NCT02458872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77,280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

May 28, 2015

Last Update Submit

June 1, 2017

Conditions

Hospitalization

Keywords

Clinical AlarmsPatient Safety

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 44 weeks

Secondary Outcomes (2)

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

    The 24 hours before a safety huddle opportunity versus the 24 hours before a safety huddle opportunity

  • Implementation outcomes

    Within 4 hours after the huddle intervention occurred

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Safety huddle alarm intervention.

Behavioral: safety huddle alarm intervention

Control Arm

NO INTERVENTION

Usual care.

Interventions

safety huddle alarm interventionBEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 29489921DERIVED

Study Officials

  • Christopher P Bonafide, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 1, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

US(1)