NCT06944340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

April 15, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

TraumaTrauma OutcomesWHO Trauma Care ChecklistTrauma ChecklistInjuryEmergency Care

Outcome Measures

Primary Outcomes (3)

  • Improvement in Injury Severity Score (ISS)

    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

    Consciousness levels of participant. Average change/rise/fall. Higher GCS means better outcome

    Measured at presentation and 1 hour post-treatment.

  • level of Pain

    Pain levels using the Visual Analogue Scale (VAS). A lower VAS score means better outcome.

    Assessed after initial management.

Secondary Outcomes (5)

  • All-Cause Mortality Rate

    1 month post-treatment.

  • Incidence of Post-Trauma Complications

    1 month post-treatment

  • Number of Bed-Bound Days

    From admission to discharge (up to 1 month)

  • Patient Satisfaction Score

    Assessed at 1 month follow-up.

  • Rate of Missed Injuries

    Identified during 1-month follow-up.

Study Arms (2)

Standard Trauma Care

NO INTERVENTION

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.

WHO Trauma Care Checklist-Guided Care

EXPERIMENTAL

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.

Other: WHO Trauma Care Checklist

Interventions

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.

WHO Trauma Care Checklist-Guided Care

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years old
  • Glasgow Coma Scale (GCC) equal to or more than 10
  • Consenting to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 23489711BACKGROUND
  • 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.

    PMID: 32868497BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Medical Officer

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 25, 2025

Study Start

April 26, 2025

Primary Completion

August 15, 2025

Study Completion

September 1, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations