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TraumaNCT05430165

Trauma Follow-Up Prediction (Project 2: Aim 1)

An observational study of Trauma and Injury Traumatic, run by Mefire Alain Chichom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Traumatic injury and inadequate follow-up care are a significant cause of morbidity and 10% of all deaths in sub-Saharan Africa (SSA). In Cameroon, ~50% of all emergency department (ED) visits are due to traumatic injury, which is likely only ~60% of all traumatic injuries. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Trauma, Injury Traumatic, Injuries
What is being tested?
Standard mHealth screening (triage) tool
How many people
4,500 participants
Where
No sites listed yet
Study dates
15 May 2023to 15 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

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

Study population: A prospective cohort study of all eligible admitted trauma patients in the Cameroon Trauma registry (CTR) and a qualitative study of 110 in-depth interviews (IDIs). The 10 study sites of the CTR are as follows: 1. Laquintinie Hospital of Douala, (Littoral region) 2. Limbé Regional Hospital, (Southwest region) 3. Pouma Catholic Hospital, (Littoral region) 4. Edea Regional Hospital, (Littoral region) 5. The Emergency and Reanimation Center of Yaounde, (Centre Region) 6. Bafoussam Regional Hospital (West region) 7. Maroua Regional Hospital (Far north region) 8. Bafia district hospital (Centre Region) 9. Kribi District hospital (South Region) 10. Bertoua Regional Hospital (East Region)

Who may be able to join

  • Trauma Registry (CTR): Patients satisfying the following inclusion criteria will be included in the registry:
  • Patients with acute traumatic injury i.e. within 2 weeks of presentation for care.
  • Trauma patients who are formally admitted to the hospital as in-patients.
  • Trauma patients who die upon arriving to the Emergency Departments or while admitted in the hospital.
  • Trauma patients who are transferred to other health facilities.
  • Trauma patients with indications for hospital admission (based on physicians' assessments) but leave against medical advice
  • Trauma patients who are kept under observation in the Emergency Department for over 24 hours
  • Standard mHealth Triage Tool Eligibility: The mHealth triage tool will be administered to the subset of patients included in the trauma registry who are admitted then discharged home after treatment.

Who cannot join

  • Trauma Registry Exclusion criteria: Patients will not be excluded based on age, gender, race, or nationality. If patients or their surrogate decision-maker do not give consent to participation, those patients will be excluded.
  • According to the World Health Organization (WHO) injury definition, the following will be excluded from the definition of "injury": "Whereas the above definition of an injury includes drowning (lack of oxygen), hypothermia (lack of heat), strangulation (lack of oxygen), decompression sickness or "the bends" (excess nitrogen compounds) and poisonings (by toxic substances), it does NOT include conditions that result from continual stress, such as carpal tunnel syndrome, chronic back pain and poisoning due to infections. Mental disorders and chronic disability, although these may be eventual consequences of physical injury, are also excluded by the above definition."
  • Although included in the WHO definition, poisonings will be excluded from the CTR as these have been extremely rare events in the CTR to date and are not typically included in trauma registries in most other contexts.
  • Patients who are not formally admitted and discharged within 24 hours from the Emergency Ward will be excluded.

Trial locations and contacts

No sites are listed yet.

Alain Chichom-Mefire, MD contact

+237677530532

chichom.mefire@ubuea.cm

Fanny Dissak-Delon, MD, PhD contact

fannynadia@gmail.com

About this study

Official title: Using Data-Adaptive Methods to Optimize Follow Up Of Injured Patients After Hospital Discharge in Cameroon (Aim 1)

Traumatic injury and inadequate follow-up care are a significant cause of morbidity and 10% of all deaths in sub-Saharan Africa (SSA). In Cameroon, ~50% of all emergency department (ED) visits are due to traumatic injury, which is likely only ~60% of all traumatic injuries. In the subset of patients who seek care, follow-up after discharge can save lives, yet is uncommon due to both supply-side (e.g., under-resourced health systems, poor data) and demand-side (e.g., poverty) barriers, resulting in preventable complications after discharge (e.g., sepsis, osteomyelitis). Consequently, better follow-up care of trauma patients is a neglected, but high-yield opportunity to improve injury outcomes, especially when coupled with mobile health technologies (mHealth) to better predict and implement post-discharge care, preventing disability and death.

Thus, in this study, the investigators will scale up an existing trauma registry and expand use of a mHealth screening tool (triage tool). At 10 hospitals, the investigators will implement a trauma registry and mHealth tool and evaluate success in a mixed-methods study; a quantitative prospective cohort of all eligible injured patients will be followed for 6 months after discharge and an inductive qualitative study.

Read the detailed description

Injury is the largest contributor to the global burden of surgical disease and the cause of 10% of all deaths in Sub-Saharan Africa (SSA). In SSA countries like Cameroon, injured people face multiple obstacles to trauma care, including potentially lifesaving follow-up care after hospital discharge. To significantly improve health in the SSA, there is an urgent need for effective, innovative, and scalable approaches to reduce morbidity and mortality from injury. Follow-up care of trauma patients is a neglected, but high-yield opportunity to improve injury outcomes, especially when coupled with mobile health technologies (mHealth) to better predict and implement post-discharge care. The ubiquity and high penetration of mobile phones in Cameroon provides a novel opportunity to improve injury care in the country. The long-term goal of this project is to improve trauma outcomes and reduce the burden associated with injury in Cameroon, with the overall objective of preventing disability and death.

A critical barrier to improved trauma outcomes in resource-limited SSA contexts is the rapid identification of patients who would benefit from further care and successful retention of these patients through treatment completion. Building on the investigators established research infrastructure in Cameroon, using an implementation science approach, the team will conduct a mixed-methods study and first expand the existing trauma registry to 10 hospitals and scale-up an mHealth, phone-based screening tool (triage tool) to identify trauma patients in Cameroon who would benefit from further formal medical care post-discharge. The second part of the study will consist of an inductive qualitative study using in-depth interviews (IDIs) with all the stakeholders: patients, ED staff, and CTR and mHealth research staff. In addition to the IDIs, the research team will also conduct a non-participant observation of the project's implementation, analyzing the behaviors of each stakeholder and the dynamics of interactions between them. The project's implementation will be assessed using domains of the Consolidated Framework for Implementation Research (CFIR) as theoretical framework. These data gathered in this aim will be triangulated to guide adaptation and optimization of the intervention in Aim 2.

Being tested
Standard mHealth screening (triage) tool
Keywords
Cameroon, Sub-Sahara Africa, mHealth
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.

  • Standard mHealth screening (triage) toolOther

    Standard mHealth triage tool administered to eligible trauma patients by phone at 2 weeks, 1 month, 3 months, and 6 months post-hospital discharge. The mHealth triage tool is a survey that includes a 7-item questionnaire to identify their need for follow-up care.

    The need for follow-up care at any of the 4 follow-ups is defined as a flagged response to ≥1 question on the 7-item screening survey.

Study groups in NCT05430165
Study groupRoleWhat they receive
Aim 1 Prospective CohortAll eligible admitted trauma patients in the trauma registry and a qualitative study of 110 in-depth interviews (IDIs).
Receives: Other: Standard mHealth screening (triage) tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Successful Contacts

    Proportion of hospitalized trauma patients who are reached by mobile phone at 2weeks post-discharge.

    Measured: 2 weeks post-discharge

  2. Proportion of Successful Contacts

    Proportion of hospitalized trauma patients who are reached by mobile phone at 1 month post-discharge.

    Measured: 1 month post-discharge

  3. Proportion of Successful Contacts

    Proportion of hospitalized trauma patients who are reached by mobile phone at 3 months post-discharge.

    Measured: 3 months post-discharge

  4. Proportion of Successful Contacts

    Proportion of hospitalized trauma patients who are reached by mobile phone at 6 months post-discharge.

    Measured: 6 months post-discharge

  5. Proportion needing follow-up care.

    Proportion of hospitalized trauma patients who are reached by mobile phone at 2 weeks post-discharge and who are identified by the standard screening tool as needing follow-up care.

    Measured: 2 weeks post-discharge

  6. Proportion needing follow-up care.

    Proportion of hospitalized trauma patients who are reached by mobile phone at 1 month post-discharge and who are identified by the standard screening tool as needing follow-up care.

    Measured: 1 month post-discharge

  7. Proportion needing follow-up care.

    Proportion of hospitalized trauma patients who are reached by mobile phone at 3 months post-discharge and who are identified by the standard screening tool as needing follow-up care.

    Measured: 3 months post-discharge

  8. Proportion needing follow-up care.

    Proportion of hospitalized trauma patients who are reached by mobile phone at 6 months post-discharge and who are identified by the standard screening tool as needing follow-up care.

    Measured: 6 months post-discharge

  9. Proportion needing follow-up care.

    Cumulative Proportion of hospitalized trauma patients who are reached by mobile phone over the study period and who are identified by the standard screening tool as needing follow-up care.

    Measured: 24 months

  10. Qualitative outcomes: Examine Inner setting of the Consolidated Framework for Implementation Research (CFIR)

    Examine through qualitative data, the inner setting domain of the Consolidated Framework for Implementation Research (CFIR) among patients, facility staff, and research assistants

    Measured: 6 months through 24 months

  11. Qualitative outcomes: Examine Outer setting of the Consolidated Framework for Implementation Research (CFIR)

    Examine through qualitative data, the outer setting domain of the Consolidated Framework for Implementation Research (CFIR) among patients, facility staff, and research assistants

    Measured: 6 months through 24 months

  12. Qualitative outcomes: Examine Characteristics of individuals using the Consolidated Framework for Implementation Research (CFIR)

    Examine through qualitative data, the Characteristics of individuals using the Consolidated Framework for Implementation Research (CFIR) among patients, facility staff, and research assistants

    Measured: 6 months through 24 months

  13. Qualitative outcomes: Examine Process of implementation using the Consolidated Framework for Implementation Research (CFIR)

    Examine through qualitative data, the process of implementation using the Consolidated Framework for Implementation Research (CFIR) among patients, facility staff, and research assistants.

    Measured: 6 months through 24 months

Secondary outcomes (1)
  1. Disability assessed by Augmented Glasgow Outcomes Scale-Extended (aGOSE)

    Assess disability for the total cohort and subgroups (study site, socioeconomic status, injury mechanism, injury type, participant demographics, hospital type) at each timepoint as determined by Augmented Glasgow Outcomes Scale-Extended (aGOSE). A possible score of 1 through 8; lowest score of 1 means death while maximum score of 8 means Upper good recovery.

    Measured: 24 months; after the last participant recruited in month 18 completes 6 month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start15 May 2023 (estimated)
  3. Primary completion15 Nov 2024 (estimated)
  4. Study completion15 Nov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05430165
Sponsor's protocol ID
GRANT13254336
Other IDs
U54TW012087
Status last verified
May 2023
First submitted
5 Jun 2022
Last updated
3 May 2023
Results posted
No
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 to Harnessing Data Science for Health Discovery and Innovation in Africa (DSI Africa) consortium and other researchers.

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma and Injury Traumatic, run by Mefire Alain Chichom.

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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alain Chichom-Mefire, MD (+237677530532, chichom.mefire@ubuea.cm), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Successful Contacts (time frame: 2 weeks post-discharge). The study lists 13 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 3 May 2023.

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