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Completed

NCT Number: NCT02180854

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg University Hospital

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Other

Increased monitoring frequency

Other

Primary outcomes

  1. Number of patients with an EWS >/= 2

    Time frame: 24 hours after first EWS after admission

    Clinical deterioration is correlated to elevated EWS

Secondary outcomes

  1. Number of patients with an aggregated score of EWS >/= 5 or >/= 7

    Time frame: 24 to 48 hours

  2. EWS >/ = 2

    Time frame: 48 hours

  3. Mortality

    Time frame: 72 hours and 30 days

  4. Length of hospital stay

    Time frame: 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.

  5. Number of patients with an individual score of EWS >/= 3

    Time frame: 24 to 48 hours after first EWS on admission

  6. Number of serious adverse events during first 72 hours of admission

    Time frame: 72 hours

    Serious adverse events is either cardiac arrest, unexpected death or admission to intensive care unit (ICU)

Other outcomes

  1. Number of EWS measurements performed during first 48 hours of admission

    Time frame: 48 hours

  2. Number of MET calls during first 72 hours of admission

    Time frame: 72 hours

    MET = medical emergency team

  3. Number of patients where escalation protocol is adhered to

    Time frame: 48 hours

    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)

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 3, 2014
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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