NCT03347149

Brief Summary

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

November 13, 2017

Last Update Submit

April 6, 2018

Conditions

Clinical Alarms

Keywords

AlarmsAlarm FatigueAlarm NuisanceAlarm ReductionPatient MonitoringIntensive Care

Outcome Measures

Primary Outcomes (1)

  • Number of Alarms

    red and yellow alarms with subgroups

    2 month per phase with 2 month washout (6 month overall)

Study Arms (2)

Pre-Phase (Control)

no Alarm Advisor Software installed

Post-Phase (Observation)

Alarm Advisor Software implemented

Device: Alarm Advisor Software

Interventions

Alarm Advisor SoftwareDEVICE

Providing advice on alarm limits as part of routine medical care

Post-Phase (Observation)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Routinely monitored intensive care patients

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Marjorie Funk, PhD, Professor

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 20, 2017

Study Start

August 28, 2017

Primary Completion

March 11, 2018

Study Completion

March 11, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)