator site. EWS measures of a number of physiological parameters that are aggregated to a common score, that directs monitoring frequency, clinical interventions and competency of the provider.

Patients with low scores (0 - 1) are monitored every 12th hour and seldom experience serious adverse events. The optimal monitoring frequency for this group is unknown, and presently based on a compromise between patient safety and work load issues.

The aim of the present study is to explore if an 8 hourly monitoring interval (intervention) is correlated with a better outcome than 12 hour intervals (control), based on the number of patients that deteriorate to a higher EWS 24 hours after hospital admission in each group.

Detailed Description

Acute deterioration among hospitalised patient can result in serious adverse events like cardiac arrest, unexpected death or unanticipated intensive care unit (ICU) admission. Most events are preceeded by deteriorating vital signs, and potentially avoidable. To detect and treat hospitalised patients at risk of clinical deterioration in a timely manner, an early warning score (EWS) was introduced at the investigator site. EWS includes measures for respiratory rate, arterial hemoglobin oxygen saturation, pulse rate, systolic blood pressure, level of consciousness according to AVPU score, temperature, and whether a patient receives supplementary oxygen. Each vital sign can be assigned between 0 to 3 points (supplementary oxygen 0 or 2) depending on how much it deviates from a predefined threshold; the values are added to an aggregated score from 0 to 20, higher scores indicating more severe disease. An escalation protocol that directs the type of clinical response and competency of the provider according to EWS triggers was also introduced as an integrated part of the system. Patients with low scores (0 - 1) are monitored every 12th hour and seldom experience serious adverse events. The optimal monitoring frequency for this group is unknown, and presently based on a compromise between patient safety and work load issues. The aim of the present study is to explore if an 8 hourly monitoring interval (intervention) is correlated with a better outcome than 12 hour intervals (control) in the group of patients that have an EWS of 0 or 1 on admission. Deterioration is based on the number of patients that deteriorate to a higher EWS 24 hours after the first EWS is measured. Since serious adverse events in this population are rare the primary outcome is clinical deterioration defined as number of patients with elevated EWS \>/= 2 in each group, 24 hours after admission to the hospital. This is a cluster-randomized, non-blinded, pragmatic, interventional study of acutely admitted, adult patients to surgical or medical wards at our hospital.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
January 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Asger Petersen

M.D., Consultant in Critical Care Medicine

Bispebjerg Hospital

Eligibility Criteria

Inclusion Criteria

  • first EWS on admission = 0 or 1
  • age \>/ = 18 years

Exclusion Criteria

  • chronically elevated EWS
  • terminal disease and comfort care only
  • conditions that warrant closer observation according to hospital guidelines

Outcomes

Primary Outcomes

Number of patients with an EWS >/= 2

Time Frame: 24 hours after first EWS after admission

Clinical deterioration is correlated to elevated EWS

Secondary Outcomes

  • EWS >/ = 2(48 hours)
  • Number of serious adverse events during first 72 hours of admission(72 hours)
  • Length of hospital stay(30 days)
  • Number of patients with an aggregated score of EWS >/= 5 or >/= 7(24 to 48 hours)
  • Mortality(72 hours and 30 days)
  • Number of patients with an individual score of EWS >/= 3(24 to 48 hours after first EWS on admission)

Study Sites (1)

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