- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06944340
Evaluating the Impact of WHO Trauma Care Checklist on Clinical Outcome of Patients
Evaluating the Impact of World Health Organization Trauma Care Checklist on Clinical Outcome of Patients: A Prospective Randomized Controlled Trial
This study is being conducted at the Department of Trauma and Orthopedics at Khyber Teaching Hospital, Peshawar. It will test whether using the World Health Organization (WHO) Trauma Care Checklist can help improve the care and recovery of patients who have experienced physical injuries (trauma).
Injuries are a major cause of death and disability, especially in countries like Pakistan. When someone is seriously injured, doctors must act quickly and carefully to save lives and prevent long-term problems. Checklists are simple tools that help healthcare providers make sure nothing is missed during treatment.
In this study, adult trauma patients will be randomly divided into two groups:
One group will receive the standard trauma care (Group A). The other group will receive trauma care with the help of the WHO checklist (Group B).
Doctors will compare the outcomes of both groups by looking at things like pain levels, injury severity, recovery progress, complications (like infections or organ problems), and overall satisfaction. The goal is to see if the checklist makes a meaningful difference in patient recovery and safety.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background
Trauma is one of the leading causes of mortality and long-term disability worldwide. In Pakistan, the burden of traumatic injuries is significant, especially among younger individuals. Contributing factors include road traffic accidents, workplace injuries, natural disasters, and violence. Despite being preventable and manageable in many cases, the lack of standardized emergency protocols and system-level interventions has resulted in suboptimal trauma care and increased complications. The WHO developed the TCC to support healthcare providers in delivering consistent, high-quality trauma care, especially in resource-limited settings.
Objective
This study aims to evaluate whether implementing the WHO Trauma Care Checklist during the initial assessment and management of trauma patients improves clinical outcomes compared to standard care alone. The primary hypothesis is that the checklist will help reduce complications, improve injury assessment accuracy, and enhance patient satisfaction.
Study Design and Setting
This is a prospective, single-blinded, randomized controlled trial being conducted at the Department of Trauma and Orthopedics, Khyber Teaching Hospital, Peshawar. The study will be conducted over six months following ethical approval.
Participants
A total of 60 adult trauma patients (aged 18-60 years) who meet specific inclusion criteria will be enrolled using simple random sampling. Participants will be randomly allocated to one of two groups:
Group A: Standard trauma care without the WHO checklist Group B: Standard trauma care with the WHO checklist Patients with severe comorbidities, pregnancy, chemotherapy, chronic mental illness, or substance abuse will be excluded.
Intervention
The WHO Trauma Care Checklist will be used by the clinical team during the initial management of patients in Group B. The checklist includes key safety steps related to airway, breathing, circulation, disability assessment, and exposure/environment, along with other evidence-based practices to prevent missed injuries and reduce medical errors.
Data Collection and Tools
Baseline demographic and clinical data will be collected at admission. Outcome assessments will include:
Improvement in Injury Severity Score (ISS) Visual Analogue Scale (VAS) for pain Glasgow Coma Scale (GCS) Duration of hospital stay and number of bed-bound days Occurrence of complications (e.g., sepsis, renal failure, pneumonia, wound infection) Mortality Missed injuries at presentation Patient satisfaction (rated on a 1-10 scale) Medical charts, direct observation, and patient interviews will serve as the primary data sources. Injury severity will be assessed by trained researchers using a standardized scoring system.
Follow-Up
Patients will be followed during their hospital stay and for one month post-discharge through phone calls or in-person visits. All outcomes will be assessed both at discharge and during the follow-up period.
Data Analysis
SPSS will be used for statistical analysis. Descriptive statistics will summarize patient characteristics and clinical outcomes. Independent t-tests and chi-square tests will compare outcomes between groups. A significance level of p < 0.05 will be used.
Significance
The results of this trial will help determine whether the WHO Trauma Care Checklist improves trauma care quality and outcomes in a low-resource hospital setting. If effective, the checklist could be implemented more widely to enhance trauma care across similar settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KPK
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Peshawar, KPK, Pakistan, 25000
- Emergency Department, Khyber Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 60 years old
- Glasgow Coma Scale (GCC) equal to or more than 10
- Consenting to participate in the study
Exclusion Criteria:
- Patients who do not meet the inclusion criteria
- Patients who refrain from continuing the study
- Patients with the incomplete checklist
- Pregnancy
- History of chronic mental illness, lung or kidney disease
- Undergoing chemotherapy.
- Illicit drug dependency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Trauma Care
Patients receive routine trauma care adhering to the hospital's existing protocols without using the WHO Trauma Care Checklist.
Treatment includes stabilization, diagnostics, surgical/non-surgical interventions, and post-operative care as per institutional standards.
|
|
|
Experimental: WHO Trauma Care Checklist-Guided Care
Patients receive trauma care guided by the WHO Trauma Care Checklist.
The checklist is systematically applied by trained clinicians at critical stages of care (e.g., admission, pre-operative, post-operative, and discharge phases) to ensure adherence to evidence-based practices, including airway management, hemorrhage control, infection prevention, and monitoring for complications.
|
A standardized checklist developed by the WHO for trauma care, designed to reduce errors and ensure compliance with critical steps in trauma management. Implemented by trained clinicians during patient assessment and treatment phases. Components include verification of patient identity, assessment of airway/breathing/circulation, pain management, monitoring for missed injuries, and post-resuscitation care. Checklist use is documented in medical records. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in Injury Severity Score (ISS)
Time Frame: Assessed at admission and after initial management.
|
difference in ISS at admission and after initial management.
A higher difference means a better outcome.
|
Assessed at admission and after initial management.
|
|
Glasgow Coma Scale (GCS) Score
Time Frame: Measured at presentation and 1 hour post-treatment.
|
Consciousness levels of participant.
Average change/rise/fall.
Higher GCS means better outcome
|
Measured at presentation and 1 hour post-treatment.
|
|
level of Pain
Time Frame: Assessed after initial management.
|
Pain levels using the Visual Analogue Scale (VAS).
A lower VAS score means better outcome.
|
Assessed after initial management.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-Cause Mortality Rate
Time Frame: 1 month post-treatment.
|
Incidence of death within 1 month post-trauma.
|
1 month post-treatment.
|
|
Incidence of Post-Trauma Complications
Time Frame: 1 month post-treatment
|
Rates of complications (e.g., cardiac arrest, pneumonia, pulmonary embolism, sepsis, wound infections).
|
1 month post-treatment
|
|
Number of Bed-Bound Days
Time Frame: From admission to discharge (up to 1 month)
|
Duration of immobilization during hospitalization
|
From admission to discharge (up to 1 month)
|
|
Patient Satisfaction Score
Time Frame: Assessed at 1 month follow-up.
|
Patient-reported satisfaction with care quality on a scale of 1-10.
Higher scores mean better outcomes.
|
Assessed at 1 month follow-up.
|
|
Rate of Missed Injuries
Time Frame: Identified during 1-month follow-up.
|
Proportion of injuries undetected during initial assessment.
|
Identified during 1-month follow-up.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hyder AA, Razzak JA. The challenges of injuries and trauma in Pakistan: an opportunity for concerted action. Public Health. 2013 Aug;127(8):699-703. doi: 10.1016/j.puhe.2012.12.020. Epub 2013 Mar 13.
- Bidhendi S, Ahmadi A, Fouladinejad M, Bazargan-Hejazi S. Evaluating implementation of WHO Trauma Care Checklist vs. modified WHO checklist in improving trauma patient clinical outcomes and satisfaction. J Inj Violence Res. 2021 Jan;13(1):5-12. doi: 10.5249/jivr.v13i1.1579. Epub 2020 Aug 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 526/DME/KMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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