Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04547192 |
| Other study ID # |
R21TW011685 |
| Secondary ID |
1R21TW011685-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
Kwame Nkrumah University of Science and Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
