Reducing the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles (NCT02319421) | Clinical Trial Compass
CompletedNot Applicable
Reducing the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles
United States812 participantsStarted 2015-03
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in alarm rate before and after intervention
Timeframe: 24 hours before intervention and 72 hours after intervention