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

NCT ID: NCT04994600

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-19

Study Completion Date

2023-09-01

Brief Summary

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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

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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

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Alarm Fatigue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EFA_1st_phase

Exploratory factor analysis group. All staff members (physicians, specialist nurses, respiratory therapists) of Charite intensive care units

No interventions assigned to this group

CFA_2nd_phase

Confirmatory factor analysis group. All staff members (physicians, specialist nurses, respiratory therapists) of collaborating intensive care units.

Reduces number of question items

Intervention Type OTHER

The number of alarm fatigue questions are reduced to about 15 in the CFA\_2nd\_phase group.

Interventions

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Reduces number of question items

The number of alarm fatigue questions are reduced to about 15 in the CFA\_2nd\_phase group.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vivantes Klinikum im Friedrichshain, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Landsberger Allee 49, 10249 Berlin

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Gießen, UKGM GmbH, Justus-Liebig-Universität Gießen, Klinik für Anästhesiologie, Rudolf-Buchheim Str. 7, 35392 Gießen

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Heidelberg, Klinik für Anästhesiologie, Im Neuenheimer Feld 420, 69120 Heidelberg

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Ulm, Klinik für Anästhesiologie und Intensivmedizin, Albert-Einstein-Allee 23, 89081 Ulm

UNKNOWN

Sponsor Role collaborator

Technische Universität München, Klinik für Anästhesiologie und Intensivmedizin, Klinikum rechts der Isar Ismaninger Str. 22, 81675 München

UNKNOWN

Sponsor Role collaborator

Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum Klinik für Anästhesiologie, Hölkeskampring 40, 44625 Herne

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Felix Balzer

Prof. Dr. med. Dr. rer. nat.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felix Balzer, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite Universitaetsmedizin Berlin

Locations

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Charite Universtitaetsmedizin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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alarmZen1

Identifier Type: -

Identifier Source: org_study_id

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