The EMS Sleep Health Study: A Randomized Controlled Trial
NCT ID: NCT04218279
Last Updated: 2022-04-05
Study Results
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View full resultsBasic Information
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TERMINATED
NA
678 participants
INTERVENTIONAL
2020-02-24
2021-07-31
Brief Summary
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Detailed Description
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1. enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and
2. determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue.
The investigators will recruit EMS nationwide for EMS agencies to participate in this study and focus on moderately sized EMS agencies with between 50 and 300 employees (yet we will not outright exclude smaller or larger organizations). Agencies that run dual ground-based and air-medical EMS services are eligible. Maximum enrollment at the agency-level is n=30 EMS agencies. Agencies will be randomized upon enrollment to one of two arms: \[1\] Intervention group; or \[2\] the Wait-List control group. The intervention group will receive immediate access to the intervention materials (the 10 brief Sleep Health Education Modules). The wait-list control group will receive access to intervention materials at 3 months post enrollment/baseline.
Within each agency, the investigators will recruit individual EMS clinicians to participate. Goal enrollment within each agency is a minimum of 30 and a maximum of 50 EMS clinicians.
All individual EMS clinician participants will undergo informed consent, answer a baseline survey, and be queried via mobile phone text message at regular intervals which will begin upon enrollment. These mobile phone text message queries will assess indicators of sleep and fatigue. All participants will be asked to answer two follow up surveys at 3 months and 6 months. The total duration of study participation is 6 months. The primary outcome of interest is sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome of interest is fatigue as measured by the Chalder Fatigue Questionnaire (CFQ).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Sleep Health Education
At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.
Sleep Health Education
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Wait List Control
At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue..
Sleep Health Education
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Interventions
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Sleep Health Education
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Eligibility Criteria
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Inclusion Criteria
1. 18 years of age or older
2. Currently working as an EMS clinician
3. Working a minimum of one shift a week
4. Working \& residing in the United States
5. Working at one of the EMS organizations that agreed to participate in this study
6. Have a cellular, mobile, or smart phone that can send and receive text messages
7. Willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months
Exclusion Criteria
1. Individuals \<18 years of age
2. Not currently working as an EMS clinician
3. Does not work a minimum of one shift a week
4. Does not work and/reside in the United States
5. Does not work at one of the EMS organizations that agreed to participate in this study
6. Does not have a cellular, mobile, or smart phone that can send and receive text messages
7. Is not willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months.
18 Years
100 Years
ALL
Yes
Sponsors
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National Highway Traffic Safety Administration (NHTSA)
FED
National Association of State EMS Officials
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Daniel Patterson, PhD, NRP
Associate Professor
Principal Investigators
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Daniel Patterson
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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Patterson PD, Martin SE, MacAllister SA, Weaver MD, Patterson CG. Variations in Sleep, Fatigue, and Difficulty with Concentration Among Emergency Medical Services Clinicians During Shifts of Different Durations. Int J Environ Res Public Health. 2025 Apr 6;22(4):573. doi: 10.3390/ijerph22040573.
Patterson PD, Martin SE, Brassil BN, Hsiao WH, Weaver MD, Okerman TS, Seitz SN, Patterson CG, Robinson K. The Emergency Medical Services Sleep Health Study: A cluster-randomized trial. Sleep Health. 2023 Feb;9(1):64-76. doi: 10.1016/j.sleh.2022.09.013. Epub 2022 Nov 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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DTNH2215R00029
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY19080090
Identifier Type: -
Identifier Source: org_study_id
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