Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000067370
Ethics application status
Approved
Date submitted
10/01/2017
Date registered
13/01/2017
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Date results information initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to test the effectiveness of the I-DECIDED device assessment tool in improving care and prompt removal of intravenous catheters in hospital patients
Scientific title
The I-DECIDED Study: An interrupted time-series study to test the effectiveness of a device assessment and removal tool in supporting clinical decision-making to improve intravenous catheter care and reduce redundancy of intravenous catheters in hospital patients
Secondary ID [1] 290875 0
Nil
Universal Trial Number (UTN)
U1111-1191-4662
Trial acronym
I-DECIDED
Identify if the patient has a device
Does the patient need the device?
Effective function?
Complications or concerns
Infection prevention
Dressing and securement integrity
Evaluate concerns and Educate patient/family as needed
Document the decision to continue to monitor, change the dressing and securement, or remove the device
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular access devices 301579 0
Condition category
Condition code
Infection 301290 301290 0 0
Studies of infection and infectious agents
Cardiovascular 301311 301311 0 0
Other cardiovascular diseases
Public Health 301312 301312 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interrupted time-series study to assess the effect of the introduction of a peripheral intravenous catheter (PIVC) device assessment and removal tool in 3 Queensland hospitals.
There will be four study phases, Pre-baseline (T0) (one month), and Baseline (T1), Intervention (T2), and Evaluation (T3), each of 4 months duration.

Pre-baseline (T0) - 1 month. . Clinicometric testing of the I-DECIDED tool will be undertaken, including content validity assessment, clinical utility and feasibility, inter-rater and intra-rater reliability assessments.

Baseline (T1) - 4 months. Baseline observations will include: usual clinical practice of PIVC assessment and documentation; device utilisation ratios; prevalence of redundant PIVCs; IV complications; loose, moist or soiled dressings; primary BSI data. Consultation with key stakeholders, staff focus groups (n = 7 groups), bedside interviews with patients (n = 24), PIVC assessments (n = 480), and chart audits (n = 480) will be conducted.

Implementation (T2) - 4 months. The I-DECIDED tool will be implemented in 7 wards across 3 hospitals. Regular meetings with key local opinion leaders will continue during this period. Two staff champions per ward will be identified and trained to support other staff in the use of the tool and facilitate implementation. Education sessions for staff and education brochures for patients will be developed and provided. Regular ward updates, and informal discussions about the I-DECIDED study will be conducted. Data collection will not occur during this phase.

Evaluation (T3) - 4 months. During this period the tool will continue to be used and the activities of T1 (staff focus groups (n = 7), IV assessments (n = 480), chart audits (n = 480), and patient bedside interviews (n = 24)) will be repeated. Regular meetings with key local opinion leaders will continue, and ongoing education and feedback to staff will be provided at ward in-service sessions. The purpose of this phase is to determine the effectiveness, feasibility and acceptability of the I-DECIDED tool for IV assessment, management and documentation of IV care.

Intervention code [1] 296822 0
Other interventions
Comparator / control treatment
Seven wards in 3 hospitals will receive the intervention (education and implementation of an assessment tool). There will be no control groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300701 0
Change in the number of redundant PIVCs in T3 (evaluation phase), compared to T1 (preliminary phase). Redundant IV catheter is defined as device in situ without a clear purpose; i.e., not used for intravenous fluids, blood products, parenteral nutrition, or medications for the past 24 hours and not anticipated to be used in the next 24 hours (e.g., planned procedure, cardiac monitoring in situ, history of seizures, unstable medical condition or recent rapid response call).
Timepoint [1] 300701 0
7, 8, 9, 10, 11 months after implementation of the new tool
Primary outcome [2] 300702 0
Change in the number of loose or soiled IV dressings in T3, compared to T1.
Loose dressing is defined as edges of the IV dressing peeling away from the skin.
Soiled dressing is defined as moist or dry ooze evident on the outside of the IV dressing.
Timepoint [2] 300702 0
7, 8, 9, 10, 11 months after implementation of the new tool
Primary outcome [3] 300703 0
Change in the number of IV complications in T3, compared to T1.
IV complications defined as:
Pain > 2/10 (ask patient and gently palpate dressing)
ANY redness, swelling, discharge, hardness, palpable cord (visual inspection)
Timepoint [3] 300703 0
7, 8, 9, 10, 11 months after implementation of the new tool
Secondary outcome [1] 330648 0
Proportion of patients with increased engagement in IV assessment.
Engagement defined as verbal report from patients that they feel comfortable about speaking up if they have any concerns about their IV.
Timepoint [1] 330648 0
7 months after implementation of assessment tool
Secondary outcome [2] 330649 0
Change in the quality and frequency of documentation of IV assessment.
Defined as a nursing entry in the patient's chart each shift describing the IV assessment and decision taken to continue or remove the IV.
Timepoint [2] 330649 0
7, 8, 9, 10, 11 months after implementation of the tool
Secondary outcome [3] 332820 0
• A change in the incidence of S. aureus bacteraemia bloodstream infection in T3, compared to T1.
Timepoint [3] 332820 0
T3: Evaluation phase (February - August 2018) will be compared to T1 (Preliminary phase) (March - August 2017)
Secondary outcome [4] 336758 0
Staff focus group feedback on usability of I-DECIDED tool and the barriers and enablers to PIVC assessment and prompt removal
Timepoint [4] 336758 0
T1 and T3

Eligibility
Key inclusion criteria
Inclusion criteria
• Vascular access experts and clinicians with experience in PIVC assessment who provide informed consent to participate in the content validity assessment.
• Staff nurses who provide written informed consent to participate in the ‘think aloud’ assessment.
• Patients over 18 years with a peripheral intravenous catheter and able to provide informed verbal consent to participate in PIVC assessments and chart audits
• Patients over 18 years with a peripheral intravenous catheter and able to provide informed written consent to participate in bedside interviews
• Nurses working clinically on the medical and surgical wards where the project will take place, and who provide informed written consent to participate in focus groups
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients admitted for palliative treatment or who are on a care of the dying pathway

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
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Interrupted time-series study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study, designed to ascertain feasibility of conducting a larger study, and as such is not powered for statistical significance. The predicted outcome of implementing this simple but comprehensive tool is an improved experience of IV therapy, early detection of complications, fewer redundant PIVCs, and improved documentation. The current sample size has been based upon predicted participant availability, based on data from the participating hospitals. As the study has already received enthusiastic verbal support from nursing management at each site, staff recruitment to participate in focus groups is unlikely to be difficult. The I-DECIDED tool encourages patient participation in PIVC assessment, and from our group’s previous research in consumer experience of PIVCs, it is likely that the majority of patients will consent to be involved.
• Content validity assessment (T0) = 5–6 vascular access experts and 5-6 clinicians experienced in PIVC assessment
• Think aloud assessments (T0) = 5 staff nurses experienced in PIVC assessment
• PIVC assessments and chart audits: approximately 20 assessments/hospital x 3 hospitals x 8 time-points x 2 phases (T1, T3) = 960.
• Staff focus groups: 4–6 staff/ward x 7 wards x 2 phases (T1, T3) = 48–72 staff
• Patient bedside interviews: 4 patients/ward x 7 wards x 2 phases (T1, T3) = 48 patients

Data analysis
Clinicometric properties (reliability, validity, acceptability, feasibility) of the I-DECIDED tool will be analysed [Cronbach’s alpha (internal consistency), kappa calculations (inter-rater reliability), interclass correlation coefficient (ICC), and content validity index (CVI)] and the tool will be modified accordingly.
CI Ray-Barruel and statistician will have access to the final dataset. Analysis and reporting will follow the SQUIRE 2.0 guidelines. Clinical effectiveness of the I-DECIDED tool will be measured by statistical comparison of prevalence trends (PIVC utilisation, redundancy, all complications, BSI rates, substandard dressings, and missing documentation) across time-points before (n = 8) and after (n = 8) the intervention. Statistical process control (SPC) analysis to assess the effects of the intervention will be used. SPC charts will display data collected at the 16 time-points and indicate patterns of variation over the duration of the study, with built-in thresholds (upper and lower limits) to highlight significant variations in practice, such as seasonal bed occupancy. Bed occupancy data and staffing ratios will be collected on the study screening log at each time-point for this purpose.
Taped interviews with staff and patients will be transcribed and data analysed based on Norwood's framework using an inductive analysis process to allow themes to emerge from the data. Two researchers will independently conduct a simple thematic analysis of the audio transcripts and field notes of the focus groups and bedside interviews. Key themes and concepts will be categorised, and then the researchers will meet to discuss and achieve consensus on the meaning of the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2017
Actual
3/08/2017
Date of last participant enrolment
Anticipated
31/07/2018
Actual
30/10/2018
Date of last data collection
Anticipated
31/07/2018
Actual
30/10/2018
Sample size
Target
1100
Accrual to date
Final
867
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7245 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 7246 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [3] 9757 0
Holy Spirit Northside - Chermside
Recruitment postcode(s) [1] 15014 0
4032 - Chermside
Recruitment postcode(s) [2] 15015 0
4108 - Coopers Plains
Recruitment postcode(s) [3] 18535 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 295307 0
University
Name [1] 295307 0
Griffith University
Country [1] 295307 0
Australia
Funding source category [2] 298395 0
Charities/Societies/Foundations
Name [2] 298395 0
Australian College for Infection Prevention and Control
Country [2] 298395 0
Australia
Primary sponsor type
Individual
Name
Dr Gillian Ray-Barruel
Address
Menzies Health Institute Queensland,
N48, Health Sciences Building
Nathan campus Griffith University
170 Kessels Road
NATHAN QLD 4111
Country
Australia
Secondary sponsor category [1] 294131 0
Individual
Name [1] 294131 0
Professor Claire M Rickard
Address [1] 294131 0
Menzies Health Institute Queensland,
N48, Health Sciences Building
Nathan campus Griffith University
170 Kessels Road
NATHAN QLD 4111
Country [1] 294131 0
Australia
Secondary sponsor category [2] 294132 0
Individual
Name [2] 294132 0
Professor Marie Cooke
Address [2] 294132 0
Menzies Health Institute Queensland,
N48, Health Sciences Building
Nathan campus Griffith University
170 Kessels Road
NATHAN QLD 4111
Country [2] 294132 0
Australia
Secondary sponsor category [3] 294303 0
Individual
Name [3] 294303 0
Professor Marion Mitchell
Address [3] 294303 0
Menzies Health Institute Queensland, N48, Health Sciences Building Nathan campus Griffith University 170 Kessels Road NATHAN QLD 4111
Country [3] 294303 0
Australia
Secondary sponsor category [4] 295945 0
Individual
Name [4] 295945 0
Dr Vineet Chopra
Address [4] 295945 0
University of Michigan Health System and VA Ann Arbor Health System, Ann Arbor, Michigan, USA
Country [4] 295945 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296637 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 296637 0
Office for Research
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111
Ethics committee country [1] 296637 0
Australia
Date submitted for ethics approval [1] 296637 0
17/02/2017
Approval date [1] 296637 0
13/03/2017
Ethics approval number [1] 296637 0
Griffith University (Ref No. 2017/152)
Ethics committee name [2] 296641 0
The Prince Charles Hospital, Metro North Hospital and Health Service Human Research Ethics Committee
Ethics committee address [2] 296641 0
Research, Ethics and Governance Unit,
Building 14,
The Prince Charles Hospital
Rode Road, Chermside QLD 4032
Ethics committee country [2] 296641 0
Australia
Date submitted for ethics approval [2] 296641 0
09/02/2017
Approval date [2] 296641 0
06/03/2017
Ethics approval number [2] 296641 0
HREC/17/QPCH/47
Ethics committee name [3] 299387 0
St Vincent’s Health and Aged Care Human Research and Ethics Committee [EC00324]
Ethics committee address [3] 299387 0
c/o Holy Spirit Northside Private Hospital
627 Rode Road
Chermside QLD 4032
Ethics committee country [3] 299387 0
Australia
Date submitted for ethics approval [3] 299387 0
06/09/2017
Approval date [3] 299387 0
03/11/2017
Ethics approval number [3] 299387 0
17/28

Summary
Brief summary
Aim: To test the effectiveness of an invasive device assessment and removal tool (I-DECIDED) in improving Intravenous (IV) catheter care in hospital patients.
Significance: Each year in Australia, almost 10 million patients are admitted to hospital. Around 70% will need an IV catheter for fluids or medicines. Yet 30-50% of IVs have painful complications or stop working before treatment is finished. Complications leading to failure include infiltration, extravasation, occlusion, accidental removal, or symptoms of phlebitis (pain, redness, swelling, palpable cord, hardness of the vein, red streak along the vein, and/or purulence). The failure of an IV catheter before treatment is completed requires the re-siting of a new device, leading to discomfort for the patient and often delays in treatment. A recent economic analysis of data from a multi-site Queensland randomised trial showed the mean cost of catheter replacement was approximately $70 when staff time and equipment was calculated.
Expected outcomes and benefits: As well as being an assessment tool, the I-DECIDED mnemonic encourages patient participation. I-DECIDED is also an audit and education tool, teaching nurses and doctors the essential components of IV care. A structured and comprehensive approach to IV assessment and care would promote early detection of complications, and prompt removal of IV catheters when no longer needed. This will reduce unnecessary pain and suffering for patients, decrease the risk of potentially deadly bloodstream infection, and reduce treatment delays and hospital costs. This could benefit millions of Australians annually.
Future directions
The proposed study will test the utility of the I-DECIDED tool in guiding assessment and care of peripheral IV catheters. Following the collection of pilot data and feedback from staff and patients, it is likely that the study will be expanded to test the tool for assessing other IV catheters (non-tunnelled central venous catheters, peripherally-inserted central venous catheters) in other hospital units. Additional approvals will be sought at that time, as appropriate.
I will work towards I-DECIDED being implemented in partnership with the Australian Commission of Safety & Quality in Healthcare. I-DECIDED will provide a platform for innovation and research projects in other invasive medical devices, including urinary catheters. The mnemonic I-DECIDED works in Spanish, Portuguese, French and Italian, and could be made global. Nurse collaborators from my existing Australian and international research networks have expressed interest in trialling the I-DECIDED tool.
Trial website
http://www.avatargroup.org.au/i-decided.html
Trial related presentations / publications
Public notes
Attachments [1] 1583 1583 0 0
/AnzctrAttachments/372137-I-DECIDED HREC 17-47 Final Approval (Multi) 06.03.17.pdf (Ethics approval)
Attachments [2] 1872 1872 0 0
/AnzctrAttachments/372137(v29-06-2017-15-01-06)-I-DECIDED HREC 17-47 Final Approval (Multi) 06.03.17.pdf (Ethics approval)
Attachments [3] 2354 2354 0 0
/AnzctrAttachments/372137-HREC_17-28_Approval_20171103.pdf (Ethics approval)
Attachments [4] 2355 2355 0 0
/AnzctrAttachments/372137-I-DECIDED protocol v8.1_01092017.pdf (Protocol)

Contacts
Principal investigator
Name 71606 0
Dr Gillian Ray-Barruel
Address 71606 0
Menzies Health Institute Queensland
N48, Health Sciences Building
Nathan campus. Griffith University
170 Kessels Road
Nathan QLD 4111
Country 71606 0
Australia
Phone 71606 0
+61737358442
Fax 71606 0
Email 71606 0
[email protected]
Contact person for public queries
Name 71607 0
Dr Gillian Ray-Barruel
Address 71607 0
Menzies Health Institute Queensland
N48, Health Sciences Building
Nathan campus. Griffith University
170 Kessels Road
Nathan QLD 4111
Country 71607 0
Australia
Phone 71607 0
+61737358442
Fax 71607 0
Email 71607 0
[email protected]
Contact person for scientific queries
Name 71608 0
Dr Gillian Ray-Barruel
Address 71608 0
Menzies Health Institute Queensland
N48, Health Sciences Building
Nathan campus. Griffith University
170 Kessels Road
Nathan QLD 4111
Country 71608 0
Australia
Phone 71608 0
+61737358442
Fax 71608 0
Email 71608 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
Sharing participant data in a public forum was not included in the university/hospital agreements or ethics approvals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6497Study protocolRay-Barruel G, Cooke M, Mitchell M, Chopra V, Rickard CM. Implementing the I-DECIDED clinical decision-making tool for peripheral intravenous catheter assessment and safe removal: protocol for an interrupted time-series study. BMJ Open. 2018;8.   372137-(Uploaded-18-12-2019-15-51-46)-Study-related document.pdf
6498Informed consent form    372137-(Uploaded-18-12-2019-15-58-50)-Study-related document.pdf
6499Ethical approval    372137-(Uploaded-18-12-2019-16-00-44)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImplementing the I-DECIDED clinical decision-making tool for peripheral intravenous catheter assessment and safe removal: Protocol for an interrupted time-series study.2018https://dx.doi.org/10.1136/bmjopen-2017-021290
EmbaseReduction in 'Just in Case' cannula rates with a structured assessment and decision tool: An interrupted time-series study.2018https://dx.doi.org/10.1016/j.idh.2018.09.038
EmbaseThe impact of a structured assessment and decision tool (I-DECIDED) on improving care of peripheral intravenous catheters: A multicenter, interrupted time-series study.2023https://dx.doi.org/10.1016/j.ijnurstu.2023.104604
N.B. These documents automatically identified may not have been verified by the study sponsor.