FatigueSaFTiENCT04456764
The Sleep and Teamwork in EMS Study
A study testing SaFTiE in people with Fatigue and Sleep, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- SaFTiE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 708 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2020to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: 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.
Read the 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.
- Being tested
- SaFTiE, Attention Placebo Control
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaFTiEBehavioural
A multi-modal fatigue risk management program.
Attention Placebo ControlBehavioural
Also called Teamwork
A multi-modal teamwork assessment program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SaFTiE |
| 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. Receives: Behavioral: Attention Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: At baseline, 3 months, and 6 months
Secondary outcomes (5)
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.
Measured: 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]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start16 Sep 2020
- Primary completion11 Dec 2023
- Study completion31 Mar 2024
Why it stopped: Performance period ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Daniel Patterson, PhD, NRP, University of Pittsburgh
- Investigators
- P. Daniel Patterson, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456764
- Sponsor's protocol ID
- STUDY19040354
- Other IDs
- R01OH011502
- Acronym
- SaFTiE
- Status last verified
- May 2025
- First submitted
- 29 Jun 2020
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Daniel Patterson P, Martin SE, Weaver MD, Patterson CG, Smith CN, Parmanto B, Wayan Pulantara I, Weiss LS, Tripp RP, Guyette FX, Buysse DJ. Real-time text message intervention to mitigate workplace fatigue in emergency medical services: A cluster-randomized trial. Sleep Health. 2026 Jun;12(3):479-487. doi: 10.1016/j.sleh.2026.02.011. Epub 2026 Mar 24.
PubMed 41881743
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT04456764
- Acronym / sponsor ID
- SaFTiE / STUDY19040354
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Performance period ended
- Enrolment
- 708 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Posted 25 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SaFTiE | Experimental | Behavioral: SaFTiEThe 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 comparator | Behavioral: Attention Placebo ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaFTiEA multi-modal fatigue risk management program. | Behavioural | SaFTiE |
| Attention Placebo ControlAlso: TeamworkA multi-modal teamwork assessment program. | Behavioural | Attention Placebo Control |
Primary outcome
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]
5 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 3 months, and 6 months
Poor Sleep Quality
Time frame: At 6 months
Inter-Shift Recovery Measure
Time frame: At baseline, 3 months, and 6 months
Acute Fatigue Measure
Time frame: Baseline, 3 months, and 6 months
Chronic Fatigue Measure
Time frame: Baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41881743Daniel Patterson P, Martin SE, Weaver MD, Patterson CG, Smith CN, Parmanto B, Wayan Pulantara I, Weiss LS, Tripp RP, Guyette FX, Buysse DJ. Real-time text message intervention to mitigate workplace fatigue in emergency medical services: A cluster-randomized trial. Sleep Health. 2026 Jun;12(3):479-487. doi: 10.1016/j.sleh.2026.02.011. Epub 2026 Mar 24.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P. Daniel Patterson, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaFTiE in people with Fatigue and Sleep, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: At baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04456764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.