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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01692847
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : April 4, 2016
Information provided by (Responsible Party):
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.

Condition or disease
Severe Sepsis Cardiac Arrest Respiratory Failure

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.

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Study Type : Observational
Actual Enrollment : 678 participants
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)
Study Start Date : October 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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.

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

  2. Daily workload for the ward's personnel [ Time Frame: 15 months ]
    Does the IGS reduce the daily workload related to patient surveillance for the general ward personnel.

  3. Level of satisfaction [ Time Frame: 15 months ]
    Do Nurses and Doctors express a higher level of satisfaction with the IGS in place than with their current paper-based surveillance.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • less than 24h on ward

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01692847

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Philips Healthcare Identifier: NCT01692847    
Other Study ID Numbers: SD-05163-BBN-IGS
12/WA/0050 ( Other Identifier: Research Ethics Committee )
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philips Healthcare:
patient deterioration
rapid response teams
acute care teams
early warning scoring
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes