Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (USA)

April 6, 2018 updated by: Philips Healthcare

Nurses' Customization of Physiologic Monitor Alarms: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software

This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post- implementation of an "Alarm Advisor software".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded.

In an interim period an Alarm Advisor software will be introduced to the unit. In a second phase (post-implementation) the same set of alarm data will be recorded.

The "Alarm Advisor" Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits).

The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

Study Type

Observational

Enrollment (Actual)

1336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06516
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Routinely monitored intensive care patients

Description

Inclusion Criteria:

- Patients admitted to the intensive care units during the study periods

Exclusion Criteria:

- none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-Phase (Control)
no Alarm Advisor Software installed
Post-Phase (Observation)
Alarm Advisor Software implemented
Device: Alarm Advisor Software
Providing advice on alarm limits as part of routine medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Alarms
Time Frame: 2 month per phase with 2 month washout (6 month overall)
red and yellow alarms with subgroups
2 month per phase with 2 month washout (6 month overall)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

Collaborators

Yale University

Investigators

  • Principal Investigator: Marjorie Funk, PhD, Professor, Yale School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2017

Primary Completion (Actual)

March 11, 2018

Study Completion (Actual)

March 11, 2018

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PMS-BBN-US-AA-2.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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