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Clinical Trials/NCT04456764
NCT04456764TerminatedNot Applicable

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

University of Pittsburgh1 site in 1 country708 target enrollmentStarted: September 16, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
708
Locations
1
Primary Endpoint
Fatigue

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

SaFTiE

Experimental

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.

Intervention: SaFTiE (Behavioral)

Attention Placebo Control

Placebo Comparator

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.

Intervention: Attention Placebo Control (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel Patterson, PhD, NRP

Associate Professor

University of Pittsburgh

Study Sites (1)

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