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

Completed

• Conditions: Alarm Fatigue
• Interventions: Other: Reduces number of question items

• Registration Number: NCT04994600
• Lead Sponsor: Charite University, Berlin, Germany

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.

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 Timeline

• Study Start: 2021-03-19
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-06
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CFA_2nd_phase	Reduces number of question items	Confirmatory factor analysis group. All staff members (physicians, specialist nurses, respiratory therapists) of collaborating intensive care units.

Primary Outcome Measures

Name	Time	Method
Rate of alarm fatigue	6 months	Develop an online alarm fatigue survey questionnaire to be completed across campuses and hospitals by ICU staff.

Trial Locations

Locations (1)

Charite Universtitaetsmedizin; 🇩🇪 Berlin, Germany