Clinical trial NCT04218279: The EMS Sleep Health Study: A Randomized Controlled Trial
Official title: The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Quality
Fatigue
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Highway Traffic Safety Administration (NHTSA)
name: National Association of State EMS Officials
First posted: 2020-01-06
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The experiment seeks to determine the impact of a sleep health and fatigue education and training program on diverse indicators of sleep and fatigue among Emergency Medical Services (EMS) personnel. The overarching goals of this research study are to \[1\] 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 accomplish these goals by using a cluster-randomized trial study design with a wait-list control group.

Detailed description: The overarching goals of this research study are to:

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).

Eligibility criteria: Inclusion Criteria:

* EMS Personnel:

  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:

* EMS Personnel:

  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.

Primary outcomes:
measure: Change From Baseline in Sleep Quality at 3 Months
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Change From Baseline in Fatigue at 3 Months
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Daniel Patterson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.