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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Cardiac Arrest; Severe Sepsis

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 Type: Observational
• Enrollment (Actual): 678

Contacts and Locations

Study Locations

• United Kingdom
  • Penrhosgarnedd
    • Bangor, Penrhosgarnedd, United Kingdom, LL572PW
      • Ysbyty Gwynedd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• less than 24h on ward

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
RRT calls prior to IGS use; Patients who triggered ACT/RRT calls prior to the installation of the IGS (Intellivue Guardian System)
RRT calls during IGS use; 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?

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

Collaborators and Investigators

• Sponsor: Philips Healthcare
• Investigators: Principal Investigator: Christian P Subbe, MD, Bangor University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (Estimate): September 25, 2012

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: April 1, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: patient deterioration; rapid response teams; early warning scoring; acute care teams
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Respiratory Insufficiency
• Other Study ID Numbers: SD-05163-BBN-IGS; 12/WA/0050 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO