Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

NCT02180854 | Completed

• 1 other identifier: Delstudie4
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Early warning score; Rapid response systems; Medical emergency team

Outcome Measures

Primary Outcomes (1)

• Number of patients with an EWS >/= 2

  Clinical deterioration is correlated to elevated EWS

  24 hours after first EWS after admission

Secondary Outcomes (6)

• 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

  30 days

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

  24 to 48 hours after first EWS on admission

Other Outcomes (3)

• Number of EWS measurements performed during first 48 hours of admission

  48 hours

• Number of MET calls during first 72 hours of admission

  72 hours

• Number of patients where escalation protocol is adhered to

  48 hours

Study Arms (2)

Intervention (8 hours)

EXPERIMENTAL

EWS every 8 hours

Other: Increased monitoring frequency

Control (12 hours)

ACTIVE COMPARATOR

EWS every 12 hours

Other: Control group

Interventions

Control group OTHER

Control (12 hours)

Increased monitoring frequency OTHER

Intervention (8 hours)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first EWS on admission = 0 or 1
• age \>/ = 18 years

You may not qualify if:

• chronically elevated EWS
• terminal disease and comfort care only
• conditions that warrant closer observation according to hospital guidelines

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• TrygFonden, Denmark: collaborator

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Death, Sudden

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• John A Petersen, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Consultant in Critical Care Medicine

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 3, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

DK (1)