NCT02916212

Brief Summary

This project aims to reduce the frequency of duplicate, false and clinically insignificant alarms in hospital units, and subsequent alarm fatigue resulting from excessive alarm frequency. The investigators will implement evidence-based guidelines for alarm optimization according to patient-population specific parameters, and evaluate alarm frequency and staff perception of alarm fatigue at baseline and 60 days after implementation of this quality improvement initiative.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 30, 2019

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

September 22, 2016

Last Update Submit

January 28, 2019

Conditions

No Applicable Condition; Study of Physiologic Monitor Alarms

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of frequency of total alarms by hospital unit at 60 days

    At baseline and 60 days following implementation

Secondary Outcomes (3)

  • Change from baseline of number of alarms per bed

    At baseline and 60 days following implementation

  • Change from baseline of number of alarms per day per bed

    At baseline and 60 days following implementation

  • Change from baseline of perceived alarm fatigue, assessed using a questionnaire

    At baseline and 60 days following implementation

Study Arms (2)

Experimental

EXPERIMENTAL

Hospital units where alarms have been optimized

Other: Optimized alarm profiles

Control

NO INTERVENTION

Hospital units where alarms remain unchanged

Interventions

Optimized alarm profilesOTHER
Experimental

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing staff at selected units at Duke University Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 27, 2016

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 30, 2019

Record last verified: 2016-09