Trial Outcomes & Findings for The Sleep and Teamwork in EMS Study (NCT NCT04456764)
NCT ID: NCT04456764
Last Updated: 2025-05-18
Results Overview
A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) \[minimum score=0, maximum score=11, and scores \>=4 indicate mental and physical fatigue\]
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
708 participants
Primary outcome timeframe
At baseline, 3 months, and 6 months
Results posted on
2025-05-18
Participant Flow
Unit of analysis: EMS Agencies
Participant milestones
| Measure |
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.
SaFTiE: A multi-modal fatigue risk management program.
|
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
|---|---|---|
|
Overall Study
STARTED
|
385 54
|
323 54
|
|
Overall Study
COMPLETED
|
319 47
|
272 44
|
|
Overall Study
NOT COMPLETED
|
66 7
|
51 10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Among participants who provided information on Age
Baseline characteristics by cohort
| Measure |
SaFTiE
n=385 Participants
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.
SaFTiE: A multi-modal fatigue risk management program.
|
Attention Placebo Control
n=323 Participants
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
Total
n=708 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.6 • n=371 Participants • Among participants who provided information on Age
|
35.3 years
STANDARD_DEVIATION 9.8 • n=318 Participants • Among participants who provided information on Age
|
36.6 years
STANDARD_DEVIATION 10.3 • n=689 Participants • Among participants who provided information on Age
|
|
Sex: Female, Male
Female
|
138 Participants
n=370 Participants • Among participants who provided information on sex
|
105 Participants
n=317 Participants • Among participants who provided information on sex
|
243 Participants
n=687 Participants • Among participants who provided information on sex
|
|
Sex: Female, Male
Male
|
232 Participants
n=370 Participants • Among participants who provided information on sex
|
212 Participants
n=317 Participants • Among participants who provided information on sex
|
444 Participants
n=687 Participants • Among participants who provided information on sex
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=368 Participants • Among participants who provided information on Ethnicity
|
12 Participants
n=315 Participants • Among participants who provided information on Ethnicity
|
36 Participants
n=683 Participants • Among participants who provided information on Ethnicity
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
339 Participants
n=368 Participants • Among participants who provided information on Ethnicity
|
298 Participants
n=315 Participants • Among participants who provided information on Ethnicity
|
637 Participants
n=683 Participants • Among participants who provided information on Ethnicity
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=368 Participants • Among participants who provided information on Ethnicity
|
5 Participants
n=315 Participants • Among participants who provided information on Ethnicity
|
10 Participants
n=683 Participants • Among participants who provided information on Ethnicity
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=371 Participants • Among participants who provided information on Race
|
0 Participants
n=318 Participants • Among participants who provided information on Race
|
1 Participants
n=689 Participants • Among participants who provided information on Race
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=371 Participants • Among participants who provided information on Race
|
1 Participants
n=318 Participants • Among participants who provided information on Race
|
6 Participants
n=689 Participants • Among participants who provided information on Race
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=371 Participants • Among participants who provided information on Race
|
0 Participants
n=318 Participants • Among participants who provided information on Race
|
0 Participants
n=689 Participants • Among participants who provided information on Race
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=371 Participants • Among participants who provided information on Race
|
4 Participants
n=318 Participants • Among participants who provided information on Race
|
12 Participants
n=689 Participants • Among participants who provided information on Race
|
|
Race (NIH/OMB)
White
|
339 Participants
n=371 Participants • Among participants who provided information on Race
|
301 Participants
n=318 Participants • Among participants who provided information on Race
|
640 Participants
n=689 Participants • Among participants who provided information on Race
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=371 Participants • Among participants who provided information on Race
|
8 Participants
n=318 Participants • Among participants who provided information on Race
|
22 Participants
n=689 Participants • Among participants who provided information on Race
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=371 Participants • Among participants who provided information on Race
|
4 Participants
n=318 Participants • Among participants who provided information on Race
|
8 Participants
n=689 Participants • Among participants who provided information on Race
|
|
Chalder Fatigue Questionnaire (CFQ)
|
5.3 units on a scale
STANDARD_DEVIATION 2.9 • n=369 Participants • Among participants who provided information on Chalder Fatigue Questionnaire (CFQ)
|
5.2 units on a scale
STANDARD_DEVIATION 3.1 • n=316 Participants • Among participants who provided information on Chalder Fatigue Questionnaire (CFQ)
|
5.3 units on a scale
STANDARD_DEVIATION 3.0 • n=685 Participants • Among participants who provided information on Chalder Fatigue Questionnaire (CFQ)
|
PRIMARY outcome
Timeframe: At baseline, 3 months, and 6 monthsPopulation: Among participants who provided survey data
A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) \[minimum score=0, maximum score=11, and scores \>=4 indicate mental and physical fatigue\]
Outcome measures
| Measure |
SaFTiE
n=369 Participants
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.
SaFTiE: A multi-modal fatigue risk management program.
|
Attention Placebo Control
n=316 Participants
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
|---|---|---|
|
Fatigue
Baseline
|
260 Participants
|
219 Participants
|
|
Fatigue
3 months
|
172 Participants
|
122 Participants
|
|
Fatigue
6 months
|
144 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Among participants who completed the survey
The PSQI measures sleep quality using a survey instrument with scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Outcome measures
| Measure |
SaFTiE
n=369 Participants
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.
SaFTiE: A multi-modal fatigue risk management program.
|
Attention Placebo Control
n=316 Participants
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
9.0 score on a scale
Standard Deviation 3.5
|
8.8 score on a scale
Standard Deviation 3.8
|
|
Pittsburgh Sleep Quality Index (PSQI)
3 months
|
7.9 score on a scale
Standard Deviation 3.6
|
7.9 score on a scale
Standard Deviation 4.0
|
|
Pittsburgh Sleep Quality Index (PSQI)
6 months
|
7.4 score on a scale
Standard Deviation 3.6
|
7.5 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Among participants who reported poor sleep at baseline and had survey data at 6 months
A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) \[minimum score=0, maximum score=21, and scores \>=6 indicate poor sleep quality\]
Outcome measures
| Measure |
SaFTiE
n=240 Participants
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.
SaFTiE: A multi-modal fatigue risk management program.
|
Attention Placebo Control
n=206 Participants
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
|---|---|---|
|
Poor Sleep Quality
|
188 Participants
|
177 Participants
|
SECONDARY outcome
Timeframe: At baseline, 3 months, and 6 monthsPopulation: Among participants who answered the OFER survey
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.
Outcome measures
| Measure |
SaFTiE
n=369 Participants
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.
SaFTiE: A multi-modal fatigue risk management program.
|
Attention Placebo Control
n=316 Participants
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
|---|---|---|
|
Inter-Shift Recovery Measure
Baseline
|
51.4 score on a scale
Standard Deviation 25.6
|
55.0 score on a scale
Standard Deviation 25.1
|
|
Inter-Shift Recovery Measure
At 3 months
|
52.0 score on a scale
Standard Deviation 25.2
|
57.1 score on a scale
Standard Deviation 24.7
|
|
Inter-Shift Recovery Measure
At 6 months
|
52.3 score on a scale
Standard Deviation 24.9
|
55.7 score on a scale
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Among participants who answered the OFER survey
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.
Outcome measures
| Measure |
SaFTiE
n=369 Participants
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.
SaFTiE: A multi-modal fatigue risk management program.
|
Attention Placebo Control
n=316 Participants
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
|---|---|---|
|
Acute Fatigue Measure
Baseline
|
59.8 score on a scale
Standard Deviation 23.7
|
57.6 score on a scale
Standard Deviation 25.1
|
|
Acute Fatigue Measure
3 months
|
58.7 score on a scale
Standard Deviation 24.7
|
52.8 score on a scale
Standard Deviation 25.1
|
|
Acute Fatigue Measure
6 months
|
58.6 score on a scale
Standard Deviation 23.4
|
56.1 score on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Among participants who answered the OFER survey
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.
Outcome measures
| Measure |
SaFTiE
n=369 Participants
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.
SaFTiE: A multi-modal fatigue risk management program.
|
Attention Placebo Control
n=316 Participants
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.
Attention Placebo Control: A multi-modal teamwork assessment program.
|
|---|---|---|
|
Chronic Fatigue Measure
Baseline
|
35.8 score on a scale
Standard Deviation 25.0
|
32.7 score on a scale
Standard Deviation 24.4
|
|
Chronic Fatigue Measure
3 months
|
38.9 score on a scale
Standard Deviation 26.6
|
33.9 score on a scale
Standard Deviation 25.3
|
|
Chronic Fatigue Measure
6 months
|
38.8 score on a scale
Standard Deviation 26.5
|
37.2 score on a scale
Standard Deviation 26.8
|
Adverse Events
SaFTiE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Placebo Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place