Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Intensive Care Units

Alarm Fatigue Clinical Trial

— alarmZen1  

Official title:

Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Nurses and Medical Doctors in Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994600
• Other study ID #: alarmZen1
• Status: Completed
• Start date: March 19, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• physicians of German intensive care units
• specialist nurses of German intensive care units
• respiratory therapists of German intensive care units

Exclusion Criteria:

• Refusal to participate

Related Conditions & MeSH terms

• Alarm Fatigue
• Fatigue

Intervention

Other:
• Reduces number of question items
The number of alarm fatigue questions are reduced to about 15 in the CFA_2nd_phase group.

Locations

Country	Name	City	State
Germany	Charite Universtitaetsmedizin	Berlin

Sponsors (7)

Lead Sponsor

Collaborator

Charite University, Berlin, Germany

Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Klinik für Anästhesiologie, Hölkeskampring 40, 44625 Herne, Technische Universität München, Klinik für Anästhesiologie und Intensivmedizin, Klinikum rechts der Isar Ismaninger Str. 22, 81675 München, 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, Vivantes Klinikum im Friedrichshain, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Landsberger Allee 49, 10249 Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of alarm fatigue	Develop an online alarm fatigue survey questionnaire to be completed across campuses and hospitals by ICU staff.	6 months