Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients
Primary Purpose
Wounds and Injury
Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
Mobile Phone-based Triage Tool
Sponsored by

About this trial
This is an interventional supportive care trial for Wounds and Injury focused on measuring Aftercare, Telemedicine, Africa South of the Sahara
Eligibility Criteria
Inclusion Criteria:
- All trauma registry patients at participating hospitals who provided cellphone numbers and are alive at hospital discharge are eligible for inclusion regardless of age, injury severity, or hospital disposition status.
Sites / Locations
- Laquintinie Hospital
- Edea Regional Hospital
- Limbé Regional Referral Hospital
- Pouma Catholic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Mobile Phone-administered Triage Tool
Mobile Phone-administered Triage Tool
Arm Description
For each hospital site: Baseline data will be collected for six months.
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.
Outcomes
Primary Outcome Measures
Proportion of Successful Contacts
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.
Mean Number of Attempts Required to Achieve a Successful Contact
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.
Mean Cost Associated with Personnel Time
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.
Mean Cost Associated with Telephone Time
This measure will be calculated by averaging how much the telephone company charges for making the required phone calls.
Telephone Triage Tool Administration Time
This measure will be calculated based on how much time it takes to administer the telephone triage tool.
Physician Assessment of Whether a Patient Would Benefit from Further Services
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).
Acceptability Score of Mobile Phones as a Follow-up Tool
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.
Proportion of Injured Patients Who Seek Clinical Follow-up Evaluation
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.
Proportion of Injured Patients Who Receive Follow-up Treatment
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.
Mean Number of Days After Discharge that Follow-up Treatment is First Sought
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.
Secondary Outcome Measures
Mean Work Days Lost as a Consequence of Injury
The average number of days that participants in the study report not being able to go to work as a result of their injury.
Mean Length of Disability as a Consequence of Injury
The average duration (in days) that participants in the study report experience some disability as a result of their injury.
Mean Glasgow Outcomes Scale-Extended (GOSE) Disability Level
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.
Full Information
NCT ID
NCT03805646
First Posted
January 11, 2019
Last Updated
October 7, 2022
Sponsor
University of California, Los Angeles
Collaborators
University of Buea
1. Study Identification
Unique Protocol Identification Number
NCT03805646
Brief Title
Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients
Official Title
A Mobile Phone-based Triage Tool to Identify Discharged Trauma Patients in Need of Further Care in Cameroon
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of Buea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injury
Keywords
Aftercare, Telemedicine, Africa South of the Sahara
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1712 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Mobile Phone-administered Triage Tool
Arm Type
No Intervention
Arm Description
For each hospital site: Baseline data will be collected for six months.
Arm Title
Mobile Phone-administered Triage Tool
Arm Type
Experimental
Arm 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(s)
Mobile Phone-based Triage Tool
Intervention 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.
Primary Outcome Measure Information:
Title
Proportion of Successful Contacts
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.
Time Frame
6 months after enrollment
Title
Mean Number of Attempts Required to Achieve a Successful Contact
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.
Time Frame
6 months after enrollment
Title
Mean Cost Associated with Personnel Time
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.
Time Frame
6 months after enrollment
Title
Mean Cost Associated with Telephone Time
Description
This measure will be calculated by averaging how much the telephone company charges for making the required phone calls.
Time Frame
6 months after enrollment
Title
Telephone Triage Tool Administration Time
Description
This measure will be calculated based on how much time it takes to administer the telephone triage tool.
Time Frame
1 day after administration of the telephone triage tool (i.e. about 2 weeks after enrollment)
Title
Physician Assessment of Whether a Patient Would Benefit from Further Services
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).
Time Frame
Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
Title
Acceptability Score of Mobile Phones as a Follow-up Tool
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.
Time Frame
2 weeks after enrollment and 6 months after enrollment
Title
Proportion of Injured Patients Who Seek Clinical Follow-up Evaluation
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.
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)
Title
Proportion of Injured Patients Who Receive Follow-up Treatment
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.
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)
Title
Mean Number of Days After Discharge that Follow-up Treatment is First Sought
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.
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)
Secondary Outcome Measure Information:
Title
Mean Work Days Lost as a Consequence of Injury
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.
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)
Title
Mean Length of Disability as a Consequence of Injury
Description
The average duration (in days) that participants in the study report experience some disability as a result of their 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)
Title
Mean Glasgow Outcomes Scale-Extended (GOSE) Disability Level
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.
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)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All trauma registry patients at participating hospitals who provided cellphone numbers and are alive at hospital discharge are eligible for inclusion regardless of age, injury severity, or hospital disposition status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Juillard, MD, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laquintinie Hospital
City
Douala
Country
Cameroon
Facility Name
Edea Regional Hospital
City
Edea
Country
Cameroon
Facility Name
Limbé Regional Referral Hospital
City
Limbe
Country
Cameroon
Facility Name
Pouma Catholic Hospital
City
Pouma
Country
Cameroon
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available upon reasonable request.
Learn more about this trial
Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients
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