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

Primary Purpose

Injury Traumatic, Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optimized version of the mHealth screening tool (intervention) using the machine learning approach
Sponsored by
University of Buea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injury Traumatic focused on measuring Cameroon, Sub-Sahara Africa, mHealth, Machine learning, Injury, Trauma, Mobile phone, SuperLearner

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Optimized version of the mHealth screening tool (intervention) Eligibility: The optimized version of mHealth screening 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard mHealth screening tool

    Optimized version of the mHealth screening tool (intervention) using the machine learning approach

    Arm Description

    This is a tested standard phone screening tool which determines the need for in-person follow-up after a patient has been discharge. Consenting trauma patients will be contacted via mobile phone at 0.5, 1, 3, and 6 months post-discharge by a research assistant to complete the screening which will guide whether or not the patient should seek follow-up care based on the number of flagged responses to ≥1 question on the 7-item screening survey.

    This arm will receive an improvement to the mHealth triage tool using a machine learning approach. Patients will be called using the optimized tool at outcome timepoints (3 months, 6months and 12months). At each call, research assistants will complete the GOSE survey and the mHealth triage tool, entering call outcomes and patient responses directly into the mHealth system. If follow-up care is indicated, the research assistant will share that information with the patient and offer to schedule an appointment.

    Outcomes

    Primary Outcome Measures

    Assess Glasgow Outcomes Scale-Extended (GOSE) score
    This outcome will measure recovery after traumatic injury and ranges from 1 (death), 2 (vegetative state), through 8 (good upper recovery).

    Secondary Outcome Measures

    GOSE score
    This outcome will measure recovery after traumatic injury and ranges from 1 (death), 2 (vegetative state), through 8 (good upper recovery).
    Proportion reached by mobile phones
    Number and proportion of hospitalized trauma patients who are reached by mobile phone after discharge in both arms
    Proportion needing follow-up care
    Number and proportion of hospitalized trauma patients who are reached by mobile phone post-discharge and who are identified by the screening tool as needing follow-up care.

    Full Information

    First Posted
    July 14, 2022
    Last Updated
    July 18, 2022
    Sponsor
    University of Buea
    Collaborators
    Fogarty International Center of the National Institute of Health, University of California, Los Angeles, University of California, Berkeley
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05464017
    Brief Title
    Trauma Follow-Up Prediction (Project 2: Aim 2)
    Official Title
    Using Data-Adaptive Methods to Optimize Follow Up Of Injured Patients After Hospital Discharge in Cameroon (Aim 2)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2024 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Buea
    Collaborators
    Fogarty International Center of the National Institute of Health, University of California, Los Angeles, University of California, Berkeley

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Approximately 9% of the world's deaths, more than 5 million deaths annually, are due to injury. In high-income countries, where the epidemiology and outcomes of traumatic injury are well characterized, trauma primarily affects young, productive members of the population and is associated with significant long-term disability. In sub-Saharan Africa (SSA) countries like Cameroon, injured people face multiple obstacles to trauma care, including potentially lifesaving follow-up care after hospital discharge. The Investigators' community-based survey of 8,065 patients in South west Cameroon found that 34.6% of injured respondents did not seek immediate formal care after injury, and another 9.9% only sought formal care after alternative means, such as consultation with traditional medicine practitioners. In Cameroon, for the 65.4% of injured people who seek formal care after injury,5 therapeutic itineraries can be complex, often involving poorly supported referrals to other facilities or transitions away from formal care. As a result, formal systems of care fail to retain trauma patients for follow-up care, a missed opportunity as these patients have already overcome significant financial and personal challenges to seek initial care for their injuries. Consequently, discharged trauma patients who may benefit from follow-up care often delay care until advanced complications develop. The objective of this study is to evaluate a machine learning optimized phone-based screening tool that predicts which trauma patients are most likely to benefit from follow-up care. A Cluster randomized trial controlled trail will be carried out in 10 hospitals in Cameroon involving 852 trauma patients. The control group shall use the existing standard mHealth screening tool while the intervention shall use the optimized version of the mHealth screening tool (intervention) using the machine learning approach. Patients shall be followed up over a 6 months period to determine the proportion of trauma post discharge patients that need follow up care using mobile phone.
    Detailed Description
    The technological convergence of mHealth and machine learning provides an unprecedented opportunity to transform injury care in SSA, particularly for disadvantaged populations. The ubiquity of mobile phones and the advent of mHealth provides a novel opportunity to improve injury care in SSA. Given high levels of mobile phone penetration in Cameroon (85% to 95%) and elsewhere in SSA, the investigators designed and piloted an mHealth, phone-based 7-item screening tool for trauma patients to predict the need for in-person follow-up care after discharge. If effective, this approach could efficiently identify the subset of patients most likely to benefit from follow-up care, which is more feasible, scalable, and cost-effective than blanket advice for post-discharge care. The investigators found that phone follow-up is feasible and acceptable and a validation study revealed good correlation of the screening tool with an independent, in-person exam. Investigators will build upon their prior research and use data science to improve, implement and evaluate the mHealth screening tool, with the ultimate objective of reducing the crippling burden of injury. This will be achieved by leveraging on machine learning, which has demonstrated promise in optimizing trauma care and trauma systems.The novel combination of mHealth and machine learning provides a powerful opportunity to transform access to health care for those least likely to receive it. Building on existing knowledge, the investigators hypothesize that a data-adaptive, machine-learning approach to outcomes prediction could radically improve survival and reduce morbidity after injury in SSA. Investigators will apply a machine learning approach to adaptively optimize the mHealth triage tool, improving the phone call timing and algorithm that predicts the need for follow-up care via a cluster randomized controlled trial. This will be achieved using SuperLearner for prediction and cross-validated targeted maximum likelihood estimation (CV-TMLE) for variable importance, using the trauma registry, contact attempt, and screening survey data collected in Aim 1. The overall goal is to improve the mHealth tool's prediction of vulnerable patients needing follow-up care after discharge. This study shall be conducted over an 18-months period; enrollment in 6 months and follow-up participants for 12 months. Investigators will evaluate the impact of the optimized approach in a randomized study in 10 hospitals with 852 injury patients with the primary outcome of the Glasgow Outcomes Scale-Extended (GOSE)24,25 score at 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injury Traumatic, Injuries
    Keywords
    Cameroon, Sub-Sahara Africa, mHealth, Machine learning, Injury, Trauma, Mobile phone, SuperLearner

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Investigators will implement improvements to the mHealth triage tool using a machine learning approach, optimizing both the efficiency of the call schedule and the prediction of which patients are most likely to benefit from follow-up care given data collected at the hospital through the CTR, as well as post-discharge phone contact attempts and survey information. The backbone of investigators' estimators is the ensemble machine learning algorithm the Superlearner
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    852 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard mHealth screening tool
    Arm Type
    No Intervention
    Arm Description
    This is a tested standard phone screening tool which determines the need for in-person follow-up after a patient has been discharge. Consenting trauma patients will be contacted via mobile phone at 0.5, 1, 3, and 6 months post-discharge by a research assistant to complete the screening which will guide whether or not the patient should seek follow-up care based on the number of flagged responses to ≥1 question on the 7-item screening survey.
    Arm Title
    Optimized version of the mHealth screening tool (intervention) using the machine learning approach
    Arm Type
    Experimental
    Arm Description
    This arm will receive an improvement to the mHealth triage tool using a machine learning approach. Patients will be called using the optimized tool at outcome timepoints (3 months, 6months and 12months). At each call, research assistants will complete the GOSE survey and the mHealth triage tool, entering call outcomes and patient responses directly into the mHealth system. If follow-up care is indicated, the research assistant will share that information with the patient and offer to schedule an appointment.
    Intervention Type
    Device
    Intervention Name(s)
    Optimized version of the mHealth screening tool (intervention) using the machine learning approach
    Intervention Description
    An improvement to the mHealth triage tool using a machine learning approach, optimizing the efficiency of call schedule and the prediction of which patients are most likely to benefit from follow-up care given data collected at the hospital through the Cameroon Trauma Registry, as well as post-discharge phone contact attempts and survey information. The backbone of the estimators is the ensemble machine learning algorithm the Superlearner, which has been applied to medical contexts, including injury and trauma. It is a theory-driven method based on cross-validation, which combines potentially many different learners (e.g., standard regression, tree regression, random forest, neural nets) such that the model chosen (a weighted average of the learners) is asymptotically equivalent to the so called "Oracle" - the learner that fits optimally for the data-generating distribution. Note, double-robust CV-TMLE versions of this estimator are available as the tmle3mopttx function in tlverse.
    Primary Outcome Measure Information:
    Title
    Assess Glasgow Outcomes Scale-Extended (GOSE) score
    Description
    This outcome will measure recovery after traumatic injury and ranges from 1 (death), 2 (vegetative state), through 8 (good upper recovery).
    Time Frame
    At 3 months
    Secondary Outcome Measure Information:
    Title
    GOSE score
    Description
    This outcome will measure recovery after traumatic injury and ranges from 1 (death), 2 (vegetative state), through 8 (good upper recovery).
    Time Frame
    At 6 and 12 months
    Title
    Proportion reached by mobile phones
    Description
    Number and proportion of hospitalized trauma patients who are reached by mobile phone after discharge in both arms
    Time Frame
    At 0.5, 1, 3, and 6 months
    Title
    Proportion needing follow-up care
    Description
    Number and proportion of hospitalized trauma patients who are reached by mobile phone post-discharge and who are identified by the screening tool as needing follow-up care.
    Time Frame
    At 0.5, 1, 3, and 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Optimized version of the mHealth screening tool (intervention) Eligibility: The optimized version of mHealth screening 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alain Chichom-Mefire, MD
    Phone
    +237677530532
    Email
    chichom.mefire@ubuea.cm
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fanny JN Dissak-Delon, MD, PhD
    Phone
    +237697582185
    Email
    fannynadia@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alain Chichom-Mefire, MD
    Organizational Affiliation
    University of Buea
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Catherine Juillard, MD, MPH
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.

    Learn more about this trial

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

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