Condition category
Haematological Disorders
Date applied
06/03/2018
Date assigned
21/03/2018
Last edited
27/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Venous catheters (small flexible tubes placed into veins) are the most commonly used invasive devices in hospitals worldwide. Patients can experience multiple problems during the insertion, maintenance and management of these devices. Catheter-related bloodstream infections (CRBSI) can have one of the worst impacts for patients and are potentially preventable. The rate of these infections associated with peripheral venous catheters (catheters in peripheral veins such as arms, legs, hands and feet) is between 0.1 - 0.5 per 1000 catheter per day. CRBSIs can prolong hospital stay between two and eleven days and cause mortality rate of up to 25%. Ensuring health professionals follow clinical practice guidelines when using peripheral venous catheters may help improve this care. This study aims to assess the effect of a combination of different strategies to help nurses follow these guidelines, and determine the effect of this on patients.

Who can participate?
Staff nurses and hospital patients aged over 18 years with peripheral venous catheter

What does the study involve?
Participants are randomized by ward to one of two groups. Those in the first group receive an intervention that lasts 12 months and uses several methods instructing new clinical practice guidelines. These include posters, technology, feedback, and dace to face training. Those in the control group continue with normal practice.

What are the possible benefits and risks of participating?
Participants involved in the study may help researchers to reduce catheter-related adverse events and minimize variability in healthcare. There are no direct risks associated with the study.

Where is the study run from?
1. Manacor Hospital (Spain)
2. Inca Hospital (Spain)
3. Costa Del Sol Hospital (Spain)
4. Saint John Divine Hospital (Spain)
5. Can Misses Ibiza Hospital (Spain)

When is the study starting and how long is it expected to run for?
September 2017 – February 2020

Who is funding the study?
College of Nurses of the Balearic Islands (Spain)

Who is the main contact?
Mr Ian Blanco-Mavillard (Public)
ianblanco@hmanacor.org

Trial website

https://proyectoprebacp.wixsite.com/prebacp

Contact information

Type

Public

Primary contact

Mr Ian Blanco-Mavillard

ORCID ID

http://orcid.org/0000-0003-2851-5631

Contact details

Hospital de Manacor
Carretera Manacor Alcudia
Manacor
Islas Baleares
Manacor
07500
Spain
+34 (0)971 847 000
ianblanco@hmanacor.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI2017-0192

Study information

Scientific title

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.

Acronym

PREBACP

Study hypothesis

Primary hypothesis:
The implementation of multimodal intervention will decrease the incidence of adverse events (Catheter-related bloodstream infections, extravasation, obstruction and phlebitis) associated with the use of peripheral venous catheters (PVCs) in adult hospital patients.

Secondary hypothesis:
1. Nursing practice outcomes: The fidelity of nurses to the recommendations for insertion and management of peripheral venous catheter within the Clinical Practice Guideline (CPG) in hospital wards receiving the intervention will demonstrate reduce healthcare variability, increase documented nursing records of peripheral vascular accesses (complete records) and increase extractions of the catheter tip culture from all PVC removed in patients experiencing adverse events.
2. Clinical outcomes: The fidelity of nurses to the recommendations for insertion and management of peripheral venous catheter within the CPG in hospital wards receiving the intervention, will reduce hospital length of stay (HLOS)
3. Health economic outcomes: The cost of implementation development will be compensated for the savings in length of stay hospital resulting from decreased to incidence of Catheter-related bloodstream infections.
4. Process evaluation: The contextual and individual factors on the utilization of knowledge in clinical practice decisions and impact on hospital ward processes and practice measured by Nursing Work Index (NWI) and Evidence-Based Practice Questionnaire (EBPQ).

Ethics approval

Ethics and Research Committee of the Balearic Islands (CEI-IB), 20/10/2017, ref: IB 3492/17 PI

Study design

Multicentre pragmatic cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Adverse events (Catheter-related bloodstream infections, extravasation, obstruction and phlebitis) associated with the use of PVCs in adult hospital patients.

Intervention

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 out.
6. User and family information related to peripheral catheter. Informative leaflets containing recommendations adapted to the language of the patients will be provided.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Incidence of adverse events associated with the use of PVCs is measured by assessing hospital records at 3, 6, 9, 12 months

Secondary outcome measures

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).

Overall trial start date

01/09/2017

Overall trial end date

01/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All staff nurses
2. Adult hospital patients (>18 years) with peripheral venous catheter inserted

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

20 wards and 100 participants will be included in each cluster

Participant exclusion criteria

1. Emergency, critical care, pediatrics, maternity, peri-operative, operative rooms, and psychiatric areas

Recruitment start date

01/04/2018

Recruitment end date

01/01/2019

Locations

Countries of recruitment

Spain

Trial participating centre

Manacor Hospital
Manacor
07500
Spain

Trial participating centre

Inca Hospital
Inca
07300
Spain

Trial participating centre

Costa del Sol Hospital
Marbella
29603
Spain

Trial participating centre

Saint John Divine Hospital
Palma Mallorca
07007
Spain

Trial participating centre

Can Misses Ibiza Hospital
Ibiza
07800
Spain

Sponsor information

Organisation

Evidence, Lifestyles and Health Research Group

Sponsor details

Research Institute of Health Sciences
University of the Balearic Islands
Carretera de Valldemossa km 7.5
Palma
07122
Spain
+34 (0)971 171 312
evesresearch@uib.es

Sponsor type

Research organisation

Website

http://evesresearch.uib.cat/

Funders

Funder type

University/education

Funder name

College of Nurses of the Balearic Islands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Ian Blanco Mavillard (ianblanco@hmanacor.org). Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available beginning 3 months and ending 5 years following article publication. Investigators whose proposed use of data has been approved by an independent review committee identified for this purpose for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication.
Available documents: Study Protocol

Intention to publish date

01/02/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30045737

Publication citations

Additional files

Editorial Notes

27/07/2018: Publication reference added.