Wounds and InjuryNCT03805646
Mobile Phone-administered Triage Tool to Followup on Discharged Trauma Patients
A study testing Mobile Phone-based Triage Tool in people with Wounds and Injury, run by University of California, Los Angeles at 4 sites in Cameroon.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injury
- What is being tested?
- Mobile Phone-based Triage Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,990 participants
- Where
- 4 sitesCameroon
- Study dates
- 5 Aug 2019to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Cameroon4 sites
Laquintinie Hospital
Douala
Edea Regional Hospital
Edéa
Limbé Regional Referral Hospital
Limbe
Pouma Catholic Hospital
Pouma
About this study
Official title: A Mobile Phone-based Triage Tool to Identify Discharged Trauma Patients in Need of Further Care in Cameroon
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.
Read the 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.
- Conditions
- Wounds and Injury
- Being tested
- Mobile Phone-based Triage Tool
- Keywords
- Aftercare, Telemedicine, Africa South of the Sahara
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone-based Triage ToolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No Mobile Phone-administered Triage Tool | No intervention | For each hospital site: Baseline data will be collected for six months. This extended beyond 6 months due to the COVID pandemic* |
| Mobile Phone-administered Triage Tool | Experimental | 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.
This extended beyond 1 year due to the COVID pandemic* Receives: Other: Mobile Phone-based Triage Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Successful Contacts
The number of successful contacts will be divided by the total number of contacts. A "successful" contact is when an enrolled patient answered the phone, and consented to the research assistant administering the questionnaire(s) planned for that phone call.
Measured: 2 weeks after enrollment
Median Number of Attempts Required to Achieve a Successful Contact
This is the median number of call attempts made until a research assistant is able to successfully administer the questionnaire(s) planned for that phone call.
Measured: 2 weeks after enrollment
Median Cost Associated With Personnel Time
This measure is median monthly costs incurred to pay the research assistant for the time s/he spends making the required phone calls per patient.
Measured: At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID))
Median Cost Associated With Telephone Time
This measure is the median costs incurred to make phone calls per patient in each study phase.
Measured: At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID))
Telephone Triage Tool Administration Time
This measure will be calculated based on how much time it takes to administer the telephone triage tool.
Measured: After administration of the telephone triage tool (i.e. about 2 weeks after enrollment)
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).
Measured: Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
Physician Assessment of Whether a Patient Was at Moderate to High Risk for a Poor Outcome (HR) Without Additional Intervention
After a physician examines a participant, s/he will determine whether s/he thinks the participant is at low, moderate or high risk for a poor outcome (HR) without additional intervention using subjective clinical assessment.
Measured: Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
Triage Risk Score (TRS)
To develop a sensitive model capable of risk stratifying triaged patients for high risk (HR), all candidate questions from the telephone triage tool found to associate with HR on univariate regression were weighted by their predictive coefficient and added to generate a triage risk score (TRS) ranging from a minimum score of 0 (lowest risk) to a maximum possible score of 43.9 (highest risk). Triage Risk Score (TRS) less than or equal to 1.3 (1st quartile) was designated as low risk, TRS 1.4 to 4.0 (2nd \& 3rd quartile) as moderate risk, and TRS greater than or equal to 4.1 (fourth quartile) as high risk.
Measured: At the end of intervention phase (about 1 year after enrollment).
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.
Measured: 2 weeks after enrollment
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 the 2 weeks post-discharge phonecall.
Measured: After the 2week post-discharge phonecall.
Secondary outcomes (4)
Glasgow Outcomes Scale-Extended (GOSE) Disability Level
The 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 score is reported for the 2-week post-discharge timepoint.
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories (worse to best respectively): Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) which was used in this study provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category.
Measured: At the 2week post-discharge telephone phonecall.
Economic Consequences of Injury: Did it Become More Difficult for the Family to Afford Expenses Such as Food and Rent?
Participants were asked if following the injury it became more difficult for the family to afford expenses such as food and rent.
Measured: At the 2week post-discharge telephone phonecall.
Economic Consequences of Injury: Did the Family Spend Saved Money?
Participants were asked if following the injury the family had to spend their savings.
Measured: At the 2week post-discharge telephone phonecall.
Economic Consequences of Injury: Did the Family Borrow Money?
Participants were asked if following the injury the family had to borrow money to meet up with expenses.
Measured: At the 2week post-discharge telephone phonecall.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start5 Aug 2019
- Primary completion31 Aug 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wounds and InjuryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 3,990 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Buea
- Responsible party
- Principal investigator, Catherine Juillard, MD, MPH, University of California, Los Angeles
- Investigators
- Catherine Juillard, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805646
- Sponsor's protocol ID
- GRANT12763845
- Status last verified
- Nov 2024
- First submitted
- 11 Jan 2019
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data for all primary and secondary outcome measures will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Phone-based Triage Tool to Identify Discharged Trauma Patients in Need of Further Care in Cameroon
- ClinicalTrials.gov ID
- NCT03805646
- Acronym / sponsor ID
- GRANT12763845
- Conditions
- Wounds and Injury
- Keywords
- Aftercare, Telemedicine, Africa South of the Sahara
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,990 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Buea
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| No Mobile Phone-administered Triage Tool | No intervention | –For each hospital site: Baseline data will be collected for six months. This extended beyond 6 months due to the COVID pandemic* |
| Mobile Phone-administered Triage Tool | Experimental | Other: Mobile Phone-based Triage ToolFor 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. This extended beyond 1 year due to the COVID pandemic* |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Phone-based Triage ToolThe 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. | Other | Mobile Phone-administered Triage Tool |
Primary outcome
Proportion of Successful Contacts
Time frame: 2 weeks after enrollment
The number of successful contacts will be divided by the total number of contacts. A "successful" contact is when an enrolled patient answered the phone, and consented to the research assistant administering the questionnaire(s) planned for that phone call.
Median Number of Attempts Required to Achieve a Successful Contact
Time frame: 2 weeks after enrollment
This is the median number of call attempts made until a research assistant is able to successfully administer the questionnaire(s) planned for that phone call.
Median Cost Associated With Personnel Time
Time frame: At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID))
This measure is median monthly costs incurred to pay the research assistant for the time s/he spends making the required phone calls per patient.
Median Cost Associated With Telephone Time
Time frame: At the end of the study (2 weeks after the 2-year intervention phase (extended due to COVID))
This measure is the median costs incurred to make phone calls per patient in each study phase.
Telephone Triage Tool Administration Time
Time frame: After administration of the telephone triage tool (i.e. about 2 weeks after enrollment)
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
Time frame: Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
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).
Physician Assessment of Whether a Patient Was at Moderate to High Risk for a Poor Outcome (HR) Without Additional Intervention
Time frame: Immediately after the physician administers the physical exam (i.e. about 3 weeks after enrollment)
After a physician examines a participant, s/he will determine whether s/he thinks the participant is at low, moderate or high risk for a poor outcome (HR) without additional intervention using subjective clinical assessment.
Triage Risk Score (TRS)
Time frame: At the end of intervention phase (about 1 year after enrollment).
To develop a sensitive model capable of risk stratifying triaged patients for high risk (HR), all candidate questions from the telephone triage tool found to associate with HR on univariate regression were weighted by their predictive coefficient and added to generate a triage risk score (TRS) ranging from a minimum score of 0 (lowest risk) to a maximum possible score of 43.9 (highest risk). Triage Risk Score (TRS) less than or equal to 1.3 (1st quartile) was designated as low risk, TRS 1.4 to 4.0 (2nd \& 3rd quartile) as moderate risk, and TRS greater than or equal to 4.1 (fourth quartile) as high risk.
Acceptability Score of Mobile Phones as a Follow-up Tool
Time frame: 2 weeks after enrollment
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
Time frame: After the 2week post-discharge phonecall.
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 the 2 weeks post-discharge phonecall.
4 secondary outcomes
Glasgow Outcomes Scale-Extended (GOSE) Disability Level
Time frame: At the 2week post-discharge telephone phonecall.
Economic Consequences of Injury: Did it Become More Difficult for the Family to Afford Expenses Such as Food and Rent?
Time frame: At the 2week post-discharge telephone phonecall.
Economic Consequences of Injury: Did the Family Spend Saved Money?
Time frame: At the 2week post-discharge telephone phonecall.
Economic Consequences of Injury: Did the Family Borrow Money?
Time frame: At the 2week post-discharge telephone phonecall.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. De-identified individual participant data for all primary and secondary outcome measures will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Juillard, MD, MPH principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone-based Triage Tool in people with Wounds and Injury, run by University of California, Los Angeles at 4 sites in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Successful Contacts (time frame: 2 weeks after enrollment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.