Impaired Driving, Injuries, Insomnia, Obstructive Sleep Apnea, Restless Leg Syndrome, Shift-Work Sleep Disorder
Conditions
Keywords
sleep, firefighter, fire, apnea, insomnia, shift, narcolepsy, restless leg, rls, fatigue, actigraph, actigraphy, actiwatch, safety, sleepiness, sleepy, work, hours, Federal Emergency Management Agency, drowsy
Brief summary
Firefighters work some of the most demanding schedules known under highly stressful and demanding conditions. The need to work frequent extended shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. Sleep disorders are common, costly, and treatable, but often remain undiagnosed and untreated and it is likely that a significant proportion of firefighters suffer from undiagnosed sleep disorders which will further impair their sleep and exacerbate fatigue.In the current proposal, we aim to address the health, performance and safety issues related to fatigue in firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue Management Program (CFFMP) that we have termed 'Operation Healthy Sleep.'
Detailed description
We propose to use a station-level, randomized experimental design to test the hypotheses that implementation of a Comprehensive Firefighter Fatigue Management Program will: 1. improve the mean total sleep, alertness and cognitive performance of firefighters; 2. improve firefighter safety, as determined by: 1. decreased rates of motor vehicle crashes; 2. decreased on-the-job injuries; 3. improve firefighter performance, as determined by decreased response time; 4. improve firefighters' health, as determined by: 1. diagnosis and treatment of sleep disorders 2. improved general health indices 3. decreased number of 'sick' days 5. improve firefighters' and families' job satisfaction and ability to cope with extended work hours.
Interventions
OTHERSleep 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.
Sponsors
Federal Emergency Management Agency
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* This proposal includes research involving human subjects (fire department employees). * Active firefighters working in the study fire department will be eligible to participate in the study. * All applicants will be considered without bias, regardless of race, ethnicity, or national origin.
Exclusion criteria
* Non fire department employees
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Firefighters' Performance, as Determined by Response Time Over 12 Months | 12 months | 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. |
| Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months | 12 months | 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. |
| Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months | 12 months | Fewer 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. |
| Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months | 12 months | Fewer 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving | Baseline to 12 months | 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. |
| Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic | Baseline to 12 months | 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. |
| Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours | Baseline to 12 months | 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. |
| Change in Firefighters' Health, as Determined by General Health Indices; | Baseline to 12 months | 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. |
| Change in the Mean Total Sleep Time | Baseline to 12 months | 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. |
| Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings | Baseline to 12 months | 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. |
| Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone | Baseline to 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire | Baseline (Study start) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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. | 601 |
| Control Current practice | 588 |
| Total | 1,189 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 44.4 Years STANDARD_DEVIATION 7.4 | 43.6 Years STANDARD_DEVIATION 7.4 | 42.7 Years STANDARD_DEVIATION 7.3 |
| Race/Ethnicity, Customized Asian | 3 participants | 4 participants | 1 participants |
| Race/Ethnicity, Customized Biracial | 2 participants | 9 participants | 7 participants |
| Race/Ethnicity, Customized Black | 40 participants | 85 participants | 45 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 6 participants | 4 participants |
| Race/Ethnicity, Customized Native American | 1 participants | 4 participants | 3 participants |
| Race/Ethnicity, Customized White | 540 participants | 1081 participants | 541 participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 583 Participants | 1173 Participants | 590 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 416 | 0 / 15 |
| serious Total, serious adverse events | 0 / 416 | 0 / 15 |
Outcome results
Primary
Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months
Fewer 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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months | 0.11 incidents/firefighter | Standard Deviation 0.35 |
| Control | Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months | 0.10 incidents/firefighter | Standard Deviation 0.31 |
p-value: 0.87t-test, 2 sided
Primary
Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months
Fewer 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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months | 0.37 injury report/firefighter | Standard Deviation 0.63 |
| Control | Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months | 0.40 injury report/firefighter | Standard Deviation 0.63 |
p-value: 0.3195% CI: [0.6, 0.98]t-test, 2 sided
Primary
Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months | Disability/Injury days | 1.4 days/firefighter | Standard Deviation 5.9 |
| Intervention | Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months | Sick days | 3.1 days/firefighter | Standard Deviation 4.3 |
| Control | Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months | Disability/Injury days | 2.6 days/firefighter | Standard Deviation 8.5 |
| Control | Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months | Sick days | 3.2 days/firefighter | Standard Deviation 4.5 |
Comparison: Analysis for 'sick' daysp-value: 0.66t-test, 2 sided
Comparison: Analysis for 'disability/injury' daysp-value: 0.033t-test, 2 sided
Comparison: Mixed model analysis was conducted for 'disability/injury' daysp-value: 0.003Mixed Models Analysis
Primary
Firefighters' Performance, as Determined by Response Time Over 12 Months
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.
Time frame: 12 months
Population: 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.
Secondary
Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours
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.
Time frame: Baseline to 12 months
Population: 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.
Secondary
Change in Firefighters' Health, as Determined by General Health Indices;
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.
Time frame: Baseline to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Firefighters' Health, as Determined by General Health Indices; | 3.73 units on a scale | Standard Deviation 0.82 |
| Control | Change in Firefighters' Health, as Determined by General Health Indices; | 3.68 units on a scale | Standard Deviation 0.81 |
p-value: 0.46Paired t-test, 2-sided
Secondary
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone
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.
Time frame: Baseline to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone | 0.06 Incidents/month | Standard Deviation 0.38 |
| Control | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone | 0.05 Incidents/month | Standard Deviation 0.26 |
p-value: 0.71paired t-test
Secondary
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving
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.
Time frame: Baseline to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving | 0.22 Incidents/month | Standard Deviation 0.63 |
| Control | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving | 0.14 Incidents/month | Standard Deviation 0.65 |
p-value: 0.31paired t-test
Secondary
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic
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.
Time frame: Baseline to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic | 0.21 Incidents/month | Standard Deviation 0.72 |
| Control | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic | 0.09 Incidents/month | Standard Deviation 0.36 |
Comparison: Sleeping while stopped in trafficp-value: 0.16Paired t-test, 2-sided
Secondary
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings
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.
Time frame: Baseline to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings | 0.41 Incidents/month | Standard Deviation 1.39 |
| Control | Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings | 0.30 Incidents/month | Standard Deviation 0.78 |
p-value: 0.65paired t-test
Secondary
Change in the Mean Total Sleep Time
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.
Time frame: Baseline to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in the Mean Total Sleep Time | 44.84 Hours/week | Standard Deviation 7.05 |
| Control | Change in the Mean Total Sleep Time | 45.98 Hours/week | Standard Deviation 6.48 |
Comparison: Of the 100 participants who completed both the pre- and post-study survey (see Patient Flow), only 62 completed answered the question about sleep duration at both time pointsp-value: 0.22Paired t-test
Other Pre-specified
Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire | Any sleep disorder | 179 participants |
| Intervention | Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire | Shiftwork Disorder | 40 participants |
| Intervention | Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire | Obstructive Sleep Apnea | 135 participants |
| Intervention | Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire | Insomnia | 33 participants |
| Intervention | Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire | Restless Legs Syndrome | 15 participants |
Comparison: This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group
Comparison: This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group
Comparison: This analysis describes the prevalence of the risk of insomnia; there is no comparison group
Comparison: This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group
Comparison: This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group