Clinical AlarmsNCT03347149
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (USA)
An observational study of Clinical Alarms, run by Philips Healthcare at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Alarms
- What is being tested?
- Alarm Advisor Software
- Type of treatment
- Medical device
- How many people
- 1,336 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 11 Mar 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Routinely monitored intensive care patients
Who may be able to join
- Patients admitted to the intensive care units during the study periods
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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".
Read the 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.
- Conditions
- Clinical Alarms
- Being tested
- Alarm Advisor Software
- Keywords
- Alarms, Alarm Fatigue, Alarm Nuisance, Alarm Reduction, Patient Monitoring, Intensive Care
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alarm Advisor SoftwareDevice
Providing advice on alarm limits as part of routine medical care
| Study group | Role | What they receive |
|---|---|---|
| Pre-Phase (Control) | no Alarm Advisor Software installed | |
| Post-Phase (Observation) | Alarm Advisor Software implemented Receives: Device: Alarm Advisor Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Alarms
red and yellow alarms with subgroups
Measured: 2 month per phase with 2 month washout (6 month overall)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start28 Aug 2017
- Primary completion11 Mar 2018
- Study completion11 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical AlarmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Marjorie Funk, PhD, Professor, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347149
- Sponsor's protocol ID
- PMS-BBN-US-AA-2.01
- Status last verified
- Apr 2018
- First submitted
- 13 Nov 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses' Customization of Physiologic Monitor Alarms: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software
- ClinicalTrials.gov ID
- NCT03347149
- Acronym / sponsor ID
- PMS-BBN-US-AA-2.01
- Conditions
- Clinical Alarms
- Keywords
- Alarms, Alarm Fatigue, Alarm Nuisance, Alarm Reduction, Patient Monitoring, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,336 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 11 Mar 2018 (actual)
- Study completion
- 11 Mar 2018 (actual)
- First posted
- 20 Nov 2017 (actual)
- 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 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".
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Phase (Control) | – | –no Alarm Advisor Software installed |
| Post-Phase (Observation) | – | Device: Alarm Advisor SoftwareAlarm Advisor Software implemented |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Routinely monitored intensive care patients
Key inclusion criteria (1 listed)
- Patients admitted to the intensive care units during the study periods
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Alarm Advisor SoftwareProviding advice on alarm limits as part of routine medical care | Device | Post-Phase (Observation) |
Primary outcome
Number of Alarms
Time frame: 2 month per phase with 2 month washout (6 month overall)
red and yellow alarms with subgroups
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 10 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Marjorie Funk, PhD, Professor principal investigator
Yale School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Alarms, run by Philips Healthcare at 1 site in United States.
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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of Alarms (time frame: 2 month per phase with 2 month washout (6 month overall)). 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 10 Apr 2018.