Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-23 @ 12:18 PM
Study NCT ID:
NCT03506958
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2018-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-05', 'size': 177028, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-13T06:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-16', 'studyFirstSubmitDate': '2018-04-07', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '12 weeks after treatment', 'description': 'Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '1 week and 6 weeks after treatment', 'description': 'Patient satisfaction measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)'}, {'measure': 'Complications of treatment', 'timeFrame': '12 weeks after treatment', 'description': 'Assessment of treatment complications'}, {'measure': 'Pain score', 'timeFrame': '12 weeks after treatment', 'description': 'Assessment of pain score using a visual-analogue scale (VAS)'}, {'measure': 'Physical functioning', 'timeFrame': '12 weeks after treatment', 'description': 'Physical functioning according to the 12-item World Health Organisation (WHO) Disability Assessment Schedule II'}, {'measure': 'Limitations in functions of upper extremities (if applicable)', 'timeFrame': '12 weeks after treatment', 'description': 'Limitations in functions of upper extremities according to the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire'}, {'measure': 'General health status', 'timeFrame': '12 weeks after treatment', 'description': 'General health status according to the General Health Questionnaire (GHQ)'}, {'measure': 'Quality of life', 'timeFrame': '12 weeks after treatment', 'description': 'Quality of life using the EuroQol (EQ5D) questionnaire'}, {'measure': 'Time consumption', 'timeFrame': '1 week, 6 weeks, and 12 weeks after treatment', 'description': 'Time consumption (waiting time, treatment time, travelling time)'}, {'measure': 'Costs', 'timeFrame': '12 weeks after treatment', 'description': 'Costs of treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fractures, Bone', 'Dislocations']}, 'referencesModule': {'references': [{'pmid': '30782924', 'type': 'DERIVED', 'citation': 'Verbeek T, Arentsen H, Breet EJ, Kuipers MM, Lubbert PHW, Burger H. Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol. BMJ Open. 2019 Feb 19;9(2):e025046. doi: 10.1136/bmjopen-2018-025046.'}]}, 'descriptionModule': {'briefSummary': 'Treatment of fractures and dislocations are generally organized in the hospital setting. However, equal care for patients with non-complex fractures or dislocations may be provided in general practices. While substitution of trauma care from the secondary to the primary care setting is stimulated by the government and insurers, it is unknown what the patient satisfaction level is and which determinants affect this patient satisfaction. Therefore, the primary objective of this study is to determine the effect of treatment in a general practice on patient satisfaction compared to treatment in a hospital. The secondary objectives include assessments in quality of life, patient-reported outcomes and cost-effectiveness. Besides, results will be discussed using a small focus group consisting of patients (n=15 per group) and healthcare providers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Two hundred patients with an X-ray confirmed diagnosis of a non-complex fracture or dislocation and planned to be treated in either the general practice Zorgplein Lemmer or Antonius Hospital Sneek will be recruited, 100 per center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* X-ray confirmed diagnosis of a non-complex fracture or dislocation, which can be treated in the primary care setting according to the treatment protocol.\n* Ability of the patient or assigned representative to understand the content of the patient information/informed consent form.\n* Signed and dated written informed consent. Parents of patients of age 12-17 must provide a signed and dated written informed consent as well.\n\nExclusion Criteria:\n\n* Patients of age 11 years and younger.\n* Patients presenting outside ordinary business hours.'}, 'identificationModule': {'nctId': 'NCT03506958', 'briefTitle': 'Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals Versus in General Practitioners in the Netherlands: Prospective Cohort Study Protocol', 'orgStudyIdInfo': {'id': '20170277'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Practice', 'description': 'Hundred patients with an X-ray confirmed diagnosis of a non-complex fracture or dislocation and planned to be treated in the general practice Zorgplein Lemmer.', 'interventionNames': ['Procedure: Standard trauma care']}, {'label': 'Hospital', 'description': 'Hundred patients with an X-ray confirmed diagnosis of a non-complex fracture or dislocation and planned to be treated in the Antonius Hospital Sneek.', 'interventionNames': ['Procedure: Standard trauma care']}], 'interventions': [{'name': 'Standard trauma care', 'type': 'PROCEDURE', 'description': "In both groups, all procedures and management will be done according to the hospital's standard of care.", 'armGroupLabels': ['General Practice', 'Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8531EB', 'city': 'Lemmer', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'General Practice Zorgplein Lemmer', 'geoPoint': {'lat': 52.84618, 'lon': 5.70912}}, {'zip': '8601 ZK', 'city': 'Sneek', 'state': 'Provincie Friesland', 'country': 'Netherlands', 'facility': 'Antonius Hospital Sneek', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Antonius Hospital Sneek', 'class': 'UNKNOWN'}, {'name': 'Innovatiefonds De Friesland Zorgverzekeraar (DFZ)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-doc researcher', 'investigatorFullName': 'dr. T. Verbeek', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}