Fatigue, Sleep
Conditions
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 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.
Interventions
BEHAVIORALSaFTiE
A multi-modal fatigue risk management program.
BEHAVIORALAttention Placebo Control
A multi-modal teamwork assessment program.
Sponsors
National Institute for Occupational Safety and Health (NIOSH/CDC)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | At baseline, 3 months, and 6 months | A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) \[minimum score=0, maximum score=11, and scores \>=4 indicate mental and physical fatigue\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, 3 months, and 6 months | The PSQI measures sleep quality using a survey instrument with scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
| Poor Sleep Quality | At 6 months | A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) \[minimum score=0, maximum score=21, and scores \>=6 indicate poor sleep quality\] |
| Inter-Shift Recovery Measure | At baseline, 3 months, and 6 months | 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. |
| Acute Fatigue Measure | Baseline, 3 months, and 6 months | 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. |
| Chronic Fatigue Measure | Baseline, 3 months, 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 385 |
| 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. | 323 |
| Total | 708 |
Baseline characteristics
| Characteristic | SaFTiE | Attention Placebo Control | Total |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 10.6 | 35.3 years STANDARD_DEVIATION 9.8 | 36.6 years STANDARD_DEVIATION 10.3 |
| Chalder Fatigue Questionnaire (CFQ) | 5.3 units on a scale STANDARD_DEVIATION 2.9 | 5.2 units on a scale STANDARD_DEVIATION 3.1 | 5.3 units on a scale STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 12 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 339 Participants | 298 Participants | 637 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 8 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 339 Participants | 301 Participants | 640 Participants |
| Sex: Female, Male Female | 138 Participants | 105 Participants | 243 Participants |
| Sex: Female, Male Male | 232 Participants | 212 Participants | 444 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Fatigue
A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) \[minimum score=0, maximum score=11, and scores \>=4 indicate mental and physical fatigue\]
Time frame: At baseline, 3 months, and 6 months
Population: Among participants who provided survey data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SaFTiE | Fatigue | Baseline | 260 Participants |
| SaFTiE | Fatigue | 3 months | 172 Participants |
| SaFTiE | Fatigue | 6 months | 144 Participants |
| Attention Placebo Control | Fatigue | Baseline | 219 Participants |
| Attention Placebo Control | Fatigue | 3 months | 122 Participants |
| Attention Placebo Control | Fatigue | 6 months | 107 Participants |
p-value: 0.55Mixed Models Analysis
Secondary
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.
Time frame: Baseline, 3 months, and 6 months
Population: Among participants who answered the OFER survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SaFTiE | Acute Fatigue Measure | Baseline | 59.8 score on a scale | Standard Deviation 23.7 |
| SaFTiE | Acute Fatigue Measure | 3 months | 58.7 score on a scale | Standard Deviation 24.7 |
| SaFTiE | Acute Fatigue Measure | 6 months | 58.6 score on a scale | Standard Deviation 23.4 |
| Attention Placebo Control | Acute Fatigue Measure | Baseline | 57.6 score on a scale | Standard Deviation 25.1 |
| Attention Placebo Control | Acute Fatigue Measure | 3 months | 52.8 score on a scale | Standard Deviation 25.1 |
| Attention Placebo Control | Acute Fatigue Measure | 6 months | 56.1 score on a scale | Standard Deviation 24 |
p-value: 0.04Mixed Models Analysis
Secondary
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.
Time frame: Baseline, 3 months, 6 months
Population: Among participants who answered the OFER survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SaFTiE | Chronic Fatigue Measure | 3 months | 38.9 score on a scale | Standard Deviation 26.6 |
| SaFTiE | Chronic Fatigue Measure | Baseline | 35.8 score on a scale | Standard Deviation 25 |
| SaFTiE | Chronic Fatigue Measure | 6 months | 38.8 score on a scale | Standard Deviation 26.5 |
| Attention Placebo Control | Chronic Fatigue Measure | Baseline | 32.7 score on a scale | Standard Deviation 24.4 |
| Attention Placebo Control | Chronic Fatigue Measure | 3 months | 33.9 score on a scale | Standard Deviation 25.3 |
| Attention Placebo Control | Chronic Fatigue Measure | 6 months | 37.2 score on a scale | Standard Deviation 26.8 |
p-value: 0.02Mixed Models Analysis
Secondary
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.
Time frame: At baseline, 3 months, and 6 months
Population: Among participants who answered the OFER survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SaFTiE | Inter-Shift Recovery Measure | Baseline | 51.4 score on a scale | Standard Deviation 25.6 |
| SaFTiE | Inter-Shift Recovery Measure | At 3 months | 52.0 score on a scale | Standard Deviation 25.2 |
| SaFTiE | Inter-Shift Recovery Measure | At 6 months | 52.3 score on a scale | Standard Deviation 24.9 |
| Attention Placebo Control | Inter-Shift Recovery Measure | Baseline | 55.0 score on a scale | Standard Deviation 25.1 |
| Attention Placebo Control | Inter-Shift Recovery Measure | At 3 months | 57.1 score on a scale | Standard Deviation 24.7 |
| Attention Placebo Control | Inter-Shift Recovery Measure | At 6 months | 55.7 score on a scale | Standard Deviation 25.1 |
p-value: 0.51Mixed Models Analysis
Secondary
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.
Time frame: Baseline, 3 months, and 6 months
Population: Among participants who completed the survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SaFTiE | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 9.0 score on a scale | Standard Deviation 3.5 |
| SaFTiE | Pittsburgh Sleep Quality Index (PSQI) | 3 months | 7.9 score on a scale | Standard Deviation 3.6 |
| SaFTiE | Pittsburgh Sleep Quality Index (PSQI) | 6 months | 7.4 score on a scale | Standard Deviation 3.6 |
| Attention Placebo Control | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 8.8 score on a scale | Standard Deviation 3.8 |
| Attention Placebo Control | Pittsburgh Sleep Quality Index (PSQI) | 3 months | 7.9 score on a scale | Standard Deviation 4 |
| Attention Placebo Control | Pittsburgh Sleep Quality Index (PSQI) | 6 months | 7.5 score on a scale | Standard Deviation 3.7 |
p-value: 0.12Mixed Models Analysis
Secondary
Poor Sleep Quality
A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) \[minimum score=0, maximum score=21, and scores \>=6 indicate poor sleep quality\]
Time frame: At 6 months
Population: Among participants who reported poor sleep at baseline and had survey data at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SaFTiE | Poor Sleep Quality | 188 Participants |
| Attention Placebo Control | Poor Sleep Quality | 177 Participants |
p-value: 0.0986Mixed Models Analysis