Trial Outcomes & Findings for Fire Fighter Fatigue Management Program: Operation Healthy Sleep (NCT NCT01988129)
NCT ID: NCT01988129
Last Updated: 2017-03-16
Results Overview
We assessed 'sick days' cumulatively over 12 months in two ways from departmental payroll records; the number of 24-hour pay periods coded as 'sick' time per firefighter and the number of 24-hr pay periods coded as injury and disability per firefighter. Fewer sick days is indicative of better health.
COMPLETED
NA
1189 participants
12 months
2017-03-16
Participant Flow
We invited 73 departments to consider participating based on size and workload, and received 32 responses. Based on interview, selection was based on department cooperation, the practicalities of initiating the program, and the availability of departmental measures for analysis. We selected a mid-sized fire department with \~1200 firefighters.
32 fire department stations were paired according to the previous calendar years' workload. One station from each pair (16 stations) was randomly assigned to receive the program. All personnel from the intervention stations were instructed to attend scheduled education sessions.
Participant milestones
| Measure |
Intervention
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening.
32 stations were paired according to workload. One from each pair was randomized to receive the intervention program. Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related hazards and discussed the importance of sleep, and included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
Current practice.
Current practice. Firefighters in the Control Stations continued their normal role and were not invited to attend the sleep education and sleep disorders screening program. There was no formal contact with the control group.
As part of normal operational requirements, a small number of firefighters are reassigned to other stations each day and therefore 18/588 firefighters from control stations happened to be reassigned to an intervention station on the day of the education session and attended the session.
|
|---|---|---|
|
Overall Study
STARTED
|
601
|
588
|
|
Overall Study
Attended Education Session
|
542
|
18
|
|
Overall Study
Screened for Sleep Disorders
|
416
|
15
|
|
Overall Study
Completed 1-year Follow-up Survey
|
100
|
4
|
|
Overall Study
COMPLETED
|
601
|
588
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Baseline characteristics by cohort
| Measure |
Intervention
n=601 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=588 Participants
Current practice
|
Total
n=1189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
44.4 Years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
43.6 Years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
590 Participants
n=99 Participants
|
583 Participants
n=107 Participants
|
1173 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
541 participants
n=99 Participants
|
540 participants
n=107 Participants
|
1081 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
45 participants
n=99 Participants
|
40 participants
n=107 Participants
|
85 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Biracial
|
7 participants
n=99 Participants
|
2 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsWe assessed 'sick days' cumulatively over 12 months in two ways from departmental payroll records; the number of 24-hour pay periods coded as 'sick' time per firefighter and the number of 24-hr pay periods coded as injury and disability per firefighter. Fewer sick days is indicative of better health.
Outcome measures
| Measure |
Intervention
n=601 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=588 Participants
Current practice
|
|---|---|---|
|
Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months
Sick days
|
3.1 days/firefighter
Standard Deviation 4.3
|
3.2 days/firefighter
Standard Deviation 4.5
|
|
Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months
Disability/Injury days
|
1.4 days/firefighter
Standard Deviation 5.9
|
2.6 days/firefighter
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: 12 monthsFewer motor vehicle crashes is indicative of better health. We assessed motor vehicle crashes cumulatively over 12 months. Accidents were counted as any incident that resulted in the filing and review of a departmental Fleet Accident Report.
Outcome measures
| Measure |
Intervention
n=601 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=588 Participants
Current practice
|
|---|---|---|
|
Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months
|
0.11 incidents/firefighter
Standard Deviation 0.35
|
0.10 incidents/firefighter
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: 12 monthsFewer on-the-job injuries is indicative of better health. We assessed injuries cumulatively over 12 months. Injuries that triggered the filing of an official city government accident report as the result of following normal departmental procedures were included in this study.
Outcome measures
| Measure |
Intervention
n=601 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=588 Participants
Current practice
|
|---|---|---|
|
Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months
|
0.37 injury report/firefighter
Standard Deviation 0.63
|
0.40 injury report/firefighter
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Following review of departmental records, we determined that 'turn-out time' and 'clearance time' were not appropriate measures of firefighter' performance in relation to sleep and alertness given the multiple factors that could affect them. We therefore did not address this aim.
A lower response time is indicative of better performance. Following detailed review of departmental procedures and records, we determined that 'turn-out time' was already very rapid and not considered an accurate measure of firefighters' performance by the department. Similarly, 'clearance time' (time from the start until the end of the event), which could last for many hours, was also not considered an appropriate measure of firefighter' performance in relation to sleep and alertness given the multiple factors, many of which are not under the control of the firefighters, that could affect clearance times. We therefore did not address this aim.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Within-subject pre- versus post-study. Only 62/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.
A higher total sleep time is indicative of better sleep. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm. The analysis for total sleep time is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey, and had at least 1 week of work scheduled in the 4 weeks prior to each survey.
Outcome measures
| Measure |
Intervention
n=62 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=62 Participants
Current practice
|
|---|---|---|
|
Change in the Mean Total Sleep Time
|
44.84 Hours/week
Standard Deviation 7.05
|
45.98 Hours/week
Standard Deviation 6.48
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Within-subject pre- versus post-study. Only 27/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.
A lower number of times reported falling asleep during meetings is indicative of better alertness and cognitive performance. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm. The analysis for the number of times individuals reported sleeping during meetings is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Outcome measures
| Measure |
Intervention
n=27 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=27 Participants
Current practice
|
|---|---|---|
|
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings
|
0.41 Incidents/month
Standard Deviation 1.39
|
0.30 Incidents/month
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Within-subject pre- versus post-study. Only 88/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.
A lower number of times reported sleeping on the telephone is indicative of better alertness and cognitive performance. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm. The analysis for the number of times individuals reported sleeping on the telephone is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Outcome measures
| Measure |
Intervention
n=88 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=88 Participants
Current practice
|
|---|---|---|
|
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone
|
0.06 Incidents/month
Standard Deviation 0.38
|
0.05 Incidents/month
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Within-subject pre- versus post-study. Only 81/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.
A lower number of times reported sleeping while driving is indicative of better alertness and cognitive performance. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm. The analysis for the number of times individuals reported being sleepy while driving is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Outcome measures
| Measure |
Intervention
n=81 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=81 Participants
Current practice
|
|---|---|---|
|
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving
|
0.22 Incidents/month
Standard Deviation 0.63
|
0.14 Incidents/month
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Within-subject pre- versus post-study. Only 82/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.
A lower number of times reported sleeping while stopped in traffic is indicative of better alertness and cognitive performance. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm. The analysis for the number of times individuals reported sleeping while stopped in traffic is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Outcome measures
| Measure |
Intervention
n=82 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=82 Participants
Current practice
|
|---|---|---|
|
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic
|
0.21 Incidents/month
Standard Deviation 0.72
|
0.09 Incidents/month
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: Within-subject pre- versus post-study. Only 97/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm. A higher health index is indicative of better health. We assessed general health with the question ' In general, would you say your health is Excellent/Very good/Good/Fair/Poor?' and coded the answers from 5-1, respectively.
Outcome measures
| Measure |
Intervention
n=97 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
n=97 Participants
Current practice
|
|---|---|---|
|
Change in Firefighters' Health, as Determined by General Health Indices;
|
3.73 units on a scale
Standard Deviation 0.82
|
3.68 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters' and families' job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.
In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters' and families' job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Study start)Population: A total of 431 firefighters completed the sleep disorders screening survey including 416 from the intervention stations and 15 who were temporarily assigned to duty in the intervention stations on the day of the survey. We did not consider these 15 firefighters as a separate population.
Firefighters were instructed to attend a mandatory 30-min education training presentation as operations allowed. Following the education, firefighters were invited and encouraged to complete a voluntary sleep disorders screening questionnaire. This questionnaire used validated, self-report screening tools for Obstructive Sleep Apnea (OSA), moderate to severe insomnia, restless legs syndrome and shift work disorder. All of the respondents who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a local American Academy of Sleep Medicine-certified, partnering sleep clinics if they chose to follow-up. Participants were also free to seek medical follow-up elsewhere. Telephone calls were made to all high risk participants to ensure that they were aware of the results, and to facilitate clinic scheduling. Participants were asked to provide voluntary medical records release consent for tracking diagnoses.
Outcome measures
| Measure |
Intervention
n=431 Participants
Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening
Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
|
Control
Current practice
|
|---|---|---|
|
Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
Any sleep disorder
|
179 participants
|
—
|
|
Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
Obstructive Sleep Apnea
|
135 participants
|
—
|
|
Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
Insomnia
|
33 participants
|
—
|
|
Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
Restless Legs Syndrome
|
15 participants
|
—
|
|
Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
Shiftwork Disorder
|
40 participants
|
—
|
Adverse Events
Intervention
Control
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