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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03805646
Other study ID # GRANT12763845
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2019
Est. completion date September 14, 2022

Study information

Verified date October 2022
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1712
Est. completion date September 14, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Mobile Phone-based Triage Tool
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.

Locations

Country Name City State
Cameroon Laquintinie Hospital Douala
Cameroon Edea Regional Hospital Edea
Cameroon Limbé Regional Referral Hospital Limbe
Cameroon Pouma Catholic Hospital Pouma

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles University of Buea

Country where clinical trial is conducted

Cameroon, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months after enrollment
Primary 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. 6 months after enrollment
Primary 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. 6 months after enrollment
Primary 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. 6 months after enrollment
Primary Telephone Triage Tool Administration Time This measure will be calculated based on how much time it takes to administer the telephone triage tool. 1 day after administration of the telephone triage tool (i.e. about 2 weeks after enrollment)
Primary 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). Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
Primary 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. 2 weeks after enrollment and 6 months after enrollment
Primary 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. After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
Primary 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. After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
Primary 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. After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
Secondary 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. After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
Secondary 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. After the final participant undergoes the 6-month telephone follow-up protocol (i.e. about 28 months after enrollment of the first participant)
Secondary 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. 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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