Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001119987p
Ethics application status
Submitted, not yet approved
Date submitted
2/09/2020
Date registered
29/10/2020
Date last updated
29/10/2020
Date data sharing statement initially provided
29/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating patient experiences and healthcare providers' awareness of use of indwelling urinary catheters in hospital
Scientific title
Duration and appropriateness of indwelling urinary catheters in hospital inpatients: Capturing patients’ experience and healthcare providers’ awareness. A cross-sectional study
Secondary ID [1] 302222 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary tract infection 318917 0
Condition category
Condition code
Infection 316898 316898 0 0
Studies of infection and infectious agents
Public Health 317232 317232 0 0
Health service research
Renal and Urogenital 317233 317233 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross-sectional study: one observation per participant.

This research project aims to (1) assess the patient experience of having an indwelling urinary catheter (IDC); and (2) identify any knowledge or practice gaps in healthcare provider awareness of IDC appropriateness at QEII Jubilee Hospital.
Furthermore, this project seeks to evaluate the overall incidence of IDC-related complications from adverse events and/or infection at QEII Jubilee Hospital, captured in RiskMan and/or Auslab data.
We aim to obtain a sample size of about 200 patient participants. The hospital has 190 inpatient beds, with approximately 25% having an IDC at any given time. Screening of the iEMR for patients with an IDC will be conducted Monday–Friday for one month. Patients can only be recruited once, regardless of the number of catheterisations.

Inpatients with an IDC will first be identified via a daily report generated from the integrated
electronic medical record (iEMR), and these patients will be approached individually to
confirm the continued presence of an IDC. The investigator will introduce themselves as part
of the study team (not the treating team), provide a participant information sheet, briefly
explain the study aims and objectives, and seek the patient’s consent to participate in a
questionnaire about their experience with the IDC. The patient will be given time (up to 30
minutes) to read the information sheet and ask any questions. If the patient agrees to
participate, written consent will be obtained. If the patient declines to participate, no
information will be collected.
Questionnaire data will be collected on paper. The investigator will ask the patient 10
questions about the patient’s experience of having the IDC (Patient data collection form,
v1.0, 20 August 2020). Patient age and gender will be collected. The last four numbers of the
unit record number will be collected to enable matching of patient and healthcare provider
feedback, but these will be removed from the data and destroyed once the matched data has
been collected. No other identifying patient details will be collected. The patient questionnaire should take 5–10 minutes to complete over a single session.

Next, the investigator will identify the healthcare providers (medical and/or nursing staff)
with responsibility for the patient with the IDC. The investigator will separately interview
each member of the patient’s medical team and nursing staff, as available. The investigator
will explain the study aims and objectives to the provider, provide a participant information sheet, and seek their consent to participate in a questionnaire about the patient’s IDC. The
healthcare provider will be given up to 5 minutes to read the information sheet and ask any
questions. If the provider agrees to participate, written consent will be obtained. If the
provider declines to participate, no information will be collected. Provider communication
will occur on the same day as near as possible to the patient visit to ensure temporal
congruence of findings. No patient care will be interrupted to facilitate this study.
Questionnaire data will be collected on paper. The investigator will ask the healthcare
provider 8 questions about the patient’s experience of having the IDC (Staff data collection
form, v1.0, 20 August 2020). Provider category (medical/nursing) and role designation will
be recorded, but no identifying personal details will be collected. Providers will not be
allowed to view medical records or examine the patient during the questionnaire. If the
provider is unsure of any responses, they will be offered the opportunity to further elaborate
on any reasons for lack of IDC awareness. The health provider questionnaire should take 5 minutes to complete over a single session.

Healthcare providers’ responses will be matched to the patient’s responses and iEMR
documentation (date of IDC insertion; indication for IDC).

Anonymous CAUTI data will be sourced from the hospital Infection Prevention and
Management Service monthly report.
Intervention code [1] 318513 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325000 0
Prevalence of healthcare provider awareness of IDC assessed by completion of the healthcare provider questionnaire.
Timepoint [1] 325000 0
Assessed once per patient for study duration (1 month)
Primary outcome [2] 325001 0
Prevalence of healthcare provider knowledge of indications of IDC assessed by completion of the healthcare provider questionnaire.
Timepoint [2] 325001 0
Assessed once per patient for study duration (1 month)
Primary outcome [3] 325002 0
Prevalence of patient awareness of indications for IDC assessed by completion of the patient questionnaire.
Timepoint [3] 325002 0
Assessed once per patient for study duration (1 month)
Secondary outcome [1] 386524 0
Prevalence of patients who are satisfied with their catheter assessed by completion of the patient questionnaire.
Timepoint [1] 386524 0
Assessed once per patient for study duration (1 month)
Secondary outcome [2] 386525 0
Prevalence of patients who express concerns with their IDC assessed by completion of the patient questionnaire.
Timepoint [2] 386525 0
Assessed once per patient for study duration (1 month)
Secondary outcome [3] 386526 0
Prevalence of patients who are reluctant to ask if the IDC can be removed assessed by completion of the patient questionnaire.
Timepoint [3] 386526 0
Assessed once per patient for study duration (1 month)
Secondary outcome [4] 386527 0
Prevalence of patients who experience adverse events with their IDC assessed by completion of the patient questionnaire. (i.e. patient self-report)
The questionnaire asks patients "Did you have any symptoms or problems during the insertion of the catheter? If yes, please comment:" and "Do you currently have any concerns or problems with the catheter? If yes, please comment:"
This is a patient-focussed questionnaire. Therefore whatever symptoms the patients report will be noted. (e.g. 'blood in urine', 'burning sensation' etc.). (We do not expect patients to use medical jargon such as 'bacteriuria', 'haematuria', etc.)
Timepoint [4] 386527 0
Assessed once per patient for study duration (1 month)
Secondary outcome [5] 386528 0
Prevalence of catheter-associated urinary tract infection (CAUTI) during the study period (1 month)
Timepoint [5] 386528 0
Daily infection control data will be obtained from hospital database for the study duration (1 month)
Secondary outcome [6] 387434 0
Staff awareness of any patient concerns with the IDC, as assessed by completion of the healthcare provider questionnaire.
Timepoint [6] 387434 0
Assessed once per patient for study duration (1 month)

Eligibility
Key inclusion criteria
1. Medical or surgical inpatients aged 18 years or older with IDC in situ for more than 48 hours.

2. Healthcare providers (senior medical officers, registrar/principal house officers, senior house officers, junior house officers, interns, medical students, nursing staff) who hold direct responsibility for their patients on inpatient care teams.
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 elective short stay
2. Palliative care and intensive care patients
3. Patients with cognitive impairment or communication difficulties
4. Patients with IDC inserted prior to hospital admission
5. Long-term indwelling catheters for irreversible chronic disease (neurological conditions/bladder outlet obstruction/urethral strictures/cerebral palsy, etc.)

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics for patient (age, gender, specialty) and provider characteristics (role designation) will be used to define study samples.
Results will be depicted as percentage of provider-patient observations that were incorrect about the presence of an IDC. This percentage will also be assessed after stratifying by the level of training (senior medical officer, registrar/principal house officer, senior house officer, junior house officer, intern, student and nurses), patient age and sex, and the appropriateness of catheterisation. Given the categorical nature of the data, differences among provider types and training levels will be compared using chi-square test; two-sided testing with P < 0.05 will be considered significant in this analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2020
Actual
Date of last participant enrolment
Anticipated
11/12/2020
Actual
Date of last data collection
Anticipated
11/12/2020
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17424 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 31152 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 306645 0
Hospital
Name [1] 306645 0
Queen Elizabeth II Jubilee Hospital
Country [1] 306645 0
Australia
Primary sponsor type
Individual
Name
Dr Haesel Tan Li Yeen
Address
Cnr Troughton and Kessels Roads, Coopers Plains, QLD 4108
Country
Australia
Secondary sponsor category [1] 307194 0
Individual
Name [1] 307194 0
Dr Gillian Ray-Barruel
Address [1] 307194 0
Griffith University School of Nursing and Midwifery
170 Kessels Road, N48_2.12
Nathan QLD 4111
Country [1] 307194 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306827 0
Metro South HREC
Ethics committee address [1] 306827 0
Ethics committee country [1] 306827 0
Australia
Date submitted for ethics approval [1] 306827 0
03/09/2020
Approval date [1] 306827 0
Ethics approval number [1] 306827 0
Ethics committee name [2] 306829 0
Griffith University HREC
Ethics committee address [2] 306829 0
Ethics committee country [2] 306829 0
Australia
Date submitted for ethics approval [2] 306829 0
01/10/2020
Approval date [2] 306829 0
Ethics approval number [2] 306829 0

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

Contacts
Principal investigator
Name 105150 0
Dr Haesel Tan Li Yeen
Address 105150 0
Principal House Officer,
QEII Jubilee Hospital
Cnr Troughton and Kessels Roads
Coopers Plains QLD 4108
Country 105150 0
Australia
Phone 105150 0
+61 0432189933
Fax 105150 0
Email 105150 0
[email protected]
Contact person for public queries
Name 105151 0
Haesel Tan Li Yeen
Address 105151 0
Principal House Officer,
QEII Jubilee Hospital
Cnr Troughton and Kessels Roads
Coopers Plains QLD 4108
Country 105151 0
Australia
Phone 105151 0
+61 0432189933
Fax 105151 0
Email 105151 0
[email protected]
Contact person for scientific queries
Name 105152 0
Haesel Tan Li Yeen
Address 105152 0
Principal House Officer,
QEII Jubilee Hospital
Cnr Troughton and Kessels Roads
Coopers Plains QLD 4108
Country 105152 0
Australia
Phone 105152 0
+61 0432189933
Fax 105152 0
Email 105152 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
No plans to share individual participant data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9031Study protocolTan Yi Leen, H., Ray-Barruel, G., Henderson, A., Fergusson, A., Smith, A. Duration and appropriateness of indwelling urinary catheters in hospital inpatients: Capturing patients’ experience and healthcare providers’ awareness. A cross-sectional study (Protocol v1, 20 August 2020). [email protected] 380523-(Uploaded-02-09-2020-16-36-38)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Indwelling urinary catheterisation can be a painfu... [More Details]

Documents added automatically
No additional documents have been identified.