Fatigue, Sleep Quality
Conditions
Brief summary
The experiment seeks to determine the impact of a sleep health and fatigue education and training program on diverse indicators of sleep and fatigue among Emergency Medical Services (EMS) personnel. The overarching goals of this research study are to \[1\] enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and \[2\] determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue. The investigators will accomplish these goals by using a cluster-randomized trial study design with a wait-list control group.
Detailed description
The overarching goals of this research study are to: 1. enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and 2. determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue. The investigators will recruit EMS nationwide for EMS agencies to participate in this study and focus on moderately sized EMS agencies with between 50 and 300 employees (yet we will not outright exclude smaller or larger organizations). Agencies that run dual ground-based and air-medical EMS services are eligible. Maximum enrollment at the agency-level is n=30 EMS agencies. Agencies will be randomized upon enrollment to one of two arms: \[1\] Intervention group; or \[2\] the Wait-List control group. The intervention group will receive immediate access to the intervention materials (the 10 brief Sleep Health Education Modules). The wait-list control group will receive access to intervention materials at 3 months post enrollment/baseline. Within each agency, the investigators will recruit individual EMS clinicians to participate. Goal enrollment within each agency is a minimum of 30 and a maximum of 50 EMS clinicians. All individual EMS clinician participants will undergo informed consent, answer a baseline survey, and be queried via mobile phone text message at regular intervals which will begin upon enrollment. These mobile phone text message queries will assess indicators of sleep and fatigue. All participants will be asked to answer two follow up surveys at 3 months and 6 months. The total duration of study participation is 6 months. The primary outcome of interest is sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome of interest is fatigue as measured by the Chalder Fatigue Questionnaire (CFQ).
Interventions
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Sponsors
National Highway Traffic Safety Administration (NHTSA)
National Association of State EMS Officials
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* EMS Personnel: 1. 18 years of age or older 2. Currently working as an EMS clinician 3. Working a minimum of one shift a week 4. Working & residing in the United States 5. Working at one of the EMS organizations that agreed to participate in this study 6. Have a cellular, mobile, or smart phone that can send and receive text messages 7. Willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months
Exclusion criteria
* EMS Personnel: 1. Individuals \<18 years of age 2. Not currently working as an EMS clinician 3. Does not work a minimum of one shift a week 4. Does not work and/reside in the United States 5. Does not work at one of the EMS organizations that agreed to participate in this study 6. Does not have a cellular, mobile, or smart phone that can send and receive text messages 7. Is not willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Sleep Quality at 3 Months | baseline to 3 months | Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fatigue at 3 Months | baseline to 3 months | Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sleep Health Education At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.
Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website. | 316 |
| Wait List Control At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue..
Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website. | 362 |
| Total | 678 |
Baseline characteristics
| Characteristic | Total | Wait List Control | Sleep Health Education |
|---|---|---|---|
| Age, Continuous | 38.3 years STANDARD_DEVIATION 9.9 | 37.4 years STANDARD_DEVIATION 10.1 | 39.3 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 18 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 596 Participants | 322 Participants | 274 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 8 Participants | 12 Participants |
| Mean Chadler Fatigue Questionnaire Score | 6.6 units on a scale STANDARD_DEVIATION 2.7 | 6.55 units on a scale STANDARD_DEVIATION 2.8 | 6.64 units on a scale STANDARD_DEVIATION 2.6 |
| Mean Pittsburgh Sleep Quality Index Score | 8.87 units on a scale STANDARD_DEVIATION 3.5 | 8.96 units on a scale STANDARD_DEVIATION 3.6 | 8.77 units on a scale STANDARD_DEVIATION 3.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) White | 604 Participants | 320 Participants | 284 Participants |
| Sex: Female, Male Female | 189 Participants | 92 Participants | 97 Participants |
| Sex: Female, Male Male | 460 Participants | 255 Participants | 205 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
Change From Baseline in Sleep Quality at 3 Months
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.
Time frame: baseline to 3 months
Population: Complete cases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Health Education | Change From Baseline in Sleep Quality at 3 Months | -0.53 units on a scale | Standard Deviation 2.64 |
| Wait List Control | Change From Baseline in Sleep Quality at 3 Months | -0.08 units on a scale | Standard Deviation 2.6 |
Secondary
Change From Baseline in Fatigue at 3 Months
Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue.
Time frame: baseline to 3 months
Population: Complete cases
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Health Education | Change From Baseline in Fatigue at 3 Months | 0.19 units on a scale | Standard Deviation 2.23 |
| Wait List Control | Change From Baseline in Fatigue at 3 Months | 0.01 units on a scale | Standard Deviation 2.45 |