search
Back to results

Fire Fighter Fatigue Management Program: Operation Healthy Sleep

Primary Purpose

Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep disorders education and screening
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shift-Work Sleep Disorder focused on measuring sleep, firefighter, fire, apnea, insomnia, shift, narcolepsy, restless leg, rls, fatigue, actigraph, actigraphy, actiwatch, safety, sleepiness, sleepy, work, hours, Federal Emergency Management Agency, drowsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BWH Division of Sleep Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 27, 2010
Last Updated
February 8, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Federal Emergency Management Agency
search

1. Study Identification

Unique Protocol Identification Number
NCT01988129
Brief Title
Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Official Title
Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Federal Emergency Management Agency

4. Oversight

Data Monitoring Committee
No

5. 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.'
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: improve the mean total sleep, alertness and cognitive performance of firefighters; improve firefighter safety, as determined by: decreased rates of motor vehicle crashes; decreased on-the-job injuries; improve firefighter performance, as determined by decreased response time; improve firefighters' health, as determined by: diagnosis and treatment of sleep disorders improved general health indices decreased number of 'sick' days improve firefighters' and families' job satisfaction and ability to cope with extended work hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome, Obstructive Sleep Apnea, Impaired Driving, Injuries
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sleep disorders education and screening
Intervention Description
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.
Primary Outcome Measure Information:
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
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
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
Other Pre-specified Outcome Measures:
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Lockley, Ph.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
BWH Division of Sleep Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fire Fighter Fatigue Management Program: Operation Healthy Sleep

We'll reach out to this number within 24 hrs