The Sleep and Teamwork in EMS Study

Fatigue Clinical Trial

— SaFTiE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04456764
• Other study ID #: STUDY19040354
• Secondary ID: R01OH011502
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 708
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Sleep

Intervention

Behavioral:
• SaFTiE
A multi-modal fatigue risk management program.
• Attention Placebo Control
A multi-modal teamwork assessment program.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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