Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes

Completed

• Conditions: Severe Sepsis; Respiratory Failure; Cardiac Arrest

• Registration Number: NCT01692847
• Lead Sponsor: Philips Healthcare

Brief Summary

A hospitals manual method of patient monitoring will be implemented in an automated system and supported by an early patient deterioration detection for timely escalation. The purpose of this study is to assess if clinical outcomes of patients in Acute Care are significantly improved by such a system.

Detailed Description

The purpose of this study is to assess if the Philips IntelliVue Guardian Solution (IGS) with all its components can significantly improve clinical outcomes for deteriorating patients on a general medical ward prior and after referral to the hospitals' Acute Care Team (ACT). Further, to provide evidence that the Philips IGS assists to increase the efficiency of a hospital's Early Warning Scoring process (afferent and efferent arm of the escalation system).

The introduction of such an intelligent automated system offers a unique opportunity to address the breakdown in the chain of prevention by strengthening the reliability of calls-for-help to responders through a technical solution with the potential for a more timely escalation where appropriate.

In this study the hospital's Standard of Care protocol for the monitoring of vital signs (including timing, vital signs collected and escalation instructions) will be implemented in a commercially available intelligent automatic monitoring and notification system. No investigational procedures or devices are associated with this protocol.

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-25
• Study Start: 2012-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 678

Inclusion Criteria

• all patients admitted to the study units during the period of data collection

Exclusion Criteria

• less than 24h on ward

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of outcome for patients after implementing the IGS	15 months	Does the IGS significantly increase positive outcomes for deteriorating patients after referral to the RRT/ACT as measured by the MAELOR score

Secondary Outcome Measures

Name	Time	Method
Early detection of patient deterioration	15 months	Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.
Daily workload for the ward's personnel	15 months	Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.
Level of satisfaction	15 months	Do Nurses and Doctors express a higher level of satisfaction with the IGS in place than with their current paper-based surveillance.

Trial Locations

Locations (1)

Ysbyty Gwynedd Hospital; 🇬🇧 Bangor, Penrhosgarnedd, United Kingdom