Impact of a Data-driven Monitor Alarm Reduction Strategy Implemented in Safety Huddles

NCT ID: NCT02458872

Last Updated: 2017-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hospitalization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Arm

Safety huddle alarm intervention.

Group Type EXPERIMENTAL

safety huddle alarm intervention

Intervention Type BEHAVIORAL

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.

Control Arm

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

safety huddle alarm intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Academic Pediatric Association

INDUSTRY

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher P Bonafide, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29489921 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-011896

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nighttime Communication Study
NCT01836601 COMPLETED NA