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

NCT05430165 | Unknown

• 2 other identifiers: GRANT13254336U54TW012087
• Study Type: observational
• Target: 4,500
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Trauma; Injury Traumatic; Injuries

Keywords

Cameroon; Sub-Sahara Africa; mHealth

Outcome Measures

Primary Outcomes (13)

• Proportion of Successful Contacts

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

  2 weeks post-discharge

• Proportion of Successful Contacts

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

  1 month post-discharge

• Proportion of Successful Contacts

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

  3 months post-discharge

• Proportion of Successful Contacts

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

  6 months post-discharge

• 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.

  2 weeks post-discharge

• 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.

  1 month post-discharge

• 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.

  3 months post-discharge

• 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.

  6 months post-discharge

• 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.

  24 months

• 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

  6 months through 24 months

• 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

  6 months through 24 months

• 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

  6 months through 24 months

• 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.

  6 months through 24 months

Secondary Outcomes (1)

• Disability assessed by Augmented Glasgow Outcomes Scale-Extended (aGOSE)

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

Study Arms (1)

Aim 1 Prospective Cohort

All eligible admitted trauma patients in the trauma registry and a qualitative study of 110 in-depth interviews (IDIs).

Other: Standard mHealth screening (triage) tool

Interventions

Standard mHealth screening (triage) tool OTHER

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.

Aim 1 Prospective Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mefire Alain Chichom: lead
• Fogarty International Center of the National Institute of Health: collaborator
• University of California, Los Angeles: collaborator
• University of California, Berkeley: collaborator

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Triage; Equipment and Supplies

Intervention Hierarchy (Ancestors)

Emergency Medical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alain Chichom-Mefire, MD

  University of Buea

  PRINCIPAL INVESTIGATOR

• Catherine Juillard, MD, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Chichom-Mefire, MD

CONTACT

+237677530532; chichom.mefire@ubuea.cm

Fanny Dissak-Delon, MD, PhD

CONTACT

fannynadia@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 24, 2022
• Study Start: May 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share