Fire Fighter Fatigue Management Program: Operation Healthy Sleep

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01988129
• Collaborator: Federal Emergency Management Agency (U.S. Fed)
• Enrollment: 1,189
• Location: 1
• Arms: 2
• Duration (Months): 54
• Patients Per Site Per Month: 22

Study Details

Study Description

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.'

Condition or Disease	Intervention/Treatment	Phase
Shift-Work Sleep Disorder; Insomnia; Restless Leg Syndrome; Obstructive Sleep Apnea; Impaired Driving; Injuries	Other: Sleep disorders education and screening	N/A

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:

3. decreased rates of motor vehicle crashes;

4. decreased on-the-job injuries;

5. improve firefighter performance, as determined by decreased response time;

6. improve firefighters' health, as determined by:

7. diagnosis and treatment of sleep disorders

8. improved general health indices

9. decreased number of 'sick' days

10. improve firefighters' and families' job satisfaction and ability to cope with extended work hours.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1189 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fire Fighter Fatigue Management Program: Operation Healthy Sleep
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Other: 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.
No Intervention: Control 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Other Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BWH Division of Sleep Medicine	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Brigham and Women's Hospital
• Federal Emergency Management Agency

Investigators

• Principal Investigator: Steven Lockley, Ph.D., Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Charles Andrew Czeisler, MD, PhD, Charles A Czeisler, Ph.D., M.D.,, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01988129
• Other Study ID Numbers: 2009-P-000697
• First Posted: Nov 20, 2013
• Last Update Posted: Mar 16, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Charles Andrew Czeisler, MD, PhD, Charles A Czeisler, Ph.D., M.D.,, Brigham and Women's Hospital: sleep; firefighter; fire; apnea; insomnia; shift; narcolepsy; restless leg; rls; fatigue; actigraph; actigraphy; actiwatch; safety; sleepiness; sleepy; work; hours; Federal Emergency Management Agency; drowsy
• Additional relevant MeSH terms: Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Psychomotor Agitation; Restless Legs Syndrome; Sleep Disorders, Circadian Rhythm; Fatigue

Study Results

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 Detail	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.

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	601	588
Attended Education Session	542	18
Screened for Sleep Disorders	416	15
Completed 1-year Follow-up Survey	100	4
COMPLETED	601	588
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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.	Current practice	Total of all reporting groups
Overall Participants	601	588	1189
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	42.7 (7.3)	44.4 (7.4)	43.6 (7.4)
Sex: Female, Male (Count of Participants)
Female	11 1.8%	5 0.9%	16 1.3%
Male	590 98.2%	583 99.1%	1173 98.7%
Race/Ethnicity, Customized (participants) [Number]
White	541 90%	540 91.8%	1081 90.9%
Black	45 7.5%	40 6.8%	85 7.1%
Hispanic	4 0.7%	2 0.3%	6 0.5%
Asian	1 0.2%	3 0.5%	4 0.3%
Native American	3 0.5%	1 0.2%	4 0.3%
Biracial	7 1.2%	2 0.3%	9 0.8%

Outcome Measures

1. Primary Outcome

Title	Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Current practice
Measure Participants	601	588
Sick days	3.1 (4.3)	3.2 (4.5)
Disability/Injury days	1.4 (5.9)	2.6 (8.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	Analysis for 'sick' days
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	Analysis for 'disability/injury' days
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	Mixed model analysis was conducted for 'disability/injury' days
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed model analysis with nested random effects for possible station-level and station-pairing correlation (3-level hierarchical linear model)

2. Primary Outcome

Title	Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Current practice
Measure Participants	601	588
Mean (Standard Deviation) [incidents/firefighter]	0.11 (0.35)	0.10 (0.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Current practice
Measure Participants	601	588
Mean (Standard Deviation) [injury report/firefighter]	0.37 (0.63)	0.40 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.98
	Parameter Dispersion	Type: Value:
	Estimation Comments	The Odds Ratio analyses compared the odds of reporting at least one injury during the study between those who did (n=560) and did not (n=629) attend the education sessions, regardless of station assignment (intervention or control).

4. Secondary Outcome

Title	Change in the Mean Total Sleep Time
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention - Study Start	Intervention - Post-study Follow-up
Arm/Group Description	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.	Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
Measure Participants	62	62
Mean (Standard Deviation) [Hours/week]	44.84 (7.05)	45.98 (6.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	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 points
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	Paired t-test
	Comments

5. Secondary Outcome

Title	Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention - Study Start	Intervention - Post-study Follow-up
Arm/Group Description	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.	Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
Measure Participants	27	27
Mean (Standard Deviation) [Incidents/month]	0.41 (1.39)	0.30 (0.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	paired t-test
	Comments

6. Secondary Outcome

Title	Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention - Study Start	Intervention - Post-study Follow-up
Arm/Group Description	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.	Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
Measure Participants	88	88
Mean (Standard Deviation) [Incidents/month]	0.06 (0.38)	0.05 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	paired t-test
	Comments

7. Primary Outcome

Title	Firefighters' Performance, as Determined by Response Time Over 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Current practice
Measure Participants	0	0

8. Other Pre-specified Outcome

Title	Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Baseline (Intervention)
Arm/Group Description	Firefighters in the intervention group who volunteered to complete the sleep disorders screening survey
Measure Participants	431
Any sleep disorder	179 29.8%
Obstructive Sleep Apnea	135 22.5%
Insomnia	33 5.5%
Restless Legs Syndrome	15 2.5%
Shiftwork Disorder	40 6.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention
	Comments	This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of firefighters screened
	Estimated Value	41.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention
	Comments	This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of firefighters screene
	Estimated Value	31.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention
	Comments	This analysis describes the prevalence of the risk of insomnia; there is no comparison group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of firefighters screene
	Estimated Value	7.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention
	Comments	This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of firefighters screene
	Estimated Value	3.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention
	Comments	This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of firefighters screene
	Estimated Value	9.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention - Study Start	Intervention - Post-study Follow-up
Arm/Group Description	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.	Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
Measure Participants	81	81
Mean (Standard Deviation) [Incidents/month]	0.22 (0.63)	0.14 (0.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.31
	Comments
	Method	paired t-test
	Comments

10. Secondary Outcome

Title	Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention - Study Start	Intervention - Post-study Follow-up
Arm/Group Description	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.	Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
Measure Participants	82	82
Mean (Standard Deviation) [Incidents/month]	0.21 (0.72)	0.09 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	Sleeping while stopped in traffic
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	Paired t-test, 2-sided
	Comments

11. Secondary Outcome

Title	Change in Firefighters' Health, as Determined by General Health Indices;
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention - Study Start	Intervention - Post-study Follow-up
Arm/Group Description	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.	Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
Measure Participants	97	97
Mean (Standard Deviation) [units on a scale]	3.73 (0.82)	3.68 (0.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments
	Method	Paired t-test, 2-sided
	Comments

12. Secondary Outcome

Title	Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Intervention - Study Start	Intervention - Post-study Follow-up
Arm/Group Description	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.	Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
Measure Participants	0	0

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	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.
Arm/Group Title	Intervention		Control
Arm/Group Description	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.		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.
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/416 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/416 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.