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Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Primary Purpose

In-hospital Deterioration, Intra Hospital Cardiac Arrest, Sudden Death

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Control group
Increased monitoring frequency
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for In-hospital Deterioration focused on measuring Early warning score, Rapid response systems, Medical emergency team

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bispebjerg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention (8 hours)

Control (12 hours)

Arm Description

EWS every 8 hours

EWS every 12 hours

Outcomes

Primary Outcome Measures

Number of patients with an EWS >/= 2
Clinical deterioration is correlated to elevated EWS

Secondary Outcome Measures

Number of patients with an aggregated score of EWS >/= 5 or >/= 7
EWS >/ = 2
Mortality
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.
Number of patients with an individual score of EWS >/= 3
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)

Full Information

First Posted
June 27, 2014
Last Updated
February 6, 2015
Sponsor
Bispebjerg Hospital
Collaborators
TrygFonden, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02180854
Brief Title
Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients
Official Title
Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
TrygFonden, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In-hospital Deterioration, Intra Hospital Cardiac Arrest, Sudden Death
Keywords
Early warning score, Rapid response systems, Medical emergency team

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention (8 hours)
Arm Type
Experimental
Arm Description
EWS every 8 hours
Arm Title
Control (12 hours)
Arm Type
Active Comparator
Arm Description
EWS every 12 hours
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Type
Other
Intervention Name(s)
Increased monitoring frequency
Primary Outcome Measure Information:
Title
Number of patients with an EWS >/= 2
Description
Clinical deterioration is correlated to elevated EWS
Time Frame
24 hours after first EWS after admission
Secondary Outcome Measure Information:
Title
Number of patients with an aggregated score of EWS >/= 5 or >/= 7
Time Frame
24 to 48 hours
Title
EWS >/ = 2
Time Frame
48 hours
Title
Mortality
Time Frame
72 hours and 30 days
Title
Length of hospital stay
Description
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.
Time Frame
30 days
Title
Number of patients with an individual score of EWS >/= 3
Time Frame
24 to 48 hours after first EWS on admission
Title
Number of serious adverse events during first 72 hours of admission
Description
Serious adverse events is either cardiac arrest, unexpected death or admission to intensive care unit (ICU)
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Number of EWS measurements performed during first 48 hours of admission
Time Frame
48 hours
Title
Number of MET calls during first 72 hours of admission
Description
MET = medical emergency team
Time Frame
72 hours
Title
Number of patients where escalation protocol is adhered to
Description
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)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Petersen, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg University Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

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Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

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