Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federal Emergency Management Agency | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.'
We propose to use a station-level, randomized experimental design to test the hypotheses that implementation of a Comprehensive Firefighter Fatigue Management Program will:
improve the mean total sleep, alertness and cognitive performance of firefighters;
improve firefighter safety, as determined by:
improve firefighter performance, as determined by decreased response time;
improve firefighters' health, as determined by:
improve firefighters' and families' job satisfaction and ability to cope with extended work hours.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening. The 32 fire department stations were paired according to the previous calendar years' workload. One station from each pair was randomly assigned to receive the intervention program. Sleep education sessions were scheduled according to station. On the education day(s) assigned to that stations, all personnel present that day were instructed to attend, and 542/601 did so. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep disorders education and screening | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Lockley, Ph.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BWH Division of Sleep Medicine | Boston | Massachusetts | 02215 | United States |
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | days/firefighter | 12 months |
|
12 months
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. There was 0 adverse events in either group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, including 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 which used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. Those who screened positive for any sleep disorder were notified as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up. Of the 431 firefighters completed the sleep disorders screening survey, 416 were from the intervention stations. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven W. Lockley PhD | Brigham and Women's Hospital | 16177324977 | slockley@hms.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012148 | Restless Legs Syndrome |
| D020181 | Sleep Apnea, Obstructive |
| D014947 | Wounds and Injuries |
| D001049 | Apnea |
| D009290 | Narcolepsy |
| D005221 | Fatigue |
| D000077260 | Sleepiness |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline to 12 months |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| 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. | Baseline to 12 months |
| Baseline (Study start) |
| BG001 | Control | Current practice |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The data reflect the categories collected by the fire department | Number | participants |
|
| OG001 | Control | Current practice |
|
|
|
| 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. | Posted | Mean | Standard Deviation | incidents/firefighter | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | injury report/firefighter | 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Hours/week | Baseline to 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Incidents/month | Baseline to 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Incidents/month | Baseline to 12 months |
|
|
|
|
| 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. | 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. | Posted | 12 months |
|
|
| 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. | 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. | Posted | Number | participants | Baseline (Study start) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Incidents/month | Baseline to 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Incidents/month | Baseline to 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 months |
|
|
|
|
| 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. | 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. | Posted | Baseline to 12 months |
|
|
| 0 |
| 416 |
| 0 |
| 416 |
| EG001 | Control | A total of 15/588 firefighters in the control stations who were temporarily assigned to duty in the intervention stations on the day of the survey completed the screening survey. The remaining 573 firefighters did not complete the survey and therefore there are no adverse event data to report. | 0 | 15 | 0 | 15 |
Not provided
Not provided
| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020447 | Parasomnias |
| D012891 | Sleep Apnea Syndromes |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006970 | Disorders of Excessive Somnolence |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| Title | Measurements |
|---|---|
|
| Restless Legs Syndrome |
|
| Shiftwork Disorder |
|
| Percentage of firefighters screene |
| 31.3 |
| 2-Sided |
| Superiority or Other |
| This analysis describes the prevalence of the risk of insomnia; there is no comparison group | Percentage of firefighters screene | 7.7 | 2-Sided | Superiority or Other |
| This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group | Percentage of firefighters screene | 3.5 | 2-Sided | Superiority or Other |
| This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group | Percentage of firefighters screene | 9.3 | 2-Sided | Superiority or Other |