Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles

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.

Study Overview

• Status: Completed
• Conditions: Hospitalization
• Intervention / Treatment: Behavioral: safety huddle alarm intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 77280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Usual care.
Experimental: Intervention Arm; Safety huddle alarm intervention.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the unit-wide rate of alarms per patient-day at 44 weeks	Baseline and 44 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-post huddle patient-level difference in differences of alarm rates	The difference in the rate of alarms in individual patients in the 24 hours after discussion in a huddle compared with themselves in the 24 hours before the huddle, patients on the same unit as the huddle but whose alarms are not discussed, and patients on units without the alarm huddle intervention.	The 24 hours before a safety huddle opportunity versus the 24 hours before a safety huddle opportunity
Implementation outcomes	Proportion of huddles in post-implementation data collection period that included discussion of at least 1 patient's alarms, proportion of patients in whom a change in monitor delay time was recommended who had delay time changed in a direction consistent with the recommendations within 4 hours	Within 4 hours after the huddle intervention occurred

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Academic Pediatric Association

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Patient Safety; Clinical Alarms
• Other Study ID Numbers: 15-011896

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No