Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 11:42 PM
Study NCT ID:
NCT03363308
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2017-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063130', 'term': 'Maternal Death'}, {'id': 'D066088', 'term': 'Infant Death'}, {'id': 'D050497', 'term': 'Stillbirth'}], 'ancestors': [{'id': 'D063129', 'term': 'Parental Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a cluster-randomized trial in phase I and interrupted time series in phase II'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2017-11-30', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean number or percent of items correctly answered', 'timeFrame': '1 day', 'description': 'Each observed structured clinical exam (OSCE) or knowledge tests has between 13 and 38 items. A participant needs to achieve 85% correct score to pass at post-training to assess provider competencies. The main indicator for analysis will be the mean number of items (or percent of items) correctly answered. This mean percent of items correctly answered will be done pre-training, post-training and after 6 months. This will be done in the 8 intervention group facilities only in Phase I and again in the 8 new facilities in Phase II.'}, {'measure': 'Intrapartum perinatal death ratio', 'timeFrame': '1 day', 'description': 'Defined as death of a fetus during labor who had heart tones documented on arrival in the maternity and neonatal deaths prior to 24 hours, divided by total births.'}, {'measure': 'Percent of women after childbirth who adopt a family planning method immediately post-pregnancy or intend to adopt a method by six weeks post-pregnancy.', 'timeFrame': '3 days', 'description': 'Percent of women after childbirth who adopt a family planning method over all women who give birth in a facility'}], 'secondaryOutcomes': [{'measure': 'maternal mortality', 'timeFrame': '3 days', 'description': 'number of maternal deaths over number of live births'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal Death', 'Infant Death', 'Stillbirth']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.', 'detailedDescription': "The health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2.\n\nObjective 1: For objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. The intervention's effects will be assessed by comparing an intervention group and a control group of facilities. These will be selected from 16 Kinshasa health facilities. Intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (Phase 1) in a difference-in-difference analysis. In Phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement.\n\nOverall, in Phase 1, eight intervention sites will be matched to eight sites serving as controls. In Phase 2, the eight Phase 1 control sites will then receive the same package as the intervention sites in Phase 1. Sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). Within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health providers:\n\n * Currently on the roster of maternity ward providers working at one of the 16 selected facilities at the time of the training module.\n * Willing to attend a Jhpiego clinical training workshop and offer consent as study participant.\n * Age 18 or older.\n\nExclusion Criteria:\n\n* there are no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT03363308', 'briefTitle': 'Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa', 'organization': {'class': 'OTHER', 'fullName': 'Jhpiego'}, 'officialTitle': 'Effects of a Health Workforce Capacity Building and Quality Improvement Intervention on Intrapartum Stillbirth, Early Newborn Mortality and Post-pregnancy Family Planning in Kinshasa: a Cluster Randomized Evaluation', 'orgStudyIdInfo': {'id': 'OPP1156220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1', 'description': 'training for health care workers supplemented by QI teams', 'interventionNames': ['Behavioral: training for health care workers supplmented by QI teams']}, {'type': 'NO_INTERVENTION', 'label': 'Phase 2'}], 'interventions': [{'name': 'training for health care workers supplmented by QI teams', 'type': 'BEHAVIORAL', 'otherNames': ['Practice coordinator training after training session', 'Practice sessions using anatomic models', 'SMS reminder messages and quizzes', 'Routine calls between mentors and providers', 'Health information officer training', 'Data collection and use training', 'Supply of simulators, equipment, kits and other', 'Develop quality improvement teams and review of action plans', 'Routine calls between project staff and mentors'], 'description': 'Jhpiego will deliver maternal and newborn health and family planning (MNH+FP) training using evidence-based low-dose, high-frequency (LDHF) learning approaches and support hospital staff-led quality improvement efforts to increase the coverage of facility-based high-impact interventions, including care of the mother and newborn on the day of birth and through the first week postpartum and post abortion services.', 'armGroupLabels': ['Phase 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kinshasa', 'country': 'Democratic Republic of the Congo', 'facility': 'Jhpiego DRC', 'geoPoint': {'lat': -4.32758, 'lon': 15.31357}}], 'overallOfficials': [{'name': 'Virgile Kikaya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jhpiego DRC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jhpiego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}