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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05430165
• Other study ID #: GRANT13254336
• Secondary ID: U54TW012087
• Status: Not yet recruiting
• Start date: May 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2023
• Source: University of Buea
• Contact: Alain Chichom-Mefire, MD
• Phone: +237677530532
• Email: chichom.mefire[@]ubuea.cm
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4500
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Trauma Registry (CTR): Patients satisfying the following inclusion criteria will be included in the registry:

1. Patients with acute traumatic injury i.e. within 2 weeks of presentation for care.

2. Trauma patients who are formally admitted to the hospital as in-patients.

3. Trauma patients who die upon arriving to the Emergency Departments or while admitted in the hospital.

4. Trauma patients who are transferred to other health facilities.

5. Trauma patients with indications for hospital admission (based on physicians' assessments) but leave against medical advice

6. 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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Injuries
• Injury Traumatic
• Trauma
• Wounds and Injuries

Intervention

Other:
• Standard mHealth screening (triage) tool
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Mefire Alain Chichom	Fogarty International Center of the National Institute of Health, University of California, Berkeley, University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Successful Contacts	Proportion of hospitalized trauma patients who are reached by mobile phone at 2weeks post-discharge.	2 weeks post-discharge
Primary	Proportion of Successful Contacts	Proportion of hospitalized trauma patients who are reached by mobile phone at 1 month post-discharge.	1 month post-discharge
Primary	Proportion of Successful Contacts	Proportion of hospitalized trauma patients who are reached by mobile phone at 3 months post-discharge.	3 months post-discharge
Primary	Proportion of Successful Contacts	Proportion of hospitalized trauma patients who are reached by mobile phone at 6 months post-discharge.	6 months post-discharge
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	24 months; after the last participant recruited in month 18 completes 6 month follow-up.