Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Sudden Death Clinical Trial

Official title:

Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180854
• Other study ID #: Delstudie4
• Status: Completed
• Phase: N/A
• First received: June 27, 2014
• Last updated: February 6, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Other:
• Control group

• Increased monitoring frequency

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of EWS measurements performed during first 48 hours of admission		48 hours	No
Other	Number of MET calls during first 72 hours of admission	MET = medical emergency team	72 hours	Yes
Other	Number of patients where escalation protocol is adhered to	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)	48 hours	Yes
Primary	Number of patients with an EWS >/= 2	Clinical deterioration is correlated to elevated EWS	24 hours after first EWS after admission	Yes
Secondary	Number of patients with an aggregated score of EWS >/= 5 or >/= 7		24 to 48 hours	Yes
Secondary	EWS >/ = 2		48 hours	Yes
Secondary	Mortality		72 hours and 30 days	Yes
Secondary	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	Yes
Secondary	Number of patients with an individual score of EWS >/= 3		24 to 48 hours after first EWS on admission	Yes
Secondary	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	Yes