Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Not Applicable

Completed

• Conditions: Sudden Death; In-hospital Deterioration; Intra Hospital Cardiac Arrest
• Interventions: Other: Control group; Other: Increased monitoring frequency

• Registration Number: NCT02180854
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control (12 hours)	Control group	EWS every 12 hours
Intervention (8 hours)	Increased monitoring frequency	EWS every 8 hours

Primary Outcome Measures

Name	Time	Method
Number of patients with an EWS >/= 2	24 hours after first EWS after admission	Clinical deterioration is correlated to elevated EWS

Secondary Outcome Measures

Name	Time	Method
EWS >/ = 2	48 hours
Number of serious adverse events during first 72 hours of admission	72 hours	Serious adverse events is either cardiac arrest, unexpected death or admission to intensive care unit (ICU)
Length of hospital stay	30 days	Participants will be followed for the duration of their hospital stay, which is on average 3 - 5 days. Assessment of this data point will take place 30 days after admission.
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

Trial Locations

Locations (1)

Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark