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The Sleep Health and Fatigue Education Program for the Administrators of Emergency Medical Services Agencies (CODE3)

4 de noviembre de 2026 actualizado por: Daniel Patterson, PhD, NRP, University of Pittsburgh

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

184

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Paul D Patterson, PhD
  • Número de teléfono: 412-647-3078
  • Correo electrónico: pdp3@pitt.edu

Copia de seguridad de contactos de estudio

  • Nombre: Maureen Morgan
  • Número de teléfono: 412-647-3078
  • Correo electrónico: morganma@upmc.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

Otros nombres:
  • Sleep health and fatigue education program
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

Otros nombres:
  • Sleep health and fatigue education program

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in policy (EMS Administrators)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in sleep health (Frontline EMS personnel)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Paul D Patterson, PhD, University of Pittsburgh

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de diciembre de 2026

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

31 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

4 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Publicado por primera vez (Actual)

10 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY26070003
  • 307-SR-23 (Otro número de subvención/financiamiento: American Academy of Sleep Medicine Foundation)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

Requests for sharing data will be reviewed 12 months after publication of the study's main findings by the study investigators.

Criterios de acceso compartido de IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .