The Sleep and Teamwork in EMS Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2024-03-31

Brief Summary

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

More than half of Emergency Medical Services (EMS) workers report work-related mental and physical fatigue. Odds of injury among fatigued EMS workers are nearly double that of non-fatigued workers. There is a compelling need to reduce fatigue among EMS workers, yet few EMS organizations have a formal fatigue management program and many may not be cost-effective or evidence-based. This trial addresses national goals of the National Occupational Research Agenda (NORA) and tests a novel approach to fatigue risk management that is easily scalable to large workforces and low-cost for employers of shift workers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The EMS Sleep Health Study: A Randomized Controlled Trial

NCT04218279

Sleep Quality Fatigue

TERMINATED NA

The SleepTrackTXT2 Randomized Trial With Air-medical Personnel

NCT02783027

Poor Quality Sleep Fatigue

COMPLETED NA

Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts

NCT06100809

Fatigue Shift Work Type Circadian Rhythm Sleep Disorder

NOT_YET_RECRUITING NA

Tech4Rest Trial With Team Truck Drivers

NCT03108599

Sleep Sleep Disturbance Sleep Disorder, Shift Work +4 more

COMPLETED NA

Fire Fighter Fatigue Management Program: Operation Fight Fatigue

NCT01672502

Shift-Work Sleep Disorder Insomnia Restless Leg Syndrome +2 more

COMPLETED NA

Detailed Description

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

The investigators will test an enhanced version of our SleepTrackTXT pilot intervention - Sleep and Fatigue Treatment in EMS (SaFTiE) - in a two-arm parallel cluster-randomized design of EMS agencies. Our unit of randomization will be the EMS agency, with the intervention deployed as a Fatigue Risk Management Program that can be integrated into an agency's existing program. During the active intervention phase, the investigators will use SaFTiE and an attention placebo control (APC) group to test the specific effect of our multi-component intervention on EMS worker fatigue and sleep health.

Conditions

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

Fatigue Sleep

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

OTHER

Blinding Strategy

NONE

Study Groups

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

SaFTiE

The SaFTiE intervention includes: \[a\] real-time text-message assessments of fatigue and sleep during and between scheduled shift work; \[b\] tailored text-message alerts that promote adopting evidence based strategies for mitigating fatigue when high levels of fatigue or sleepiness are reported; \[c\] a mobile app that delivers goal setting, summary data of sleep/fatigue indicators from all study participants, and video interviews of EMS clinicians focused on sleep and fatigue.

Group Type EXPERIMENTAL

SaFTiE

Intervention Type BEHAVIORAL

A multi-modal fatigue risk management program.

Attention Placebo Control

The attention placebo control includes: \[a\] real-time text-message assessments of teamwork during and between scheduled shift work; \[b\] text-message alerts that promote techniques for mitigating poor teamwork when episodes of poor teamwork are reported; \[c\] a mobile app that delivers goal setting, summary data of teamwork indicators from all study participants, and video interviews of EMS clinicians focused on teamwork.

Group Type PLACEBO_COMPARATOR

Attention Placebo Control

Intervention Type BEHAVIORAL

A multi-modal teamwork assessment program.

Interventions

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

SaFTiE

A multi-modal fatigue risk management program.

Intervention Type BEHAVIORAL

Attention Placebo Control

A multi-modal teamwork assessment program.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Teamwork

Eligibility Criteria

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

Inclusion Criteria

* 18 years or older
* Live in United States (including Hawaii and Alaska)
* Licensed / certified EMS clinician
* Currently work in shifts
* Do at least one clinical shift per week
* Own a smartphone
* Willing to answer monthly surveys and daily text-messages,

Exclusion Criteria

* Exclude EMS personnel who are primarily administrative with non-clinical duties
* Are restricted from using personal smartphone during periods of work
* Do not own a smartphone capable of running the study mobile app

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes