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| ID | Type | Description | Link |
|---|---|---|---|
| DTNH2215R00029 | Other Grant/Funding Number | National Highway Traffic Safety Administration (NHTSA) |
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Trial enrollment terminated early due to end of funding period.
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| Name | Class |
|---|---|
| National Highway Traffic Safety Administration (NHTSA) | FED |
| National Association of State EMS Officials | OTHER |
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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.
The overarching goals of this research study are to:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Health Education | Experimental | At 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 Comparator | 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.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Health Education | Other | Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fatigue at 3 Months | Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue. | baseline to 3 months |
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Inclusion Criteria:
EMS Personnel:
Exclusion Criteria:
EMS Personnel:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Patterson | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40283798 | Derived | 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. | |
| 36372657 | Derived |
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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.
The de-identified data will be made available immediately following publication and upon approval from the funding organization. No end date.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Complete cases | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months |
|
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We did not assess for adverse events in this study given the minimal risk and study design.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| P. Daniel Patterson | University of Pittsburgh | 412-864-3830 | pdp3@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2020 | Apr 4, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2020 | Jan 27, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Unblinded
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| 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. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Some participants did not answer the question about sex. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Some participants did not complete the survey. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Some participants did not complete the survey. | Count of Participants | Participants |
|
| Mean Pittsburgh Sleep Quality Index Score | Minimum score possible = 0. Maximum score possible = 21. Higher is worse indicating poorer sleep quality. | Mean | Standard Deviation | units on a scale |
|
| Mean Chadler Fatigue Questionnaire Score | Minimum score possible = 0. Maximum score possible = 11. Higher score indicating worse mental and physical fatigue. | Some participants did not complete the survey. | Mean | Standard Deviation | units on a scale |
|
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. |
|
|
| Secondary | Change From Baseline in Fatigue at 3 Months | Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue. | Complete cases | Posted | Mean | Standard Deviation | units on a scale | baseline to 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001523 |
| Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|