The EMS Sleep Health Study: A Randomized Controlled Trial

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04218279
• Collaborator: National Highway Traffic Safety Administration (NHTSA) (U.S. Fed), National Association of State EMS Officials (NASEMSO) (Other)
• Enrollment: 678
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.2
• Patients Per Site Per Month: 39.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Quality; Fatigue	Other: Sleep Health Education	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 678 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Unblinded
• Primary Purpose: Other
• Official Title: The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial
• Actual Study Start Date: Feb 24, 2020
• Actual Primary Completion Date: Jul 31, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Sleep Health Education; Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Active Comparator: 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..	Other: Sleep Health Education; Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Sleep Quality at 3 Months [baseline to 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.

Secondary Outcome Measures

1. Change From Baseline in Fatigue at 3 Months [baseline to 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261

Sponsors and Collaborators

• University of Pittsburgh
• National Highway Traffic Safety Administration (NHTSA)
• National Association of State EMS Officials (NASEMSO)

Investigators

• Principal Investigator: Daniel Patterson, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 4, 2020
• Informed Consent Form - May 8, 2020

More Information

Publications

None provided.

• Responsible Party: Daniel Patterson, PhD, NRP, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04218279
• Other Study ID Numbers: STUDY19080090; DTNH2215R00029
• First Posted: Jan 6, 2020
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatigue

Study Results

Participant Flow

Arm/Group Title	Sleep Health Education	Wait List Control
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	316	362
COMPLETED	211	225
NOT COMPLETED	105	137

Baseline Characteristics

Arm/Group Title	Sleep Health Education	Wait List Control	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	316	362	678
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.3 (9.6)	37.4 (10.1)	38.3 (9.9)
Sex: Female, Male (Count of Participants)
Female	97 30.7%	92 25.4%	189 27.9%
Male	205 64.9%	255 70.4%	460 67.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	16 5.1%	18 5%	34 5%
Not Hispanic or Latino	274 86.7%	322 89%	596 87.9%
Unknown or Not Reported	12 3.8%	8 2.2%	20 2.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.9%	7 1.9%	10 1.5%
Asian	0 0%	2 0.6%	2 0.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 0.3%	4 1.1%	5 0.7%
White	284 89.9%	320 88.4%	604 89.1%
More than one race	8 2.5%	8 2.2%	16 2.4%
Unknown or Not Reported	6 1.9%	7 1.9%	13 1.9%
Mean Pittsburgh Sleep Quality Index Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.77 (3.3)	8.96 (3.6)	8.87 (3.5)
Mean Chadler Fatigue Questionnaire Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.64 (2.6)	6.55 (2.8)	6.6 (2.7)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Sleep Quality at 3 Months
Description	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.
Time Frame	baseline to 3 months

Outcome Measure Data

Analysis Population Description

Complete cases

Arm/Group Title	Sleep Health Education	Wait List Control
Arm/Group Description	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.	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.
Measure Participants	209	223
Mean (Standard Deviation) [units on a scale]	-0.53 (2.64)	-0.08 (2.60)

2. Secondary Outcome

Title	Change From Baseline in Fatigue at 3 Months
Description	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.
Time Frame	baseline to 3 months

Outcome Measure Data

Analysis Population Description

Complete cases

Arm/Group Title	Sleep Health Education	Wait List Control
Arm/Group Description	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.	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.
Measure Participants	208	222
Mean (Standard Deviation) [units on a scale]	0.19 (2.23)	0.01 (2.45)

Adverse Events

Adverse Event Reporting Description	We did not assess for adverse events in this study given the minimal risk and study design.
Arm/Group Title	Sleep Health Education		Wait List Control
Arm/Group Description	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.		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.
All Cause Mortality
	Sleep Health Education		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Sleep Health Education		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Sleep Health Education		Wait List Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.