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The Sleep and Teamwork in EMS Study (SaFTiE)

Primary Purpose

Fatigue, Sleep

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SaFTiE
Attention Placebo Control
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SaFTiE

Attention Placebo Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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]
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]
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]

Secondary Outcome Measures

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]
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]
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]
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.
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.
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.

Full Information

First Posted
June 29, 2020
Last Updated
May 1, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
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1. Study Identification

Unique Protocol Identification Number
NCT04456764
Brief Title
The Sleep and Teamwork in EMS Study
Acronym
SaFTiE
Official Title
Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Sleep

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SaFTiE
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Placebo Control
Arm Type
Placebo Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
SaFTiE
Intervention Description
A multi-modal fatigue risk management program.
Intervention Type
Behavioral
Intervention Name(s)
Attention Placebo Control
Other Intervention Name(s)
Teamwork
Intervention Description
A multi-modal teamwork assessment program.
Primary Outcome Measure Information:
Title
Fatigue
Description
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]
Time Frame
At baseline
Title
Fatigue
Description
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]
Time Frame
At 3 months
Title
Fatigue
Description
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]
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Poor Sleep Quality
Description
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]
Time Frame
At baseline
Title
Poor Sleep Quality
Description
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]
Time Frame
At 3 months
Title
Poor Sleep Quality
Description
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]
Time Frame
At 6 months
Title
Fatigue and inter-shift recovery
Description
[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.
Time Frame
At baseline
Title
Fatigue and inter-shift recovery
Description
[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.
Time Frame
At 3 months
Title
Fatigue and inter-shift recovery
Description
[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.
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
P. Daniel Patterson, PhD
Phone
412-864-3830
Email
pdp3@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Wesoloski
Phone
412-647-0517
Email
wesoloskiba@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. Daniel Patterson, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P. Daniel Patterson, PhD
Phone
412-864-3830
Email
pdp3@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

The Sleep and Teamwork in EMS Study

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