Study Stopped
Performance period ended
The Sleep and Teamwork in EMS Study
SaFTiE
Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial
2 other identifiers
interventional
708
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedStudy Start
First participant enrolled
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedResults Posted
Study results publicly available
November 25, 2024
CompletedMay 18, 2025
May 1, 2025
3.2 years
June 29, 2020
October 4, 2024
May 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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, 3 months, and 6 months
Secondary Outcomes (5)
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 Arms (2)
SaFTiE
EXPERIMENTALThe 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
PLACEBO COMPARATORThe 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.
Interventions
A multi-modal teamwork assessment program.
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination prior to reaching goal enrollment leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- P. Daniel Patterson
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
P. Daniel Patterson, PhD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 2, 2020
Study Start
September 16, 2020
Primary Completion
December 11, 2023
Study Completion
March 31, 2024
Last Updated
May 18, 2025
Results First Posted
November 25, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Following publication of the primary study papers with primary and secondary outcomes reported.
- Access Criteria
- The study team will develop a process to receive requests from outside the study team for de-identified datasets should there be no NIOSH/CDC supported data repository.
The investigators will work with NIOSH/CDC and share de-identified research data via a NIOSH/CDC or NIH managed repository if requested. The study team will develop a process to receive requests from outside the study team for de-identified datasets should there be no NIOSH/CDC supported data repository.