Behavior ProblemNCT04547192
Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form
A study testing Improving initial care of the injured in people with Behavior Problem, run by Kwame Nkrumah University of Science and Technology at 1 site in Ghana.
Trial summary
Brief Summary: 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Behavior Problem
- What is being tested?
- Improving initial care of the injured
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,105 participants
- Where
- 1 siteGhana
- Study dates
- 1 Oct 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Emergency health care providers at the study hospitals
- Patient with injury who is treated in the emergency unit of one of the study hospitals
Who cannot join
- Non-emergency health care providers at the study hospitals
- Non-injured patient at the study hospitals
Trial locations and contacts
1 site in 1 country.
About this study
Brief Summary: 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. The investigators 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. The investigators propose a pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design. Specifically, the investigators 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.
Read the detailed description
Background: Injuries constitute an important public health problem in Ghana and other low- and middle-income countries (LMIC). The large burden of injury can be reduced by strengthening the process of care (1). The period of initial assessment and care of the injured has been identified as having the potential for significant errors (2, 3). Quality improvement efforts can reduce these errors (4, 5).
A systematic approach to the initial assessment and care of the injured ensures early detection of life-threatening conditions, prompting timely performance of necessary interventions (6, 7). The WHO Trauma Care Checklist (TCC), specifically developed for the early assessment and care of injured patients, led to improvements in key performance indicators of care as well as a decrease in mortality (1). Despite the usefulness of checklists in surgical practice, many countries report low usage rates (8-11). One unique barrier with the TCC is its application at the end of the initial trauma assessment, by which time some members of the trauma team may have left (12). Other approaches that would trigger more automatic use of the checklist might achieve the objectives of the TCC while improving compliance to its use. The Trauma Intake Form (TIF) to be tested in this study has been designed to achieve this goal.
An additional functionality of the TIF is improving data recording for both better immediate clinical care and better ability to conduct quality improvement programs. Data elements needed for this purpose were created through a Delphi process to develop a set of key performance indicators that were deemed to be accurate proxies of quality trauma care, simple to measure and feasible to collect at non-tertiary hospitals of LMICs (13). The TIF was created as a means of operationalizing key performance indicators by building them into the clinical chart of injured patients undergoing initial care in emergency units.
The extent to which a systematic approach is employed in the initial assessment of injured patients arriving at emergency units of district and regional hospitals in Ghana is unknown. With successful training of emergency health service providers in the use of the TIF and its subsequent adoption, improvements in systematic assessment and care of the injured in these hospitals can be achieved.
Specific aim 1. To determine the effectiveness of the TIF to function as a checklist for increasing the appropriate use of key performance indicators during care of the injured in emergency units in district and regional hospitals in Ghana, as assessed by independent observers.
Hypothesis: The TIF will increase the appropriate use of key performance indicators by significant and clinically meaningful levels. For example, we expect the TIF to increase the percent of all injured patients whose blood pressure is checked at arrival by a minimum of 8%, and increase the percent of those with heart rate checked by a minimum of 8%. For seriously injured patients, we expect the TIF to improve the achievement of additional key performance indicators by clinically meaningful levels. For example, we expect the TIF to increase the percent of patients with chest examination by a minimum of 8%, increase the percent of patients with hemoperitoneum ruled out by a minimum of 12%, and improve the percent of patients with examination of all distal pulses by a minimum of 13%.
Specific aim 2. To determine the percent of injured patients with adequate data on initial assessment before vs. after introduction of the TIF in emergency units in district and regional hospitals in Ghana.
Hypothesis. The TIF will increase documentation of important clinical data on injured patients (including all of the following: time of injury, mechanism of injury, respiratory rate at presentation, heart rate at presentation, blood pressure at presentation, consciousness level at presentation, temperature at presentation, and time of disposition) by at least 5%.
Specific aim 3. To increase the capacity of the Kwame Nkrumah University of Science and Technology and the network of district and regional hospitals in to undertake high-quality trauma care research, including clinical trials.
Methods A pragmatic randomized clinical trial will be carried out at 8 district and regional hospitals in Ghana. 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.
The unit of randomization will be hospitals and a stepped-wedge design will be used to select which hospitals will start use of the TIF at what time. We have select eight hospitals across four regions in Ghana to represent district or regional hospitals with more than adequate flow of injured patients (≥75 patients per month)
The effectiveness of the TIF will be assessed at the 8 study hospitals by measuring the use of key performance indicators during initial care of the injured before vs. after introduction of the TIF. Data on the key performance indicators will be obtained from observations by research assistants (RAs) of care provided by Emergency Health Service Providers (EHSPs) and by data from medical records. The investigators will obtain written consent from the EHSPs whose actions will be observed.
The investigators will then station RAs in the emergency units of recruited hospitals to observe EHSP practices regarding initial care of the injured using an observation form (derived from the TIF) as the investigators observe EHSPs assess and manage each participant arriving during the 8-hour shift of the RAs. The RAs will fill the form without interaction with EHSPs or the participant. For any components of the assessment and management that RAs are unable to directly observe, RAs will obtain information from the participants records to complete the observation form before the participant leaves the emergency unit.
After introduction of the TIF, RAs will complete the observation form for each participant as before. Prior to the participant leaving the emergency unit, RAs will make a blinded copy of the TIF completed by the EHSP in assessing and managing the participant. RAs will complete the observation form with information from participants records and/or from the EHSP-filled TIF. Both before and after introduction of the TIF, RAs will review the medical records of all participants observed for additional safety-related data, including occurrence of complications or death. These details will also be obtained from medical records at time of discharge for all participants who are admitted to the hospital.
The investigators will employ a stepped-wedge design in sequentially introducing the TIF to the 8 selected hospitals considered as 4 groups of 2 hospitals each. First, following 14 weeks of initial observation of EHSP practices at all 8 selected hospitals, the investigators will conduct a training workshop for EHSPs of the first randomly-selected group of hospitals on use of the TIF. Following the workshop, the EHSPs will be encouraged to begin use of the TIF at their hospitals. After another 14 weeks, the investigators will conduct the two-day training workshop for the next group of randomly selected hospitals, after which use of the TIF will begin at those hospitals. The investigators will continue this sequential conduct of training workshops followed by use of TIF every 14 weeks until all 8 hospitals have been exhausted. The RAs will continue to observe EHSP practices for a further 14 weeks during which the TIF will be in use at all 8 hospitals. The total duration of observation of EHSP practices will be 70 weeks. At the end of year one, the investigators will organize a one-day workshop for leadership of participating hospitals to review study progress.
- Conditions
- Behavior Problem
- Being tested
- Improving initial care of the injured
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving initial care of the injuredOther
Improvement in Care Processes
| Study group | Role | What they receive |
|---|---|---|
| Pre TIF introduction | No intervention | Emergency Health Service prior to introduction of TIF. |
| Post introduction of TIF | Experimental | Emergency Health Service after introduction of TIF. Receives: Other: Improving initial care of the injured |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana
The percentage of injured patients for whom key performance indicated eg. (Blood pressure, heart rate, oxygen saturation etc. ) are measured at initial assessment by emergency health service providers.
Measured: 17.5 months
Secondary outcomes (1)
Mortality
All cause in-hospital mortality
Measured: Patients were followed for mortality until 18 months, when the last enrolled patient left hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design.
- Masking
- None (open label)
- Enrolment
- 4,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwame Nkrumah University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Peter Donkor, Study director, Kwame Nkrumah University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547192
- Sponsor's protocol ID
- R21TW011685
- Other IDs
- 1R21TW011685-01
- Status last verified
- Dec 2023
- First submitted
- 3 Sep 2020
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gyedu A, Boakye FN, Mensah S, Donkor P, Mock C. Traumatic Brain Injury Care and Use of a Standardized Trauma Intake Form in Ghana. J Surg Res. 2026 Jan;317:226-234. doi: 10.1016/j.jss.2025.11.022. Epub 2025 Dec 11.
PubMed 41385976Gyedu A, Issaka A, Donkor P, Mock C. Utilization of a Trauma Quality Improvement Tool in a Clinical Trial: Effects When Tool Not Used. World J Surg. 2025 Jul;49(7):1960-1968. doi: 10.1002/wjs.12633. Epub 2025 May 19.
PubMed 40387168Gyedu A, Amponsah-Manu F, Mensah S, Donkor P, Mock C. An evaluation of the Hawthorne effect in a clinical trial of trauma care in Ghana. World J Surg. 2024 Dec;48(12):3020-3026. doi: 10.1002/wjs.12410. Epub 2024 Nov 8.
PubMed 39516191Gyedu A, Amponsah-Manu F, Awuku K, Ameyaw E, Korankye KK, Donkor P, Mock C. Differences in trauma care between district and regional hospitals and impact of a trauma intake form with decision support prompts in Ghana: A stepped-wedge cluster randomized trial. World J Surg. 2024 Mar;48(3):527-539. doi: 10.1002/wjs.12082. Epub 2024 Feb 5.
PubMed 38312029Gyedu A, Stewart BT, Nakua E, Donkor P. Standardized trauma intake form with clinical decision support prompts improves care and reduces mortality for seriously injured patients in non-tertiary hospitals in Ghana: stepped-wedge cluster randomized trial. Br J Surg. 2023 Oct 10;110(11):1473-1481. doi: 10.1093/bjs/znad253.
PubMed 37612450
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form
- ClinicalTrials.gov ID
- NCT04547192
- Acronym / sponsor ID
- R21TW011685
- Conditions
- Behavior Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,105 participants (actual)
- Lead sponsor
- Kwame Nkrumah University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Summary: 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. The investigators 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. The investigators propose a pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design. Specifically, the investigators 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.
Detailed description
Background: Injuries constitute an important public health problem in Ghana and other low- and middle-income countries (LMIC). The large burden of injury can be reduced by strengthening the process of care (1). The period of initial assessment and care of the injured has been identified as having the potential for significant errors (2, 3). Quality improvement efforts can reduce these errors (4, 5).
A systematic approach to the initial assessment and care of the injured ensures early detection of life-threatening conditions, prompting timely performance of necessary interventions (6, 7). The WHO Trauma Care Checklist (TCC), specifically developed for the early assessment and care of injured patients, led to improvements in key performance indicators of care as well as a decrease in mortality (1). Despite the usefulness of checklists in surgical practice, many countries report low usage rates (8-11). One unique barrier with the TCC is its application at the end of the initial trauma assessment, by which time some members of the trauma team may have left (12). Other approaches that would trigger more automatic use of the checklist might achieve the objectives of the TCC while improving compliance to its use. The Trauma Intake Form (TIF) to be tested in this study has been designed to achieve this goal.
An additional functionality of the TIF is improving data recording for both better immediate clinical care and better ability to conduct quality improvement programs. Data elements needed for this purpose were created through a Delphi process to develop a set of key performance indicators that were deemed to be accurate proxies of quality trauma care, simple to measure and feasible to collect at non-tertiary hospitals of LMICs (13). The TIF was created as a means of operationalizing key performance indicators by building them into the clinical chart of injured patients undergoing initial care in emergency units.
The extent to which a systematic approach is employed in the initial assessment of injured patients arriving at emergency units of district and regional hospitals in Ghana is unknown. With successful training of emergency health service providers in the use of the TIF and its subsequent adoption, improvements in systematic assessment and care of the injured in these hospitals can be achieved.
Specific aim 1. To determine the effectiveness of the TIF to function as a checklist for increasing the appropriate use of key performance indicators during care of the injured in emergency units in district and regional hospitals in Ghana, as assessed by independent observers.
Hypothesis: The TIF will increase the appropriate use of key performance indicators by significant and clinically meaningful levels. For example, we expect the TIF to increase the percent of all injured patients whose blood pressure is checked at arrival by a minimum of 8%, and increase the percent of those with heart rate checked by a minimum of 8%. For seriously injured patients, we expect the TIF to improve the achievement of additional key performance indicators by clinically meaningful levels. For example, we expect the TIF to increase the percent of patients with chest examination by a minimum of 8%, increase the percent of patients with hemoperitoneum ruled out by a minimum of 12%, and improve the percent of patients with examination of all distal pulses by a minimum of 13%.
Specific aim 2. To determine the percent of injured patients with adequate data on initial assessment before vs. after introduction of the TIF in emergency units in district and regional hospitals in Ghana.
Hypothesis. The TIF will increase documentation of important clinical data on injured patients (including all of the following: time of injury, mechanism of injury, respiratory rate at presentation, heart rate at presentation, blood pressure at presentation, consciousness level at presentation, temperature at presentation, and time of disposition) by at least 5%.
Specific aim 3. To increase the capacity of the Kwame Nkrumah University of Science and Technology and the network of district and regional hospitals in to undertake high-quality trauma care research, including clinical trials.
Methods A pragmatic randomized clinical trial will be carried out at 8 district and regional hospitals in Ghana. 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.
The unit of randomization will be hospitals and a stepped-wedge design will be used to select which hospitals will start use of the TIF at what time. We have select eight hospitals across four regions in Ghana to represent district or regional hospitals with more than adequate flow of injured patients (≥75 patients per month)
The effectiveness of the TIF will be assessed at the 8 study hospitals by measuring the use of key performance indicators during initial care of the injured before vs. after introduction of the TIF. Data on the key performance indicators will be obtained from observations by research assistants (RAs) of care provided by Emergency Health Service Providers (EHSPs) and by data from medical records. The investigators will obtain written consent from the EHSPs whose actions will be observed.
The investigators will then station RAs in the emergency units of recruited hospitals to observe EHSP practices regarding initial care of the injured using an observation form (derived from the TIF) as the investigators observe EHSPs assess and manage each participant arriving during the 8-hour shift of the RAs. The RAs will fill the form without interaction with EHSPs or the participant. For any components of the assessment and management that RAs are unable to directly observe, RAs will obtain information from the participants records to complete the observation form before the participant leaves the emergency unit.
After introduction of the TIF, RAs will complete the observation form for each participant as before. Prior to the participant leaving the emergency unit, RAs will make a blinded copy of the TIF completed by the EHSP in assessing and managing the participant. RAs will complete the observation form with information from participants records and/or from the EHSP-filled TIF. Both before and after introduction of the TIF, RAs will review the medical records of all participants observed for additional safety-related data, including occurrence of complications or death. These details will also be obtained from medical records at time of discharge for all participants who are admitted to the hospital.
The investigators will employ a stepped-wedge design in sequentially introducing the TIF to the 8 selected hospitals considered as 4 groups of 2 hospitals each. First, following 14 weeks of initial observation of EHSP practices at all 8 selected hospitals, the investigators will conduct a training workshop for EHSPs of the first randomly-selected group of hospitals on use of the TIF. Following the workshop, the EHSPs will be encouraged to begin use of the TIF at their hospitals. After another 14 weeks, the investigators will conduct the two-day training workshop for the next group of randomly selected hospitals, after which use of the TIF will begin at those hospitals. The investigators will continue this sequential conduct of training workshops followed by use of TIF every 14 weeks until all 8 hospitals have been exhausted. The RAs will continue to observe EHSP practices for a further 14 weeks during which the TIF will be in use at all 8 hospitals. The total duration of observation of EHSP practices will be 70 weeks. At the end of year one, the investigators will organize a one-day workshop for leadership of participating hospitals to review study progress.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design.
| Arm | Type | Receives |
|---|---|---|
| Pre TIF introduction | No intervention | –Emergency Health Service prior to introduction of TIF. |
| Post introduction of TIF | Experimental | Other: Improving initial care of the injuredEmergency Health Service after introduction of TIF. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Emergency health care providers at the study hospitals
- Patient with injury who is treated in the emergency unit of one of the study hospitals
Key exclusion criteria (2 listed)
- Non-emergency health care providers at the study hospitals
- Non-injured patient at the study hospitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving initial care of the injuredImprovement in Care Processes | Other | Post introduction of TIF |
Primary outcome
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana
Time frame: 17.5 months
The percentage of injured patients for whom key performance indicated eg. (Blood pressure, heart rate, oxygen saturation etc. ) are measured at initial assessment by emergency health service providers.
1 secondary outcome
Mortality
Time frame: Patients were followed for mortality until 18 months, when the last enrolled patient left hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41385976Gyedu A, Boakye FN, Mensah S, Donkor P, Mock C. Traumatic Brain Injury Care and Use of a Standardized Trauma Intake Form in Ghana. J Surg Res. 2026 Jan;317:226-234. doi: 10.1016/j.jss.2025.11.022. Epub 2025 Dec 11.
- Derived from this study: PubMed 40387168Gyedu A, Issaka A, Donkor P, Mock C. Utilization of a Trauma Quality Improvement Tool in a Clinical Trial: Effects When Tool Not Used. World J Surg. 2025 Jul;49(7):1960-1968. doi: 10.1002/wjs.12633. Epub 2025 May 19.
- Derived from this study: PubMed 39516191Gyedu A, Amponsah-Manu F, Mensah S, Donkor P, Mock C. An evaluation of the Hawthorne effect in a clinical trial of trauma care in Ghana. World J Surg. 2024 Dec;48(12):3020-3026. doi: 10.1002/wjs.12410. Epub 2024 Nov 8.
- Derived from this study: PubMed 38312029Gyedu A, Amponsah-Manu F, Awuku K, Ameyaw E, Korankye KK, Donkor P, Mock C. Differences in trauma care between district and regional hospitals and impact of a trauma intake form with decision support prompts in Ghana: A stepped-wedge cluster randomized trial. World J Surg. 2024 Mar;48(3):527-539. doi: 10.1002/wjs.12082. Epub 2024 Feb 5.
- Derived from this study: PubMed 37612450Gyedu A, Stewart BT, Nakua E, Donkor P. Standardized trauma intake form with clinical decision support prompts improves care and reduces mortality for seriously injured patients in non-tertiary hospitals in Ghana: stepped-wedge cluster randomized trial. Br J Surg. 2023 Oct 10;110(11):1473-1481. doi: 10.1093/bjs/znad253.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Donkor study director
Kwame Nkrumah University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving initial care of the injured in people with Behavior Problem, run by Kwame Nkrumah University of Science and Technology at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana (time frame: 17.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04547192, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.