Study Stopped
Trial enrollment terminated early due to end of funding period.
The EMS Sleep Health Study: A Randomized Controlled Trial
The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial
2 other identifiers
interventional
678
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2020
CompletedStudy Start
First participant enrolled
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedResults Posted
Study results publicly available
April 5, 2022
CompletedApril 5, 2022
April 1, 2022
1.4 years
January 2, 2020
January 27, 2022
April 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Sleep Quality at 3 Months
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.
baseline to 3 months
Secondary Outcomes (1)
Change From Baseline in Fatigue at 3 Months
baseline to 3 months
Study Arms (2)
Sleep Health Education
EXPERIMENTALAt baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue.
Wait List Control
ACTIVE COMPARATORAt 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..
Interventions
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Eligibility Criteria
You may qualify if:
- EMS Personnel:
- years of age or older
- Currently working as an EMS clinician
- Working a minimum of one shift a week
- Working \& residing in the United States
- Working at one of the EMS organizations that agreed to participate in this study
- Have a cellular, mobile, or smart phone that can send and receive text messages
- 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
You may not qualify if:
- EMS Personnel:
- Individuals \<18 years of age
- Not currently working as an EMS clinician
- Does not work a minimum of one shift a week
- Does not work and/reside in the United States
- Does not work at one of the EMS organizations that agreed to participate in this study
- Does not have a cellular, mobile, or smart phone that can send and receive text messages
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (2)
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.
PMID: 40283798DERIVEDPatterson 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.
PMID: 36372657DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- P. Daniel Patterson
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Patterson
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Unblinded
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 6, 2020
Study Start
February 24, 2020
Primary Completion
July 31, 2021
Study Completion
July 31, 2021
Last Updated
April 5, 2022
Results First Posted
April 5, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The de-identified data will be made available immediately following publication and upon approval from the funding organization. No end date.
- Access Criteria
- Access will be provided to researchers who provide a methodologically sound proposal and have been approved by the funding organization and by the University of Pittsburgh.
All of the individual de-identified participant data collected during the trial will be shared with the funding organization (the National Highway Traffic Safety Administration (NHTSA)) and with researchers who provide a methodologically sound proposal and have been approved by the funding organization and by the University of Pittsburgh.