Clinical trial NCT04643652: Effective Strategies to Reduce Noise and Related Distractions
Official title: Effective Strategies to Reduce Noise and Noise Related Distractions in the ICU : a Stepped Wedge Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noise Exposure
Intensive Care Unit
Safety Issues
Keywords: Noise
ICU
Alarms
Annoyance
Distractions
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Stepped Wedge Cluster Randomised Model
Primary purpose: OTHER

Brief summary: Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels. In addition, many medical and nursing ICU staff members work together with numerous visiting consultants resulting in an additional sound burden. As is already known, in the ICU environment, many activities carried out by healthcare professionals, require a high level of concentration. So, the noisy ICU environment causes interruptions in activities that require concentration and induce in this way, a higher potential for errors. The World Health Organization (WHO) and the Environmental Protection Agency (EPA) set standards for sound levels in hospitals with a recommendation for patient treatment areas. There is a clear trend for increasing hospital noise since the sixties. According to healthcare professionals, one of the strongest contributing factors of noise in the ICU environment are monitoring alarms as they occur very frequently. Additionally, ICU nurses experience high levels of stress towards clinical alarms and are becoming alarm fatigue, which means that the staff becomes desensitized because of an excessive number of alarms and may disable or silence alarms without checking the patient . Consensus dictates the importance of reducing sound pressure levels and the numerous alarm signals from monitor alarms in the ICU. In the study, we focus on busy predetermined areas in the ICU.

This study aims to determine the effect of an intervention bundle, aimed at the reduction of "noise" (decibels) and its effect on health care professionals.

Detailed description: Design:

The introduction is done by a stepped wedge cluster randomized design. The study will be carried out in five 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 receive 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 annoyance, as a result of ambient noise (NRS-annoyance).

Data analysis will be supported with the use of Excel, Phyton and SPSS.

Eligibility criteria: Inclusion Criteria:

• Healthcare providers present during the study period (about 250) are asked to participate between august 2022 and december 2023.

Exclusion Criteria:

• Healthcare providers who do not speak / read the Dutch language

Primary outcomes:
measure: Sound pressure levels
timeFrame: through study completion, an average of 1 year
measure: Acoustic alarms
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Interruptions
timeFrame: through study completion, an average of 1 year
measure: Annoyance (as an emotional impact on health care providers)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gld
Study officials:
affiliation: Radboud UMC, Dep.Intensive Care, Nijmegen, The Netherlands
name: Hans vd Hoeven, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: