The Sleep Health and Fatigue Education Program for the Administrators of Emergency Medical Services Agencies (CODE3)
The CODE3 First Responder Sleep Health Program
The investigators aim to pilot test an education program designed to address workplace sleep health and fatigue. The education program targets employers (administrators) of United States (U.S.)-based emergency medical services (EMS) and fire department operations. Data from this pilot, proof-of-concept study will provide data to inform larger studies.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Poor sleep and fatigue are widespread among first responder personnel such as EMTs and paramedics. Prior research shows that greater than 80% of frontline EMS personnel report fatigue. Unfortunately, there is no gold standard education program specifically for the administrators of EMS / first responder operations that raises awareness of current evidence based guidelines for sleep health and fatigue risk management.
The investigators aim to pilot test an education program specifically designed for employers (administrators) of U.S.-based EMS / fire operations. Data from this pilot study will provide much needed data regarding this type of education program and guide future, larger studies focused on poor sleep and fatigue in first responder operations.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul D Patterson, PhD
- Phone Number: 412-647-3078
- Email: pdp3@pitt.edu
Study Contact Backup
- Name: Maureen Morgan
- Phone Number: 412-647-3078
- Email: morganma@upmc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
EMS administrators are eligible if they are:
- 18 years of age or older
- Actively working as EMS administrator at any type of EMS agency
Frontline EMS personnel are eligible if they are:
- 18 years of age or older
- Actively working a minimum of 1 shift per week on the ambulance
- Affiliated with an agency involved in this research study based on an EMS administrator signing up first
Exclusion Criteria:
-
EMS administrators are not eligible if they are:
- Affiliated with a first responder organization that does not employ frontline EMS clinicians
- Daily operations do not involve frontline EMS personnel operating ambulances and taking care of patients either in an emergent or non-emergent situation 24 hours a day
- Administrator does not provide direct oversight of frontline EMS personnel
Frontline EMS personnel are not eligible if they:
- Are not affiliated with an EMS operation that is enrolled in this research study by an EMS administrator at their agency/operation
- Do not work at least 1 shift per week at the agency as a frontline EMS personnel taking care of patients in emergent or non-emergent situations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMS Administrators
A short education program focused on importance of sleep health and fatigue delivered to emergency medical services administrators (EMS Administrator Arm) |
A short education program focused on importance of sleep health and fatigue delivered to emergency medical services administrators
Other Names:
|
|
Experimental: Frontline EMS personnel
Frontline EMS personnel employed at EMS agencies where EMS administrators are exposed to the Sleep Health and Fatigue Education Program |
A short education program focused on importance of sleep health and fatigue delivered to emergency medical services administrators
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in policy (EMS Administrators)
Time Frame: At baseline and at 6-9 months follow-up
|
A single question: "Did participant's EMS agency create a new or change an existing policy after watching the CODE3 Sleep & Fatigue in EMS Program? __Yes. __No." |
At baseline and at 6-9 months follow-up
|
|
Change in sleep quality (Frontline EMS personnel)
Time Frame: At baseline and at 6-9 months follow-up
|
Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) among frontline EMS personnel. The PSQI solicits self-reported responses on 19 survey items that primarily use a Likert type response scale that are weighted using prescribed formulas and reference the prior month. Scores range from 0 - 21 with scores 6- 21 indicating poor sleep quality. A PSQI score decrease > = 3 points is considered clinically meaningful and associated with a reduction in signs and symptoms of poor sleep. |
At baseline and at 6-9 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sleep health (Frontline EMS personnel)
Time Frame: At baseline and at 6-9 months follow-up
|
Sleep health as measured by the RU-SATED survey instrument (Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration). The survey solicits self-reported responses on a Likert type response scale to 6 items that reference the prior month. Six items, each scored 0-2. Response of 0 = Never/rarely; 1 = Sometimes; 2 = Usually/always. Total score = sum of six items. There are no universally established clinical cut points for the RU-SATED; however, higher scores suggest good sleep health. |
At baseline and at 6-9 months follow-up
|
|
Change in daytime sleepiness (Frontline EMS personnel)
Time Frame: At baseline and at 6-9 months follow-up
|
Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS). The ESS solicits self-reported responses on a Likert type scale to 8 items. Items are scored using a prescribed algorithm with scores ranging from 0 - 24. Higher scores indicate greater daytime sleepiness. A score decrease of > = 2 points is considered clinically meaningful and associated with a reduction in signs and symptoms of daytime sleepiness. |
At baseline and at 6-9 months follow-up
|
|
Change in fatigue (Frontline EMS personnel)
Time Frame: At baseline and at 6-9 months follow-up
|
Fatigue (mental and physical) is measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ solicits self-reported responses on a Likert type response scale to 11 survey items. One approach to scoring includes: Less than usual = 0; No more than usual = 1; More than usual = 2; Much more than usual = 3. The more commonly used approach to scoring (bimodal approach) includes: Less than usual = 0; No more than usual = 0; More than usual = 1; Much more than usual = 1. Scores > = 4 suggest severe mental and physical fatigue. |
At baseline and at 6-9 months follow-up
|
|
Change in chronic fatigue (Frontline EMS personnel)
Time Frame: At baseline and at 6-9 months follow-up
|
Chronic fatigue (CF) is measured with the CF sub-scale survey instrument of the Occupational Fatigue Exhaustion/Recovery Scale (OFER-15). Responses for the CF sub-scale are solicited for 5 items using a Likert response scale: 0 = strongly disagree to 6 = strongly agree. Scoring involves summing the 5 items, dividing by 30 and then multiplying by 100. Scores range from 0 to 100. Final scores 0 - 25 suggest Low CF; scores 26 - 50 suggest Low to Moderate CF; scores 51 - 75 suggest Moderate to High CF; scores 76 to 100 suggest High CF. |
At baseline and at 6-9 months follow-up
|
|
Change in acute fatigue (Frontline EMS personnel)
Time Frame: At baseline and at 6-9 months follow-up
|
Acute fatigue (AF) is measured with the AF sub-scale survey instrument of the Occupational Fatigue Exhaustion/Recovery Scale (OFER-15). Responses for the AF sub-scale are solicited for 5 items using a Likert response scale: 0 = strongly disagree to 6 = strongly agree. Scoring involves summing the 5 items, dividing by 30 and then multiplying by 100. Scores range from 0 to 100. Final scores 0 - 25 suggest Low AF; scores 26 - 50 suggest Low to Moderate AF; scores 51 - 75 suggest Moderate to High AF; scores 76 to 100 suggest High AF. Two items of the AF sub-scale are reverse scored/coded. |
At baseline and at 6-9 months follow-up
|
|
Change in Intershift Recovery (Frontline EMS personnel)
Time Frame: At baseline and at 6-9 months follow-up
|
Intershift Recovery between shifts (IR) is measured with the IR sub-scale survey instrument of the Occupational Fatigue Exhaustion/Recovery Scale (OFER-15). Responses for the IR sub-scale are solicited for 5 items using a Likert response scale: 0 = strongly disagree to 6 = strongly agree. Scoring involves summing the 5 items, dividing by 30 and then multiplying by 100. Scores range from 0 to 100. Final scores 0 - 25 suggest Low IR; scores 26 - 50 suggest Low to Moderate IR; scores 51 - 75 suggest Moderate to High IR; scores 76 to 100 suggest High IR. Three items of the IR sub-scale are reverse scored/coded. |
At baseline and at 6-9 months follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul D Patterson, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY26070003
- 307-SR-23 (Other Grant/Funding Number: American Academy of Sleep Medicine Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified data and a data dictionary will be shared with other researchers (investigators) on a case-by-case basis and based on the required procedures and guidance as outlined by the University of Pittsburgh in the Data Use Agreements provided by the Office of Sponsored Programs.
IPD Sharing Time Frame
Requests for sharing data will be reviewed 12 months after publication of the study's main findings by the study investigators.
IPD Sharing Access Criteria
Requests must adhere to the policies and requirements of the University of Pittsburgh as outlined in Data Use Agreements. De-identified data files and a data dictionary can be shared using University of Pittsburgh approved mechanisms.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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