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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02319421
Other study ID # 14-010928
Secondary ID
Status Completed
Phase N/A
First received December 15, 2014
Last updated April 18, 2017
Start date March 2015
Est. completion date January 2017

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 812
Est. completion date January 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Alarm Reduction Script
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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