Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-29 @ 10:54 PM
Study NCT ID:
NCT04055103
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Quality Based on the Joint Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-24', 'size': 342179, 'label': 'Study Protocol and Statistical Analysis Plan: Main protocol', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-12T09:45', 'hasProtocol': True}, {'date': '2018-03-01', 'size': 301995, 'label': 'Study Protocol: Annex 1: Grant Application Form', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-12T09:55', 'hasProtocol': True}, {'date': '2018-10-24', 'size': 761411, 'label': 'Study Protocol: Annex 2: Data Delivery Agreement', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-12T09:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each arm will receive the intervention for 6 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival (yes/no)', 'timeFrame': '1 year follow-up during trial', 'description': 'Patient survival after HA/TKA surgery'}, {'measure': '1-year revision rate (%)', 'timeFrame': '1 year follow-up during trial', 'description': 'Number of revisions performed within one year adjusted for patient characteristics'}, {'measure': 'Prolonged length-of stay (yes/no)', 'timeFrame': '1 year follow-up during trial', 'description': 'Prolonged length-of-stay in the overall upper quartile'}, {'measure': 'Readmission (yes/no)', 'timeFrame': '1 year follow-up during trial', 'description': 'Readmission within 30 days after discharge'}, {'measure': 'Number of Complications', 'timeFrame': '1 year follow-up during trial', 'description': 'Number of complications'}, {'measure': 'Composite outcome measure (Textbook Outcome)', 'timeFrame': '1 year follow-up during trial', 'description': 'Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.'}], 'secondaryOutcomes': [{'measure': 'Number of Quality Improvement Initiatives', 'timeFrame': '1 year follow-up during trial', 'description': 'Number of quality improvement Initiatives with the aim to improve the quality of care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.'], 'conditions': ['Registries', 'Quality Improvement', 'Hip Arthropathy', 'Knee Arthropathy', 'Hospital Performance']}, 'referencesModule': {'references': [{'pmid': '35732486', 'type': 'DERIVED', 'citation': 'van Schie P, van Bodegom-Vos L, Zijdeman TM, Nelissen RGHH, Marang-van de Mheen PJ; IQ Joint study group. Effectiveness of a multifaceted quality improvement intervention to improve patient outcomes after total hip and knee arthroplasty: a registry nested cluster randomised controlled trial. BMJ Qual Saf. 2023 Jan;32(1):34-46. doi: 10.1136/bmjqs-2021-014472. Epub 2022 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'Test whether an intervention, consisting of frequently feedback of performance outcomes and education will improve patient care, expressed in better functional outcomes, fewer complications and more quality improving interventions.', 'detailedDescription': 'A randomized controlled trial will be conducted where hospitals will be randomized to an early versus late group, stratified by teaching status as this might influence the time available for quality improvement. Randomization will be done using a computer generated randomization table in a 1:1 ratio. During the study only orthopedic surgeons performing THA and TKA will receive monthly feedback by email.\n\nThe intervention will consist of the following components:\n\n* Monthly feedback of performance outcomes;\n* Education on how to use joint registry data for quality improvement;\n* Create awareness by sending monthly feedback about performance; education and by asking what improvement activities have been introduced;\n* Hospitals will be linked to hospital with opposite performance outcomes to exchange information and find areas for improvement.\n\nDuring the trial, the investigators will conduct monthly measurement on intermediate outcomes showing whether the intervention reaches the target group (process evaluation). The following measurements will take place:\n\n* Knowledge among orthopaedic surgeons on their recent performance and how that relates to others;\n* Number of quality improvement activities undertaken with the aim to improve the quality of care;\n* Planned improvement activities (e.g. record review to figure out why performance is not as good as in other centers) together with who is responsible and by which time;\n* Number of people attending the meetings, number of times a specific account has accessed the LROI site to ensure that information has reached the target group;\n* Survey among orthopaedic surgeons at the end of the intervention period on knowledge learned and the extent to which they think this is sustainable in daily practice.\n\nIn addition, the investigators will compare the outcomes between the early and the late group to test the effectiveness of the intervention, using the appropriate regression techniques. In the second period the investigators will test the sustainability of this approach in daily practice by comparing the outcomes within the early group with the first period, and compare with the late group to test whether outcomes in the sustainability phase are similar as when actively supported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Dutch orthopedic clinics where hip- and knee replacement surgery is performed who agree to participate will be randomized.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04055103', 'acronym': 'IQ Joint', 'briefTitle': 'Improving Quality Based on the Joint Registry', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Improving Quality Based on the Joint Registry', 'orgStudyIdInfo': {'id': 'G18.140'}, 'secondaryIdInfos': [{'id': 'VRF2018-001', 'type': 'OTHER_GRANT', 'domain': 'Van Rens Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'Half of the participating hospitals will be in the intervention group for the first 6 months. The intervention will switch to the control group after the 6 months.', 'interventionNames': ['Other: Monthly feedback, education and linking hospitals']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Half of the participating hospitals will be in the control group for the first 6 months. The control group will undergo the intervention in the second 6 months.'}], 'interventions': [{'name': 'Monthly feedback, education and linking hospitals', 'type': 'OTHER', 'description': '\\- Give monthly feedback from LROI-data (revision rate \\& patient reported outcome measures) as well as other outcomes from the participating hospital (length-of-stay, readmission and complications), combined with education on how to use this information for improvement. This will be send monthly by email to the intervention group. Further, hospitals with worse performance for a certain outcome will be linked to hospitals with good performance for this outcome.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Perla Marang-van de Mheen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is about the performance of hospitals. The individual performance of a hospital will not be announced.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'PerlaJMarang', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}