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Clinical Trials/NCT04456764
NCT04456764
Terminated
Not Applicable

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

University of Pittsburgh1 site in 1 country708 target enrollmentSeptember 16, 2020
ConditionsFatigueSleep

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fatigue
Sponsor
University of Pittsburgh
Enrollment
708
Locations
1
Primary Endpoint
Fatigue
Status
Terminated
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2020
End Date
March 31, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Patterson, PhD, NRP

Associate Professor

University of Pittsburgh

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fatigue

Time Frame: 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 Outcomes

  • Pittsburgh Sleep Quality Index (PSQI)(Baseline, 3 months, and 6 months)
  • Poor Sleep Quality(At 6 months)
  • Inter-Shift Recovery Measure(At baseline, 3 months, and 6 months)
  • Acute Fatigue Measure(Baseline, 3 months, and 6 months)
  • Chronic Fatigue Measure(Baseline, 3 months, 6 months)

Study Sites (1)

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