- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988129
Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- BWH Division of Sleep Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months
Time Frame: 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
|
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Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months
Time Frame: 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
|
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Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months
Time Frame: 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.
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12 months
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Firefighters' Performance, as Determined by Response Time Over 12 Months
Time Frame: 12 months
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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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Mean Total Sleep Time
Time Frame: 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. |
Baseline to 12 months
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Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings
Time Frame: Baseline to 12 months
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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
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Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone
Time Frame: Baseline to 12 months
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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
|
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Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving
Time Frame: 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. |
Baseline to 12 months
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Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic
Time Frame: Baseline to 12 months
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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
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Change in Firefighters' Health, as Determined by General Health Indices;
Time Frame: Baseline to 12 months
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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
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Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours
Time Frame: Baseline to 12 months
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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.
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Baseline to 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
Time Frame: Baseline (Study start)
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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.
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Baseline (Study start)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven Lockley, Ph.D., Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Occupational Diseases
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Sleep Apnea Syndromes
- Chronobiology Disorders
- Sleep Apnea, Obstructive
- Fatigue
- Sleep Wake Disorders
- Psychomotor Agitation
- Restless Legs Syndrome
- Sleep Initiation and Maintenance Disorders
- Sleep Disorders, Circadian Rhythm
Other Study ID Numbers
- 2009-P-000697
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