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Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02180854
Enrollment
600
Registered
2014-07-03
Start date
2014-09-30
Completion date
2015-01-31
Last updated
2015-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Early warning score, Rapid response systems, Medical emergency team

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.

Interventions

OTHERControl group
OTHERIncreased monitoring frequency

Sponsors

TrygFonden, Denmark
CollaboratorINDUSTRY
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with an EWS >/= 224 hours after first EWS after admissionClinical deterioration is correlated to elevated EWS

Secondary

MeasureTime frameDescription
Mortality72 hours and 30 days
Length of hospital stay30 daysParticipants 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 >/= 324 to 48 hours after first EWS on admission
Number of serious adverse events during first 72 hours of admission72 hoursSerious adverse events is either cardiac arrest, unexpected death or admission to intensive care unit (ICU)
Number of patients with an aggregated score of EWS >/= 5 or >/= 724 to 48 hours
EWS >/ = 248 hours

Other

MeasureTime frameDescription
Number of patients where escalation protocol is adhered to48 hoursTo 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)
Number of EWS measurements performed during first 48 hours of admission48 hours
Number of MET calls during first 72 hours of admission72 hoursMET = medical emergency team

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026