The Sleep and Teamwork in EMS Study (SaFTiE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Fatigue; Sleep
• Intervention / Treatment: Behavioral: SaFTiE; Behavioral: Attention Placebo Control

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 Type: Interventional
• Enrollment (Actual): 708
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	The PSQI measures sleep quality using a survey instrument with scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.	Baseline, 3 months, and 6 months
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 6 months
Inter-Shift Recovery Measure	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.	At baseline, 3 months, and 6 months
Acute Fatigue Measure	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.	Baseline, 3 months, and 6 months
Chronic Fatigue Measure	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.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC)
• Investigators: Principal Investigator: P. Daniel Patterson, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: STUDY19040354; R01OH011502 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Following publication of the primary study papers with primary and secondary outcomes reported.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No