The Sleep and Teamwork in EMS Study

Not Applicable

Terminated

Conditions: Sleep
Fatigue

Interventions: Behavioral: SaFTiE
Behavioral: Attention Placebo Control

Registration Number: NCT04456764

Lead Sponsor: University of Pittsburgh

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 708

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SaFTiE	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.
Attention Placebo Control	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.

Primary Outcome Measures

Name	Time	Method
Fatigue	At baseline, 3 months, and 6 months	A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) \[minimum score=0, maximum score=11, and scores \>=4 indicate mental and physical fatigue\]

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	Baseline, 3 months, and 6 months	The PSQI measures sleep quality using a survey instrument with scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Poor Sleep Quality	At 6 months	A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) \[minimum score=0, maximum score=21, and scores \>=6 indicate poor sleep quality\]
Inter-Shift Recovery Measure	At baseline, 3 months, and 6 months	This is the Inter-Shift Recovery sub-scale of the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. Higher scores on the inter-shift sub-scale signify greater/improved ability to recover between shifts. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.
Acute Fatigue Measure	Baseline, 3 months, and 6 months	This is the Acute Fatigue sub-scale of the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. Higher scores on the acute fatigue sub-scale (e.g., 50-100) signify moderate to high acute fatigue. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.
Chronic Fatigue Measure	Baseline, 3 months, 6 months	This is the Chronic Fatigue sub-scale of the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. Higher scores on the chronic fatigue sub-scales (e.g., 50-100) signify moderate to high chronic fatigue. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.