Clinical trial NCT04547192: Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form
Official title: Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem
Lead sponsor: Kwame Nkrumah University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2020-09-14
Enrollment: 4105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Emergency health care providers at the study hospitals
* Patient with injury who is treated in the emergency unit of one of the study hospitals

Exclusion Criteria:

* Non-emergency health care providers at the study hospitals
* Non-injured patient at the study hospitals

Primary outcomes:
measure: Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana
timeFrame: 17.5 months
Secondary outcomes:
measure: Mortality
timeFrame: Patients were followed for mortality until 18 months, when the last enrolled patient left hospital
Other outcomes:
Locations:
city: Kumasi
country: Ghana
facility: Kwame Nkrumah University of Science and Technology
Study officials:
affiliation: Kwame Nkrumah University of Science and Technology
name: Peter Donkor
role: STUDY_DIRECTOR
References: