- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805646
Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients
A Mobile Phone-based Triage Tool to Identify Discharged Trauma Patients in Need of Further Care in Cameroon
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Douala, Cameroon
- Laquintinie Hospital
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Edea, Cameroon
- Edea Regional Hospital
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Limbe, Cameroon
- Limbé Regional Referral Hospital
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Pouma, Cameroon
- Pouma Catholic Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No Mobile Phone-administered Triage Tool
For each hospital site: Baseline data will be collected for six months.
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Experimental: Mobile Phone-administered Triage Tool
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Successful Contacts
Time Frame: 6 months after enrollment
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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.
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6 months after enrollment
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Mean Number of Attempts Required to Achieve a Successful Contact
Time Frame: 6 months after enrollment
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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.
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6 months after enrollment
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Mean Cost Associated with Personnel Time
Time Frame: 6 months after enrollment
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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.
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6 months after enrollment
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Mean Cost Associated with Telephone Time
Time Frame: 6 months after enrollment
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This measure will be calculated by averaging how much the telephone company charges for making the required phone calls.
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6 months after enrollment
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Telephone Triage Tool Administration Time
Time Frame: 1 day after administration of the telephone triage tool (i.e. about 2 weeks after enrollment)
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This measure will be calculated based on how much time it takes to administer the telephone triage tool.
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1 day after administration of the telephone triage tool (i.e. about 2 weeks after enrollment)
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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)
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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).
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Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
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Acceptability Score of Mobile Phones as a Follow-up Tool
Time Frame: 2 weeks after enrollment and 6 months after enrollment
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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.
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2 weeks after enrollment and 6 months after enrollment
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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)
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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.
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After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
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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)
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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.
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After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
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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)
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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.
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After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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The average number of days that participants in the study report not being able to go to work as a result of their injury.
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After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
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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)
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The average duration (in days) that participants in the study report experience some disability as a result of their injury.
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After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
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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)
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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.
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After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Catherine Juillard, MD, MPH, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- GRANT12763845
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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