Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form

NCT04547192 | Completed Results

• 2 other identifiers: R21TW0116851R21TW011685-01
• Study Type: interventional
• Target: 4,105
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Improving care of the injured (trauma care) is a way to the large burden of injury in low- and middle-income countries. The important initial period of trauma care is often chaotic and prone to errors. The World Health Organization created a Trauma Care Checklist (TCC), which improved key performance indicators of care at tertiary hospitals but encountered factors which decreased its uptake. The investigators propose the use of a model Trauma Intake Form (TIF) with potential to achieve the benefits of the TCC, but with automatic usage and with accompanying improvements in documentation for key elements of care. It is especially oriented for smaller hospitals. The investigators propose a pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design. Specifically, the investigators aim to determine the effectiveness the TIF to function as a checklist for increasing the appropriate use of key performance indicators during care of the injured in emergency units of non-tertiary hospitals in Ghana, as assessed by independent observers; to determine the percent of injured patients with adequate data on initial assessment before vs. after introduction of the TIF in emergency units of non-tertiary hospitals in Ghana; and to increase the capacity of the Kwame Nkrumah University of Science and Technology and the network of non-tertiary hospitals in southern Ghana to undertake high-quality trauma care research, including clinical trials.

Conditions

Behavior Problem

Outcome Measures

Primary Outcomes (1)

• Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana

  The percentage of injured patients for whom key performance indicated eg. (Blood pressure, heart rate, oxygen saturation etc. ) are measured at initial assessment by emergency health service providers.

  17.5 months

Secondary Outcomes (1)

• Mortality

  Patients were followed for mortality until 18 months, when the last enrolled patient left hospital

Study Arms (2)

Pre TIF introduction

NO INTERVENTION

Emergency Health Service prior to introduction of TIF.

Post introduction of TIF

EXPERIMENTAL

Emergency Health Service after introduction of TIF.

Other: Improving initial care of the injured

Interventions

Improving initial care of the injured OTHER

Improvement in Care Processes

Post introduction of TIF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency health care providers at the study hospitals
• Patient with injury who is treated in the emergency unit of one of the study hospitals

You may not qualify if:

• Non-emergency health care providers at the study hospitals
• Non-injured patient at the study hospitals

Sponsors & Collaborators

• Kwame Nkrumah University of Science and Technology: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Kwame Nkrumah University of Science and Technology

Kumasi, 00-000, Ghana

Location

Related Publications (4)

• Gyedu A, Issaka A, Donkor P, Mock C. Utilization of a Trauma Quality Improvement Tool in a Clinical Trial: Effects When Tool Not Used. World J Surg. 2025 Jul;49(7):1960-1968. doi: 10.1002/wjs.12633. Epub 2025 May 19.

  PMID: 40387168 DERIVED

• Gyedu A, Amponsah-Manu F, Mensah S, Donkor P, Mock C. An evaluation of the Hawthorne effect in a clinical trial of trauma care in Ghana. World J Surg. 2024 Dec;48(12):3020-3026. doi: 10.1002/wjs.12410. Epub 2024 Nov 8.

  PMID: 39516191 DERIVED

• Gyedu A, Amponsah-Manu F, Awuku K, Ameyaw E, Korankye KK, Donkor P, Mock C. Differences in trauma care between district and regional hospitals and impact of a trauma intake form with decision support prompts in Ghana: A stepped-wedge cluster randomized trial. World J Surg. 2024 Mar;48(3):527-539. doi: 10.1002/wjs.12082. Epub 2024 Feb 5.

  PMID: 38312029 DERIVED

• Gyedu A, Stewart BT, Nakua E, Donkor P. Standardized trauma intake form with clinical decision support prompts improves care and reduces mortality for seriously injured patients in non-tertiary hospitals in Ghana: stepped-wedge cluster randomized trial. Br J Surg. 2023 Oct 10;110(11):1473-1481. doi: 10.1093/bjs/znad253.

  PMID: 37612450 DERIVED

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

• Title: Dr Adam Gyedu
• Organization: KWAME NKRUMAH UNIVERSITY/SCIENCE/TECH

drgyedu@gmail.com

+233248228838

Study Officials

• Peter Donkor

  Kwame Nkrumah University of Science and Technology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 14, 2020
• Study Start: October 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)