This trial is active, not recruiting.

Condition hospitalization
Treatment safety huddle alarm intervention
Sponsor Children's Hospital of Philadelphia
Collaborator Academic Pediatric Association
Start date July 2015
End date May 2016
Trial size 61936 participants
Trial identifier NCT02458872, 15-011896


This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient units.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Safety huddle alarm intervention.
safety huddle alarm intervention
The intervention consists of a monitor alarm dashboard that displays the numbers and types of alarms for each patient, and an accompanying checklist to guide data-driven discussion of 2-4 patients with high alarm rates.
(No Intervention)
Usual care.

Primary Outcomes

Change from baseline in the unit-wide rate of alarms per patient-day at 44 weeks
time frame: Baseline and 44 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion criteria: Any nurse, physician, nurse practitioner, or physician assistant caring for a patient whose alarms are discussed in a safety huddle on an intervention unit. Exclusion criteria: none

Additional Information

Official title Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles
Principal investigator Christopher P Bonafide, MD, MSCE
Description Hospital physiologic monitors can alert clinicians to early signs of physiologic deterioration, and thus have great potential to be life-saving. However, monitors generate frequent alarms, most of which are non-actionable. When clinicians become overburdened with alarms, they begin to exhibit alarm fatigue: responding more slowly to alarms or ignoring alarms entirely. In this protocol the investigators outline the methods they will use to evaluate the impact of a safety huddle-based intervention on physiologic monitor alarm rates using a pragmatic, paired, cluster-randomized controlled trial with the intervention delivered at the unit level. This work is considered quality improvement research, and some of the approaches described in this protocol are from the field of quality improvement. Currently, at most hospitals data like this on the numbers of alarms that patients generate are only available to researchers with the software tools needed to interrogate and record data from the monitor network. The goal of this proposal is to bring this data to the safety huddles occurring daily on inpatient units in an accessible format to help teams make informed decisions about monitoring and minimize the potential of harm from alarm fatigue.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.