Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

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

Intervention / Treatment
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* Other: Control group
* Other: Increased monitoring frequency


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (8 hours)<br>EWS every 8 hours | Other: Increased monitoring frequency<br> <br> |
| Active Comparator: Control (12 hours)<br>EWS every 12 hours | Other: Control group<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early warning score, Rapid response systems, Medical emergency team