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OpenTrials
Completed

NCT Number: NCT02458872

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.

Completed

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Key information

Conditions

Hospitalization

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

safety huddle alarm intervention

Behavioral

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.

Primary outcomes

  1. Change from baseline in the unit-wide rate of alarms per patient-day at 44 weeks

    Time frame: Baseline and 44 weeks

Secondary outcomes

  1. Pre-post huddle patient-level difference in differences of alarm rates

    Time frame: The 24 hours before a safety huddle opportunity versus the 24 hours before a safety huddle opportunity

    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.

  2. Implementation outcomes

    Time frame: Within 4 hours after the huddle intervention occurred

    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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Academic Pediatric Association

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2015
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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