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

NCT02041858 | Completed

• 1 other identifier: NA_00079765
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physiologic Monitoring; Alarms

Keywords

Alarms; Physiologic Monitoring; Critical Care; Alarm fatigue; Adverse Events

Outcome Measures

Primary Outcomes (1)

• Clinically significant adverse events

  A variety of clinically significant events were assessed while subjects were on the protocol

  1 day

Secondary Outcomes (2)

• Alarm Signals

  1 day

• Alarm-triggered interventions

  1 day

Study Arms (2)

Control

NO INTERVENTION

Control arm with organizational-based alarm parameter settings

Altered Alarm Settings

EXPERIMENTAL

Altered set of alarm parameter settings.

Other: Altered Alarm Settings

Interventions

Altered Alarm Settings OTHER

An altered set of alarm parameter settings

Altered Alarm Settings

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (6)

• 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

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

  PMID: 8205831 BACKGROUND

• Tsien CL, Fackler JC. Poor prognosis for existing monitors in the intensive care unit. Crit Care Med. 1997 Apr;25(4):614-9. doi: 10.1097/00003246-199704000-00010.

  PMID: 9142025 BACKGROUND

• 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. doi: 10.1007/s001340051082.

  PMID: 10660842 BACKGROUND

• 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. doi: 10.1016/j.ajem.2005.05.015.

  PMID: 16338512 BACKGROUND

• Siebig S, Kuhls S, Imhoff M, Langgartner J, Reng M, Scholmerich 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. Epub 2009 Jan 17.

  PMID: 19327311 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

Study Officials

• Julius C Pham, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 22, 2014
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2016
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

US (1)