The Sleep and Teamwork in EMS Study

Study Overview
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Brief Summary
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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
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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 36 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. Prior to randomization the investigators will use a run-in period of 60 days with all 36 agencies to capture the natural history of the target population whereby they are naive to the study intervention. 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.

Official Title
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Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial

Conditions
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Fatigue, Sleep

Intervention / Treatment
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* Behavioral: SaFTiE
* Behavioral: Attention Placebo Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SaFTiE<br>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. | Behavioral: SaFTiE<br>* A multi-modal fatigue risk management program.<br>|
| Placebo Comparator: Attention Placebo Control<br>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. | Behavioral: Attention Placebo Control<br>* A multi-modal teamwork assessment program.<br>* Other names: Teamwork;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | 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] | At baseline | 
| Fatigue | 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] | At 3 months | 
| Fatigue | 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] | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor Sleep Quality | 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] | At baseline | 
| Poor Sleep Quality | 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] | At 3 months | 
| Poor Sleep Quality | A response of 6 or greater on the Pittsburgh Sleep Quality Index [minimum score=0, maximum score=21, and scores >=6 indicate poor sleep quality] | At 6 months | 
| Fatigue and inter-shift recovery | [Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. 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. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR 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. | At baseline | 
| Fatigue and inter-shift recovery | [Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. 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. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR 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. | At 3 months | 
| Fatigue and inter-shift recovery | [Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. 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. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR 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. | At 6 months |