HospitalizationNCT02458872
Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles
A study testing safety huddle alarm intervention in people with Hospitalization, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient units. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospitalization
- What is being tested?
- safety huddle alarm intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77,280 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2016
- 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
Inclusion criteria: Any nurse, physician, nurse practitioner, or physician assistant caring for a patient whose alarms are discussed in a safety huddle on an intervention unit.
Exclusion criteria: none
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient units.
Read the detailed description
Hospital physiologic monitors can alert clinicians to early signs of physiologic deterioration, and thus have great potential to be life-saving. However, monitors generate frequent alarms, most of which are non-actionable.
When clinicians become overburdened with alarms, they begin to exhibit alarm fatigue: responding more slowly to alarms or ignoring alarms entirely. In this protocol the investigators outline the methods they will use to evaluate the impact of a safety huddle-based intervention on physiologic monitor alarm rates using a pragmatic, paired, cluster-randomized controlled trial with the intervention delivered at the unit level. This work is considered quality improvement research, and some of the approaches described in this protocol are from the field of quality improvement.
Currently, at most hospitals data like this on the numbers of alarms that patients generate are only available to researchers with the software tools needed to interrogate and record data from the monitor network. The goal of this proposal is to bring this data to the safety huddles occurring daily on inpatient units in an accessible format to help teams make informed decisions about monitoring and minimize the potential of harm from alarm fatigue.
- Conditions
- Hospitalization
- Being tested
- safety huddle alarm intervention
- Keywords
- Clinical Alarms, Patient Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
safety huddle alarm interventionBehavioural
The intervention consists of a monitor alarm dashboard that displays the numbers and types of alarms for each patient, and an accompanying checklist to guide data-driven discussion of 2-4 patients with high alarm rates.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Safety huddle alarm intervention. Receives: Behavioral: safety huddle alarm intervention |
| Control Arm | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the unit-wide rate of alarms per patient-day at 44 weeks
Measured: Baseline and 44 weeks
Secondary outcomes (2)
Pre-post huddle patient-level difference in differences of alarm rates
The difference in the rate of alarms in individual patients in the 24 hours after discussion in a huddle compared with themselves in the 24 hours before the huddle, patients on the same unit as the huddle but whose alarms are not discussed, and patients on units without the alarm huddle intervention.
Measured: The 24 hours before a safety huddle opportunity versus the 24 hours before a safety huddle opportunity
Implementation outcomes
Proportion of huddles in post-implementation data collection period that included discussion of at least 1 patient's alarms, proportion of patients in whom a change in monitor delay time was recommended who had delay time changed in a direction consistent with the recommendations within 4 hours
Measured: Within 4 hours after the huddle intervention occurred
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HospitalizationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Pediatric Association
- Responsible party
- Sponsor
- Investigators
- Christopher P Bonafide, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458872
- Sponsor's protocol ID
- 15-011896
- Status last verified
- Jun 2017
- First submitted
- 28 May 2015
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonafide CP, Localio AR, Sternler S, Ahumada L, Dewan M, Ely E, Keren R. Safety Huddle Intervention for Reducing Physiologic Monitor Alarms: A Hybrid Effectiveness-Implementation Cluster Randomized Trial. J Hosp Med. 2018 Sep 1;13(9):609-615. doi: 10.12788/jhm.2956. Epub 2018 Feb 27.
PubMed 29489921
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles
- ClinicalTrials.gov ID
- NCT02458872
- Acronym / sponsor ID
- 15-011896
- Conditions
- Hospitalization
- Keywords
- Clinical Alarms, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77,280 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Academic Pediatric Association
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Jun 2015 (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.
This is a pragmatic, paired, cluster-randomized controlled trial evaluating the impact of a safety huddle-based intervention on physiologic monitor alarm rates on pediatric inpatient units.
Detailed description
Hospital physiologic monitors can alert clinicians to early signs of physiologic deterioration, and thus have great potential to be life-saving. However, monitors generate frequent alarms, most of which are non-actionable.
When clinicians become overburdened with alarms, they begin to exhibit alarm fatigue: responding more slowly to alarms or ignoring alarms entirely. In this protocol the investigators outline the methods they will use to evaluate the impact of a safety huddle-based intervention on physiologic monitor alarm rates using a pragmatic, paired, cluster-randomized controlled trial with the intervention delivered at the unit level. This work is considered quality improvement research, and some of the approaches described in this protocol are from the field of quality improvement.
Currently, at most hospitals data like this on the numbers of alarms that patients generate are only available to researchers with the software tools needed to interrogate and record data from the monitor network. The goal of this proposal is to bring this data to the safety huddles occurring daily on inpatient units in an accessible format to help teams make informed decisions about monitoring and minimize the potential of harm from alarm fatigue.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: safety huddle alarm interventionSafety huddle alarm intervention. |
| Control Arm | No intervention | –Usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| safety huddle alarm interventionThe intervention consists of a monitor alarm dashboard that displays the numbers and types of alarms for each patient, and an accompanying checklist to guide data-driven discussion of 2-4 patients with high alarm rates. | Behavioural | Intervention Arm |
Primary outcome
Change from baseline in the unit-wide rate of alarms per patient-day at 44 weeks
Time frame: Baseline and 44 weeks
2 secondary outcomes
Pre-post huddle patient-level difference in differences of alarm rates
Time frame: The 24 hours before a safety huddle opportunity versus the 24 hours before a safety huddle opportunity
Implementation outcomes
Time frame: Within 4 hours after the huddle intervention occurred
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 2 Jun 2017.
- Derived from this study: PubMed 29489921Bonafide CP, Localio AR, Sternler S, Ahumada L, Dewan M, Ely E, Keren R. Safety Huddle Intervention for Reducing Physiologic Monitor Alarms: A Hybrid Effectiveness-Implementation Cluster Randomized Trial. J Hosp Med. 2018 Sep 1;13(9):609-615. doi: 10.12788/jhm.2956. Epub 2018 Feb 27.
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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, MSCE 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 safety huddle alarm intervention in people with Hospitalization, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 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 from baseline in the unit-wide rate of alarms per patient-day at 44 weeks (time frame: Baseline and 44 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458872, which also lists 1 linked publication.
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 2 Jun 2017.