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Trial registered on ANZCTR


Registration number
ACTRN12620000373976p
Ethics application status
Submitted, not yet approved
Date submitted
3/03/2020
Date registered
17/03/2020
Date last updated
28/10/2021
Date data sharing statement initially provided
17/03/2020
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 invasive devices in adult hospital patients.
Scientific title
The I-DECIDED® All Devices Study: An interrupted time-series study to test the effectiveness of a device assessment and decision tool in supporting clinical decision-making to improve invasive devices care in acute adult hospital patients
Secondary ID [1] 300709 0
Nil known
Universal Trial Number (UTN)
U1111-1249-1748
Trial acronym
I-DECIDED device assessment and decision tool

IDENTIFY if a device is present
DOES the patient need the device?
EFFECTIVE function?
COMPLICATION-FREE?
INFECTION prevention
DRESSING & Securement
EVALUATE and EDUCATE
DOCUMENT your DECISION
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Invasive medical devices 316523 0
Condition category
Condition code
Infection 314767 314767 0 0
Studies of infection and infectious agents
Cardiovascular 314768 314768 0 0
Other cardiovascular diseases
Renal and Urogenital 314769 314769 0 0
Other renal and urogenital disorders
Public Health 314770 314770 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 device assessment and removal tool in 1 Queensland hospital.
There will be 3 study phases: Baseline (2 months) (T1), Intervention (1 month) (T2), and Evaluation (2 months) (T3).
Total 5 months duration.

T1. Baseline:
Staff will not yet be using the I-DECIDED® tool for all devices; therefore, this comparison will examine the usual practice of device assessment, as documented in the patient’s integrated electronic medical record (iEMR).
• Consultation with key stakeholders (nursing and medical directors, nurse unit managers, nurse educators and clinical facilitators, vascular access experts, infection prevention team) will be conducted to determine current invasive devices policy including education, device assessment tools in use, and required documentation for device surveillance.
• Invasive devices audits: The ReN will audit 5 devices per 5 wards per week for 8 weeks. Using the I-DECIDED® audit tool, the ReN will assess each device for indication, complications, dressing integrity, and documentation. The ReN will ask the patient’s nurse about the functional status of the device. Patients will be asked if the device has been assessed in the past 24 hours, and any concerns will be directed to the patient’s nurse. Data will be entered using hand-held devices and a Queensland Health-supported Microsoft Office Forms database for contemporaneous data entry. The ReN will then audit the patient’s chart for evidence of recent device assessment. Informed verbal consent will be sought from each eligible patient. All eligible patients will be provided with a Participant Information Sheet, and the study will be explained by the ReN and any questions will be addressed. No identifiable patient information will be collected.
• Device utilisation ratios will be calculated.
• Device complication data will be checked through the RiskMan database reports.
• Blood stream infection, CLABSI and CAUTI data will be requested from the hospital infection prevention and management service.

T2. Implementation phase:
The I-DECIDED® tool will be implemented with a multimodal education roll-out (tool, training, iEMR documentation). Weekly 15-minute meetings with key local stakeholders will continue.
• Two extra Project Champions per ward will be identified and trained to support other staff in the use of the tool and facilitate implementation. Champions will attend a one-off 30-minute face-to-face training session with the nurse educators with support from CI Ray-Barruel. During this time, Champions will watch a 15-minute training webinar and have a 15-minute discussion period with time for questions. Further training will be provided if requested.
• During the first two weeks of T2, two weekly 30-minute face-to-face education sessions for ward staff will be provided by hospital educators, clinical facilitators and Project Champions, with support from CI Ray-Barruel. Educational materials (webinar, posters, lanyard cards, etc.) will be provided to all wards.
• Nurses will be asked to assess “Every day, Every patient, Every device”, using the I-DECIDED® tool, and document their assessment and device plan in the patient’s iEMR.
• Medical staff will be asked to consider line removal (“Every day, Every patient, Every device”) as part of their routine medical assessment.
• Data collection will not occur during this phase.

T3. Evaluation phase:
During this period the I-DECIDED® tool will continue to be used by staff to conduct invasive devices assessments. Nurses will continue to assess all invasive devices using the I-DECIDED® tool and document their assessment and device plan in the patient’s iEMR. Medical staff will continue to consider device removal as part of their routine medical assessment. Weekly 15-minute meetings with key local opinion leaders will continue, and ongoing education and audit feedback to staff will be provided.
• Invasive devices audits, as per T1
• Device utilisation ratios will be calculated, as per T1
• Device complication data will be checked through the RiskMan database reports.
• Blood stream infection, CLABSI and CAUTI data will be reviewed, as per T1.
• 30 minute Focus groups with staff (in a quiet room away from the clinical area) will investigate the acceptability and feasibility of the I-DECIDED® tool for all devices. Informed written consent will be sought from focus group participants.

Intervention code [1] 317032 0
Other interventions
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323120 0
Prevalence of idle devices: Idle device is defined as a temporary invasive device with no medical indication for the past 24–48 hours or anticipated use in next 24–48 hours, as indicated in the patient chart.
Timepoint [1] 323120 0
Weekly data collection during T1 and T3.
Primary outcome [2] 323121 0
Prevalence of device complications, as reported in patient chart or RiskMan database.
Known potential complications or adverse events related to all invasive devices include patient discomfort, dislodgement, occlusion, pressure injury, or medical adhesive related skin injury (MARSI). Vascular access devices may also result in infiltration, extravasation, bleeding and nerve damage.
Timepoint [2] 323121 0
Weekly data collection during T1 and T3.
Secondary outcome [1] 380856 0
Prevalence of confirmed device-related infection, as per the hospital Infection Management reports, including prevalence of CLABSI, CAUTI, and S. aureus bacteraemia BSI.
Timepoint [1] 380856 0
Weekly data collection during T1 and T3.
Secondary outcome [2] 380996 0
Central line device utilisation ratios will be calculated as catheter-days divided by patient days.
Timepoint [2] 380996 0
Weekly data collection during T1 and T3.
Secondary outcome [3] 380997 0
Indwelling urinary catheters device utilisation ratios will be calculated as catheter-days divided by patient days.
Timepoint [3] 380997 0
Weekly data collection during T1 and T3.
Secondary outcome [4] 380998 0
PIVC device utilisation ratios will be calculated as number of PIVCs per total number of patients per ward, and number of PIVCs per patient
Timepoint [4] 380998 0
Weekly data collection during T1 and T3.
Secondary outcome [5] 380999 0
Staff focus group feedback on usability of I-DECIDED® tool and the barriers and enablers to device assessment and decision making
Timepoint [5] 380999 0
During the final month of T3.
Secondary outcome [6] 381000 0
Proportion of days where a device plan was documented in the iEMR.
Timepoint [6] 381000 0
Weekly data collection during T1 and T3.

Eligibility
Key inclusion criteria
• Patients over 18 years with an invasive device and able to provide informed verbal consent to participate in device audits.
• Nurses and medical staff 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
• Patients with any communication or linguistic difficulties.
• Patients admitted for palliative treatment.

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
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 (device necessity, 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.

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. Key themes and concepts will be categorised, and the researchers will meet to discuss and achieve consensus on the meaning of the data.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
6/07/2020
Actual
Date of last participant enrolment
Anticipated
27/11/2020
Actual
Date of last data collection
Anticipated
27/11/2020
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16058 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 29570 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 305154 0
University
Name [1] 305154 0
Griffith University
Country [1] 305154 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] 305513 0
Individual
Name [1] 305513 0
Professor Claire M Rickard
Address [1] 305513 0
Menzies Health Institute Queensland,
N48, Health Sciences Building
Nathan campus Griffith University
170 Kessels Road
NATHAN QLD 4111
Country [1] 305513 0
Australia
Secondary sponsor category [2] 305514 0
Individual
Name [2] 305514 0
Dr Vineet Chopra
Address [2] 305514 0
University of Michigan North Campus Research Complex
2800 Plymouth Road,
Building 16, Room 432W
Ann Arbor MI 48109-2800
USA
Country [2] 305514 0
United States of America
Other collaborator category [1] 281223 0
Individual
Name [1] 281223 0
Ms Tain Gardiner
Address [1] 281223 0
Queen Elizabeth II Jubilee Hospital
Cnr Troughton and Kessels Roads
Coopers Plains QLD 4108
Country [1] 281223 0
Australia
Other collaborator category [2] 281224 0
Individual
Name [2] 281224 0
Mrs Angela Fergusson
Address [2] 281224 0
Queen Elizabeth II Jubilee Hospital
Cnr Troughton and Kessels Roads
Coopers Plains QLD 4108
Country [2] 281224 0
Australia
Other collaborator category [3] 281225 0
Individual
Name [3] 281225 0
Prof Marie Cooke
Address [3] 281225 0
Menzies Health Institute Queensland,
N48, Health Sciences Building
Nathan campus Griffith University
170 Kessels Road
NATHAN QLD 4111
Country [3] 281225 0
Australia
Other collaborator category [4] 281226 0
Individual
Name [4] 281226 0
Prof Marion Mitchell
Address [4] 281226 0
Menzies Health Institute Queensland,
N48, Health Sciences Building
Nathan campus Griffith University
170 Kessels Road
NATHAN QLD 4111
Country [4] 281226 0
Australia
Other collaborator category [5] 281227 0
Individual
Name [5] 281227 0
Dr Min-Lin Wu
Address [5] 281227 0
Menzies Health Institute Queensland,
N48, Health Sciences Building
Nathan campus Griffith University
170 Kessels Road
NATHAN QLD 4111
Country [5] 281227 0
Australia
Other collaborator category [6] 282040 0
Individual
Name [6] 282040 0
Dr Andrew Henderson
Address [6] 282040 0
Infection Prevention and Management Service
QEII Jubilee Hospital
Cnr Kessles and Troughton Roads
Coopers Plains QLD 4108
Country [6] 282040 0
Australia
Other collaborator category [7] 282041 0
Individual
Name [7] 282041 0
Ms Nicola Robinson
Address [7] 282041 0
Clinical Nurse Consultant
Infection Prevention and Management Service
QEII Jubilee Hospital
Cnr Kessels and Troughton Roads
Coopers Plains QLD 4108
Country [7] 282041 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305520 0
Metro South Health Service District HREC
Ethics committee address [1] 305520 0
Ethics committee country [1] 305520 0
Australia
Date submitted for ethics approval [1] 305520 0
03/11/2020
Approval date [1] 305520 0
Ethics approval number [1] 305520 0
Ethics committee name [2] 305521 0
Griffith University HREC
Ethics committee address [2] 305521 0
Ethics committee country [2] 305521 0
Australia
Date submitted for ethics approval [2] 305521 0
03/11/2020
Approval date [2] 305521 0
Ethics approval number [2] 305521 0

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

Contacts
Principal investigator
Name 100654 0
Dr Gillian Ray-Barruel
Address 100654 0
Menzies Health Institute Queensland
N48_2.21 Health Sciences Building
Nathan campus. Griffith University
170 Kessels Road
Nathan QLD 4111
Country 100654 0
Australia
Phone 100654 0
+61 409384964
Fax 100654 0
Email 100654 0
g.ray-barruel@griffith.edu.au
Contact person for public queries
Name 100655 0
Gillian Ray-Barruel
Address 100655 0
Menzies Health Institute Queensland
N48_2.21 Health Sciences Building
Nathan campus. Griffith University
170 Kessels Road
Nathan QLD 4111
Country 100655 0
Australia
Phone 100655 0
+61 409384964
Fax 100655 0
Email 100655 0
g.ray-barruel@griffith.edu.au
Contact person for scientific queries
Name 100656 0
Gillian Ray-Barruel
Address 100656 0
Menzies Health Institute Queensland
N48_2.21 Health Sciences Building
Nathan campus. Griffith University
170 Kessels Road
Nathan QLD 4111
Country 100656 0
Australia
Phone 100656 0
+61 409384964
Fax 100656 0
Email 100656 0
g.ray-barruel@griffith.edu.au

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 is not included in the university/hospital agreements or ethics approvals.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7373Informed consent form    379399-(Uploaded-17-03-2020-12-04-23)-Study-related document.pdf



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.