Clinical trial NCT02180854: 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
Overall status: COMPLETED
Phase: NA
Conditions: In-hospital Deterioration
Intra Hospital Cardiac Arrest
Sudden Death
Keywords: Early warning score
Rapid response systems
Medical emergency team
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2014-07-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of patients with an EWS >/= 2
timeFrame: 24 hours after first EWS after admission
Secondary outcomes:
measure: Number of patients with an aggregated score of EWS >/= 5 or >/= 7
timeFrame: 24 to 48 hours
measure: EWS >/ = 2
timeFrame: 48 hours
measure: Mortality
timeFrame: 72 hours and 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Number of patients with an individual score of EWS >/= 3
timeFrame: 24 to 48 hours after first EWS on admission
measure: Number of serious adverse events during first 72 hours of admission
timeFrame: 72 hours
Other outcomes:
measure: Number of EWS measurements performed during first 48 hours of admission
timeFrame: 48 hours
measure: Number of MET calls during first 72 hours of admission
timeFrame: 72 hours
measure: Number of patients where escalation protocol is adhered to
timeFrame: 48 hours
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: John A Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References: