Vascular Access Devices Clinical Trial
Official title:
Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children: a Stepped Wedge Cluster Randomized Trial
NCT number | NCT05378568 |
Other study ID # | FNF202112 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 30, 2022 |
Est. completion date | October 30, 2022 |
Verified date | February 2023 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4652 |
Est. completion date | October 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 28 Days to 18 Years |
Eligibility | Inclusion Criteria for nurses: - Nurses have been working in the siting more than 1 year - Nurses who can independently perform nursing operations (complete the contents related to intravenous infusion in the standardized training of hospital and pass the examination) Inclusion Criteria for patients: - Patients receiving intravenous infusion - Hospitalized patients aged 28 days to 18 years Exclusion Criteria for nurses: - Nurses who has not obtained the practicing qualification certificate - Nurses refused to participate in the study Exclusion Criteria for patients: - The indwelling time is less than 24h - Patients who were put into intravenous catheter at admission and did not receive new catheter during hospitalization - Patients with only one stat(st) order for intravenous infusion during hospitalization - Patients refused to participate in the study |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Error rate in peripheral intravenous infusion device selection | 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%. | 6 months | |
Secondary | The knowledge level of nurses' intravenous infusion device selection | 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. | 6 months | |
Secondary | Compliance of evidence-based practice behavior of nurses | compliance of each review indicator = (the number of correct implementation of this indicator by nurses)/(the total number of reviews of this indicator) *100% | 6 months | |
Secondary | Incidence of infiltration and/or extravasation | 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‰. | 6 months | |
Secondary | The cost of intravenous infusion consumables | 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. | 6 months | |
Secondary | Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework | 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. | 6 months |
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