<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/NCT03805646</url>
  </required_header>
  <id_info>
    <org_study_id>GRANT12763845</org_study_id>
    <nct_id>NCT03805646</nct_id>
  </id_info>
  <brief_title>Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients</brief_title>
  <official_title>A Mobile Phone-based Triage Tool to Identify Discharged Trauma Patients in Need of Further Care in Cameroon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Buea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</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>
      After being admitted to and then discharged from a hospital in Cameroon for having&#xD;
      experienced an injury, there is no established way for the health system to check in on how&#xD;
      the discharged person is doing. The investigators have developed a set of questions with the&#xD;
      hope that asking these questions--over the phone--to those who have been discharged from the&#xD;
      hospital will allow them to determine which post-discharge patients would benefit from&#xD;
      further care. The investigators believe that asking these questions over the phone is a good&#xD;
      way of determining which post-discharge trauma patients would benefit from further care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Broadly, this study aims to answer three questions. (1) Is it feasible to call discharged&#xD;
      trauma patients on their mobile phones to check up on them? (2) Can a defined set of&#xD;
      questions help determine which discharged trauma patients require further medical care (and&#xD;
      which discharged trauma patients do not require further medical care)? (3) Will checking in&#xD;
      on discharged trauma patients reduce their experience of disability and economic&#xD;
      consequences?&#xD;
&#xD;
      If an individual was a trauma patient who was admitted at and then discharged from one of the&#xD;
      study's partner hospitals in Cameroon, the discharged individual (hereafter referred to as&#xD;
      &quot;the participant') will be receiving phone calls from one of the study's research assistants&#xD;
      at the following post-discharge timepoints: 2 weeks, 1 month, 3 months, and 6 months. Whether&#xD;
      the research assistant administers the defined set of questions developed by the study's&#xD;
      investigators (see question 2, above) will depend on when the participant was discharged from&#xD;
      the hospital. Regardless, all participants will be asked other important questions about the&#xD;
      injury and any associated disabilities and economic consequences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2019</start_date>
  <completion_date type="Actual">September 14, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>None of the interventional study model categories aptly describe the study. The step-wedge design of the study means each site has historical controls; the only thing determining whether an individual receives the intervention or not is time (that is, whether the hospital site s/he was admitted to happens to be in the pre-intervention/baseline data collection phase or the intervention phase).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Successful Contacts</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>The number of successful contacts will be divided by the total number of contacts. A &quot;successful&quot; contact is a phone call during which the research assistant has completed administered the questionnaire(s) planned for that phone call.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Attempts Required to Achieve a Successful Contact</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>This will be calculated by averaging the number of call attempts made until a research assistant is able to successfully administer the questionnaire(s) planned for that phone call.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Cost Associated with Personnel Time</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>This measure will be calculated by averaging how much it costs to pay the research assistant for the time s/he spends making the required phone calls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Cost Associated with Telephone Time</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>This measure will be calculated by averaging how much the telephone company charges for making the required phone calls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Telephone Triage Tool Administration Time</measure>
    <time_frame>1 day after administration of the telephone triage tool (i.e. about 2 weeks after enrollment)</time_frame>
    <description>This measure will be calculated based on how much time it takes to administer the telephone triage tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Assessment of Whether a Patient Would Benefit from Further Services</measure>
    <time_frame>Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)</time_frame>
    <description>This is a binary measure. After a physician examines a participant, s/he will determine whether s/he thinks the participant would benefit from further services (including additional follow-up care, and/or diagnostic or therapeutic interventions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability Score of Mobile Phones as a Follow-up Tool</measure>
    <time_frame>2 weeks after enrollment and 6 months after enrollment</time_frame>
    <description>This is a numerical measure that represents the sum of the positive responses that participants give to each question that assesses the acceptability of mobile phones as a follow-up tool. The scale for the acceptability score of mobile phones as a follow-up tool ranges from 0 to 6, where 0 means the participant's responses indicate the participant believes mobile phones are definitely not an acceptable follow-up tool and 6 means the participant's responses indicate the participant believes mobile phones are definitely an acceptable follow-up tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Injured Patients Who Seek Clinical Follow-up Evaluation</measure>
    <time_frame>After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)</time_frame>
    <description>This will be calculated as follows: The denominator will be the number of discharged trauma patients enrolled in the study. The numerator will be the number of discharged trauma patients enrolled in the study who seek any clinical follow-up evaluation at any time point post-discharge but by the 6-month post-enrollment mark.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Injured Patients Who Receive Follow-up Treatment</measure>
    <time_frame>After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)</time_frame>
    <description>This will be calculated as follows: The denominator will be the number of discharged trauma patients enrolled in the study. The numerator will be the number of discharged trauma patients enrolled in the study who receive any clinical follow-up evaluation at any time point post-discharge but by the 6-month post-enrollment mark.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Number of Days After Discharge that Follow-up Treatment is First Sought</measure>
    <time_frame>After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)</time_frame>
    <description>Participants enrolled in the study who seek any clinical follow-up evaluation at any time point post-discharge by the 6-month post-enrollment mark will be asked how many days after discharge they sought follow-up treatment. The average number of days will then be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Work Days Lost as a Consequence of Injury</measure>
    <time_frame>After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)</time_frame>
    <description>The average number of days that participants in the study report not being able to go to work as a result of their injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Length of Disability as a Consequence of Injury</measure>
    <time_frame>After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)</time_frame>
    <description>The average duration (in days) that participants in the study report experience some disability as a result of their injury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Glasgow Outcomes Scale-Extended (GOSE) Disability Level</measure>
    <time_frame>After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)</time_frame>
    <description>The average GOSE disability level that participants in the study report. For each participant, GOSE disability level will be determined using the augmented GOSE (aGOSE) instrument, which assesses factors like the participant's independence inside and outside the home, work, social and leisure activities, family and friendship, etc. Each time after administration of the aGOSE instrument, the participant's GOSE disability level will be calculated. The aGOSE instrument will be administered at the 2-week, 1-month, 3-month, and 6-month post-discharge timepoints.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1712</enrollment>
  <condition>Wounds and Injury</condition>
  <arm_group>
    <arm_group_label>No Mobile Phone-administered Triage Tool</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For each hospital site: Baseline data will be collected for six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile Phone-administered Triage Tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For each hospital site: After the first six months of baseline data collection, the mobile phone-administered triage tool (or &quot;Mobile Phone-based Triage Tool&quot;) will be implemented for a year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Phone-based Triage Tool</intervention_name>
    <description>The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury.</description>
    <arm_group_label>Mobile Phone-administered Triage Tool</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All trauma registry patients at participating hospitals who provided cellphone numbers&#xD;
             and are alive at hospital discharge are eligible for inclusion regardless of age,&#xD;
             injury severity, or hospital disposition status.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Juillard, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laquintinie Hospital</name>
      <address>
        <city>Douala</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edea Regional Hospital</name>
      <address>
        <city>Edea</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limbé Regional Referral Hospital</name>
      <address>
        <city>Limbe</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pouma Catholic Hospital</name>
      <address>
        <city>Pouma</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cameroon</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Catherine Juillard, MD, MPH</investigator_full_name>
    <investigator_title>Associate Professor In-Residence</investigator_title>
  </responsible_party>
  <keyword>Aftercare</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Africa South of the Sahara</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be made available upon reasonable request.</ipd_description>
  </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/NCT03805646
org study id: GRANT12763845
nct id: NCT03805646
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After being admitted to and then discharged from a hospital in Cameroon for having
      experienced an injury, there is no established way for the health system to check in on how
      the discharged person is doing. The investigators have developed a set of questions with the
      hope that asking these questions--over the phone--to those who have been discharged from the
      hospital will allow them to determine which post-discharge patients would benefit from
      further care. The investigators believe that asking these questions over the phone is a good
      way of determining which post-discharge trauma patients would benefit from further care.
Broadly, this study aims to answer three questions. (1) Is it feasible to call discharged
      trauma patients on their mobile phones to check up on them? (2) Can a defined set of
      questions help determine which discharged trauma patients require further medical care (and
      which discharged trauma patients do not require further medical care)? (3) Will checking in
      on discharged trauma patients reduce their experience of disability and economic
      consequences?

      If an individual was a trauma patient who was admitted at and then discharged from one of the
      study's partner hospitals in Cameroon, the discharged individual (hereafter referred to as
      "the participant') will be receiving phone calls from one of the study's research assistants
      at the following post-discharge timepoints: 2 weeks, 1 month, 3 months, and 6 months. Whether
      the research assistant administers the defined set of questions developed by the study's
      investigators (see question 2, above) will depend on when the participant was discharged from
      the hospital. Regardless, all participants will be asked other important questions about the
      injury and any associated disabilities and economic consequences.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: None of the interventional study model categories aptly describe the study. The step-wedge design of the study means each site has historical controls; the only thing determining whether an individual receives the intervention or not is time (that is, whether the hospital site s/he was admitted to happens to be in the pre-intervention/baseline data collection phase or the intervention phase).
primary purpose: Supportive Care
masking: None (Open Label)
measure: Proportion of Successful Contacts
time frame: 6 months after enrollment
description: The number of successful contacts will be divided by the total number of contacts. A "successful" contact is a phone call during which the research assistant has completed administered the questionnaire(s) planned for that phone call.
measure: Mean Number of Attempts Required to Achieve a Successful Contact
time frame: 6 months after enrollment
description: This will be calculated by averaging the number of call attempts made until a research assistant is able to successfully administer the questionnaire(s) planned for that phone call.
measure: Mean Cost Associated with Personnel Time
time frame: 6 months after enrollment
description: This measure will be calculated by averaging how much it costs to pay the research assistant for the time s/he spends making the required phone calls.
measure: Mean Cost Associated with Telephone Time
time frame: 6 months after enrollment
description: This measure will be calculated by averaging how much the telephone company charges for making the required phone calls.
measure: Telephone Triage Tool Administration Time
time frame: 1 day after administration of the telephone triage tool (i.e. about 2 weeks after enrollment)
description: This measure will be calculated based on how much time it takes to administer the telephone triage tool.
measure: Physician Assessment of Whether a Patient Would Benefit from Further Services
time frame: Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
description: This is a binary measure. After a physician examines a participant, s/he will determine whether s/he thinks the participant would benefit from further services (including additional follow-up care, and/or diagnostic or therapeutic interventions).
measure: Acceptability Score of Mobile Phones as a Follow-up Tool
time frame: 2 weeks after enrollment and 6 months after enrollment
description: This is a numerical measure that represents the sum of the positive responses that participants give to each question that assesses the acceptability of mobile phones as a follow-up tool. The scale for the acceptability score of mobile phones as a follow-up tool ranges from 0 to 6, where 0 means the participant's responses indicate the participant believes mobile phones are definitely not an acceptable follow-up tool and 6 means the participant's responses indicate the participant believes mobile phones are definitely an acceptable follow-up tool.
measure: Proportion of Injured Patients Who Seek Clinical Follow-up Evaluation
time frame: After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
description: This will be calculated as follows: The denominator will be the number of discharged trauma patients enrolled in the study. The numerator will be the number of discharged trauma patients enrolled in the study who seek any clinical follow-up evaluation at any time point post-discharge but by the 6-month post-enrollment mark.
measure: Proportion of Injured Patients Who Receive Follow-up Treatment
time frame: After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
description: This will be calculated as follows: The denominator will be the number of discharged trauma patients enrolled in the study. The numerator will be the number of discharged trauma patients enrolled in the study who receive any clinical follow-up evaluation at any time point post-discharge but by the 6-month post-enrollment mark.
measure: Mean Number of Days After Discharge that Follow-up Treatment is First Sought
time frame: After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
description: Participants enrolled in the study who seek any clinical follow-up evaluation at any time point post-discharge by the 6-month post-enrollment mark will be asked how many days after discharge they sought follow-up treatment. The average number of days will then be calculated.
measure: Mean Work Days Lost as a Consequence of Injury
time frame: After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
description: The average number of days that participants in the study report not being able to go to work as a result of their injury.
measure: Mean Length of Disability as a Consequence of Injury
time frame: After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
description: The average duration (in days) that participants in the study report experience some disability as a result of their injury.
measure: Mean Glasgow Outcomes Scale-Extended (GOSE) Disability Level
time frame: After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
description: The average GOSE disability level that participants in the study report. For each participant, GOSE disability level will be determined using the augmented GOSE (aGOSE) instrument, which assesses factors like the participant's independence inside and outside the home, work, social and leisure activities, family and friendship, etc. Each time after administration of the aGOSE instrument, the participant's GOSE disability level will be calculated. The aGOSE instrument will be administered at the 2-week, 1-month, 3-month, and 6-month post-discharge timepoints.
arm group label: No Mobile Phone-administered Triage Tool
arm group type: No Intervention
description: For each hospital site: Baseline data will be collected for six months.
arm group label: Mobile Phone-administered Triage Tool
arm group type: Experimental
description: For each hospital site: After the first six months of baseline data collection, the mobile phone-administered triage tool (or "Mobile Phone-based Triage Tool") will be implemented for a year.
intervention type: Other
intervention name: Mobile Phone-based Triage Tool
description: The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury.
arm group label: Mobile Phone-administered Triage Tool
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine Juillard, MD, MPH
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
facility: 
facility: 
facility: 
country: Cameroon
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Catherine Juillard, MD, MPH
investigator title: Associate Professor In-Residence
mesh term: Wounds and Injuries
sharing ipd: No
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be made available upon reasonable request.