Clinical AlarmsNCT02319421
Reducing the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles
A study testing Alarm Reduction Script in people with Clinical Alarms, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Alarms
- What is being tested?
- Alarm Reduction Script
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Reducine the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles
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.
Read more
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.
- Conditions
- Clinical Alarms
- Being tested
- Alarm Reduction Script
- Keywords
- Alarm fatigue
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alarm Reduction ScriptOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Other: Alarm Reduction Script |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours before intervention and 72 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical AlarmsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher P Bonafide, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319421
- Sponsor's protocol ID
- 14-010928
- Status last verified
- Apr 2017
- First submitted
- 15 Dec 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducine the Risk of Alarm Fatigue Through the Use of Focused Management in Safety Huddles
- ClinicalTrials.gov ID
- NCT02319421
- Acronym / sponsor ID
- 14-010928
- Conditions
- Clinical Alarms
- Keywords
- Alarm fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Subjects | Experimental | Other: Alarm Reduction ScriptPhysicians 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". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alarm Reduction ScriptThe 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. | Other | Primary Subjects |
Primary outcome
Change in alarm rate before and after intervention
Time frame: 24 hours before intervention and 72 hours 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher P Bonafide, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alarm Reduction Script in people with Clinical Alarms, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alarm rate before and after intervention (time frame: 24 hours before intervention and 72 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.