Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Intensive Care Unit
  • Noise Exposure
  • Safety Issues
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Stepped Wedge Cluster Randomised ModelMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

Design: The introduction is done by a stepped wedge cluster randomized design. The study will be carried out in seven units of the department of intensive care medicine of the Radboud University Medical Center, a 950-bed university hospital in the Netherlands. The study focus on health care provider...

Design: The introduction is done by a stepped wedge cluster randomized design. The study will be carried out in seven units of the department of intensive care medicine of the Radboud University Medical Center, a 950-bed university hospital in the Netherlands. The study focus on health care providers in the ICU.The research consists of the introduction of an intervention bundle to reduce noise and therefore interruptions during their daily work activities. Inclusion: All health care providers present at the ICU, during the study period (about 350) are asked to participate. They will recieve information about the aim, content and relevance of the study and will be asked for participation.They are free to refuse to participate in the study (e.g. part of observations, survey). Methods: The data collection focuses on quantitative noise measurements at the predetermined locations in ICU units during the study period. In addition, during the entire study period (control and intervention), we analyse the amount and type of alarms. Thirdly, we collect data with regard to disruptions during the daily work process of healthcare professionals (e.g. during "high-risk moments", such as: medication preparation) by observations. Finally, health care providers are asked about their perceived emotional impact e.g. annoyance, as a result of ambient noise (questionaires). Items in the questionnaires are e.g: degree of annoyance as a result of alarms, conversation, equipment, pagers/telefoons. Data analysis will be supported with the use of Phyton and MatLab.

Tracking Information

NCT #
NCT04643652
Collaborators
Not Provided
Investigators
Principal Investigator: Hans vd Hoeven, MD, PhD Radboud UMC, Dep.Intensive Care, Nijmegen, The Netherlands