Clinical trial NCT01692847: Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes
Official title: Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Cardiac Arrest
Respiratory Failure
Keywords: patient deterioration
rapid response teams
acute care teams
early warning scoring
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators plan to observe a non-probability, convenience sample of patients which will consist primarily of acutely ill hospitalized adult patients (at least 18 years of age). Study participants will be recruited from all eligible patients during the enrollment period who are having vital signs monitoring performed as Standard of Care.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* less than 24h on ward

Primary outcomes:
measure: Improvement of outcome for patients after implementing the IGS
timeFrame: 15 months
Secondary outcomes:
measure: Early detection of patient deterioration
timeFrame: 15 months
measure: Daily workload for the ward's personnel
timeFrame: 15 months
measure: Level of satisfaction
timeFrame: 15 months
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd Hospital
state: Penrhosgarnedd
Study officials:
affiliation: Bangor University
name: Christian P Subbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. doi: 10.1186/s13054-017-1635-z.