Effect of Altered Alarm Settings on Patient Adverse Events and Alarm Signal Frequency

Physiologic Monitoring Clinical Trial

Official title:

Effect of Altered Alarm Settings on Patient Adverse Events and Alarm Signal Frequency: A Randomized Controlled Trial Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041858
• Other study ID #: NA_00079765
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: March 2, 2017
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alarm fatigue, a lack of response to an alarm due to desensitization, is a national problem. The problem of alarm desensitization is multifaceted and is related to a high false alarm rate, poor positive predictive value, lack of alarm standardization and the large number of medical devices with built in alarms in use today. Cardiac monitor alarms are intended to notify the healthcare practitioner that a clinical crisis is imminent. However, hundreds of physiologic monitor alarms occur on monitored units each day. As a result, practitioners are highly vulnerable to alarm fatigue which has resulted in serious harm to patients and death due to staff inattention from alarm signal desensitization. Research indicates that 80-99.4% of monitor alarms are false or clinically insignificant. Alarm hazards is the number one medical device technology hazard of 2012 and has been listed by ECRI (Emergency Care Research Institute) among the top 3 medical device hazards for the past three years (ECRI, 2011). Delivering actionable alarm information to care providers is challenging given the significant number of false alarms.

Ideally, alarms should activate for events in greatest need of clinical attention without increasing the risk of adverse patient outcomes. This is not the case with current monitoring technology which is designed for high sensitivity and low specificity. Practitioners must use clinical intuition for determining how conservatively alarms should be set to be most useful. There is no research evidence to support how best to set alarms without affecting patient outcomes.

Quality improvement studies performed at The Johns Hopkins Hospital have demonstrated that the frequency of alarm signals can be reduced by more than 50% through an altered set of alarm parameters. This reduction in alarm signals has lead to an increase awareness of alarms that do occur as well as create a quieter, healing environment for patients. Although this change was not associated with a "noticeable" increase in adverse patient events, this important outcome was not rigorously studied.

The specific aims of this pilot study is to determine if decreasing the number of alarms by using an altered set of alarm parameters has an effect on patient outcomes in an intensive care unit.

This project may have a significant impact on patient safety. A decrease in noise at the bedside may result in less distraction to caregivers and may have a positive effect on patient recovery. It is expected that the altered set of monitor default parameters will result in a decrease in audible alarms without increasing clinically significant adverse patient events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: All patients who are in the Coronary Care Unit and able to provide consent during the collection time period will be considered for inclusion. This unit consists of adult patients with a primary cardiac etiology for their illness. The vast majority of these patients are either there for coronary artery disease or congestive heart failure.

Exclusion Criteria: Patients who are unable to provide consent to participate

Related Conditions & MeSH terms

• Alarms
• Physiologic Monitoring

Intervention

Other:
• Altered Alarm Settings
An altered set of alarm parameter settings

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Atzema C, Schull MJ, Borgundvaag B, Slaughter GR, Lee CK. ALARMED: adverse events in low-risk patients with chest pain receiving continuous electrocardiographic monitoring in the emergency department. A pilot study. Am J Emerg Med. 2006 Jan;24(1):62-7. — View Citation

Chambrin MC, Ravaux P, Calvelo-Aros D, Jaborska A, Chopin C, Boniface B. Multicentric study of monitoring alarms in the adult intensive care unit (ICU): a descriptive analysis. Intensive Care Med. 1999 Dec;25(12):1360-6. — View Citation

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. Review. — View Citation

Lawless ST. Crying wolf: false alarms in a pediatric intensive care unit. Crit Care Med. 1994 Jun;22(6):981-5. — View Citation

Siebig S, Kuhls S, Imhoff M, Langgartner J, Reng M, Schölmerich J, Gather U, Wrede CE. Collection of annotated data in a clinical validation study for alarm algorithms in intensive care--a methodologic framework. J Crit Care. 2010 Mar;25(1):128-35. doi: 10.1016/j.jcrc.2008.09.001. — View Citation

Tsien CL, Fackler JC. Poor prognosis for existing monitors in the intensive care unit. Crit Care Med. 1997 Apr;25(4):614-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant adverse events	A variety of clinically significant events were assessed while subjects were on the protocol	1 day
Secondary	Alarm Signals	The number of alarm signals were assessed while the subject was on the protocol.	1 day
Secondary	Alarm-triggered interventions	The number and type of alarm-triggered interventions were assessed while the patient was on the protocol.	1 day