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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Philips Healthcare
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01692847
First received: September 21, 2012
Last updated: May 14, 2014
Last verified: December 2012
  Purpose

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.


Condition
Deteriorating Patients on General Medical Wards

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examination of the Impact of Better Surveillance and Communication of Patient Deterioration on Patient Related Outcomes (VitalCare - Guardian Version 2)

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Improvement of outcome for patients after implementing the IGS [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    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:
  • Early detection of patient deterioration [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    Does the IGS detect patient deterioration earlier and therefore prevent or shorten periods of severe illness.

  • Daily workload for the ward's personnel [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.

  • Level of satisfaction [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Do Nurses and Doctors express a higher level of satisfaction with the IGS in place than with their current paper-based surveillance.


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients who triggered ACT/RRT calls prior to use of the IGS
All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the system used to collect vital signs and inform the staff about deteriorations.
Patients who triggered ACT/RRT calls after installation of IGS
All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the system used to collect vital signs and inform the staff about deteriorations. In Group 2, the IGS (FDA approved and CE marked) is the vital signs collection and information 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692847

Contacts
Contact: Bernd P Duller, MD +49 160 7081553 bernd.duller@philips.com

Locations
United Kingdom
Ysbyty Gwynedd Hospital Recruiting
Bangor, Penrhosgarnedd, United Kingdom, LL572PW
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Christian P Subbe, MD Bangor University
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01692847     History of Changes
Other Study ID Numbers: SD-05163-BBN-IGS, 12/WA/0050
Study First Received: September 21, 2012
Last Updated: May 14, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Philips Healthcare:
patient deterioration
rapid response teams
acute care teams
early warning scoring

ClinicalTrials.gov processed this record on November 24, 2014