Clinical trial NCT06944340: Evaluating the Impact of WHO Trauma Care Checklist on Clinical Outcome of Patients
Official title: Evaluating the Impact of World Health Organization Trauma Care Checklist on Clinical Outcome of Patients: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma Related Injuries
Trauma
Keywords: Trauma
Trauma Outcomes
WHO Trauma Care Checklist
Trauma Checklist
Injury
Emergency Care
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group, single-blinded, parallel assignment randomized controlled trial. Patients are randomly allocated to either receive standard trauma care (control group) or standard care enhanced with the WHO Trauma Care Checklist (intervention group). Outcomes are compared between groups over a 1-month follow-up period.
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Improvement in Injury Severity Score (ISS)
timeFrame: Assessed at admission and after initial management.
measure: Glasgow Coma Scale (GCS) Score
timeFrame: Measured at presentation and 1 hour post-treatment.
measure: level of Pain
timeFrame: Assessed after initial management.
Secondary outcomes:
measure: All-Cause Mortality Rate
timeFrame: 1 month post-treatment.
measure: Incidence of Post-Trauma Complications
timeFrame: 1 month post-treatment
measure: Number of Bed-Bound Days
timeFrame: From admission to discharge (up to 1 month)
measure: Patient Satisfaction Score
timeFrame: Assessed at 1 month follow-up.
measure: Rate of Missed Injuries
timeFrame: Identified during 1-month follow-up.
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Emergency Department, Khyber Teaching Hospital
state: KPK
Study officials:
References:
citation: 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.
citation: 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.