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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)

Conditions
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Severe Sepsis, Cardiac Arrest, Respiratory Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients admitted to the study units during the period of data collection Exclusion Criteria: less than 24h on ward

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RRT calls prior to IGS use<br>Patients who triggered ACT/RRT calls prior to the installation of the IGS (Intellivue Guardian System) | |
| RRT calls during IGS use<br>Patients who triggered ACT/RRT calls after the installation of IGS. All patients on the study ward receive the same care in both groups. The only difference is the system used to collect vital signs and to inform the staff about patient deteriorations. In Group 2, the IGS (FDA approved and CE marked) is the vital signs collection and information system. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of outcome for patients after implementing the IGS | Does the IGS significantly increase positive outcomes for deteriorating patients after referral to the RRT/ACT as measured by the MAELOR score | 15 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient deterioration, rapid response teams, acute care teams, early warning scoring