- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916212
Quality Improvement - Monitoring Alarm Optimization Study (QI-MAOS)
January 28, 2019 updated by: Duke University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nursing staff at selected units at Duke University Hospital
Exclusion Criteria:
- NA
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Hospital units where alarms have been optimized
|
|
|
No Intervention: Control
Hospital units where alarms remain unchanged
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline of frequency of total alarms by hospital unit at 60 days
Time Frame: At baseline and 60 days following implementation
|
At baseline and 60 days following implementation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline of number of alarms per bed
Time Frame: At baseline and 60 days following implementation
|
At baseline and 60 days following implementation
|
|
Change from baseline of number of alarms per day per bed
Time Frame: At baseline and 60 days following implementation
|
At baseline and 60 days following implementation
|
|
Change from baseline of perceived alarm fatigue, assessed using a questionnaire
Time Frame: At baseline and 60 days following implementation
|
At baseline and 60 days following implementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 27, 2016
Study Record Updates
Last Update Posted (Actual)
January 30, 2019
Last Update Submitted That Met QC Criteria
January 28, 2019
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Pro00073369
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.