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

NCT01692847 | Completed DMC

• 2 other identifiers: SD-05163-BBN-IGS12/WA/0050
• Study Type: observational
• Target: 678
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis; Cardiac Arrest; Respiratory Failure

Keywords

patient deterioration; rapid response teams; acute care teams; early warning scoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Early detection of patient deterioration

  15 months

• Daily workload for the ward's personnel

  15 months

• Level of satisfaction

  15 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• less than 24h on ward

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (1)

Ysbyty Gwynedd Hospital

Bangor, Penrhosgarnedd, LL572PW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28288655 DERIVED

MeSH Terms

Conditions

Sepsis; Heart Arrest; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Christian P Subbe, MD

  Bangor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 25, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 4, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)