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Trial registered on ANZCTR


Registration number
ACTRN12621001497897
Ethics application status
Approved
Date submitted
26/07/2021
Date registered
4/11/2021
Date last updated
19/07/2022
Date data sharing statement initially provided
4/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Difficult Access Requires Thought, Training and Technology (DART3): An implementation study investigating the effect of a co-developed escalation pathway on peripheral intravenous catheter insertion success and insertion-related complications in patients with difficult intravenous access.
Scientific title
Difficult Access Requires Thought, Training and Technology (DART3): An implementation study investigating the effect of a co-developed escalation pathway on peripheral intravenous catheter insertion success and insertion-related complications in patients with difficult intravenous access.
Secondary ID [1] 304612 0
None
Universal Trial Number (UTN)
U1111-1267-1907
Trial acronym
DART3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult intravenous access 322549 0
Condition category
Condition code
Public Health 320177 320177 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early identification and management of patients with difficult intravenous access (DIVA) is complex and dependent on patient, illness or injury, and provider characteristics. Prospective identification of patients with DIVA using vessel assessment instruments, combined with the use of high-quality clinical guidelines or escalation pathways (to more skilled inserters) is recommended in order to maximise first-time insertion success and to prevent peripheral intravenous catheter (PIVC) insertion failure. Our preliminary work demonstrates a strong need for a DIVA identification process which accurately highlights those patients who have DIVA; and links to an insertion escalation pathway, incorporating the use of ultrasound (US) if needed, so that DIVA patients have a better chance of having a PIVC successfully inserted on the first attempt. The current study aims to evaluate the clinical and cost-effectiveness of DIVA identification and escalation pathways. Co-production of a DIVA identification tool (e.g., screening for DIVA risk factors) and escalation pathways (e.g., escalation based on DIVA classification and inserter skill) with an Advisory group, will be undertaken by the research team at each site. Implementation strategies will be underpinned by the Behaviour Change Wheel intervention functions and policy categories and be evidence informed. Core components which the pathways must contain include:

DIVA identification pathway
- Able to be used across all disciplines/clinical areas where PIVCs are inserted
- Applicable to all patients
- History of DIVA should be assessed – Patient-reported, and medical records
- Prompt user to consider whether there is a clear indication for vascular access/PIVC insertion (refer user to ACSQHC PIVC Standards: Device Appropriateness)
- Vein visibility and palpability assessment as minimum requirements for DIVA assessment
- Lack of vein palpability and visibility should automatically classify a patient as DIVA, overriding other criteria
- Inserter skill and confidence should be assessed:
- Should not be prescriptive – allow integration of clinical judgement in decision-making process

Escalation pathway
- Timely response: Escalation to occur in reasonable timeframe
- Pathway must be applicable at all hours across all days of the week
- Distinct escalation pathways for inserters of different skill levels, and for non-DIVA and DIVA patients
- Sites should strive to construct an ideal escalation pathway, that may not be achievable initially, but can be a goal to reach towards
- Pathway must consider the urgency of PIVC insertion, and not be applicable for Resus/Code Blue situations

Implementation strategies
- Implementation strategies should:
o Be multimodal (i.e. same content delivered via different platforms/ media)
o Leverage off existing staff and workflows at each site for promoting best practice PIVC insertion, care and removal (not solely rely on research staff and investigators)
o Consider evidence-based strategies from previous vascular access or other clinical implementation projects (e.g. bundles in published papers)
- Intensity of implementation strategies should be flexible and adjusted throughout the project as necessary
- Education must include content to improve awareness of device appropriateness and vascular access requirement
- DIVA information resource should be provided to patients to facilitate patient empowerment (i.e. to request US insertions if history of DIVA is known)
- Sites will ensure appropriate infection prevention measures are in place for ultrasound equipment:
o Consider use of “DIVA Pack” containing sterile probe covers, disinfectant wipes, sterile gel, etc.
o Consider providing laminated card outlining cleaning procedures for US
- Site investigators will garner support for pathway within hospital (including executives and clinical staff)
- Change champions should understand the escalation pathway and DIVA tool well to guide others in its use
- Advisory group to consider the cohort/s of inserters to escalate to given the number of projected DIVA patients and advanced inserter availability at different times/days
- Method should be developed by advisory groups to ensure that ultrasounds are accessible/locatable when needed.
- Formal implementation plan should be developed by site advisory groups addressing each component of an implementation plan template developed by Core Group
o Advisory groups must identify or create workforce for escalation.
o Site-specific advisory groups must consider methods of changing clinician viewpoints on ultrasound-guided PIVC insertion, and normalising it as a part of standard practice

The intervention will involve (delivered via stepped wedge cluster RCT [with inbuilt process evaluation]) the implementation and evaluation of the DIVA identification and escalation pathways’ effect on clinical and implementation outcomes from four clusters at the Queensland Children’s Hospital (QCH), Royal Brisbane and Women’s Hospital (RBWH), and Gold Coast University Hospital (GCUH). All 12 hospital clusters (wards/departments) will start the trial in the control phase for two months, with baseline measures taken. Following this, one cluster per hospital will randomly (computer generated) step-up to implementation every two months over an 8-month period, until all are fully implemented. The exposure to the intervention will differ per cluster (depending on randomisation) but be between 6 and 12 months. At each time point, a random sample of a minimum 20 PIVC insertion procedures will be studied per cluster. This will be achieved by randomly selecting dates for data collection, rostering research nurses on those dates and collecting a minimum of 20 PIVC insertions that occur sequentially while the research nurse is available.

An internal process evaluation will be undertaken guided by the Consolidated Framework for Implementation Research to i) establish the extent to which the intervention is implemented as intended (implementation fidelity), over time and across different sites; ii) to ascertain how staff understand and respond to the intervention, over time and across different sites; and iii) to explore the context over time and across different sites and determine factors (including managerial, economic, organisational and work level) that affect implementation. Up to 5 staff per cluster will be interviewed (in-person or via telephone) by a member of the research team. Purposive sampling will be used to select staff involved in implementation or intervention delivery.

Intervention fidelity will be promoted by the Project Manager who will develop a study manual, train ReNs (Research Nurses), monitor allocation integrity and data quality, and work with investigators/ReNs to address any issues. Education and training to implement the intervention willl reflect literature, pilot educational programs developed by the partners, sound educational principles, and standards, (e.g., the Australasian Society for Ultrasound in Medicine requires >/=2 hours of teaching (>1 hour practical), a post-test, two supervised (marked, interactive) formative assessments and a third summative assessment) and will be delivered in-person, where feasible, by the ReNs or another member of the research team (e.g., Project Manager). Implementation education will provide evidence-based advice, but individual clinicians will make decisions (e.g. insertion site) based on patient needs.
Intervention code [1] 320977 0
Prevention
Intervention code [2] 321501 0
Early detection / Screening
Comparator / control treatment
In the control steps, clusters will continue usual care. This will vary by site, however, in general usual care will be landmark insertion by default; with no/minimally implemented pathway to assess level of difficulty; and ad hoc referral to ultrasound skilled practitioners, typically after failed landmark attempts.
Control group
Active

Outcomes
Primary outcome [1] 328061 0
First attempt success: one needle puncture, by one inserter; to achieve PIVC insertion for DIVA patients; collected using study-specific checklist and review of patients' medical records.
Timepoint [1] 328061 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [1] 397387 0
First attempt success: one needle puncture, by one inserter, to achieve PIVC insertion for all patients; collected via patient assessment and audit of patient medical chart
Timepoint [1] 397387 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [2] 397388 0
Ultrasound adoption: proportion of DIVA patients with ultrasound used at first, or any attempt (composite outcome); collected via patient assessment and audit of patient medical chart
Timepoint [2] 397388 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [3] 397389 0
Number of attempts: numbers of skin punctures to attempt PIVC placement; collected via patient assessment and audit of patient medical chart
Timepoint [3] 397389 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [4] 397391 0
PIVC necessity: PIVC used for fluids or medications within 24 hours (excluding patients who require a prophylactic PIVC in situ as part of their treatment e.g. status epilepticus); collected via patient assessment and audit of patient medical chart
Timepoint [4] 397391 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [5] 397392 0
PIVC failure: a composite measure of local infection, primary bloodstream infection (BSI), occlusion, infiltration/extravasation, dislodgement (includes leaking), thrombosis and/or phlebitis; collected via patient assessment and audit of patient medical chart
Timepoint [5] 397392 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [6] 397393 0
PIVC dwell time: time from PIVC insertion to PIVC removal (in hours); collected via patient assessment and audit of patient medical chart
Timepoint [6] 397393 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [7] 397394 0
Insertion/post-insertion complications: A composite measure of insertion and post-insertion complications including, bruising, haematoma, nerve injury, arterial puncture, or skin injury, and local infection, primary bloodstream infection (BSI), occlusion, infiltration/extravasation, dislodgement (includes leaking), thrombosis and/or phlebitis; collected via patient assessment and audit of patient medical chart.
Timepoint [7] 397394 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [8] 397395 0
Cost-effectiveness: Direct and indirect healthcare costs to the health system, patients/carers: (time to insertion/therapy, cost of products, number of staff, staff time, costs of responding to failed insertion including cancelled appointments); collected via patient assessment, chart audit and hospital medical records. This will be assessed as a composite outcome.
Timepoint [8] 397395 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [9] 397396 0
Patient/carer/parent satisfaction: 0-10 numeric rating scale; collected via patient assessment
Timepoint [9] 397396 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [10] 400084 0
Patient pain with insertion procedure: 0-10 numeric rating scale; collected via patient assessment
Timepoint [10] 400084 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [11] 400085 0
Initial inserter satisfaction with pathway 0-10 numeric rating scale
Timepoint [11] 400085 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [12] 400087 0
Successful inserter (if not initial inserter) satisfaction with pathway 0-10 numeric rating scale
Timepoint [12] 400087 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [13] 400088 0
Cluster level routinely collected rates of blood stream infections (i.e., primary BSI and S. Aureus BSI); collected via audit of patient medical chart
Timepoint [13] 400088 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention
Secondary outcome [14] 400092 0
Staff perceptions of guideline acceptability, barriers and clinical decisions affecting the use of the intervention; collected via semi-structured one-on-one interviews
Timepoint [14] 400092 0
Timepoint 0: Baseline prior to introducing the intervention;
Timepoint 1: During the implementation of the intervention (months 3 to 10 after baseline; the dates on which data collection occurs in each cluster will be randomly selected during the intervention phase using computer generated allocation. Data will be collected from 10 PIVCs per cluster per month. Each PIVC will only be studied once at the following phases of PIVC care: on insertion, once per day, on removal, 48 hours after removal);
Timepoint 2: +3 month after the implementation of the intervention; and,
Timepoint 3: +6 months after the implementation of the intervention

Eligibility
Key inclusion criteria
Cluster eligibility is emergency department, inpatient ward or day procedure unit where >10 PIVCs/week are typically inserted. Across each cluster at each participating hospital, any PIVC, inclusive of short and long PIVC being inserted may be considered for inclusion. Patient eligibility: Patient (DIVA or non-DIVA) of any age (neonate to elderly) prescribed PIVC insertion.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: Emergencies (e.g. MET call) requiring intraosseous access. Exclusion areas are operating theatres, radiology, rehabilitation or psychiatric units because they either have all expert inserters so have less insertion failure, or rarely insert PIVCs.

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 cluster at each site will be randomly allocated using a central, web-based randomisation service (hosted by Griffith University) to step up each timepoint with allocation concealment until study commencement.
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 (hosted by Griffith University) to step up each month (1:1:1 ratio).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
A stepped wedge, cluster RCT (with inbuilt process evaluation) will be used to implement and evaluate the DIVA Identification and Ultrasound Escalation Pathway and associated implementation strategies at the Queensland Children’s Hospital (QCH), Royal Brisbane and Women’s Hospital (RBWH) and Gold Coast University Hospital (GCUH). This design is highly suited to evaluate service delivery interventions where evidence of effectiveness exists, stakeholder commitment is high, and simultaneous rollout is unfeasible; it has previously been used to evaluate a related implementation topic of CVC insertion bundles.

The dates on which data collection occurs will be randomly selected using computer generated allocation to achieve a random sample of a minimum of 20 patients per cluster per timepoint.

This study involves an evolution and evaluation of healthcare practice, in comparison to individual, participant-level research. As such, a random sample of 20 PIVC insertions in each cluster will be assessed at each timepoint.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Sample size
The study has been designed to have adequate statistical power to test the primary hypothesis. We expect that approximately 40% of recruited patients will be DIVAs (8 per cluster sample) and 60% non-DIVA (12 per cluster sample). Using Hemming’s method for cluster RCTs, including correction for intra class correlation (rho=0.03 constant throughout study), a two-sample test of proportions with 4 steps, 3 clusters randomised at each step, and 20 patients/cluster. For patients classified as DIVA, we assume the current percentage of first attempt insertion success is 50% (based on prior meta-analysis12 and consistent with our pilot50), and that there will be a 50% relative improvement to 75% of first attempt insertion success. With 20 patients recruited per cluster we will have >90% power to detect a statistically significant difference in first attempt insertion success before and after exposure to the intervention for DIVA patients (alpha=0.05).

When considering the effect of the intervention on all recruited patients, we assume the current first insertion success percentage in non-DIVA patients is 70%, and that this will rise to 80% post-intervention. This is equivalent to an overall change from 62% first attempt insertion success to 78% first attempt insertion success. With 240 patients at each of the 5 data collection periods (baseline plus 4 steps), we have >90% power to detect a statistically significant difference between pre- and post-implementation of pathways (alpha=0.05).
To measure sustainability of the primary endpoint we will continue to assess 240 patients at each sustainability time point (3 and 6 months). We will have data on 168 DIVA patients receiving the pathway at steps 3 and 4, and 192 DIVA patients at the 3- and 6-month follow-up periods combined. This will allow the identification of a drop in first attempt insertion success from 75% to <60% post-intervention with 80% power (alpha=0.05).12,50 When considering all patients regardless of DIVA status we have 420 at steps 3 and 4 and 480 at follow-up, giving 80% power to identify an overall drop in first attempt insertion success from 78% to <70% post-intervention (alpha=0.05). This leads to a total sample size of 1680 observations, consisting of 240 observations at each of the 7 periods (baseline, steps 1-4, 3- and 6-month follow-up).

Statistical analysis
Descriptive statistics will be characterised as mean (standard deviation) or median (25th-75th percentile) as appropriate, and categorical data will be characterised as frequency (percentage). The primary outcome, first insertion success in DIVA patients, will be analysed using a multi-level mixed-effects logistic regression model, with pathway (DIVA/escalation) and time period (baseline/step 1-4) included as fixed effects, with a pathway-by-period interaction term. Clinical unit (cluster) and hospital will be included as random effects, with clinical unit nested within hospital. The effect estimate will be presented as an odds ratio (OR) with 95% confidence intervals (95%CI). Secondary outcomes with binary data will be analysed using mixed-effects logistic regression models. Secondary outcomes with interval data will be assessed using mixed-effects linear regression models, with effect estimates presented as mean difference and 95%CI. Secondary outcomes with continuous, but non-interval, data will be assessed using mixed-effects median regression models, with effect estimate presented as median difference and 95%CI. Secondary outcomes with count data will be assessed using mixed-effects Poisson regression models, with effect estimates presented as incidence rate ratios and 95%CI. Secondary outcomes with time-to-event outcomes will be assessed using Cox Proportional regression models, with effect estimates presented as hazard ratios and 95%CIs. For time-to-event outcomes life tables will be constructed when appropriate. The primary analysis will be ‘intention-to-treat’, with ‘per protocol’ (PP) analyses assessing the effect of protocol compliance.

Cost-effectiveness analysis
The primary cost-effectiveness analysis will be conducted from a health system perspective. The primary outcome will be the incremental cost per incremental gain in first time insertion success. Results will be presented as incremental cost-effectiveness ratios (ICERs) with 95% credible intervals. Seemingly Unrelated Regression (SUR) will be used to estimate the ICER and characterise uncertainty as it is robust for non-normal data distributions, allows for correlation between costs/effects, will allow for control of any baseline/confounding variables and has been previously used in economic evaluation alongside stepped-wedge clinical trials51. Per patient costs will be estimated using a micro-costing or bottom-up approach, with initial measures in natural unit resource use. Next, each resource will be valued using unit prices (purchasing agreements or estimates from shadow prices). Costs associated with implementation with be annualised over assumed life expectancy of practice change (seven years) and attributed to each patient based total target patient population estimates. Data will be collected for all patients during the pre-implementation, post-implementation and sustainability phase. ICER will be estimated based on the incremental costs and effect between patients of the pre-implementation phase compared to the post-implementation or sustainability phase separately. Ultrasound will be cost-effective if the ICER less than or equal to the a priori cost effectiveness threshold for the value of first-time insertion sourced from the literature. A scatter graph of costs and effect will be used to characterise uncertainty in the ICER based on the results of the SUR. To explore the uncertainty in cost effectiveness threshold, cost effectiveness acceptability curves will assess the probability that ultrasound guided insertion is cost-effective over a range of cost effectiveness threshold values.

Process evaluation
An internal process evaluation will be undertaken guided by the Consolidated Framework for Implementation Research. The aims and objectives of the process evaluation (PE) are i) to establish the extent to which the intervention is implemented as intended (implementation fidelity), over time and across different sites; ii) to ascertain how staff understand and respond to the intervention, over time and across different sites; and iii) to explore the context over time and across different sites and determine factors (including managerial, economic, organisational and work level) that affect implementation.

Data collection methods for the PE will be:
- Initial site visits to obtain information on context and usual practice collected through interviews with staff involved in the implementation and delivery of the intervention, using purposive sampling to obtain a range of participants;
- In person and/or telephone interviews with research staff and local champions in the intervention phase to obtain information regarding the implementation process, acceptability of the intervention, barriers and clinical decisions affecting the use of the intervention.
- Final site visits to undertake interviews with a purposive sample of staff involved in implementation or intervention delivery to ascertain guideline acceptability, how workflows supported (or did not support) the pathways’ implementation, what was helpful or challenging when operationalising the pathways and whether they were useful in practice.

Interviews will be recorded and professionally transcribed. Data from the PE will be analysed –using interpretive inductive thematic analysis to gain a greater understanding of clinical phenomena that yield practical applications.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
31/01/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
1680
Accrual to date
238
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19808 0
Gold Coast Hospital - Southport
Recruitment hospital [2] 19809 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 19810 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 34457 0
4215 - Southport
Recruitment postcode(s) [2] 34458 0
4101 - South Brisbane
Recruitment postcode(s) [3] 34459 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 308974 0
Government body
Name [1] 308974 0
National Health and Medical Research Council
Country [1] 308974 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 309908 0
University
Name [1] 309908 0
Griffith University
Address [1] 309908 0
Griffith University
170 Kessels Road
Nathan Qld 4111
Country [1] 309908 0
Australia
Other collaborator category [1] 281877 0
Hospital
Name [1] 281877 0
Royal Brisbane and Women's Hospital (Queensland Health)
Address [1] 281877 0
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston, QLD, Australia 4029
Country [1] 281877 0
Australia
Other collaborator category [2] 281878 0
Hospital
Name [2] 281878 0
Children's Health Queensland Hospital and Health Service
Address [2] 281878 0
Queensland Children's Hospital,
501 Stanley Street,
South Brisbane, QLD, Australia 4101
Country [2] 281878 0
Australia
Other collaborator category [3] 281879 0
Hospital
Name [3] 281879 0
Gold Coast Hospital and Health Service
Address [3] 281879 0
Gold Coast University Hospital
1 Hospital Blvd,
Southport, QLD, Australia 4215
Country [3] 281879 0
Australia
Other collaborator category [4] 281880 0
Government body
Name [4] 281880 0
Australian Commission on Safety and Quality in Healthcare
Address [4] 281880 0
Level 5, 255 Elizabeth St,
Sydney, NSW 2000
Country [4] 281880 0
Australia
Other collaborator category [5] 281881 0
Government body
Name [5] 281881 0
Queensland Health Aeromedical Retrieval and Disaster Management Branch
Address [5] 281881 0
Department of Health,
Level 7, 33 Charlotte St,
Brisbane, QLD, Australia 4000
Country [5] 281881 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308866 0
Children’s Health Queensland HREC
Ethics committee address [1] 308866 0
Human Research Ethics Committee
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 308866 0
Australia
Date submitted for ethics approval [1] 308866 0
19/05/2021
Approval date [1] 308866 0
17/06/2021
Ethics approval number [1] 308866 0
HREC/21/QCHQ/75125
Ethics committee name [2] 308878 0
University of Queensland HREC
Ethics committee address [2] 308878 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [2] 308878 0
Australia
Date submitted for ethics approval [2] 308878 0
24/06/2021
Approval date [2] 308878 0
25/06/2021
Ethics approval number [2] 308878 0
Ethics committee name [3] 308879 0
Griffith University Human Research Committee
Ethics committee address [3] 308879 0
Office for Research
Bray Centre (N54), Griffith University
Nathan, QLD 4111
Ethics committee country [3] 308879 0
Australia
Date submitted for ethics approval [3] 308879 0
01/07/2021
Approval date [3] 308879 0
Ethics approval number [3] 308879 0

Summary
Brief summary
Our preliminary work demonstrates a strong need for a DIVA identification process which accurately highlights those patients who have DIVA; and links to an insertion escalation pathway, incorporating the use of ultrasound if needed, so that DIVA patients have a better chance of having a PIVC successfully inserted on the first attempt. The three-phased project will develop, implement and evaluate the clinical and cost-effectiveness of DIVA identification and escalation pathways.

The Difficult Access Requires Thought, Training and Technology (DART3) project aims:
(1) To understand and describe the budget and funding mechanisms for PIVC insertion procedures in Australian hospitals;
(2) To develop and pilot test sustainable DIVA identification and escalation pathways and associated implementation strategies suitable for the Australian care context; and,
(3) To test the effect of the DIVA identification and escalation pathways on clinical, cost and implementation outcomes
Trial website
https://www.avatargroup.org.au/dart3.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112154 0
Prof Claire Rickard
Address 112154 0
School of Nursing, Midwifery and Social Work-MNHHS
Level 3, Building 71/918, UQCCR, RBWH Campus
Butterfield Street,
Herston, QLD, Australia 4029
Country 112154 0
Australia
Phone 112154 0
+61 7 3365 2068
Fax 112154 0
Email 112154 0
[email protected]
Contact person for public queries
Name 112155 0
Claire Rickard
Address 112155 0
School of Nursing, Midwifery and Social Work-MNHHS
Level 3, Building 71/918, UQCCR, RBWH Campus
Butterfield Street,
Herston, QLD, Australia 4029
Country 112155 0
Australia
Phone 112155 0
+61 7 3365 2068
Fax 112155 0
Email 112155 0
[email protected]
Contact person for scientific queries
Name 112156 0
Claire Rickard
Address 112156 0
School of Nursing, Midwifery and Social Work-MNHHS
Level 3, Building 71/918, UQCCR, RBWH Campus
Butterfield Street,
Herston, QLD, Australia 4029
Country 112156 0
Australia
Phone 112156 0
+61 7 3365 2068
Fax 112156 0
Email 112156 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
Individual participant data (IPD) for this trial (including data dictionaries) will not be available as a condition of ethics approval.


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.