Assessing the Impact of Monitor Maintenance Package Utilization

NCT06403397 | Not Yet Recruiting

• 1 other identifier: Remember Me Tool
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Alarm Fatigue; Patient Safety

Keywords

alarm fatigue; Intensive care unit; Nurse-driven monitoring bundle; patient safety

Outcome Measures

Primary Outcomes (2)

• 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.

  This outcome will measured by Current Situation Analysis Form and CEASE care package tool.

  2 months

• The use of the CEASE care package tool will lead to a reduction in alarm fatigue levels end of the 3 weeks.

  This outcome will measured by alarm fatigue scale.

  2 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Experimental group: CEASE Care Package and Remember Me Tool

Control group

NO INTERVENTION

* Working in the intensive care unit, * Willing to participate in the study voluntarily,

Interventions

Experimental group: CEASE Care Package and Remember Me Tool OTHER

Before the intervention, the intervention group will first undergo the 'Nurse Identification Form' and the 'Alarm Fatigue Scale'. The current root cause analysis of monitor alarms in the clinical setting will be conducted through the 'CEASE Care Package' and the 'Current Situation Analysis Form'. Each patient monitor in the intensive care unit will be observed and recorded by two observers for a period of 24 hours.The Monitor Alarm Control Tool - "Remember Me" will be attached beneath each monitor to facilitate easier monitoring by nurses. Nurses are expected to use the tool for a period of 15 days. After intervention; Two observers will conduct a re-evaluation using the "CEASE Care Package" and the "Current Status Analysis Form". Monitor alarms will be continuously assessed and recorded for 24 hours. Following the completion of this stage, the "Alarm Fatigue Scale" will be reapplied to the intervention group.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroğlu Bilim University

Istanbul, Şişli, 34394, Turkey (Türkiye)

Location

Related Publications (12)

• Schmid F, Goepfert MS, Reuter DA. Patient monitoring alarms in the ICU and in the operating room. Crit Care. 2013 Mar 19;17(2):216. doi: 10.1186/cc12525. No abstract available.

  PMID: 23510435 BACKGROUND

• Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available.

  PMID: 23767076 BACKGROUND

• De Vaux L, Cooper D, Knudson K, Gasperini M, Rodgerson K, Funk M. Reduction of Nonactionable Alarms in Medical Intensive Care. Biomed Instrum Technol. 2017 Feb;51(s2):58-61. doi: 10.2345/0899-8205-51.s2.58. No abstract available.

  PMID: 28296452 BACKGROUND

• Clark, T., David, Y., & Baretich, M. Impact of clinical alarms on patient safety. ACCE Healthcare Technology Foundation 2006: 1-20

  BACKGROUND

• Sendelbach S, Funk M. Alarm fatigue: a patient safety concern. AACN Adv Crit Care. 2013 Oct-Dec;24(4):378-86; quiz 387-8. doi: 10.1097/NCI.0b013e3182a903f9.

  PMID: 24153215 BACKGROUND

• Graham KC, Cvach M. Monitor alarm fatigue: standardizing use of physiological monitors and decreasing nuisance alarms. Am J Crit Care. 2010 Jan;19(1):28-34; quiz 35. doi: 10.4037/ajcc2010651.

  PMID: 20045845 BACKGROUND

• Association for the Advancement of Medical Instrumentation (2011). A siren call to action: Priority issues from the medical device alarms summit. Clinical Alarms AAMI Summit Proceedings, 5(6).

  BACKGROUND

• Cvach M. Monitor alarm fatigue: an integrative review. Biomed Instrum Technol. 2012 Jul-Aug;46(4):268-77. doi: 10.2345/0899-8205-46.4.268.

  PMID: 22839984 BACKGROUND

• 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.

  PMID: 37805362 BACKGROUND

• Alarm management. Crit Care Nurse. 2013 Oct;33(5):83-6. No abstract available.

  PMID: 24085833 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30946125 BACKGROUND

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

Serpil Topçu

CONTACT

05324676179; serpilakkustopcu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The population of the study consists of all nurses working in the intensive care units of Prof. Dr. Cemil Taşcıoğlu City Hospital. There are a total of 142 nurses working in the adult intensive care units of the hospital.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 7, 2024
• Study Start: June 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: December 15, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)