Evaluating the Impact of WHO Trauma Care Checklist on Clinical Outcome of Patients

September 15, 2025 updated by: Rao Erbaz Hassan, Khyber Teaching Hospital

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

Completed

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Emergency Department, Khyber Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2025

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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