Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308851460352 Date of Approval: 17/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The use of allied health and law enforcement trauma team registries: Lessons from a novel motorcycle trauma registry and surveillance system in Uganda
Official scientific title The use of medical trainees and law enforcement trauma registries: An examination of the impact of rural trauma team development and training on the outcomes of motorcycle related orthopedic and neurological injuries in Uganda.
Brief summary describing the background and objectives of the trial Background: Road traffic injuries (RTIs) are the third leading cause of death and will constitute 16% of the global burden of disease by 2030. Evidence suggests that 90% of RTIs mortality burden disproportionately occur in low-middle-income countries (LMICs) such as those in Africa. Our recent studies showed that most of the fatal injuries in Uganda result from motorized two wheel-car collisions, contributing to (52.6%-64.7%) of orthopedic and traumatic brain injuries. Uganda lacks adequate universal access to trauma care and injury surveillance information systems due to limited human and infrastructural resources even though universal access to quality trauma care and injury data are in-line with the 2030 Agenda for Sustainable Development Goals. Objectives of the trial: The aim of this doctoral thesis project is to evaluate the feasibility of traffic law enforcement and medical trainees in formation of trauma registries in Uganda (Africa), and to examines the effect of rural trauma teams and training on outcomes of orthopedic and neurological injuries. The trial was approved with four individual studies which will be compiled into a doctoral thesis as chapters, corresponding to the key main outcomes.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) MOTOR
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Mental and Behavioural Disorders,Musculoskeletal Diseases,Nervous System Diseases,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 27/08/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 27/08/2023
Actual Last follow-up date 27/11/2023
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 1000
Recruitment status Completed
Publication URL A link to publications will be updated accordingly.
Secondary Ids Issuing authority/Trial register
SS 5082 Uganda National Council for Science and Technology
MUREC 05 05 19 Mbarara University of Science and Technology Research and Ethics Commitee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No intervention Group U There will be no trainings for the three clustered facilities that will serve as control group. One average we hope to recruit 1-2 patients per day from each of the health facilities. The data from the motorcycle outcome registry (MOTOR) study will be collected for a total duration of 4 years The control facilities will be formed by three out of six cluster randomized regional referral hospitals (Level II trauma centers) in Eastern and Southwestern Uganda. A motorcycle trauma outcome registry (MOTOR) and demographic surveillance will be concurrently executed at these trauma centers, and the patient’s care, flow and pathways will be left to run as routine. 500 Placebo
Experimental Group Trained Group T An average 12 (5-23) trainings will be conducted per intervention site at an interval of 3 months corresponding to the duration of internship clinical rotations and schedules for deployment of medical trainees by the universities in Uganda. Each training program will be designed for one day, targeting 30 participants with a trainer: trainee ratio of 1:10 which is the maximum permissible by the committee on trauma of the American College of Surgeons. The intervention will be conducted for a total of four years. Multi-center interrupted series of cross-sectional intervention in which a total of 500 participants will be trained in trauma teams using the American College of Surgeons’ 4th edition of Rural Trauma Team Development Course© (RTTDC). This training model assumes a concept that teamwork improves clinical efficiency (www.myrttdc.com); which we hypothesize that could subsequently have an impact on transferrable knowledge and skill retention and impact on trauma outcomes. Participants will be organized into teams of five with specific roles such as team leader or team member to demonstrate the communication, transfer, and resuscitation of trauma patients using audio-visuals and simulated case scenarios. The trainee participants will include 66 (13.2%) road traffic police officers, 30 (6.0%) intern doctors, 140 (28.0%) fifth year and 264 (52.8%) third year medical students. The intervention will be executed in three out of six cluster randomized regional referral hospitals (Level II trauma centers) in Eastern and Southwestern Uganda. A motorcycle trauma outcome registry (MOTOR) and demographic surveillance will be concurrently executed at these six trauma centers, and the trained participants will form part of the rural trauma care teams and volunteering rural networks of first responders at the three intervention facilities. 500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Study 1: Medical students Intern doctors Intern nurses In-charges of accident and emergence departments Regional police officers in charge of traffic and road safety Study II-IV Patients who sustain motorcycle related injuries including: Passengers on motorcycles Motorcycle riders Pedestrians hit by motorcycles. Patient suffering from of motorcycle-motorcycle collisions Passengers or cyclists suffering from motorcycle-car collisions. Study 1: Medical students who have not started their clinical rotations in surgery at the time of the training. Studies II-IV: Pregnant women Neonates and infants 0-23months Patients with documented stroke Mentally incapacitated patients who have no legally authorized representatives to sign an informed consent. Patients who die before hospital arrival Patients who die before imaging results are obtained Patients who are passengers in car at time of accident Patients who are drivers in a car at time of accident Elderly above 80 years with increased risk of fragility fractures 80 and over: 80+ Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month 2 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/08/2019 Uganda National Council for Science and Technology UNCST
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera Road, Ntinda Kampala 6884 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pre-Hospital interval in Hours From accident scene to arrival at accident and emergence departments
Primary Outcome Referral-Exit Interval in Hours for Neurological Injuries From time a clinical referral decision is made to the time patient exits the hospital gate
Secondary Outcome Morbidity of musculoskeletal injuries based on Trauma Expectation Factor and Trauma Outcome Measure Scores Baseline Trauma Expectation Factor Score within first week of treatment and Trauma Outcome Measure Score at 90 days after injury.
Secondary Outcome Morbidity and Mortality of Neurological Injuries based on Glasgow Outcome Scale Baseline Glasgow Coma Score at 0 days and Glasgow Outcome Score at 90 days post injury.
Secondary Outcome Factors associated with unfavorable musculoskeletal trauma outcome measure score. At 90 days post injury
Secondary Outcome Factors associated with mortality of neurological injuries. At 90 days post injury
Secondary Outcome Knowledge retention from the training based on pre-and post-training mean percentage scores. Pre-training questionnaire before and at 90 days post-training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kiryandongo Hospital Kikube Kigumba 256 Uganda
Jinja Regional Referral Hospital Rotary Road Jinja 256 Uganda
Hoima Regional Referral Hospital Main street Hoima 256 Uganda
Mubende Regional Referral Hospital Fort portal Road Mubende 256 Uganda
Fort Portal Regional Referral Hospital Mugurusi Road Fort Portal 256 Uganda
Kampala International University Teaching Hospital Bushenyi Ishaka Ishaka 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Herman Lule Injury Epidemiology and Prevention Research Group, Turku Bain Injury Center, University of Turku and Turku University Hospital Turku 20540 Finland
University of Turku Graduate School Turun Yliopisto Turku 20014 Finland
Neurocentre Turku University Hospital Tyks Kiinamyllnkatu 4-8 Turku 20520 Finland
Turku University Foundation Tyks Kiinamyllynkatu 4-8 Turku 20520 Finland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Herman Lule Injury Epidemiology and Prevention Research Group, Turku Bain Injury Center, University of Turku and Turku University Hospital Turku 20540 Finland Individual
Secondary Sponsor Michael Lowery Wilson Injury Epidemiology and Prevention Research Group, University of Turku Turku 20500 Finland Individual
Secondary Sponsor Jussi Posti Neurocentre Turku University Hospital Turku 20520 Finland Individual
Secondary Sponsor Till Bearnighausen Im Neuenheimer Feld Heidelberg 130/3,691 Germany Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Barnighausen Heidelberg Institute of Global Health, The University of Heidelberg Heidelberg 69120 Germany
Prof.Dr. Patrick Kyamanywa Uganda Martyrs University Nkozi 5498 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Herman Lule lule.herman@gmail.com +256775656222 Department of Surgery, Kiryandongo Hospital
City Postal code Country Position/Affiliation
Kigumba 256 Uganda Head of Department Surgery
Role Name Email Phone Street address
Public Enquiries Robinson Ssebuufu rssebuufu@gmail.com +256772507248 Department of Surgery Mengo Hospital
City Postal code Country Position/Affiliation
Kampala 256 Uganda Associate Professor of Surgery. Head of Research and Training
Role Name Email Phone Street address
Scientific Enquiries Jussi Posti jussi.posti@utu.fi +358443804148 Turku Brain Injury Center, University of Turku and Turku University Hospital
City Postal code Country Position/Affiliation
Turku 20500 Finland Adjunct Professor. Neurotraumatology Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants for the training will get feedback after the post-test questionnaire evaluation. Patient participants will be advised on the next plans of management during follow-up calls or out-patient consultations. Before study findings will be presented in scientific conferences and published in peer reviewed journals, a copy of findings in the final bound report will be submitted to the participating hospital main libraries, departments of surgery and Internal Review Boards of Mbarara University of Science and Technology, Kampala International University and Uganda National Council for Science and Technology. The implications of findings will be shared with to authorities including district health officers, hospital directors, regional police offices and chairpersons of the motorcycle riders' associations in the respective regions and with the rural trauma networks of first responders. Priority will be made to present the preliminary findings at an international conference hosted in Uganda. De-identified participant data from this trial will be archived on a permanent weblink and will be made publicly available from the principal investigator 12 months from the date of completion. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol De-identified data will be made publicly available 12 months from the time of completion of the trial. De-identified data will be publicly available through the principal investigator 12 months from the date of completion.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.researchprotocols.org/2024/1/e55297 No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/08/2023 A typographic error has been corrected. 1006 1000
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 12/12/2023 Completed Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 14/08/2023 Since the intervention is entails training and education, the term "No intervention" provides a better description as opposed to "placebo" which is more applicable in drug related controlled trials. Control Group, Untrained Group U, There will be no trainings for the three clustered facilities that will serve as control group. One average we hope to recruit 1-2 patients from each of the health facilities., The data from the motorcycle outcome registry (MOTOR) study will be collected for a total duration of 4 years, The control facilities will be formed by three out of six cluster randomized regional referral hospitals (Level II trauma centers) in Eastern and Southwestern Uganda. A motorcycle trauma outcome registry (MOTOR) and demographic surveillance will be concurrently executed at these trauma centers, and the patient’s care, flow and pathways will be left to run as routine., 500, Placebo Control Group, No intervention Group U, There will be no trainings for the three clustered facilities that will serve as control group. One average we hope to recruit 1-2 patients per day from each of the health facilities., The data from the motorcycle outcome registry (MOTOR) study will be collected for a total duration of 4 years, The control facilities will be formed by three out of six cluster randomized regional referral hospitals (Level II trauma centers) in Eastern and Southwestern Uganda. A motorcycle trauma outcome registry (MOTOR) and demographic surveillance will be concurrently executed at these trauma centers, and the patient’s care, flow and pathways will be left to run as routine., 500, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 22/05/2024 Granted a funded doctoral position for 2024 University of Turku Graduate School, Turun Yliopisto, Turku, 20014, Finland, University,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 22/05/2024 Provided a working grant for a doctoral thesis Neurocentre Turku University Hospital Tyks, Kiinamyllnkatu 4-8, Turku, 20520, Finland, Charities/Societies/Foundation,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 22/05/2024 Provided a conference travel grant for results dissemination Turku University Foundation Tyks, Kiinamyllynkatu 4-8, Turku, 20520, Finland, Hospital,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 22/05/2024 Provided working space for data analysis and sourced funding for open access publishing through the Neurocentre of Turku University Hospital and University of Turku Jussi Posti, Neurocentre Turku University Hospital, Turku, 20520, Finland, Secondary Sponsor, Individual,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 22/05/2024 Sourced complementary funds for open access publishing through colllboration with the injury unit at the Heidelberg Institute of Global Health, Till Bearnighausen, Im Neuenheimer Feld, Heidelberg, 130/3,691, Germany, Secondary Sponsor, Other Collaborative Groups,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 22/05/2024 Link to a more detailed protocol Permanent web links to resulting publications and de-identified data will be updated accordingly. https://www.researchprotocols.org/2024/1/e55297