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Reducing the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles

Primary Purpose

Clinical Alarms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alarm Reduction Script
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Clinical Alarms focused on measuring Alarm fatigue

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligible primary participants will be the physicians and nurse practitioners caring for the PICU patients who are discussed as part of the huddle interventions. Eligible secondary participants will include all low acuity patients in the PICU at The Children's Hospital of Philadelphia.

Inclusion Criteria Primary Subjects: Any physician or nurse practioner caring for an intervention patient or control patient in the PICU at CHOP

Secondary Subjects:

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

Exclusion Criteria Primary Subjects: None

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.

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary Subjects

Arm Description

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".

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2014
Last Updated
April 18, 2017
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02319421
Brief Title
Reducing the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles
Official Title
Reducine the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Alarms
Keywords
Alarm fatigue

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
812 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Subjects
Arm Type
Experimental
Arm Description
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".
Intervention Type
Other
Intervention Name(s)
Alarm Reduction Script
Intervention Description
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 Outcome Measure Information:
Title
Change in alarm rate before and after intervention
Description
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
Time Frame
24 hours before intervention and 72 hours after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligible primary participants will be the physicians and nurse practitioners caring for the PICU patients who are discussed as part of the huddle interventions. Eligible secondary participants will include all low acuity patients in the PICU at The Children's Hospital of Philadelphia. Inclusion Criteria Primary Subjects: Any physician or nurse practioner caring for an intervention patient or control patient in the PICU at CHOP Secondary Subjects: Low acuity patients as determined by Optilink Guidelines High alarm patients (top 10-20%) Admission to the PICU Exclusion Criteria Primary Subjects: None 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher P Bonafide, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Reducing the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles

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