The Sleep and Teamwork in EMS Study (SaFTiE)

University of Pittsburgh

Status: Terminated

Conditions: Fatigue; Sleep

Treatments: Behavioral: SaFTiE; Behavioral: Attention Placebo Control

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04456764

STUDY19040354

R01OH011502 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 708 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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708 participants in 2 patient groups, including a placebo group

SaFTiE

Experimental group

Description:

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.

Treatment:

Behavioral: SaFTiE

Attention Placebo Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Attention Placebo Control