Trial Outcomes & Findings for Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form (NCT NCT04547192)

Last Updated: 2024-01-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

4105 participants

Primary outcome timeframe

17.5 months

Results posted on

2024-01-02

Participant Flow

The recruitment process is complete. Recruitment was done at ERs of 8 participating hospitals from October 1, 2020 to March 31, 2022.

New participants were enrolled for every period within a sequence. The number of participants enrolled in each Period of the stepped wedge varied but add up to a total of 4,105. 4,077 enrolled participants had complete primary data for analysis.

Unit of analysis: Hospitals

Participant milestones

Participant milestones
Measure	Sequence 1 (Hospitals 1&2) Hospitals were assigned to 14 weeks of initial observation (period 1), then 56 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 2-5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.	Sequence 2 (Hospitals 3&4) Hospitals were assigned to 28 weeks of initial observation (period 1 and 2), then 42 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 3-5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.	Sequence 3 (Hospitals 5&6) Hospitals were assigned to 42 weeks of initial observation (period 1-3), then 28 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 4 and 5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.	Sequence 4 (Hospitals 7&8) Hospitals were assigned to 56 weeks of initial observation (period 1-4), then 14 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.
Period 1: 0-14 Weeks STARTED	377 2	270 2	235 2	107 2
Period 1: 0-14 Weeks COMPLETED	370 2	268 2	230 2	106 2
Period 1: 0-14 Weeks NOT COMPLETED	7 0	2 0	5 0	1 0
Period 2: 14-28 Weeks STARTED	186 2	279 2	265 2	79 2
Period 2: 14-28 Weeks COMPLETED	186 2	278 2	264 2	79 2
Period 2: 14-28 Weeks NOT COMPLETED	0 0	1 0	1 0	0 0
Period 3: 28-42 Weeks STARTED	261 2	274 2	287 2	104 2
Period 3: 28-42 Weeks COMPLETED	259 2	274 2	281 2	104 2
Period 3: 28-42 Weeks NOT COMPLETED	2 0	0 0	6 0	0 0
Period 4: 42-56 Weeks STARTED	250 2	186 2	169 2	87 2
Period 4: 42-56 Weeks COMPLETED	248 2	186 2	169 2	87 2
Period 4: 42-56 Weeks NOT COMPLETED	2 0	0 0	0 0	0 0
Period 5: 56-70 Weeks STARTED	227 2	182 2	226 2	54 2
Period 5: 56-70 Weeks COMPLETED	227 2	182 2	225 2	54 2
Period 5: 56-70 Weeks NOT COMPLETED	0 0	0 0	1 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1 (Hospitals 1&2) Hospitals were assigned to 14 weeks of initial observation (period 1), then 56 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 2-5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.	Sequence 2 (Hospitals 3&4) Hospitals were assigned to 28 weeks of initial observation (period 1 and 2), then 42 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 3-5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.	Sequence 3 (Hospitals 5&6) Hospitals were assigned to 42 weeks of initial observation (period 1-3), then 28 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 4 and 5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.	Sequence 4 (Hospitals 7&8) Hospitals were assigned to 56 weeks of initial observation (period 1-4), then 14 weeks of observation after introduction of the Trauma Intake Form (TIF) (periods 5). Patients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.
Period 1: 0-14 Weeks Incomplete Data	7	2	5	1
Period 2: 14-28 Weeks Incomplete Data	0	1	1	0
Period 3: 28-42 Weeks Incomplete Data	2	0	6	0
Period 4: 42-56 Weeks Incomplete Data	2	0	0	0
Period 5: 56-70 Weeks Incomplete Data	0	0	1	0

Baseline Characteristics

There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre TIF Introduction n=2067 Participants Injured patients initially assessed and managed by emergency health service providers prior to introduction of the trauma intake form	Post TIF Introduction n=2010 Participants Injured patients initially assessed and managed by emergency health service providers after introduction of the trauma intake form	Total n=4077 Participants Total of all reporting groups
Age, Categorical <=18 years	453 Participants n=2067 Participants	419 Participants n=2010 Participants	872 Participants n=4077 Participants
Age, Categorical Between 18 and 65 years	1407 Participants n=2067 Participants	1501 Participants n=2010 Participants	2908 Participants n=4077 Participants
Age, Categorical >=65 years	207 Participants n=2067 Participants	90 Participants n=2010 Participants	297 Participants n=4077 Participants
Age, Continuous	29 years STANDARD_DEVIATION 16 • n=2067 Participants	30 years STANDARD_DEVIATION 16 • n=2010 Participants	29 years STANDARD_DEVIATION 16 • n=4077 Participants
Sex: Female, Male Female	517 Participants n=2047 Participants • There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.	526 Participants n=2006 Participants • There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.	1043 Participants n=4053 Participants • There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.
Sex: Female, Male Male	1,530 Participants n=2047 Participants • There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.	1,480 Participants n=2006 Participants • There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.	3010 Participants n=4053 Participants • There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=2067 Participants	0 Participants n=2010 Participants	0 Participants n=4077 Participants
Race (NIH/OMB) Asian	0 Participants n=2067 Participants	0 Participants n=2010 Participants	0 Participants n=4077 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2067 Participants	0 Participants n=2010 Participants	0 Participants n=4077 Participants
Race (NIH/OMB) Black or African American	2067 Participants n=2067 Participants	2010 Participants n=2010 Participants	4077 Participants n=4077 Participants
Race (NIH/OMB) White	0 Participants n=2067 Participants	0 Participants n=2010 Participants	0 Participants n=4077 Participants
Race (NIH/OMB) More than one race	0 Participants n=2067 Participants	0 Participants n=2010 Participants	0 Participants n=4077 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2067 Participants	0 Participants n=2010 Participants	0 Participants n=4077 Participants

PRIMARY outcome

Timeframe: 17.5 months

Population: Spine immobilized was indicated only for RTI or fall victims Tetanus considered was only indicated for parties with for bites, burns, lacerations, aord abrasions

Outcome measures

Outcome measures
Measure	Pre TIF Introduction n=2067 Participants Emergency Health Service prior to introduction of TIF.	Post Introduction of TIF n=2010 Participants Emergency Health Service after introduction of TIF. Improving initial care of the injured: Improvement in Care Processes
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Mobility at EU arrival assessed	1807 Participants	1894 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Respiratory rate at EU arrival assessed	1194 Participants	1787 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Airway assessed	1506 Participants	1978 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Chest examined	1284 Participants	1945 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Intra-abdominal bleeding evaluated	747 Participants	1776 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Spine immobilized for RTI or fall victims	250 Participants	1237 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Tetanus considered for bites, burns, lacerations, and abrasions	1241 Participants	1434 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Date of injury recorded	2012 Participants	1996 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Time of injury recorded	1969 Participants	1454 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Important clinical data documented	1083 Participants	1542 Participants
Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana Death	47 Participants	22 Participants

SECONDARY outcome

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

Population: Injured patients initially assessed and managed at emergency units of select Ghanaian non-tertiary hospitals in Ghana

All cause in-hospital mortality

Outcome measures

Outcome measures
Measure	Pre TIF Introduction n=2067 Participants Emergency Health Service prior to introduction of TIF.	Post Introduction of TIF n=2010 Participants Emergency Health Service after introduction of TIF. Improving initial care of the injured: Improvement in Care Processes
Mortality	47 Participants	22 Participants

Adverse Events

Mortality Pre-TIF Introduction

Serious events: 24 serious events

Other events: 0 other events

Deaths: 47 deaths

Mortality Post-TIF Introduction

Serious events: 6 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Mortality Pre-TIF Introduction n=2067 participants at risk Patients who died at the study hospitals before TIF introduction. All 2,067 patients in this arm were at risk	Mortality Post-TIF Introduction n=2010 participants at risk Patients who died at the study hospitals after TIF introduction. All 2,010 patients in this arm were at risk
Infections and infestations wound infection	0.77% 16/2067 • Number of events 16 • Patients were followed for adverse events until 18 months, when the last enrolled patient left hospital By the nature of their conditions, all 4,077 enrolled injured patients were at risk of death and serious adverse events.	0.30% 6/2010 • Number of events 6 • Patients were followed for adverse events until 18 months, when the last enrolled patient left hospital By the nature of their conditions, all 4,077 enrolled injured patients were at risk of death and serious adverse events.
Respiratory, thoracic and mediastinal disorders pneumonia	0.39% 8/2067 • Number of events 8 • Patients were followed for adverse events until 18 months, when the last enrolled patient left hospital By the nature of their conditions, all 4,077 enrolled injured patients were at risk of death and serious adverse events.	0.00% 0/2010 • Patients were followed for adverse events until 18 months, when the last enrolled patient left hospital By the nature of their conditions, all 4,077 enrolled injured patients were at risk of death and serious adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Dr Adam Gyedu

KWAME NKRUMAH UNIVERSITY/SCIENCE/TECH

Phone: +233248228838

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place