Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000295448
Ethics application status
Approved
Date submitted
18/02/2016
Date registered
7/03/2016
Date last updated
17/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cannulation Rates in the Emergency Department Intervention Trial
Scientific title
Can we reduce unnecessary cannulation in Emergency Department patients through a brief educational strategy?
Secondary ID [1] 288577 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CREDIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripherally Inserted Intravenous Catheters 297710 0
Condition category
Condition code
Public Health 297894 297894 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an education campaign aimed to reduce unnecessary peripheral inserted intravenous catheter use. The educational campaign includes group educational sessions with medical and nursing staff within the department of emergency medicine. The educational sessions will include a powerpoint presentation on appropriate peripheral inserted intravenous catheter use and will remind staff not to place a peripherally inserted intravenous catheter unless they are 80% sure that it will be used. There also will be posters placed in the Emergency Department and clinical champions wearing shirts reminding staff not to place a cannula unless clinically necessary. We will conduct 1X 30 minute sessions per week for 4 weeks. The nursing and medical staff involved in the study will be conducting the educational campaign. The follow-up data collection will monitor whether there has been adherence to the educational campaign.
Intervention code [1] 293965 0
Behaviour
Comparator / control treatment
No educational campaign administered. The historical data will be collected one month before the educational campaign (March 2016) and will be collected for two weeks.
Control group
Historical

Outcomes
Primary outcome [1] 297408 0
Difference in the proportions of peripherally inserted intravenous catheter placed before and after the educational campaign. Data will be collected by research nurses through direct patient observation. Patient records will be individually accessed to obtain any missing data.
Timepoint [1] 297408 0
We will examine whether the primary endpoint (peripherally inserted intravenous catheter placement) occurred within 24 hours of the patient presenting to the department. Data will be collected on patients who present to the department one month after the educational campaign.
Secondary outcome [1] 320976 0
Difference in the proportions of peripherally inserted intravenous catheter used before and after the educational campaign. Outcome data will be collected by research nurses through direct patient observation. Patient records will be individually accessed to obtain any missing data.
Timepoint [1] 320976 0
We will examine whether the secondary endpoint (peripherally inserted intravenous catheter use) occurred within 24 hours of the patient presenting to the department. Data will be collected on patients who present to the department one month after the educational campaign.

Eligibility
Key inclusion criteria
Age 18 years and older presenting to the Emergency Department
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Peripherally intravenous catheter insertion by ambulance
Triage Category 1
Interhospital transfer

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Historical controlled trial
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The pre-intervention study is powered to ensure that the rate of unused PIVC is estimated with high precision. If the proportion of unused PIVCs is 50%, we require 1068 patients with cannulas to estimate the proportion with precision of 3% and confidence level of 95%. Note that the upper estimate of 50% was chosen as this provides most conservative estimates for sample size calculations. It is estimated that approximately 65% of patients have a cannula placed. Thus, the total estimated sample size in the pre-intervention study is 1644

Used PIVC (as defined above) will also be the primary outcome for the post-intervention study. However, this study aims to assess whether there has been a reduction in the proportion of unused PIVC after the intevention. It was noted above that we will recruit 1644 patients in the pre-intervention arm to estimate the rate of unused PIVC. We propose collecting data for the same number of patients in the post-intervention study so that the unused PIVC rate post-intervention is also estimated with a high level of precision. It should be noted that this will provide adequate power to detect a difference between the pre and post-intervention groups. Specifically, to detect a reduction in rates of unused cannulas from 50% to 35%, a sample size of 480 cannulated patients (240 patients pre and 240 patients post intervention) will achieve power of 90% and alpha of 0.05.

Baseline data on the historical control and intervention group will be compared using chi-square and t-tests for categorical and continuous data respectively. To identify whether there has been a difference in the proportion of peripherally inserted intravenous catheters placed before and after the educational campaign, we will calculate the difference in the proportions (and 95% confidence intervals of the difference). A Chi-square test will also be conducted to compare the proportions of catheters placed in the historical and intervention groups.

To identify whether there has been a difference in the proportions of peripherally inserted intravenous catheters used before and after the educational campaign, we will calculate the difference in the proportion of catheters used (and 95% confidence intervals of the difference). A Chi-square test will also be conducted to compare the proportion of used catheters in the historical and intervention groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/02/2016
Date of last participant enrolment
Anticipated
31/05/2016
Actual
12/06/2016
Date of last data collection
Anticipated
Actual
13/06/2016
Sample size
Target
3288
Accrual to date
Final
4173
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5294 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 12761 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 292922 0
Charities/Societies/Foundations
Name [1] 292922 0
Queensland Emergency Medicine Research Foundation
Country [1] 292922 0
Australia
Primary sponsor type
Individual
Name
Prof Louise Cullen
Address
Department of Emergency Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 291678 0
None
Name [1] 291678 0
None
Address [1] 291678 0
None
Country [1] 291678 0
Other collaborator category [1] 278842 0
University
Name [1] 278842 0
Griffith University
Address [1] 278842 0
Centre for Applied Health Economics - School of Medicine, Griffith University, University Drive, Meadowbrook, QLD 4131
Country [1] 278842 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294427 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 294427 0
Ethics committee country [1] 294427 0
Australia
Date submitted for ethics approval [1] 294427 0
28/09/2015
Approval date [1] 294427 0
25/11/2015
Ethics approval number [1] 294427 0
HREC/15/QRBW/565

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63678 0
Prof Louise Cullen
Address 63678 0
Department of Emergency Medicine
Royal Brisbane and Women' s Hospital
Butterfield Street
HERSTON QLD 4006
Country 63678 0
Australia
Phone 63678 0
+61 7 36467901
Fax 63678 0
Email 63678 0
[email protected]
Contact person for public queries
Name 63679 0
Louise Cullen
Address 63679 0
Department of Emergency Medicine
Royal Brisbane and Women' s Hospital
Butterfield Street
HERSTON QLD 4006
Country 63679 0
Australia
Phone 63679 0
+61 7 36467901
Fax 63679 0
Email 63679 0
[email protected]
Contact person for scientific queries
Name 63680 0
Louise Cullen
Address 63680 0
Department of Emergency Medicine
Royal Brisbane and Women' s Hospital
Butterfield Street
HERSTON QLD 4006
Country 63680 0
Australia
Phone 63680 0
+61 7 36467901
Fax 63680 0
Email 63680 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
Dimensions AIPeripheral Intravenous Cannula Insertion and Use in the Emergency Department: An Intervention Study2017https://doi.org/10.1111/acem.13335
N.B. These documents automatically identified may not have been verified by the study sponsor.