No Applicable Condition; Study of Physiologic Monitor AlarmsQI-MAOSNCT02916212
Quality Improvement - Monitoring Alarm Optimization Study
A study testing Optimized alarm profiles in people with No Applicable Condition; Study of Physiologic Monitor Alarms, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- No Applicable Condition; Study of Physiologic Monitor Alarms
- What is being tested?
- Optimized alarm profiles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nursing staff at selected units at Duke University Hospital
Who cannot join
- NA
About this study
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.
- Being tested
- Optimized alarm profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized alarm profilesOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Hospital units where alarms have been optimized Receives: Other: Optimized alarm profiles |
| Control | No intervention | Hospital units where alarms remain unchanged |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of frequency of total alarms by hospital unit at 60 days
Measured: At baseline and 60 days following implementation
Secondary outcomes (3)
Change from baseline of number of alarms per bed
Measured: At baseline and 60 days following implementation
Change from baseline of number of alarms per day per bed
Measured: At baseline and 60 days following implementation
Change from baseline of perceived alarm fatigue, assessed using a questionnaire
Measured: At baseline and 60 days following implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Applicable Condition; Study of Physiologic Monitor AlarmsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916212
- Sponsor's protocol ID
- Pro00073369
- Acronym
- QI-MAOS
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement - Monitoring Alarm Optimization Study
- ClinicalTrials.gov ID
- NCT02916212
- Acronym / sponsor ID
- QI-MAOS / Pro00073369
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Optimized alarm profilesHospital units where alarms have been optimized |
| Control | No intervention | –Hospital units where alarms remain unchanged |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nursing staff at selected units at Duke University Hospital
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized alarm profiles | Other | Experimental |
Primary outcome
Change from baseline of frequency of total alarms by hospital unit at 60 days
Time frame: At baseline and 60 days following implementation
3 secondary outcomes
Change from baseline of number of alarms per bed
Time frame: 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
Change from baseline of perceived alarm fatigue, assessed using a questionnaire
Time frame: At baseline and 60 days following implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized alarm profiles in people with No Applicable Condition; Study of Physiologic Monitor Alarms, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of frequency of total alarms by hospital unit at 60 days (time frame: At baseline and 60 days following implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.