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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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13 September 2021 |
Main ID: |
ISRCTN10438530 |
Date of registration:
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21/03/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Prevention of peripheral venous catheter-related adverse events in hospital wards through the implementation of a multimodal intervention: PREBACP study
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Scientific title:
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Prevention of peripheral venous catheter-related adverse events in hospital wards through the implementation of a multimodal intervention (PREBACP study): A multicentre cluster-randomised trial protocol. |
Date of first enrolment:
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01/04/2018 |
Target sample size:
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2000 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN10438530 |
Study type:
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Interventional |
Study design:
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Multicentre pragmatic cluster-randomised controlled trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Spain
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ian
Blanco-Mavillard |
Address:
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Hospital de Manacor
Carretera Manacor Alcudia
Manacor
Islas Baleares
07500
Manacor
Spain |
Telephone:
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+34 (0)971 847 000 |
Email:
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ianblanco@hmanacor.org |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. All staff nurses 2. Adult hospital patients (>18 years) with peripheral venous catheter inserted
Exclusion criteria: 1. Emergency, critical care, pediatrics, maternity, peri-operative, operative rooms, and psychiatric areas
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adverse events/PVC failure (Catheter-related bloodstream infections, dislodgement, extravasation, obstruction and phlebitis) associated with the use of PVCs in adult hospital patients. Haematological Disorders
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Intervention(s)
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20 hospital wards from five public hospitals are the clusters included in this study. All staff nurses and hospitalised adults with PVC inserted are involved in the study. Wards are randomly allocated to the intervention or control arm using software, in blocks 1:1 with stratification by setting (medical or surgical) and hospital (to ensure homogeneity of both groups). The intervention group receives the multimodal intervention implementing clinical practice guidelines whilst the control group wards continue with routine practice. Each nurse manager is provided with information to homogenise catheter removal, catheter tip culture and haemoculture extraction, to mitigate control bias. Tips from all PVC removed in patients experiencing adverse events are cultured using a semiquantitative culture. Clinical, microbiological and ward information is collected from each patient on PVC removal. The peripheral access records are adapted from our research to collect data relating to nurse practices related to use PVC. The intervention lasts 12 months implementing evidence-based practice in healthcare related to peripheral catheters through a multimodal strategy: 1. Implementation of updated and poster protocols related to hand hygiene and aseptic measures, insertion, maintenance and removal of PVC. 2. Use of technologies applied to e-learning. 3. Feedback on the results and messages addressed to healthcare professionals to facilite adherence to recommendations 4. Facilitation of key professionals within the institution based on the PARIHS theoretical model. 5. Face-to-face training session. MasterClass related to CVP insertion, maintenance and removal will be carried o
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Primary Outcome(s)
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Incidence of adverse events associated with the use of PVCs is measured by assessing hospital records at 3, 6, 9, 12 months
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Secondary Outcome(s)
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1. Nurses' adherence to CPGs is measured by proportions of the following at 3, 6, 9 and 12 months: 1.1. documented nursing records of peripheral vascular accesses (complete records) 1.2. documented auditing records on peripheral vascular accesses maintenance 1.3. catheter tip extractions during removal of peripheral catheters 1.4. clinical effectiveness questionnaire in the prevention of peripheral venous catheter complications pre and post intervention. 2. Clinical outcomes are assessed using rates of catheter-related bloodstream infections, extravasation, obstruction, phlebitis, hospital mortality and mean HLOS associated with the use of PVCs at 3, 6, 9, 12 months. 3. The cost of implementing the multimodal intervention is assessed using HLOS for patients at 12 months (post intervention).
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Secondary ID(s)
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PI2017-0192
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Source(s) of Monetary Support
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College of Nurses of the Balearic Islands
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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01/07/2020 |
URL:
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