Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001248651
Ethics application status
Approved
Date submitted
31/08/2023
Date registered
1/12/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
1/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Just Say No to the Just in Case Cannula: An Implementation Science Trial
Scientific title
Implementing Best Practice for Peripheral Intravenous Cannula in Australian Emergency Departments: A Stepped-wedge Cluster Controlled Trial and Health Economic Analysis
Secondary ID [1] 310144 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unnecessary cannulation in emergency departments (ED) 331326 0
Condition category
Condition code
Emergency medicine 328083 328083 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The site-specific quality improvement intervention will be based upon our previous research and the Australian Commission on Safety and Quality in Health Care (ACSQHC) standard but co-designed by Emergency Department (ED) managers and clinicians and implementation scientists using validated implementation frameworks. It will be developed using human factors principles, such as equipment, environment and changing clinician heuristics rather than determining the care of individual patients.

Each ED site will co-design locally tailored intervention over a 6-month period. Focus groups and working group meetings will occur until consensus regarding site specific interventions has been reached.

Elements of the interventions will include:

1. Clinical guidelines review on the best practice for peripheral intravenous cannula (PIVC): based on ACSQHC PIVC quality indicators and locally approved guidelines.

2. Education for healthcare workers, including
• Revision of PIVC education at each site
• Monthly education sessions at each site
• Work with ED medical directors and nurse unit managers to encourage the best practice of PIVC
• Reminders at daily clinical staff briefing
• Provision of instructions to clinical staff on how to document PIVC in the Electric Medical Record (EMR)
• Flow chart to assist clinical staff to make informed decisions

3. Audit and feedback program, such as
• Spot audits
• Provision of PIVC documentation statistics to ED medical directors and nurse unit managers
• Creation of a PIVC dashboard at each site

4. Clinical and leadership champions: to support, advocate for, and spearhead the implementation initiative at each site.

5. Environment and equipment change, such as
• Audit of the intravenous (IV) trolley
• Equipment changes of IV trolley

Outputs of the co-design intervention will be determined by the principal site investigator and the site working group at each site.

There will be nine clusters and three steps. Each ED site is a cluster and will be allocated to receive the quality improvement intervention at one of three study steps.

Nine trial hospitals are.

1. Monash Medical Centre (Monash Health)
2. Casey Hospital (Monash Health)
3. Dandenong Hospital (Monash Health)
4. Alfred Hospital (Alfred Health)
5. Sandringham Hospital (Alfred Health)
6. Box Hill Hospital (Eastern Health)
7. Gold Coast University Hospital (Queensland Health)
8. Robina Hospital (Queensland Health)
9. Royal Hobart Hospital (Tasmania Health)

This means:
• Baseline data collection will commence at all ED sites at the same time
• Monash Medical Centre, Casey Hospital and Dandenong Hospital EDs will receive the quality improvement intervention in Step 1
• Alfred Hospital, Sandringham Hospital and Box Hill Hospital EDs will receive the quality improvement intervention in Step 2.
• Gold Coast University hospital, Robina Hospital and Royal Hobart Hospital EDs will receive the quality improvement intervention at Step 3
• Every cluster will provide before and after intervention routinely collected clinical and health service data.
Intervention code [1] 326914 0
Prevention
Comparator / control treatment
Proportion of unnecessary cannulation in adults attending a participating ED. Each site will undergo their usual care processes for determining the insertion/use of PIVCs, outlined in their standard operating procedure guidelines.
Control group
Active

Outcomes
Primary outcome [1] 335948 0
Proportion of PIVC cannulation per month in adults attending a participating emergency department. Routinely collected clinical and health services data will be used to measure outcomes.
Timepoint [1] 335948 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [1] 426242 0
Clinical: Assess the rate of ‘used’ cannulas per patient in ED who have a cannula inserted (ACSQHC indicator 1).

Method of assessment: statistical analysis of routinely collected clinical and health services data.
Timepoint [1] 426242 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [2] 426527 0
Clinical: Assess the Pathology ordering rates. Method of assessment: statistical analysis of routinely collected clinical and health services data.
Timepoint [2] 426527 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [3] 426528 0
Clinical: Assess the rate of reported adverse events caused by not initiating PIVC cannulation in ED.

Method of assessment: statistical analysis of routinely collected clinical and health services data.

Adverse events will be collected from RIskMan safety information system at each site (or the equivalent) and the Electric Medical Record system (EMR) (or the equivalent) at each site.

An adverse event caused by not initiating PIVC cannulation would be a delay in the provision of medical treatment, for example, a delay in the administration of intravenous antibiotics.

The adverse events will be assessed by Quality and Safety committee (or the equivalent) at each site.
Timepoint [3] 426528 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [4] 426529 0
Clinical: Assess the rate of PIVC Healthcare-Associated Staphylococcus Aureus Bacteraemia (HA-SAB) per 10,000 patient days of care under surveillance in ED (ACSQHC indicator 8).

Method of assessment: statistical analysis of routinely collected clinical and health services data; including the RIskMan safety information system at each site (or the equivalent).
Timepoint [4] 426529 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [5] 426530 0
Implementation: Assess the evidence of a locally approved policy that ensures ED healthcare professionals are competent in PIVC insertion, monitoring, and removal (ACSQHC indicator 3).

Method of assessment: audit of local policy.
Timepoint [5] 426530 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [6] 426531 0
Implementation: Assess the evidence of local arrangements that provide systematic support for decisions related to the selection of an appropriate PIVC device in ED (ACSQHC indicator 4a).

Method of assessment: audit of local arrangements.
Timepoint [6] 426531 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [7] 426532 0
Implementation: Assess the evidence of a locally approved policy that ensures ED healthcare professionals are inserting patients’ PIVCs using standard precautions, including aseptic technique and sterile, transparent, semipermeable dressing unless contraindicated (ACSQHC indicator 6).

Method of assessment: audit of local policy.
Timepoint [7] 426532 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [8] 426533 0
Implementation: Assess the evidence of a locally approved policy that defines the documentation for PIVC insertion, maintenance, removal, and regular review in ED (ACSQHC indicator 7a). Method of assessment: audit of local policy.
Timepoint [8] 426533 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.
Secondary outcome [9] 426534 0
Implementation: Site-based audit and feedback process. We will measure rates of PIVC insertion, use, safety and PIVC-related infections during pre and post intervention. Those measures will be assessed as a composite of the secondary outcome.

Method of assessment will include audit of PIVC documentation in electric medical record (EMR), focus groups and survey.
Timepoint [9] 426534 0
Data will be collected over a 36-month period in nine clusters and three steps: Intervention co-design (6 months prior to intervention implementation) followed by intervention implementation (18-30 months), Frequency of data collection: bi-weekly to monthly.

Eligibility
Key inclusion criteria
Each participating emergency department has met the following criteria to be enrolled in the study

- Have more than 50 adult presentations daily
- Electronic Medical Records (EMR) that allows data collection
- Health service consents to participation
- The Australasian College for Emergency Medicine (ACEM) accredited ED for advanced
training in Emergency Medicine

ED Adult patients' (18 years old and over) data will be collected for this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ED meeting any of the following criteria will be excluded from the trial:
- Has had an active peripheral intravenous catheter (PIVC) quality improvement intervention program within the last 12 months

Patient data (under 18 years old) and non-ED patient will not be collected for this study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC

Funding & Sponsors
Funding source category [1] 314304 0
Government body
Name [1] 314304 0
Medical research future fund (MRFF), Australian Goverment, Department of Health and Aged Care
Country [1] 314304 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 316694 0
None
Name [1] 316694 0
Address [1] 316694 0
Country [1] 316694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313416 0
Monash Health Human Research Ethics Committees (HREC)
Ethics committee address [1] 313416 0
Research Support ServicesMonash HealthLevel 2, I BlockMonash Medical Centre246 Clayton RoadClayton Victoria 3168
Ethics committee country [1] 313416 0
Australia
Date submitted for ethics approval [1] 313416 0
21/06/2023
Approval date [1] 313416 0
30/08/2023
Ethics approval number [1] 313416 0

Summary
Brief summary
Background
This implementation science trial aims to reduce unnecessary and improve peripheral intravenous catheter (PIVC) insertion in Emergency Department (ED) patients. The intervention is effective locally and recommended by ACSQHC PIVC Clinical Care Standard. This project has received $2.9M funding from the MRFF 2023-2028.

Primary Objective
To implement best practice for PIVC in Australian ED.

Methods
1. Stepped-wedge cluster-controlled trial for clinical effectiveness and safety of the intervention. We will study 9 diverse EDs and implement a package of interventions, three at a time, with 6-monthly steps. We will measure rates of PIVC insertion, use, safety and PIVC-related infections.
2. An adaptive, co-designed intervention based on our previous model/ACSQHC standards, using validated implementation and evaluation frameworks.
Trial website
https://sites.google.com/monash.edu/bestpracticepivc/home
Trial related presentations / publications



Public notes

Contacts
Principal investigator
Name 128082 0
Prof Diana Egerton-Warburton
Address 128082 0
Monash Health: 246 Clayton Rd, Clayton VIC 3168
Country 128082 0
Australia
Phone 128082 0
+61 3 9594 6666
Fax 128082 0
Email 128082 0
diana.egerton-warburton@monash.edu
Contact person for public queries
Name 128083 0
Dr Sundy Ni-Yen Yang
Address 128083 0
Monash Health: 246 Clayton Rd, Clayton VIC 3168
Country 128083 0
Australia
Phone 128083 0
+61 401322010
Fax 128083 0
Email 128083 0
sundyni-yen.yang@monashhealth.org
Contact person for scientific queries
Name 128084 0
Dr Sundy Ni-Yen Yang
Address 128084 0
Monash Health: 246 Clayton Rd, Clayton VIC 3168
Country 128084 0
Australia
Phone 128084 0
+61 401322010
Fax 128084 0
Email 128084 0
sundyni-yen.yang@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
individual participant data will not be shared. The outcomes of the trial will share with public via peer-reviewed journal publications and various guidelines.


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23764Ethical approval   

Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.