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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02458872
Other study ID # 15-011896
Secondary ID
Status Completed
Phase N/A
First received May 28, 2015
Last updated June 1, 2017
Start date July 2015
Est. completion date May 2016

Study information

Verified date June 2017
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 77280
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Academic Pediatric Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in the unit-wide rate of alarms per patient-day at 44 weeks Baseline and 44 weeks
Secondary 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
Secondary 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
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