<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456764</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19040354</org_study_id>
    <secondary_id>R01OH011502</secondary_id>
    <nct_id>NCT04456764</nct_id>
  </id_info>
  <brief_title>The Sleep and Teamwork in EMS Study</brief_title>
  <acronym>SaFTiE</acronym>
  <official_title>Real-time Intervention to Reduce Fatigue Among Emergency Medical Services Workers: A Cluster-randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Occupational Safety and Health (NIOSH/CDC)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      More than half of Emergency Medical Services (EMS) workers report work-related mental and&#xD;
      physical fatigue. Odds of injury among fatigued EMS workers are nearly double that of&#xD;
      non-fatigued workers. There is a compelling need to reduce fatigue among EMS workers, yet few&#xD;
      EMS organizations have a formal fatigue management program and many may not be cost-effective&#xD;
      or evidence-based. This trial addresses national goals of the National Occupational Research&#xD;
      Agenda (NORA) and tests a novel approach to fatigue risk management that is easily scalable&#xD;
      to large workforces and low-cost for employers of shift workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will test an enhanced version of our SleepTrackTXT pilot intervention -&#xD;
      Sleep and Fatigue Treatment in EMS (SaFTiE) - in a two-arm parallel cluster-randomized design&#xD;
      of 36 EMS agencies. Our unit of randomization will be the EMS agency, with the intervention&#xD;
      deployed as a Fatigue Risk Management Program that can be integrated into an agency's&#xD;
      existing program. Prior to randomization the investigators will use a run-in period of 60&#xD;
      days with all 36 agencies to capture the natural history of the target population whereby&#xD;
      they are naive to the study intervention. During the active intervention phase, the&#xD;
      investigators will use SaFTiE and an attention placebo control (APC) group to test the&#xD;
      specific effect of our multi-component intervention on EMS worker fatigue and sleep health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 16, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>At baseline</time_frame>
    <description>A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) [minimum score=0, maximum score=11, and scores &gt;=4 indicate mental and physical fatigue]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>At 3 months</time_frame>
    <description>A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) [minimum score=0, maximum score=11, and scores &gt;=4 indicate mental and physical fatigue]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>At 6 months</time_frame>
    <description>A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) [minimum score=0, maximum score=11, and scores &gt;=4 indicate mental and physical fatigue]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Poor Sleep Quality</measure>
    <time_frame>At baseline</time_frame>
    <description>A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) [minimum score=0, maximum score=21, and scores &gt;=6 indicate poor sleep quality]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Poor Sleep Quality</measure>
    <time_frame>At 3 months</time_frame>
    <description>A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) [minimum score=0, maximum score=21, and scores &gt;=6 indicate poor sleep quality]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Poor Sleep Quality</measure>
    <time_frame>At 6 months</time_frame>
    <description>A response of 6 or greater on the Pittsburgh Sleep Quality Index [minimum score=0, maximum score=21, and scores &gt;=6 indicate poor sleep quality]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue and inter-shift recovery</measure>
    <time_frame>At baseline</time_frame>
    <description>[Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR sub-scale signify greater/improved ability to recover between shifts. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue and inter-shift recovery</measure>
    <time_frame>At 3 months</time_frame>
    <description>[Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR sub-scale signify greater/improved ability to recover between shifts. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue and inter-shift recovery</measure>
    <time_frame>At 6 months</time_frame>
    <description>[Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR sub-scale signify greater/improved ability to recover between shifts. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1900</enrollment>
  <condition>Fatigue</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>SaFTiE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The SaFTiE intervention includes: [a] real-time text-message assessments of fatigue and sleep during and between scheduled shift work; [b] tailored text-message alerts that promote adopting evidence based strategies for mitigating fatigue when high levels of fatigue or sleepiness are reported; [c] a mobile app that delivers goal setting, summary data of sleep/fatigue indicators from all study participants, and video interviews of EMS clinicians focused on sleep and fatigue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The attention placebo control includes: [a] real-time text-message assessments of teamwork during and between scheduled shift work; [b] text-message alerts that promote techniques for mitigating poor teamwork when episodes of poor teamwork are reported; [c] a mobile app that delivers goal setting, summary data of teamwork indicators from all study participants, and video interviews of EMS clinicians focused on teamwork.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SaFTiE</intervention_name>
    <description>A multi-modal fatigue risk management program.</description>
    <arm_group_label>SaFTiE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Placebo Control</intervention_name>
    <description>A multi-modal teamwork assessment program.</description>
    <arm_group_label>Attention Placebo Control</arm_group_label>
    <other_name>Teamwork</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Live in United States (including Hawaii and Alaska)&#xD;
&#xD;
          -  Licensed / certified EMS clinician&#xD;
&#xD;
          -  Currently work in shifts&#xD;
&#xD;
          -  Do at least one clinical shift per week&#xD;
&#xD;
          -  Own a smartphone&#xD;
&#xD;
          -  Willing to answer monthly surveys and daily text-messages,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclude EMS personnel who are primarily administrative with non-clinical duties&#xD;
&#xD;
          -  Are restricted from using personal smartphone during periods of work&#xD;
&#xD;
          -  Do not own a smartphone capable of running the study mobile app&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>P. Daniel Patterson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>P. Daniel Patterson, PhD</last_name>
    <phone>412-864-3830</phone>
    <email>pdp3@pitt.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Beth Wesoloski</last_name>
    <phone>412-647-0517</phone>
    <email>wesoloskiba@upmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>P. Daniel Patterson, PhD</last_name>
      <phone>412-864-3830</phone>
      <email>pdp3@pitt.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Daniel Patterson, PhD, NRP</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will work with NIOSH/CDC and share de-identified research data via a NIOSH/CDC or NIH managed repository if requested. The study team will develop a process to receive requests from outside the study team for de-identified datasets should there be no NIOSH/CDC supported data repository.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Following publication of the primary study papers with primary and secondary outcomes reported.</ipd_time_frame>
    <ipd_access_criteria>The study team will develop a process to receive requests from outside the study team for de-identified datasets should there be no NIOSH/CDC supported data repository.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456764
org study id: STUDY19040354
secondary id: R01OH011502
nct id: NCT04456764
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
More than half of Emergency Medical Services (EMS) workers report work-related mental and
      physical fatigue. Odds of injury among fatigued EMS workers are nearly double that of
      non-fatigued workers. There is a compelling need to reduce fatigue among EMS workers, yet few
      EMS organizations have a formal fatigue management program and many may not be cost-effective
      or evidence-based. This trial addresses national goals of the National Occupational Research
      Agenda (NORA) and tests a novel approach to fatigue risk management that is easily scalable
      to large workforces and low-cost for employers of shift workers.
The investigators will test an enhanced version of our SleepTrackTXT pilot intervention -
      Sleep and Fatigue Treatment in EMS (SaFTiE) - in a two-arm parallel cluster-randomized design
      of 36 EMS agencies. Our unit of randomization will be the EMS agency, with the intervention
      deployed as a Fatigue Risk Management Program that can be integrated into an agency's
      existing program. Prior to randomization the investigators will use a run-in period of 60
      days with all 36 agencies to capture the natural history of the target population whereby
      they are naive to the study intervention. During the active intervention phase, the
      investigators will use SaFTiE and an attention placebo control (APC) group to test the
      specific effect of our multi-component intervention on EMS worker fatigue and sleep health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Fatigue
time frame: At baseline
description: A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) [minimum score=0, maximum score=11, and scores >=4 indicate mental and physical fatigue]
measure: Fatigue
time frame: At 3 months
description: A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) [minimum score=0, maximum score=11, and scores >=4 indicate mental and physical fatigue]
measure: Fatigue
time frame: At 6 months
description: A response of 4 or greater on the Chalder Fatigue Questionnaire (CFQ) [minimum score=0, maximum score=11, and scores >=4 indicate mental and physical fatigue]
measure: Poor Sleep Quality
time frame: At baseline
description: A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) [minimum score=0, maximum score=21, and scores >=6 indicate poor sleep quality]
measure: Poor Sleep Quality
time frame: At 3 months
description: A response of 6 or greater on the Pittsburgh Sleep Quality Index (PSQI) [minimum score=0, maximum score=21, and scores >=6 indicate poor sleep quality]
measure: Poor Sleep Quality
time frame: At 6 months
description: A response of 6 or greater on the Pittsburgh Sleep Quality Index [minimum score=0, maximum score=21, and scores >=6 indicate poor sleep quality]
measure: Fatigue and inter-shift recovery
time frame: At baseline
description: [Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR sub-scale signify greater/improved ability to recover between shifts. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.
measure: Fatigue and inter-shift recovery
time frame: At 3 months
description: [Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR sub-scale signify greater/improved ability to recover between shifts. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.
measure: Fatigue and inter-shift recovery
time frame: At 6 months
description: [Used with permission from the developer], the Occupational Fatigue Exhaustion Recovery (OFER) questionnaire with 3 sub-scales [Acute Fatigue (AF), Chronic Fatigue (CF), and Inter-Shift Recovery (IR)]. Individual item responses are coded 0 to 6 and summed, divided by 30, then multiplied by 100 to produce a composite sub-scale score ranging from 0 to 100. The developer suggests stratifying the continuous measure into quartiles (Low, Low/Moderate, Moderate/High, and High) for comparative purposes. Higher scores on the AF and CF sub-scales (e.g., 50-100) signify moderate to high fatigue. Higher scores on the IR sub-scale signify greater/improved ability to recover between shifts. The OFER has no minimum thresholds to define clinically meaningful change in fatigue or recovery.
arm group label: SaFTiE
arm group type: Experimental
description: The SaFTiE intervention includes: [a] real-time text-message assessments of fatigue and sleep during and between scheduled shift work; [b] tailored text-message alerts that promote adopting evidence based strategies for mitigating fatigue when high levels of fatigue or sleepiness are reported; [c] a mobile app that delivers goal setting, summary data of sleep/fatigue indicators from all study participants, and video interviews of EMS clinicians focused on sleep and fatigue.
arm group label: Attention Placebo Control
arm group type: Placebo Comparator
description: The attention placebo control includes: [a] real-time text-message assessments of teamwork during and between scheduled shift work; [b] text-message alerts that promote techniques for mitigating poor teamwork when episodes of poor teamwork are reported; [c] a mobile app that delivers goal setting, summary data of teamwork indicators from all study participants, and video interviews of EMS clinicians focused on teamwork.
intervention type: Behavioral
intervention name: SaFTiE
description: A multi-modal fatigue risk management program.
arm group label: SaFTiE
intervention type: Behavioral
intervention name: Attention Placebo Control
description: A multi-modal teamwork assessment program.
arm group label: Attention Placebo Control
other name: Teamwork
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: P. Daniel Patterson, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: P. Daniel Patterson, PhD
phone: 412-864-3830
email: pdp3@pitt.edu
last name: Beth Wesoloski
phone: 412-647-0517
email: wesoloskiba@upmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Daniel Patterson, PhD, NRP
investigator title: Associate Professor
mesh term: Fatigue
sharing ipd: Yes
ipd description: The investigators will work with NIOSH/CDC and share de-identified research data via a NIOSH/CDC or NIH managed repository if requested. The study team will develop a process to receive requests from outside the study team for de-identified datasets should there be no NIOSH/CDC supported data repository.
ipd info type: Study Protocol
ipd time frame: Following publication of the primary study papers with primary and secondary outcomes reported.
ipd access criteria: The study team will develop a process to receive requests from outside the study team for de-identified datasets should there be no NIOSH/CDC supported data repository.