Clinical trial NCT02458872: Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles
Official title: Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalization
Keywords: Clinical Alarms
Patient Safety
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Academic Pediatric Association
First posted: 2015-06-01
Enrollment: 77280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the unit-wide rate of alarms per patient-day at 44 weeks
timeFrame: Baseline and 44 weeks
Secondary outcomes:
measure: Pre-post huddle patient-level difference in differences of alarm rates
timeFrame: The 24 hours before a safety huddle opportunity versus the 24 hours before a safety huddle opportunity
measure: Implementation outcomes
timeFrame: Within 4 hours after the huddle intervention occurred
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Christopher P Bonafide, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonafide CP, Localio AR, Sternler S, Ahumada L, Dewan M, Ely E, Keren R. Safety Huddle Intervention for Reducing Physiologic Monitor Alarms: A Hybrid Effectiveness-Implementation Cluster Randomized Trial. J Hosp Med. 2018 Sep 1;13(9):609-615. doi: 10.12788/jhm.2956. Epub 2018 Feb 27.