Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

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.

Study Overview

• Status: Completed
• Conditions: Sudden Death; In-hospital Deterioration; Intra Hospital Cardiac Arrest
• Intervention / Treatment: Other: Control group; Other: Increased monitoring frequency

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (8 hours); EWS every 8 hours	Other: Increased monitoring frequency
Active Comparator: Control (12 hours); EWS every 12 hours	Other: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with an EWS >/= 2	Clinical deterioration is correlated to elevated EWS	24 hours after first EWS after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with an aggregated score of EWS >/= 5 or >/= 7		24 to 48 hours
EWS >/ = 2		48 hours
Mortality		72 hours and 30 days
Length of hospital stay	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.	30 days
Number of patients with an individual score of EWS >/= 3		24 to 48 hours after first EWS on admission
Number of serious adverse events during first 72 hours of admission	Serious adverse events is either cardiac arrest, unexpected death or admission to intensive care unit (ICU)	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of EWS measurements performed during first 48 hours of admission		48 hours
Number of MET calls during first 72 hours of admission	MET = medical emergency team	72 hours
Number of patients where escalation protocol is adhered to	To evaluate whether hospital guidelines are followed in regard to: monitoring frequency; review by physician (for EWS >/= 3); review by MET or specialist (for EWS >/= 9)	48 hours

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: TrygFonden, Denmark
• Investigators: Principal Investigator: John A Petersen, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Early warning score; Rapid response systems; Medical emergency team
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Death; Disease Progression; Death, Sudden; Clinical Deterioration
• Other Study ID Numbers: Delstudie4