Alarm FatiguealarmZen1NCT04994600
Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Intensive Care Units
An observational study of Alarm Fatigue, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
False-positive and non-actionable alarms can lead to staff desensitization ("alarm fatigue") and thus patient endangerment. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alarm Fatigue
- What is being tested?
- Reduces number of question items
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 19 Mar 2021to 1 Sep 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All staff members (physicians, specialist nurses, respiratory therapists) of German intensive care units.
Who may be able to join
- physicians of German intensive care units
- specialist nurses of German intensive care units
- respiratory therapists of German intensive care units
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Nurses and Medical Doctors in Intensive Care Units
False-positive and non-actionable alarms can lead to staff desensitization ("alarm fatigue") and thus patient endangerment. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire.
Read the detailed description
In intensive care units (ICUs), patients' vital signs are monitored automatically. As soon as one of the parameters indicates a critical or potentially critical condition, an alarm is triggered on the ward. However, if there are too many alarms, even most of which are false or require no treatment, ward staff may develop alarm fatigue and become desensitized to alarms. This puts patients at risk, especially by overhearing critical alarms. Overburdening staff with alarms is part of everyday life in most ICUs. Considering the demographic development as well as the COVID-19 pandemic, it is to be expected that the number of intensive care patients and thus also the alarm burden in intensive care units will increase. This will also be exacerbated by the increasing digitization of the ICU. Evidence-based and data-driven alarm management enables clinicians to trust alarms again. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire. The questionnaire will be collected in two phases. With the data from the first phase (N ≈ 300), the investigators aim to uncover any structure that may be latent in the questionnaire data (by exploratory factor analysis) and reduce the number of questions from 27 to ~15. The reduced questionnaire will be collected in the second phase (N ≈ 300 - 400). With the data obtained, the investigators intend to test the structure postulated in the first survey in a confirmatory factor analysis.
- Conditions
- Alarm Fatigue
- Being tested
- Reduces number of question items
- 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.
Reduces number of question itemsOther
The number of alarm fatigue questions are reduced to about 15 in the CFA_2nd_phase group.
| Study group | Role | What they receive |
|---|---|---|
| EFA_1st_phase | Exploratory factor analysis group. All staff members (physicians, specialist nurses, respiratory therapists) of Charite intensive care units | |
| CFA_2nd_phase | Confirmatory factor analysis group. All staff members (physicians, specialist nurses, respiratory therapists) of collaborating intensive care units. Receives: Other: Reduces number of question items |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of alarm fatigue
Develop an online alarm fatigue survey questionnaire to be completed across campuses and hospitals by ICU staff.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start19 Mar 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alarm FatigueStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Vivantes Klinikum im Friedrichshain, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Landsberger Allee 49, 10249 Berlin, Universitätsklinikum Gießen, UKGM GmbH, Justus-Liebig-Universität Gießen, Klinik für Anästhesiologie, Rudolf-Buchheim Str. 7, 35392 Gießen, Universitätsklinikum Heidelberg, Klinik für Anästhesiologie, Im Neuenheimer Feld 420, 69120 Heidelberg, Universitätsklinikum Ulm, Klinik für Anästhesiologie und Intensivmedizin, Albert-Einstein-Allee 23, 89081 Ulm, Technical University of Munich, Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Klinik für Anästhesiologie, Hölkeskampring 40, 44625 Herne
- Responsible party
- Principal investigator, Felix Balzer, Charite University, Berlin, Germany
- Investigators
- Felix Balzer, Prof. Dr. Dr., Principal investigator, Charite Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994600
- Sponsor's protocol ID
- alarmZen1
- Acronym
- alarmZen1
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wunderlich MM, Krampe H, Fuest K, Leicht D, Probst MB, Runge J, Schmid S, Spies C, Weiss B, Balzer F, Poncette AS; CAFQa Study Group Germany. Evaluating the Construct Validity of the Charite Alarm Fatigue Questionnaire using Confirmatory Factor Analysis. JMIR Hum Factors. 2024 Aug 8;11:e57658. doi: 10.2196/57658.
PubMed 39119994
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Nurses and Medical Doctors in Intensive Care Units
- ClinicalTrials.gov ID
- NCT04994600
- Acronym / sponsor ID
- alarmZen1 / alarmZen1
- Conditions
- Alarm Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Vivantes Klinikum im Friedrichshain, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Landsberger Allee 49, 10249 Berlin, Universitätsklinikum Gießen, UKGM GmbH, Justus-Liebig-Universität Gießen, Klinik für Anästhesiologie, Rudolf-Buchheim Str. 7, 35392 Gießen, Universitätsklinikum Heidelberg, Klinik für Anästhesiologie, Im Neuenheimer Feld 420, 69120 Heidelberg, Universitätsklinikum Ulm, Klinik für Anästhesiologie und Intensivmedizin, Albert-Einstein-Allee 23, 89081 Ulm, Technical University of Munich, Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Klinik für Anästhesiologie, Hölkeskampring 40, 44625 Herne
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 6 Aug 2021 (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.
False-positive and non-actionable alarms can lead to staff desensitization ("alarm fatigue") and thus patient endangerment. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire.
Detailed description
In intensive care units (ICUs), patients' vital signs are monitored automatically. As soon as one of the parameters indicates a critical or potentially critical condition, an alarm is triggered on the ward. However, if there are too many alarms, even most of which are false or require no treatment, ward staff may develop alarm fatigue and become desensitized to alarms. This puts patients at risk, especially by overhearing critical alarms. Overburdening staff with alarms is part of everyday life in most ICUs. Considering the demographic development as well as the COVID-19 pandemic, it is to be expected that the number of intensive care patients and thus also the alarm burden in intensive care units will increase. This will also be exacerbated by the increasing digitization of the ICU. Evidence-based and data-driven alarm management enables clinicians to trust alarms again. With this study the investigators create a basic tool to survey alarm fatigue of intensive care staff: the first German language alarm fatigue questionnaire. The questionnaire will be collected in two phases. With the data from the first phase (N ≈ 300), the investigators aim to uncover any structure that may be latent in the questionnaire data (by exploratory factor analysis) and reduce the number of questions from 27 to ~15. The reduced questionnaire will be collected in the second phase (N ≈ 300 - 400). With the data obtained, the investigators intend to test the structure postulated in the first survey in a confirmatory factor analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFA_1st_phase | – | –Exploratory factor analysis group. All staff members (physicians, specialist nurses, respiratory therapists) of Charite intensive care units |
| CFA_2nd_phase | – | Other: Reduces number of question itemsConfirmatory factor analysis group. All staff members (physicians, specialist nurses, respiratory therapists) of collaborating intensive care units. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All staff members (physicians, specialist nurses, respiratory therapists) of German intensive care units.
Key inclusion criteria (3 listed)
- physicians of German intensive care units
- specialist nurses of German intensive care units
- respiratory therapists of German intensive care units
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Reduces number of question itemsThe number of alarm fatigue questions are reduced to about 15 in the CFA_2nd_phase group. | Other | CFA_2nd_phase |
Primary outcome
Rate of alarm fatigue
Time frame: 6 months
Develop an online alarm fatigue survey questionnaire to be completed across campuses and hospitals by ICU staff.
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 8 Sep 2023.
- Derived from this study: PubMed 39119994Wunderlich MM, Krampe H, Fuest K, Leicht D, Probst MB, Runge J, Schmid S, Spies C, Weiss B, Balzer F, Poncette AS; CAFQa Study Group Germany. Evaluating the Construct Validity of the Charite Alarm Fatigue Questionnaire using Confirmatory Factor Analysis. JMIR Hum Factors. 2024 Aug 8;11:e57658. doi: 10.2196/57658.
- Individual participant dataSharing planned: Undecided
Related trials for Alarm Fatigue
RecruitingObservational study
Intraoperative Cognitive Load in Anesthesia Nurses Across Anesthetic Phases
Alarm Fatigue, Perioperative
Recruiting
Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units
Intensive Care Unit
Active, not recruiting
Effects of Relaxation, Mindfulness, and Breathing Therapy on Alarm Fatigue and Psychological Well-being in Intensive Care Nurses
Alarm Fatigue in Intensive Care Unit Nurses, Psychological Well-Being in Intensive Care Unit Nurses
Enrolling by invitation
Intervention Program for Alarm Fatigue in NICU Nurses Based on ABC-X Model
Alert Fatigue, Health Personnel
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.
Felix Balzer, Prof. Dr. Dr. principal investigator
Charite Universitaetsmedizin Berlin
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 Alarm Fatigue, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 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 8 Sep 2023. 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 Germany. 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?
Rate of alarm fatigue (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994600, which also lists 1 linked publication.
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 8 Sep 2023.