NCT02319421

Brief Summary

Context: Alarm fatigue is a threat to hospital patient safety. National surveys reveal that high alarm rates interrupt patient care, reduce trust in alarms, and lead clinicians to disable alarms entirely. Safety huddles offer an appropriate forum for reviewing alarm data and identifying patients whose high alarm rates may necessitate safe tailoring of alarm limits. Objectives: To evaluate the impact of a focused physiologic monitor alarm reduction intervention integrated into safety huddles that involves discussing safe monitor parameter adjustments on the physiologic monitor alarm rates of individual patients with high alarm rates who meet "low acuity" criteria. Study Design: A prospective, quasi-experimental pilot study of the impact of the huddle intervention on the alarm rates of low acuity high alarm rate individual patients discussed in huddles in the PICU. The huddle intervention will consist of a script to facilitate the discussion of the alarm data. Setting/Participants: Participants will include all low acuity patients and their providers in the PICU at The Children's Hospital of Philadelphia. Study Interventions and Measures: The primary outcome is the rate of crisis and warning alarms per patient day for intervention cases as compared with others in the high alarm / low acuity cohort. Safety measures will include unexpected changes in patient acuity or code blue events within one week of monitor change or discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
812

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

December 15, 2014

Last Update Submit

April 18, 2017

Conditions

Keywords

Alarm fatigue

Outcome Measures

Primary Outcomes (1)

  • Change in alarm rate before and after intervention

    Within-subject comparison evaluating the numbers of alarms and the trajectories of alarm rates in the 24 hours before and up to 72 hours after each huddle

    24 hours before intervention and 72 hours after intervention

Study Arms (1)

Primary Subjects

EXPERIMENTAL

Physicians and nurse practitioners caring for patients in the Pediatric Intensive Care Unit (PICU). An alarm reduction script will be used to help facilitate discussion of alarm data during weekday morning team "huddles".

Other: Alarm Reduction Script

Interventions

The intervention will consist of a script to facilitate the discussion of the alarm data that will take place on weekday mornings. The script will be used by huddle participants as a structured outline to rapidly discuss the high alarm low acuity patients eligible for intervention. The patients who are identified will have further discussion on rounds to determine if there are appropriate ways to reduce the alarm rates of individual patients through the safe adjustment of physiologic monitor parameters.

Primary Subjects

Eligibility Criteria

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

You may qualify if:

  • Secondary Subjects:
  • Low acuity patients as determined by Optilink Guidelines
  • High alarm patients (top 10-20%)
  • Admission to the PICU

You may not qualify if:

  • Secondary Subjects: Patients who are medically ready for transfer out of ICU or discharge home (status continuously tracked by charge nurse). Patients who are medically ready for transfer out have an accepting service in place and a bed ready on the floor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Christopher P Bonafide, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 18, 2014

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

January 1, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations