Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 2:09 PM
Study NCT ID:
NCT04547192
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2020-09-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drgyedu@gmail.com', 'phone': '+233248228838', 'title': 'Dr Adam Gyedu', 'organization': 'KWAME NKRUMAH UNIVERSITY/SCIENCE/TECH'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Patients were followed for adverse events until 18 months, when the last enrolled patient left hospital', 'description': 'By the nature of their conditions, all 4,077 enrolled injured patients were at risk of death and serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Mortality Pre-TIF Introduction', 'description': 'Patients who died at the study hospitals before TIF introduction. All 2,067 patients in this arm were at risk', 'otherNumAtRisk': 2067, 'deathsNumAtRisk': 2067, 'otherNumAffected': 0, 'seriousNumAtRisk': 2067, 'deathsNumAffected': 47, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Mortality Post-TIF Introduction', 'description': 'Patients who died at the study hospitals after TIF introduction. All 2,010 patients in this arm were at risk', 'otherNumAtRisk': 2010, 'deathsNumAtRisk': 2010, 'otherNumAffected': 0, 'seriousNumAtRisk': 2010, 'deathsNumAffected': 22, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'wound infection', 'notes': 'wound infection as indicated by health providers in the medical records. The records were reviewed for complications at the time of discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2067, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 2010, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'notes': 'pneumonia as indicated by health providers in the medical records. The records were reviewed for complications at the time of discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2067, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2010, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre TIF Introduction', 'description': 'Emergency Health Service prior to introduction of TIF.'}, {'id': 'OG001', 'title': 'Post Introduction of TIF', 'description': 'Emergency Health Service after introduction of TIF.\n\nImproving initial care of the injured: Improvement in Care Processes'}], 'classes': [{'title': 'Mobility at EU arrival assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1807', 'groupId': 'OG000'}, {'value': '1894', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory rate at EU arrival assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1194', 'groupId': 'OG000'}, {'value': '1787', 'groupId': 'OG001'}]}]}, {'title': 'Airway assessed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1506', 'groupId': 'OG000'}, {'value': '1978', 'groupId': 'OG001'}]}]}, {'title': 'Chest examined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1284', 'groupId': 'OG000'}, {'value': '1945', 'groupId': 'OG001'}]}]}, {'title': 'Intra-abdominal bleeding evaluated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '747', 'groupId': 'OG000'}, {'value': '1776', 'groupId': 'OG001'}]}]}, {'title': 'Spine immobilized for RTI or fall victims', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1453', 'groupId': 'OG000'}, {'value': '1436', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '1237', 'groupId': 'OG001'}]}]}, {'title': 'Tetanus considered for bites, burns, lacerations, and abrasions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1654', 'groupId': 'OG000'}, {'value': '1636', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1241', 'groupId': 'OG000'}, {'value': '1434', 'groupId': 'OG001'}]}]}, {'title': 'Date of injury recorded', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2012', 'groupId': 'OG000'}, {'value': '1996', 'groupId': 'OG001'}]}]}, {'title': 'Time of injury recorded', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1969', 'groupId': 'OG000'}, {'value': '1454', 'groupId': 'OG001'}]}]}, {'title': 'Important clinical data documented', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1083', 'groupId': 'OG000'}, {'value': '1542', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.54', 'pValueComment': 'Adjusted for TIF introduction and time periods as fixed effects and hospitals and time periods as random effects.', 'groupDescription': 'For mobility on EU arrival assessed,', 'statisticalMethod': 'generalized linear mixed regression mode', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.31', 'groupDescription': 'Respiratory rate at EU assessed', 'statisticalMethod': 'generalized linear mixed regression mode', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '25.29', 'groupDescription': 'Airway assessed', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '38.38', 'groupDescription': 'Chest examined', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '93.01', 'groupDescription': 'For Intra-abdominal bleeding evaluated', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '354.91', 'groupDescription': 'For Spine Immobilized for RTI or Fall Victims', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.95', 'groupDescription': 'Splinting of Fractures Considered', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.18', 'groupDescription': 'Tetanus Considered for bites, burns, lacerations, and abrasions', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03', 'groupDescription': 'Date of Injury Recorded', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.42', 'groupDescription': 'Death', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.14', 'groupDescription': 'Important Clinical Data Document', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '17.5 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Spine immobilized was indicated only for RTI or fall victims Tetanus considered was only indicated for parties with for bites, burns, lacerations, aord abrasions'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'OG000'}, {'value': '2010', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mortality Pre-TIF Introduction', 'description': 'Patients who died at the study hospitals after presenting to the hospital in the period before TIF introduction. All 2,067 patients in this arm were at risk'}, {'id': 'OG001', 'title': 'Mortality Post-TIF Introduction', 'description': 'Patients who died at the study hospitals after presenting to the hospital in the period after TIF introduction. All 2,010 patients in this arm were at risk'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.42', 'statisticalMethod': 'generalized linear mixed regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients were followed for mortality until 18 months, when the last enrolled patient left hospital', 'description': 'All cause in-hospital mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Injured patients initially assessed and managed at emergency units of select Ghanaian non-tertiary hospitals in Ghana'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1 (Hospitals 1&2)', 'description': '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).\n\nPatients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.'}, {'id': 'FG001', 'title': 'Sequence 2 (Hospitals 3&4)', 'description': '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).\n\nPatients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.'}, {'id': 'FG002', 'title': 'Sequence 3 (Hospitals 5&6)', 'description': '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).\n\nPatients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.'}, {'id': 'FG003', 'title': 'Sequence 4 (Hospitals 7&8)', 'description': '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).\n\nPatients were observed ONLY for their duration of stay in the hospital, NOT for the entire study duration.'}], 'periods': [{'title': 'Period 1: 0-14 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '377'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '270'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '235'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '370'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '268'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '230'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '7'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '2'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '5'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Incomplete Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 2: 14-28 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '186'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '279'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '265'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '186'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '278'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '264'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '1'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '1'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Incomplete Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3: 28-42 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '261'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '274'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '287'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '259'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '274'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '281'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Incomplete Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4: 42-56 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '250'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '186'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '169'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '248'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '186'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '169'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Incomplete Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 5: 56-70 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '227'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '182'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '226'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '227'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '182'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '225'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '1'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Incomplete Data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Hospitals', 'recruitmentDetails': 'The recruitment process is complete. Recruitment was done at ERs of 8 participating hospitals from October 1, 2020 to March 31, 2022.', 'preAssignmentDetails': '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.\n\n4,077 enrolled participants had complete primary data for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'BG000'}, {'value': '2010', 'groupId': 'BG001'}, {'value': '4077', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre TIF Introduction', 'description': 'Injured patients initially assessed and managed by emergency health service providers prior to introduction of the trauma intake form'}, {'id': 'BG001', 'title': 'Post TIF Introduction', 'description': 'Injured patients initially assessed and managed by emergency health service providers after introduction of the trauma intake form'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'BG000'}, {'value': '2010', 'groupId': 'BG001'}, {'value': '4077', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '453', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '872', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1407', 'groupId': 'BG000'}, {'value': '1501', 'groupId': 'BG001'}, {'value': '2908', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'BG000'}, {'value': '2010', 'groupId': 'BG001'}, {'value': '4077', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '16', 'groupId': 'BG000'}, {'value': '30', 'spread': '16', 'groupId': 'BG001'}, {'value': '29', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2047', 'groupId': 'BG000'}, {'value': '2006', 'groupId': 'BG001'}, {'value': '4053', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '517', 'groupId': 'BG000'}, {'value': '526', 'groupId': 'BG001'}, {'value': '1043', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1,530', 'groupId': 'BG000'}, {'value': '1,480', 'groupId': 'BG001'}, {'value': '3010', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There were 20 patients whose sex was not indicated before TIF and 4 patients whose sex was not indicated after TIF.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2067', 'groupId': 'BG000'}, {'value': '2010', 'groupId': 'BG001'}, {'value': '4077', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2067', 'groupId': 'BG000'}, {'value': '2010', 'groupId': 'BG001'}, {'value': '4077', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Of 2,090 patients were enrolled before TIF introduction and 2,015 after TIF introduction, 23 patients and 5, respectively were excluded due to incomplete primary outcome data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-03', 'size': 179251, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-05T10:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Pragmatic randomized clinical trial with introduction of the TIF at 8 hospitals sequentially, with start times randomized by stepped-wedge design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-29', 'studyFirstSubmitDate': '2020-09-03', 'resultsFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-29', 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appropriate Use of Key Performance Indicators in Initial Assessment and Management of the Injured at Non-tertiary Hospitals in Ghana', 'timeFrame': '17.5 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Patients were followed for mortality until 18 months, when the last enrolled patient left hospital', 'description': 'All cause in-hospital mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavior Problem']}, 'referencesModule': {'references': [{'pmid': '40387168', 'type': 'DERIVED', 'citation': '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': '39516191', 'type': 'DERIVED', 'citation': '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': '38312029', 'type': 'DERIVED', 'citation': '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': '37612450', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background: Injuries constitute an important public health problem in Ghana and other low- and middle-income countries (LMIC). The large burden of injury can be reduced by strengthening the process of care (1). The period of initial assessment and care of the injured has been identified as having the potential for significant errors (2, 3). Quality improvement efforts can reduce these errors (4, 5).\n\nA systematic approach to the initial assessment and care of the injured ensures early detection of life-threatening conditions, prompting timely performance of necessary interventions (6, 7). The WHO Trauma Care Checklist (TCC), specifically developed for the early assessment and care of injured patients, led to improvements in key performance indicators of care as well as a decrease in mortality (1). Despite the usefulness of checklists in surgical practice, many countries report low usage rates (8-11). One unique barrier with the TCC is its application at the end of the initial trauma assessment, by which time some members of the trauma team may have left (12). Other approaches that would trigger more automatic use of the checklist might achieve the objectives of the TCC while improving compliance to its use. The Trauma Intake Form (TIF) to be tested in this study has been designed to achieve this goal.\n\nAn additional functionality of the TIF is improving data recording for both better immediate clinical care and better ability to conduct quality improvement programs. Data elements needed for this purpose were created through a Delphi process to develop a set of key performance indicators that were deemed to be accurate proxies of quality trauma care, simple to measure and feasible to collect at non-tertiary hospitals of LMICs (13). The TIF was created as a means of operationalizing key performance indicators by building them into the clinical chart of injured patients undergoing initial care in emergency units.\n\nThe extent to which a systematic approach is employed in the initial assessment of injured patients arriving at emergency units of district and regional hospitals in Ghana is unknown. With successful training of emergency health service providers in the use of the TIF and its subsequent adoption, improvements in systematic assessment and care of the injured in these hospitals can be achieved.\n\nSpecific aim 1. To determine the effectiveness of the TIF to function as a checklist for increasing the appropriate use of key performance indicators during care of the injured in emergency units in district and regional hospitals in Ghana, as assessed by independent observers.\n\nHypothesis: The TIF will increase the appropriate use of key performance indicators by significant and clinically meaningful levels. For example, we expect the TIF to increase the percent of all injured patients whose blood pressure is checked at arrival by a minimum of 8%, and increase the percent of those with heart rate checked by a minimum of 8%. For seriously injured patients, we expect the TIF to improve the achievement of additional key performance indicators by clinically meaningful levels. For example, we expect the TIF to increase the percent of patients with chest examination by a minimum of 8%, increase the percent of patients with hemoperitoneum ruled out by a minimum of 12%, and improve the percent of patients with examination of all distal pulses by a minimum of 13%.\n\nSpecific aim 2. To determine the percent of injured patients with adequate data on initial assessment before vs. after introduction of the TIF in emergency units in district and regional hospitals in Ghana.\n\nHypothesis. The TIF will increase documentation of important clinical data on injured patients (including all of the following: time of injury, mechanism of injury, respiratory rate at presentation, heart rate at presentation, blood pressure at presentation, consciousness level at presentation, temperature at presentation, and time of disposition) by at least 5%.\n\nSpecific aim 3. To increase the capacity of the Kwame Nkrumah University of Science and Technology and the network of district and regional hospitals in to undertake high-quality trauma care research, including clinical trials.\n\nMethods A pragmatic randomized clinical trial will be carried out at 8 district and regional hospitals in Ghana. The intervention to be tested is the TIF to be used in recording information about injured patients during their initial assessment and care and which is designed to decrease omission of critical steps in care and so to improve care and also record keeping.\n\nThe unit of randomization will be hospitals and a stepped-wedge design will be used to select which hospitals will start use of the TIF at what time. We have select eight hospitals across four regions in Ghana to represent district or regional hospitals with more than adequate flow of injured patients (≥75 patients per month)\n\nThe effectiveness of the TIF will be assessed at the 8 study hospitals by measuring the use of key performance indicators during initial care of the injured before vs. after introduction of the TIF. Data on the key performance indicators will be obtained from observations by research assistants (RAs) of care provided by Emergency Health Service Providers (EHSPs) and by data from medical records. The investigators will obtain written consent from the EHSPs whose actions will be observed.\n\nThe investigators will then station RAs in the emergency units of recruited hospitals to observe EHSP practices regarding initial care of the injured using an observation form (derived from the TIF) as the investigators observe EHSPs assess and manage each participant arriving during the 8-hour shift of the RAs. The RAs will fill the form without interaction with EHSPs or the participant. For any components of the assessment and management that RAs are unable to directly observe, RAs will obtain information from the participants records to complete the observation form before the participant leaves the emergency unit.\n\nAfter introduction of the TIF, RAs will complete the observation form for each participant as before. Prior to the participant leaving the emergency unit, RAs will make a blinded copy of the TIF completed by the EHSP in assessing and managing the participant. RAs will complete the observation form with information from participants records and/or from the EHSP-filled TIF. Both before and after introduction of the TIF, RAs will review the medical records of all participants observed for additional safety-related data, including occurrence of complications or death. These details will also be obtained from medical records at time of discharge for all participants who are admitted to the hospital.\n\nThe investigators will employ a stepped-wedge design in sequentially introducing the TIF to the 8 selected hospitals considered as 4 groups of 2 hospitals each. First, following 14 weeks of initial observation of EHSP practices at all 8 selected hospitals, the investigators will conduct a training workshop for EHSPs of the first randomly-selected group of hospitals on use of the TIF. Following the workshop, the EHSPs will be encouraged to begin use of the TIF at their hospitals. After another 14 weeks, the investigators will conduct the two-day training workshop for the next group of randomly selected hospitals, after which use of the TIF will begin at those hospitals. The investigators will continue this sequential conduct of training workshops followed by use of TIF every 14 weeks until all 8 hospitals have been exhausted. The RAs will continue to observe EHSP practices for a further 14 weeks during which the TIF will be in use at all 8 hospitals. The total duration of observation of EHSP practices will be 70 weeks. At the end of year one, the investigators will organize a one-day workshop for leadership of participating hospitals to review study progress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency health care providers at the study hospitals\n* Patient with injury who is treated in the emergency unit of one of the study hospitals\n\nExclusion Criteria:\n\n* Non-emergency health care providers at the study hospitals\n* Non-injured patient at the study hospitals'}, 'identificationModule': {'nctId': 'NCT04547192', 'briefTitle': 'Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form', 'organization': {'class': 'OTHER', 'fullName': 'Kwame Nkrumah University of Science and Technology'}, 'officialTitle': 'Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form', 'orgStudyIdInfo': {'id': 'R21TW011685', 'link': 'https://reporter.nih.gov/quickSearch/R21TW011685', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R21TW011685-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21TW011685-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pre TIF introduction', 'description': 'Emergency Health Service prior to introduction of TIF.'}, {'type': 'EXPERIMENTAL', 'label': 'Post introduction of TIF', 'description': 'Emergency Health Service after introduction of TIF.', 'interventionNames': ['Other: Improving initial care of the injured']}], 'interventions': [{'name': 'Improving initial care of the injured', 'type': 'OTHER', 'description': 'Improvement in Care Processes', 'armGroupLabels': ['Post introduction of TIF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-000', 'city': 'Kumasi', 'country': 'Ghana', 'facility': 'Kwame Nkrumah University of Science and Technology', 'geoPoint': {'lat': 6.68848, 'lon': -1.62443}}], 'overallOfficials': [{'name': 'Peter Donkor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kwame Nkrumah University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kwame Nkrumah University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}