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.: PACTR202008876045310 Date of Approval: 28/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving initial management of the injured at Ghanaian district and regional hospitals with a Trauma Intake Form
Official scientific title Improving initial management of the injured at Ghanaian district and regional hospitals with a Trauma Intake Form
Brief summary describing the background and objectives of the trial Improving care of the injured (trauma care) is a way to the large burden of injury in low- and middle-income countries. The important initial period of trauma care is often chaotic and prone to errors. The World Health Organization created a Trauma Care Checklist (TCC), which improved key performance indicators of care at tertiary hospitals but encountered factors which decreased its uptake. We propose the use of a model Trauma Intake Form (TIF) with potential to achieve the benefits of the TCC, but with automatic usage and with accompanying improvements in documentation for key elements of care. It is especially oriented for smaller hospitals. We propose a pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design. Specifically, we aim to determine the effectiveness the TIF to function as a checklist for increasing the appropriate use of key performance indicators during care of the injured in emergency units of non-tertiary hospitals in Ghana, as assessed by independent observers; to determine the percent of injured patients with adequate data on initial assessment before vs. after introduction of the TIF in emergency units of non-tertiary hospitals in Ghana; and to increase the capacity of the Kwame Nkrumah University of Science and Technology and the network of non-tertiary hospitals in southern Ghana to undertake high-quality trauma care research, including clinical trials.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Introduction of a TIF to improve assessment of the injured
Anticipated trial start date 01/09/2020
Actual trial start date
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 3500
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Introduction of the Trauma Intake Form 35 weeks The intervention to be tested is the TIF to be used in recording information about injured patients during their initial assessment and care and which is designed to decrease omission of critical steps in care and so to improve care and also record keeping. 1750
Control Group None 35 weeks Current method of assessing injured patients 1750 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Emergency health care providers at Ghanaian district (first-level) or regional (second-level) hospitals Patient with injury who is treated in the emergency unit of one of the study hospitals Non-emergency health care providers at the study hospitals Non-injured patient at the study hospitals 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 120 Year(s) Female
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 30/04/2020 Kwame Nkrumah Univ Science and Technology Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
PMB, University Post Office Kumasi 00000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Appropriate use of key performance indicators in initial assessment and management of the injured at non-tertiary hospitals in Ghana Documentation of important clinical data on injured patients On patient discharge from hospital
Secondary Outcome Complications, e.g., wound infection, pneumonia, DVT, death At patient discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eastern Regional Hospital P.O.Box 201 Koforidua Ghana
University Hospital KNUST University Post Office Kumasi Ghana
Holy Family Hospital P.O.Box 36 Techiman Ghana
Nsawam Government Hospital P.O.Box 100 Nsawam Ghana
Suhum Government Hospital P.O.Box 149 Suhum Ghana
Ejisu Government Hospital P.O.Box 87 Ejisu Ghana
Sunyani Regional Hospital P.O.Box 27 Sunyani Ghana
Konongo Odumase Government Hospital P.O.box 16 Konongo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center 31 Center Drive Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fogarty International Center 31 Center Drive Bethesda 20892 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Emmanuel Nakua School of Public Health, KNUST Kumasi Ghana
Peter Donkor Department of Surgery, KSMD Kumasi Ghana
Charles Mock 325 Ninth Avenue Seattle 98104 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adam Gyedu drgyedu@gmail.com 0248228838 Department of Surgery, KSMD, KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Associate Professor of Surgery
Role Name Email Phone Street address
Scientific Enquiries Charles Mock cmock@uw.edu 2067449430 325 Ninth Avenue
City Postal code Country Position/Affiliation
Seattle 98104 United States of America Professor of Surgery
Role Name Email Phone Street address
Public Enquiries Adam Gyedu drgyedu@gmail.com +233248228838 Department of Surgery, KSMD, KNUST
City Postal code Country Position/Affiliation
Kumasi Ghana Associate Professor of Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes There is not a plan to make IPD available. We, however, plan to share the summary results of the study Study Protocol Starting 12 months after publication We will share information after vetting any requests
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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