Clinical trial NCT06403397: Assessing the Impact of Monitor Maintenance Package Utilization
Official title: Assessing the Impact of Monitor Maintenance Package Utilization on Patient Monitor Alarms and Nurse Alarm Fatigue
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alarm Fatigue
Patient Safety
Keywords: alarm fatigue
Intensive care unit
Nurse-driven monitoring bundle
patient safety
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a cross-controlled experimental research conducted to determine the effect of using the CEASE care package on patient monitor alarms and nurse alarm fatigue in adult intensive care units
Primary purpose: PREVENTION

Brief summary: Bedside monitors are frequently used in monitoring vital signs of critically ill patients. Nurses working in healthcare facilities, especially in intensive care units, are required to manage devices with different alarm threshold values, categories, and types of alerts, leading to alarm fatigue. In response to this serious threat to patient safety, the FDA and The Joint Commission worked to develop strategies to address alarm fatigue in 2011. Alarm monitoring, identification of the cause, and silencing are typically performed by nurses. When reviewing alarm control studies in the literature, the CEASE care package developed by Levis et al. in 2019 was encountered. The tool was developed for personalized clinical alarm monitoring for the patient.

Detailed description: Bedside monitors are frequently used in monitoring vital signs of critically ill patients. Patient monitors assist healthcare professionals in continuous monitoring of basic vital signs such as EKG (electrocardiogram), blood pressure, pulse oximetry, respiration, as well as advanced hemodynamic parameters like central venous pressure, pulmonary artery pressure. These devices alert healthcare personnel visually and audibly in case of any abnormality in the monitored parameters. According to the Sentinel Event Alert report published by The Joint Commission (TJC) in 2013, each unit can receive thousands of alarm alerts in a single day. It is stated that 85% to 99% of these alarms are either not related to the patient's clinical condition, false, or do not require any action. This situation leads to necessary alarms being silenced, ignored, or muted, thereby threatening patient safety. Thousands of patient injuries and deaths have been reported due to alarm system errors. The main reasons for alarm errors include failure to recognize the alarm, desensitization in nurses, inadequate training in monitor usage, decreased response time to alarms, deficiencies in device interface design, equipment failures, and staff shortages. Monitor alarms occur in a hierarchy of high, medium, and low priority. Each hierarchical alarm produces a different auditory tone. Clinicians use these alarm tones to determine the urgency level and appropriate alarm response. When clinically irrelevant alarms occur more frequently, there is a higher likelihood of overall alarm fatigue. Nurses working in healthcare facilities, especially in intensive care units, are required to manage devices with different alarm threshold values, categories, and types of alerts, leading to alarm fatigue. Alarm fatigue is defined as healthcare workers becoming desensitized and indifferent to many recurring or simultaneous alarm sounds. In response to this serious threat to patient safety, the FDA and The Joint Commission worked to develop strategies to address alarm fatigue in 2011. The published report emphasizes the need to identify the problem clinically and develop solution strategies tailored to the problem, to be implemented alongside general standard interventions. The report primarily focuses on adjusting alarm parameters appropriately and establishing clinic-specific protocols and procedures. Alarm monitoring, identification of the cause, and silencing are typically performed by nurses. When reviewing alarm control studies in the literature, the CEASE care package developed by Levis et al. in 2019 was encountered. The tool was developed for personalized clinical alarm monitoring for the patient. The name CEASE is formed by combining the initials of the words Communication, Electrodes, Appropriateness, Setup, and Education. Researchers found a decrease in the number of monitor alarms and alarm fatigue levels in nurses after using the CEASE care package. More supportive studies are needed for the widespread adoption of this package in clinics. In this study, the investigators aimed to demonstrate a reduction in unnecessary alarm counts and a decrease in nurse alarm fatigue levels with the use of the CEASE care package.

Eligibility criteria: Inclusion Criteria:

* Working in the intensive care unit,
* Willing to participate in the study voluntarily,
* Nurses willing to use the monitor alarm control tool (for intervention group).

Exclusion Criteria:

* Nurses who leave the intensive care unit during the data collection process and those who do not use the monitor alarm control tool

Primary outcomes:
measure: The use of the CEASE care package tool will result in a decrease in the number of alarms in the intensive care unit end of the 3 weeks.
timeFrame: 2 months
measure: The use of the CEASE care package tool will lead to a reduction in alarm fatigue levels end of the 3 weeks.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Demiroğlu Bilim University
state: Şişli
Study officials:
References:
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citation: Erbay-Dalli O, Bagci-Derinpinar K. Adaptation and validation of the Turkish version of the alarm fatigue assessment questionnaire. Enferm Intensiva (Engl Ed). 2024 Apr-Jun;35(2):114-123. doi: 10.1016/j.enfie.2023.09.001. Epub 2023 Oct 5.
citation: Alarm management. Crit Care Nurse. 2013 Oct;33(5):83-6. No abstract available.
citation: Ashrafi, S., Najafi Mehri, S., & Nehrir, B. (2017). Designing an Alarm Fatigue Assessment Questionnaire: Evaluation of the Validity and Reliability of an Instrument. Journal of Critical Care Nursing, 10(4), 0-0.
citation: Lewis CL, Oster CA. Research Outcomes of Implementing CEASE: An Innovative, Nurse-Driven, Evidence-Based, Patient-Customized Monitoring Bundle to Decrease Alarm Fatigue in the Intensive Care Unit/Step-down Unit. Dimens Crit Care Nurs. 2019 May/Jun;38(3):160-173. doi: 10.1097/DCC.0000000000000357.