alarmZen1: Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Intensive Care Units

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT04994600
Collaborator
Vivantes Klinikum im Friedrichshain, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Landsberger Allee 49, 10249 Berlin (Other), Universitätsklinikum Gießen, UKGM GmbH, Justus-Liebig-Universität Gießen, Klinik für Anästhesiologie, Rudolf-Buchheim Str. 7, 35392 Gießen (Other), Universitätsklinikum Heidelberg, Klinik für Anästhesiologie, Im Neuenheimer Feld 420, 69120 Heidelberg (Other), Universitätsklinikum Ulm, Klinik für Anästhesiologie und Intensivmedizin, Albert-Einstein-Allee 23, 89081 Ulm (Other), Technische Universität München, Klinik für Anästhesiologie und Intensivmedizin, Klinikum rechts der Isar Ismaninger Str. 22, 81675 München (Other), Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Klinik für Anästhesiologie, Hölkeskampring 40, 44625 Herne (Other)
700
1
25.4
27.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Reduces number of question items

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

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Design and Validation of a German Language Questionnaire for Measuring Alarm Fatigue in Nurses and Medical Doctors in Intensive Care Units
Actual Study Start Date :
Mar 19, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Rate of alarm fatigue [6 months]

    Develop an online alarm fatigue survey questionnaire to be completed across campuses and hospitals by ICU staff.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charite Universtitaetsmedizin Berlin Germany 10117

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • 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
  • Technische Universität München, Klinik für Anästhesiologie und Intensivmedizin, Klinikum rechts der Isar Ismaninger Str. 22, 81675 München
  • Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Klinik für Anästhesiologie, Hölkeskampring 40, 44625 Herne

Investigators

  • Principal Investigator: Felix Balzer, Prof. Dr. Dr., Charite Universitaetsmedizin Berlin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Felix Balzer, Prof. Dr. med. Dr. rer. nat., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT04994600
Other Study ID Numbers:
  • alarmZen1
First Posted:
Aug 6, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022