Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001035415
Ethics application status
Approved
Date submitted
25/01/2016
Date registered
4/08/2016
Date last updated
28/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation and evaluation of peripheral intravenous catheter (PIVC) flushing guidelines: A Stepped Wedge Cluster Randomised Trial
Scientific title
Implementation and evaluation of PIVC flushing guidelines: A Stepped Wedge Cluster Randomised Trial
Secondary ID [1] 288359 0
None
Universal Trial Number (UTN)
U1111-1178-7018
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral cannula maintenance 297354 0
Condition category
Condition code
Public Health 297545 297545 0 0
Health service research
Infection 297546 297546 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As per the Stepped Wedge design the study wards will be in both the control and intervention periods. The control is standard (random) flushing practice using manually prepared flush syringes and the intervention is according to current flushing recommendation including manufacturer prepared prefilled flush syringes. http://qheps.health.qld.gov.au/metronorth/nursing-midwifery/documents/pivc-venepuncture-resource.pdf

The intervention is centred on reinforcing and supporting adherence to current practice recommendations as follows: aspiration of blood prior to flush administration to ascertain patency, flushing pre and post drug administration, use of 0.9% sodium chloride solution, amount of flush to at last equal that of device, use of single dose prefilled device, administration via syringe no smaller than 10mL to minimise applied pressure. We do not anticipate this significantly adding to the workload of the ward or individual nurses. PIVC care and maintenance is part of the general nursing role. However, recent survey and audit of practice has shown it to be varied and inconsistent with current policy and guidelines.
The educational component will delivered over a week reiterating the current policy and practice recommendations related to PIVC flushing includes
(i) written guidelines - These written guidelines will be distributed to staff during planned inservice on ward in person. Reference: Royal Brisbane and Women’s Hospital 05450/ Proc: Peripheral Intravenous Cannulation, Venepuncture and Infusions- Adult and Paediatrics Version 6 Effective date: 12/2015 Review date: 12/2018 Printed versions are uncontrolled.
(ii) industry inservice: This will involve a representative from Becton Dickson (BD) who will educate and train staff in the use of pre filled syringes. This education and training will take place in person to all staff in the ward setting to ensure that guidelines are adhered to when using the pre filled syringe. The education and training that BD will provide detailed education and training in the use of posiflush prefilled syringes in the clinical setting.
(iii) on-line video: The information regarding the online video link will be distributed in 2 forms. These distribution methods include a link embedded in written information and distributed via a group email from each wards Nurse Unit manager. The link to the online video will be included in this group email. Following the education period data will be collected over the intervention period for approximately 4 weeks until sample of n=35 is obtained, whichever occurs first. The educational component will take place for 1 week prior to the commencement of the intervention period.
Protocol or intervention fidelity will be monitored by the Project Coordinator through weekly audits of documented flushing practice and observation.
Intervention code [1] 293664 0
Behaviour
Intervention code [2] 293666 0
Treatment: Other
Comparator / control treatment
The control is standard flushing practice using manually prepared syringe with normal saline 0.9% for flushing. There is no placebo/non-treatment group. The control group is the current standard (random) care. The intervention group is as per current recommended guidelines (currently poorly adhered to).
Control group
Active

Outcomes
Primary outcome [1] 297102 0
PIVC failure: composite of any unplanned PIVC removal, prior to completion of therapy through clinical observation and assessment. This includes occlusion (PIVC will not infuse, or leakage occurs around site when fluid injected), infiltration (leaking of fluid into surrounding tissues), dislodgement (complete), phlebitis (two or more of pain, redness, swelling and a palpable cord) and infection (local or laboratory confirmed bloodstream infection). The composite measure will increase trail precision and efficiency, and was chosen since PIVC failure is the outcome of importance to patients, with reduced patency taking various pathways to the same endpoint. This will be assessed by review of medical records and/ or questioning of clinical staff.

Timepoint [1] 297102 0
Upon removal of PIVC
Secondary outcome [1] 320024 0
Laboratory confirmed blood stream infection
Electronic pathology results will be checked 48hrs after PIVC has been removed.
Timepoint [1] 320024 0
While PIVC insitu or within 48hrs of PIVC removal
Secondary outcome [2] 320061 0
Dwell time-will be calculated from the insertion date and removal date fields, calculated from dedicated data collection sheet, completed and collected by the dedicated study registered nurse.
Timepoint [2] 320061 0
Following removal of PIVC
Secondary outcome [3] 320062 0
Clinical observation using the following criteria: Phlebitis (two or more of pain, redness, swelling and a palpable cord).
Timepoint [3] 320062 0
Phelbitis scores will be collected daily while PIVCis insitu
Secondary outcome [4] 320063 0
Dislodgement (complete fallen out) assessed through Clinical observation, report and documentation in notes and specific device outcomes sheet.
Timepoint [4] 320063 0
Data will be collected at the daily check when PIVC has been documented as dislodged
Secondary outcome [5] 320064 0
Cost (Total equipment used and staff time) assessed through Queensland Heath FAMMIS list price
Timepoint [5] 320064 0
Cost will be calculated based on the days each PIVC was insitu (per 1000 catheter days).
cost will be calculated at the completion of the trial, defined as 48 hours after the removal of the catheter from the final patient in the final ward.
Secondary outcome [6] 320065 0
Mortality (all cause).
Timepoint [6] 320065 0
Rate of mortality will be assessed on completion of the trial. Trial completion is defined as 48 hours after the removal of the catheter from the final patient in the final ward.

Eligibility
Key inclusion criteria
Inclusion criteria: (i) adults >18 years admitted to the study ward (ii) with a PIVC expected to be insitu> 24hrs (+/- contiuous infusion)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) <18years (ii) if PIVC already has an existing infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Sample: We hypothesise a difference (reduced failure) in the intervention arm against control. A recent multisite trial of 3283 patients showed failure rates of 40% using current standard (random) care.. Failure rates in a pilot trial were similar. We hypothesise that the intervention reiterating recommended flushing practice including use of prefilled flush syringes will reduce failure by an absolute proportion of 10% to 30%. An absolute reduction of 10% is clinically important. 9 wards with 35 patients in each group would give the power of the analysis (to 90% power), for a study total of 630.
Sample size calculation:
Steppedwedge, binomial complete(1) p1(0.4) p2(0.3) m(35) steps(9) k(1) rho(0.05)
Power calculation for a stepped wedge study.
For a two sample comparison of proportions (using normal approximations).
For the user specified variables:
Proportion 1: 0.4000
Proportion 2: 0.3000
The variance has been specified as being the total variance
Significance level: 0.05
Coefficient of variation (of clusters): 0.27
Intra Cluster Correlation (ICC): 0.0500
Between cluster variation (tau-squared): 0.0120
Average cluster (cell) size: 35
Number of clusters randomised per step: 1
Number of steps (not including baseline): 9

Steppedwedge estimated variables:
Total number of observations: 3150
Power: 0.9286


Analyses of primary and secondary outcome measures will be undertaken at cluster level and patient level. Our primary outcomes will be measured at the individual patient level but adjusted for the cluster structure as per the recommendation of Cochrane methods on the analyses of c-RT. Generalised Estimation Equations (GEE) models, hierarchical or generalised mixed models and multi-level models will be used to adjust for clustering of patient-level data.


Within each approach, simple analyses such as t-tests, Chi-square tests or more complex approaches such as multivariate Cox regression models will be considered. The incidence rates per 1000 hospitalised days between intervention and standard care groups will be compared at cluster level. Patient level analyses will primarily account for the intra-cluster correlation, thus increasing the statistical power of the analysis. Staff, management and patient satisfaction will be measured through a numerical rating scale (NRS) and/or qualitative data. Quantitative Data will be cleaned, checked and exported into STATA (13, Stata-Corp, Texas).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/07/2016
Date of last participant enrolment
Anticipated
31/03/2017
Actual
2/02/2017
Date of last data collection
Anticipated
Actual
4/02/2017
Sample size
Target
620
Accrual to date
Final
619
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 12554 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 292715 0
University
Name [1] 292715 0
Griffith University
Country [1] 292715 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessles Road
Nathan
Queensland, 4111
Country
Australia
Secondary sponsor category [1] 291448 0
None
Name [1] 291448 0
Address [1] 291448 0
Country [1] 291448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294200 0
Royal Brisbane and Women's Hospital HREC Office
Ethics committee address [1] 294200 0
Ethics committee country [1] 294200 0
Australia
Date submitted for ethics approval [1] 294200 0
26/11/2015
Approval date [1] 294200 0
23/12/2015
Ethics approval number [1] 294200 0
HREC/15/QRBW/592

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 840 840 0 0
/AnzctrAttachments/369954-05450proc RBWH PIVC, venepuncture and Infusions- Adults and Peads.pdf
Attachments [2] 903 903 0 0
/AnzctrAttachments/369954(v26-05-2016-12-03-35)-05450proc RBWH PIVC, venepuncture and Infusions- Adults and Peads.pdf

Contacts
Principal investigator
Name 62874 0
A/Prof Samantha Keogh
Address 62874 0
Griffith University
Nathan Campus
Bldg N48 Rm 0.07
170 Kessles Road
Nathan, Brisbane
Queensland 4111
Country 62874 0
Australia
Phone 62874 0
+61 7 36464121
Fax 62874 0
Email 62874 0
[email protected]
Contact person for public queries
Name 62875 0
Caroline Shelverton
Address 62875 0
Centre for Clinical Nursing Level 2, Building 34 RBWH Butterfield Street Herston Queensland 4029
Country 62875 0
Australia
Phone 62875 0
+61 7 36464121
Fax 62875 0
Email 62875 0
[email protected]
Contact person for scientific queries
Name 62876 0
Samantha Keogh
Address 62876 0
Griffith University
Nathan Campus
Bldg N48 Rm 0.07
170 Kessles Road
Nathan, Brisbane
Queensland 4111
Country 62876 0
Australia
Phone 62876 0
+61 7 36464121
Fax 62876 0
Email 62876 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImplementation and evaluation of short peripheral intravenous catheter flushing guidelines: A stepped wedge cluster randomised trial.2020https://dx.doi.org/10.1186/s12916-020-01728-1
N.B. These documents automatically identified may not have been verified by the study sponsor.