Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-26 @ 7:26 AM
Study NCT ID:
NCT05378568
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4652}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Error rate in peripheral intravenous infusion device selection', 'timeFrame': '6 months', 'description': 'The selection is made according to the recommendation of the guidelines. Those who conform to the recommendation are correct, those who do not conform are wrong. Calculation method: the error rate = (the number of cases with wrong peripheral intravenous infusion device selection)/(the total number of cases using peripheral intravenous infusion device)\\* 100%.'}], 'secondaryOutcomes': [{'measure': "The knowledge level of nurses' intravenous infusion device selection", 'timeFrame': '6 months', 'description': 'The questionnaire has a total of 50 questions, 24 choice questions, 12 judgment questions, and 14 fill-in-the-blank questions, each with 2 points, and the total score is 100 points. Before and after the implementation of the program, the evaluation will be conducted, a score of less than 60 is considered a failure, and a score of more than 80 is considered excellent.'}, {'measure': 'Compliance of evidence-based practice behavior of nurses', 'timeFrame': '6 months', 'description': 'compliance of each review indicator = (the number of correct implementation of this indicator by nurses)/(the total number of reviews of this indicator) \\*100%'}, {'measure': 'Incidence of infiltration and/or extravasation', 'timeFrame': '6 months', 'description': 'The bedside nurses document the number of incidents of peripheral venous infiltration and extravasation using "Pediatric Peripheral Venous Infiltration Scale". The incidence of infiltration and/or extravasation = (case numbers of infiltration and/or extravasation)/(Catheter Days per Month)×1000‰.'}, {'measure': 'The cost of intravenous infusion consumables', 'timeFrame': '6 months', 'description': 'including intravenous infusion devices (including the total number of catheters consumed by successful catheter placement and failed puncture), dress, central venous maintenance kits, infusion connectors, and tees.'}, {'measure': 'Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework', 'timeFrame': '6 months', 'description': 'including Reach, Efficacy, Adoption, Implementation, and Maintenance. Reach refers to the participation rate of training courses; Efficacy refers to the change of knowledge level and compliance of evidence-based practice behavior of nurses in the intervention group; Adoption refers to the proportion of evidence actually adopted by nurses in the intervention group and the changes of context; Implementation refers to the completion rate of each training plan in the implementation strategy；Maintenance refers to evaluating the maintenance of the selection scheme.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'implementation study', 'peripheral venous access devices', 'selection', 'effect evaluation', 'appropriateness', 'randomised trial'], 'conditions': ['Children,Hospitalized', 'Vascular Access Devices']}, 'descriptionModule': {'briefSummary': 'This study is a stepped wedge cluster randomized trial design. The object is to evaluate the influence on patient outcomes, medical staff\'s evidence-based practice behavior and hospital context after implementation of the selection scheme of venous access devices comes from" Evidence-based guidelines for clinical practice of intravenous infusion therapy in children". This study sought to compare the appropriateness of peripheral venous access device selection, to compare the incidence of infiltration and extravasation and the cost of venous infusion consumables before and after the implementation of the scheme.', 'detailedDescription': 'This study aimed to improve the standardization and suitability of device use and reduce complications associated with intravenous fluids by implementing best practice evidence for intravenous fluid device selection in children. In 2021, the Chinese Journal of Evidence-Based Pediatrics released the " Evidence-based guidelines for clinical practice of intravenous infusion therapy in children". The researchers used the evidence in this guideline as a standard to understand the current status of clinical intravenous infusion device selection and the gap between the current situation and the evidence. The evidence tailor, baseline review, develop implementation plan, conduct implementation research. A stepped wedge cluster randomized trial divided into 5 steps, 10 clusters(units), and the step size was one month. Each included ward of a tertiary first-class pediatric hospital was regarded as a group, and each step was included into randomized two groups, and the observation was maintained for one month until all units were included in the intervention in the fifth month, with a total of 6 research periods. Given the practicality of the study design, limited additional inclusion and exclusion criteria will be added.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for nurses:\n\n* Nurses have been working in the siting more than 1 year\n* Nurses who can independently perform nursing operations (complete the contents related to intravenous infusion in the standardized training of hospital and pass the examination)\n\nInclusion Criteria for patients:\n\n* Patients receiving intravenous infusion\n* Hospitalized patients aged 28 days to 18 years\n\nExclusion Criteria for nurses:\n\n* Nurses who has not obtained the practicing qualification certificate\n* Nurses refused to participate in the study\n\nExclusion Criteria for patients:\n\n* The indwelling time is less than 24h\n* Patients who were put into intravenous catheter at admission and did not receive new catheter during hospitalization\n* Patients with only one stat(st) order for intravenous infusion during hospitalization\n* Patients refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT05378568', 'briefTitle': 'Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children: a Stepped Wedge Cluster Randomized Trial', 'orgStudyIdInfo': {'id': 'FNF202112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the selection scheme of peripheral venous access devices', 'description': 'To implement the selection scheme of peripheral venous access devices, based on the Clinical Practice Guideline on Infusion Therapy in Children. Then observe the appropriateness of peripheral venous access devices selection.', 'interventionNames': ['Other: the selection scheme of peripheral venous access devices']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the existing nursing routine', 'description': 'Follow the existing nursing routine of intravenous infusion and the selection of peripheral venous access devices.', 'interventionNames': ['Other: the existing nursing routine']}], 'interventions': [{'name': 'the selection scheme of peripheral venous access devices', 'type': 'OTHER', 'description': 'Based on the "Facilitator Toolkit" of the promoting action on research implementation in health services integrated framework(i-PARIHS), the implementation plan of peripheral intravenous infusion device selection in hospitalized children was formulated and applied, so as to change the practice behavior of nurses in the intervention group. The specific process mainly includes: tailoring evidence; baseline review; situational analysis; promotion and implementation strategy like lectures, group discussions, operation demonstrations, and scenario simulations.', 'armGroupLabels': ['the selection scheme of peripheral venous access devices']}, {'name': 'the existing nursing routine', 'type': 'OTHER', 'description': "To choose infusion device according to nurse's working experience. First, nurse placed a peripheral intravenous catheter. The patients and family decide whether to place the central intravenous infusion device according to the recommendation of the medical staff.", 'armGroupLabels': ['the existing nursing routine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Ying Gu, doctor', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}