NCT04994600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

August 3, 2021

Last Update Submit

September 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of alarm fatigue

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

    6 months

Study Arms (2)

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

Interventions

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

CFA_2nd_phase

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All staff members (physicians, specialist nurses, respiratory therapists) of German intensive care units.

You may qualify if:

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

You may not qualify if:

  • \- Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Universtitaetsmedizin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Felix Balzer, Prof. Dr. Dr.

    Charite Universitaetsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Dr. rer. nat.

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 6, 2021

Study Start

March 19, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations