Effective Strategies to Reduce Noise and Related Distractions (NOISY)

Effective Strategies to Reduce Noise and Noise Related Distractions in the ICU : a Stepped Wedge Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit; Safety Issues; Noise Exposure
• Intervention / Treatment: Behavioral: Noise Reduction Bundle

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gld
    • Nijmegen, Gld, Netherlands, 6500hb
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual Care
Experimental: Intervention; Implementation of a Noise Reduction Bundle	Behavioral: Noise Reduction Bundle; Implementation of a bundle of noise reducing interventions. This concerns among other things: reduction of alarms, phone calls/pagers/ beepers, introduction of a defined period in which there is a reduction of controllable sound (quiet time), etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sound pressure levels	Sound pressure levels at predetermined locations	through study completion, an average of 1 year
Acoustic alarms	e.g. acoustic alarms (ventilation, heartrate, tension, etc )	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interruptions	e.g. number of interruptions during daily work (count)	through study completion, an average of 1 year
Annoyance (as an emotional impact on health care providers)	e.g. perceived annoyance caused by alarms, telephones, pagers, conversation	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Hans vd Hoeven, MD, PhD, Radboud UMC, Dep.Intensive Care, Nijmegen, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: ICU; Noise; Alarms; Annoyance; Distractions
• Other Study ID Numbers: 2019-5541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No