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

NCT ID: NCT06944340

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-26
• Study Completion Date: 2025-09-01

Brief Summary

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.

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.

Conditions

Trauma Related Injuries; Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

WHO Trauma Care Checklist

Intervention Type: OTHER

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.

Interventions

WHO Trauma Care Checklist

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khyber Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rao Erbaz Hassan

Trainee Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emergency Department, Khyber Teaching Hospital

Peshawar, KPK, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 23489711 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32868497 (View on PubMed)

Other Identifiers

526/DME/KMC

Identifier Type: -

Identifier Source: org_study_id