Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000252819
Ethics application status
Approved
Date submitted
28/10/2020
Date registered
9/03/2021
Date last updated
17/10/2022
Date data sharing statement initially provided
9/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing miniMAGIC in Brisbane (IMBed): An implementation study examining the impact on extravasations at the Queensland Children’s Hospital
Scientific title
Implementing miniMAGIC in Brisbane (IMBed): An implementation study examining the impact on extravasations at the Queensland Children’s Hospital
Secondary ID [1] 302557 0
None
Universal Trial Number (UTN)
U1111-1259-8351
Trial acronym
IMBed
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extravasation injury 319435 0
Condition category
Condition code
Injuries and Accidents 317403 317403 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Michigan Appropriateness Guide for Intravenous Catheters in paediatrics (miniMAGIC) was developed by the international community using the RAND/UCLA method to provide international recommendations on IV device selection. ‘miniMAGIC’ considers the following factors when making a device selection:
- infusate characteristics (i.e., peripheral vs non-peripherally compatible infusates);
- treatment duration (i.e., less than 7 days, 8-14 days, 15-30 days, greater than 31 days);
- age groups (i.e., neonates, infants, children and adolescents);
- diagnostic groups (i.e., general hospitalised, critical care, cancer care, congenital cardiac conditions, and long term health conditions); and
- insertion vessel and/or site (i.e. forearm, hand, foot, scalp, antecubital).

Within Phase 1 of the implementation project, a panel of key stakeholders, representing all health disciplines and specialties involved in the selection, insertion and management of IV devices within Children’s Health Queensland (CHQ), will be convened. Within facilitated conversations, the panel will co-develop local resources to build on the primary miniMAGIC recommendations, including identification of commonly used medications (including their local administration policies, e.g., diluent, final concentration, 24-hour continuous vs intermittent continuous vs bolus), and mapping their appropriateness across peripheral, and central IV device. Secondly, the panel will assist with the development and mapping of miniMAGIC implementation strategies across the key COM-B domains. This will include specific strategies related to the COM-B framework, such as education and training (capability), electronic medical records and mHealth applications (opportunity), and case study-based coaching (motivation). Together, and within the COM-B framework the panel will develop strategies (e.g., weekly didactic training facilitated by clinical managers, imbedding miniMAGIC recommendation into electronic medical records) for employing miniMAGIC in routine clinical practice. The extent and nature of IMBed panel membership will be defined a priori with clear expectations regarding meeting schedules, and feedback on resource development. Meetings (~4) will be convened using a combination of teleconference, Microsoft Teams and face-to-face appointments. The panel meetings will be facilitated by CI Gibson and Ullman, using an ongoing iterative process of review and discussion to achieve the study objectives. The IMBed panel will develop a plan for procedures and activities to ensure implementation. As a baseline this will include case-study based information sessions during routine education events (e.g., registrar training, nurse annual competency) and mentorship-based education by clinical champions across health disciplines. Phase 1 will occur approximately 4 weeks prior to Phase 2.

During the intervention (Phase 2; delivered via stepped wedge clustering), all divisions will start the trial in the control phase for two months, with baseline measures taken. Following this, one cluster / division will randomly (computer generated) step-up to implementation every month for up to 5 months. During the intervention phase, all eligible patients will receive the intervention as many times as clinically relevant. Sustainability will be measured at one and six months post full implementation. Each month (and time point), a random sample of 25 peripheral IV devices will be selected and assessed for appropriateness at each timepoint.

During implementation, Research Nurses (ReNs) will work with investigators, local educators, and clinical managers to review practice procedures and intervention fidelity, with the tailored Michigan Appropriateness Guide to Intravenous Cannulation for paediatrics (miniMAGIC) delivered to the local setting. Intervention fidelity will be recorded in patient medical records, with a random sample of peripheral IVs (n = 25) per cluster at each timepoint assessed to monitor treatment adherence. The mode of delivery will be developed by the key stakeholder panel, following the COM-B framework for implementation. This implementation theory considers three sources of behaviour: Capability (psychological and/or physical), Opportunity (social and/or physical), and Motivation (autonomic and/or reflexive) – COM-B. These interact to influence and are influenced by behaviour. A range of physical implementation materials will be used, as designed by the IMBed panel. This may include posters in clinical areas, lanyard summaries (for clinical staff), the miniMAGIC mHealth app (https://play.google.com/store/apps/details?id=au.edu.griffith.minimagic&hl=en_AU&gl=US / https://apps.apple.com/us/app/minimagic/id1523408770) and prompts within electronic medical records and email summaries.
Intervention code [1] 318848 0
Prevention
Comparator / control treatment
All divisions will start the trial in the control phase for two months, with baseline measures taken. In the control (baseline) steps, QCH divisions/clusters (medical, surgical, critical care) will continue with usual care, i.e. intravenous device selection based on clinician knowledge.
Control group
Active

Outcomes
Primary outcome [1] 325440 0
IV device appropriateness (compliance): percentage of IV devices audited that meet tailored miniMAGIC recommendations for selection and placement appropriateness. Collected via patient assessment and chart audit.
Timepoint [1] 325440 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Primary outcome [2] 325441 0
Extravasations: percentage of IV devices audited with medication infused into the tissue, rather than vein, during dwell. Reported using the Cincinnati Children’s Extravasation HARM, the Infusion Nurses Society Grading. Collected via patient assessment and chart audit.
Timepoint [2] 325441 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [1] 387969 0
IV device-associated bloodstream infections: % and rate per 1,000 catheter days associated with the audited peripheral IV device, in accordance with CDC definitions. Collected via patient assessment and chart audit.
Timepoint [1] 387969 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [2] 387971 0
Other IV device related insertion / post-insertion complications: first time insertion success (percentage). Collected via patient assessment and chart audit.
Timepoint [2] 387971 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [3] 387972 0
Other IV device related insertion / post-insertion complications: number of insertion attempts (median). Collected via patient assessment and chart audit.
Timepoint [3] 387972 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [4] 387973 0
Other IV device related insertion / post-insertion complications: failure during dwell. Collected via patient assessment and chart audit.
Timepoint [4] 387973 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [5] 389787 0
Other IV device related insertion / post-insertion complications: occlusion prevalence. Collected via patient assessment and chart audit.
Timepoint [5] 389787 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [6] 389788 0
Other IV device related insertion / post-insertion complications: phlebitis prevalence. Collected via patient assessment and chart audit.
Timepoint [6] 389788 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [7] 389789 0
Other IV device related insertion / post-insertion complications: thrombosis prevalence. Collected via patient assessment and chart audit.
Timepoint [7] 389789 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [8] 389790 0
Number of IV devices: required by patients to receive completion of therapy. Collected via patient assessment and chart audit.
Timepoint [8] 389790 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [9] 389791 0
Cost-effectiveness: Direct and indirect healthcare costs to the health system, patients/carers. Collected via patient assessment, chart audit and hospital medical records.
Timepoint [9] 389791 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (3, 4, and 5 months after baseline);
Timepoint 2: +1 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention

Eligibility
Key inclusion criteria
All children aged less than 18 years and admitted to either the medical, surgical, or critical care divisions at the Queensland Children's Hospital requiring intravenous cannulation.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patient aged greater than 18 years;
Outpatient or admitted to another division at the Queensland Children's Hospital; and,
Not requiring intravenous cannulation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A division/cluster will be randomly selected using a central, web-based randomisation service (hosted by Griffith University) to step up each month.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A division/cluster will be randomly selected using a central, web-based block randomisation service. service (hosted by Griffith University) to step up each month (1:1:1 ratio). The peripheral IV devices will also be randomly selected, by randomly assigning audit days per division per month (via the central, web-based randomisation service), with the first 25 peripheral IV devices in each division per month, audited by Research Nurses (ReNs). The Project Manager will undertake quality checks to ensure allocation integrity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
A stepped wedge, cluster RCT will be used to implement and evaluate miniMAGIC across the three QCH divisions (medical, surgical, critical care). All divisions will start the trial in the control phase for two months, with baseline measures taken. Following this, one cluster / division will randomly (computer generated) step-up to implementation every month. Sustainability will be measured at one and six months post full implementation. Each month (and time point), a random sample of 25 peripheral IV devices will be studied per cluster.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size and statistical power:
We estimate there is currently inappropriate IV device selection and placement in 20% of patients, and conservatively assume the intra-division-correlation coefficient = 0.03 to account for the probable non-independence of observations within the same division. With a total of 600 IV device assessments over the course of the study, we will have >80% power to detect a 50% decrease in inappropriate IV device selection/placement (alpha = 0.05).

Statistical analysis
The individual will be the unit of analysis. Between group comparison of the primary outcome will use mixed-effects binomial regression with cluster included as a random effect to account for probable non-independence of observations within divisions. Fixed effects included in the model will be phase (control/miniMAGIC) and month since baseline, as well as a group-by-time interaction term. Continuous secondary outcomes will be compared with mixed-effects linear regression, and count outcomes by mixed-effects Poisson regression. All models will account for clustering by division. The primary analysis will be ‘intention-to- treat’.

Cost-effectiveness analysis
The primary assessment will be the net monetary value of implementation estimated as the present value of the comparative cost saving per patient due to implementation multiplied by the target population, less the cost of implementation and present value of ongoing support. Comparative costs per patient will be calculated based on the expected value of reduced health service utilisation from reduced extravasations, IV device-associated bloodstream infections and number of IV devices per patient. The cost per extravasation injury (by injury severity type), replacement devices and bloodstream infection will be modelled based on current treatment protocols and estimated as the sum product of healthcare resources and their respective price including labour, time, consumables, medication and length of stay. Net monetary value of implementation will be estimated a 5 and 10 year time horizon using 5% discount rate for future benefits and costs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2021
Actual
1/04/2021
Date of last participant enrolment
Anticipated
Actual
7/02/2022
Date of last data collection
Anticipated
Actual
10/02/2022
Sample size
Target
600
Accrual to date
Final
496
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17847 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 31703 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 306993 0
Charities/Societies/Foundations
Name [1] 306993 0
Children's Hospital Foundation
Country [1] 306993 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
140 Kessels Road,
Nathan, Queensland, 4111
Country
Australia
Secondary sponsor category [1] 307567 0
None
Name [1] 307567 0
Address [1] 307567 0
Country [1] 307567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307125 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 307125 0
Ethics committee country [1] 307125 0
Australia
Date submitted for ethics approval [1] 307125 0
22/09/2020
Approval date [1] 307125 0
29/09/2020
Ethics approval number [1] 307125 0
HREC/2020/QCHQ/68226
Ethics committee name [2] 307498 0
Griffith University Human Research Committee
Ethics committee address [2] 307498 0
Ethics committee country [2] 307498 0
Australia
Date submitted for ethics approval [2] 307498 0
02/10/2020
Approval date [2] 307498 0
09/10/2020
Ethics approval number [2] 307498 0
GU Ref No: 2020/766

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

Contacts
Principal investigator
Name 106118 0
A/Prof Amanda Ullman
Address 106118 0
Menzies Health Institute Queensland & School of Nursing and Midwifery
Health Sciences (N48) Room 2.20
Griffith University, Nathan, QLD 4111
Country 106118 0
Australia
Phone 106118 0
+61 73735 6462
Fax 106118 0
Email 106118 0
[email protected]
Contact person for public queries
Name 106119 0
Amanda Ullman
Address 106119 0
Menzies Health Institute Queensland & School of Nursing and Midwifery
Health Sciences (N48) Room 2.20
Griffith University, Nathan, QLD 4111
Country 106119 0
Australia
Phone 106119 0
+61 73735 6462
Fax 106119 0
Email 106119 0
[email protected]
Contact person for scientific queries
Name 106120 0
Amanda Ullman
Address 106120 0
Menzies Health Institute Queensland & School of Nursing and Midwifery
Health Sciences (N48) Room 2.20
Griffith University, Nathan, QLD 4111
Country 106120 0
Australia
Phone 106120 0
+61 73735 6462
Fax 106120 0
Email 106120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Condition of Ethics and Public Health Act approval for the study.


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
No additional documents have been identified.