Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001696886
Ethics application status
Approved
Date submitted
30/09/2021
Date registered
10/12/2021
Date last updated
26/05/2023
Date data sharing statement initially provided
10/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of patient information cards on surgical patient comprehension and communication support
Scientific title
Assessing the effect of patient information cards on urological surgical patient comprehension and communication support (ISComS).
Secondary ID [1] 305445 0
None
Universal Trial Number (UTN)
Trial acronym
ISComS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urological surgical procedures 323820 0
Condition category
Condition code
Cancer 321320 321320 0 0
Bladder
Cancer 321321 321321 0 0
Kidney
Cancer 321322 321322 0 0
Prostate
Cancer 321323 321323 0 0
Testicular
Cancer 321324 321324 0 0
Penile (penis)
Renal and Urogenital 321325 321325 0 0
Kidney disease
Renal and Urogenital 321326 321326 0 0
Other renal and urogenital disorders
Surgery 321327 321327 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess and improve the knowledge and comprehension of surgical patients regarding their care in John Hunter Hospital Urology department- including diagnosis, planned investigations, estimated discharge date and follow up plan.
Intervention group- given routine care with the addition of a patient information card on the first post-admission morning ward round. The patient information card is updated by the team in collaboration with the patient on ward rounds or other clinical reviews throughout their admission so that question raised by the patient can be answered.
The front of the card is a picture of Urological system with what each organ is and then a space for "Questions to ask my doctor"
The back of the card has My Doctor: (answer)
My diagnosis: (Answer)
Planned tests and procedures: (answer)
My follow up: (answer)
Contact numbers
This card has been specifically designed for this study.
The patient can update this daily and answered daily by team
It is a printed card
The card lasts for the duration of admission
At least one of the investigators are on the team ward rounds everyday and instigates this process maintaining adherence.
Routine care: is the usual care that anyone having for example bladder surgery will receive. Same tests, surgeries, post operative care. The only difference is one group will receive the patient card.
As stated in the protocol Inclusion: would have the documents translated into another language as like routine clinical care would include translators. Patients who identify as Indigenous would be offered the assistance of an Indigenous liaison officer.
Intervention code [1] 321836 0
Treatment: Other
Comparator / control treatment
routine clinical care
Control group
Active

Outcomes
Primary outcome [1] 329103 0
Patients’ knowledge of their admitting diagnosis, procedures or interventions, the name of their treating doctor and follow up plans (compared to the medical record)
--> We plan to measure this as an objective score out of four (diagnosis, procedures, doctor name (any name of the treating team accepted), planned follow up) compared to the medical record
Timepoint [1] 329103 0
At discharge
Primary outcome [2] 329684 0
2. Patient satisfaction with:
a. Communication practices of medical team and information provided during admission (Likert scale scoring and visual analogue scale (0-100)
b. Overall inpatient care (Likert scale and open feedback).
We aim to then compare the results between the information card and no information card groups.
Timepoint [2] 329684 0
At discharge
Secondary outcome [1] 401490 0
Minutes spent with patients on day 1.• Ward round checklist completed for at least one day during inpatient stay, with the use of a template sticker in the patient notes. This will be timed by a stopwatch and documented in patient ward round notes and then added in to database by investigative team.
Timepoint [1] 401490 0
post admission ward round
Secondary outcome [2] 401491 0
Relevant data will be obtained by the treating team members from the digital medical records of patients held at JHH by accessing the Clinical Applications Portal (CAP). Collected information will be entered into a REDCap database and will consist of the following items, as assessed by the medical record post-discharge for baseline demographics and comparison with patient reported outcome measures:
• Age (years)
• Sex
• Diagnosis
• Investigations completed during admission and indication
• Length of stay (days)
• Admitting consultant
• Follow up planned
Timepoint [2] 401491 0
At discharge
Secondary outcome [3] 403444 0
Data collected by survey: Patient completion of the following (see attached proposed post-admission and upon discharge surveys) for patient reported outcome measures:
• Diagnosis
• Investigations planned/completed
• Treating consultant or registrar
• Follow up planned
• Understanding of medical diagnosis and care provided
• Satisfaction with care provided
• Opportunity for open feedback- with the option to instead submit an anonymous formal complaint or compliment form to the hospital associated with this if that is their preference.
Timepoint [3] 403444 0
Admission and at discharge

Eligibility
Key inclusion criteria
All patients aged 18 years and over who are admitted under the Urology team at JHH and Royal North Shore Hospital urology wards.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that are not willing to contribute their information to the study will be excluded from participation. Furthermore, patients deemed to lack competency from a medical standpoint (including dementia, delirium and acute mental illness) and non-literate patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
random computer-generated allocation-assigned by an investigator on the clinical team
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The pilot recruited 40 patients as planned. and then has moved to an RCT. The pilot was only set up to see if the study worked and it did, so nothing in the protocol changed except the inclusion of a sample size. The design of the study involves a control group and an intervention group, where the latter receives a written patient information card. To assess the main outcome (comprehension), at admission, and again at discharge, each participant will be asked four primary questions, and the number of correct answers recorded.

The primary study objective is to assess whether the mean change in number of correct answers differs between the two groups, and within each group between admission and discharge.

Testing at a 5% significance level, with power 0.95, and assuming the standard deviation of the paired differences of number of correct answers (between discharge and admission) is 0.5 for each group, the required sample size to detect a mean difference between groups of 0.4 is 84 (42 per group).
The secondary aim is to assess whether patient satisfaction scores differ between the intervention and control groups.

Testing at a 5% significance level, with power 0.95, and assuming the standard deviation of scores is 5 for each group, the required sample size to detect a mean difference between groups of 5 is 54 (27 per group), thus the larger sample size of 84 will support the secondary aim.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
14/03/2022
Date of last participant enrolment
Anticipated
28/02/2022
Actual
14/11/2022
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
84
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20642 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 24810 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 35431 0
2305 - New Lambton
Recruitment postcode(s) [2] 40457 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 309803 0
Hospital
Name [1] 309803 0
Urological Department
Country [1] 309803 0
Australia
Funding source category [2] 313948 0
Hospital
Name [2] 313948 0
Royal North Shore Hospital
Country [2] 313948 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
John Hunter Hospital,
Locked Bag No 1,
Hunter Region Mail Centre NSW 2310
Australia
Country
Australia
Secondary sponsor category [1] 311491 0
None
Name [1] 311491 0
Address [1] 311491 0
Country [1] 311491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309550 0
The Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309550 0
Ethics committee country [1] 309550 0
Australia
Date submitted for ethics approval [1] 309550 0
13/08/2021
Approval date [1] 309550 0
14/10/2021
Ethics approval number [1] 309550 0
2021/ETH11122

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

Contacts
Principal investigator
Name 114554 0
Dr Alison Blatt
Address 114554 0
John Hunter Hospital,
Department of Urology
Locked Bag No 1,
Hunter Region Mail Centre
NSW 2310 Australia
Country 114554 0
Australia
Phone 114554 0
+61 0413586994
Fax 114554 0
+61 2 4921 4274
Email 114554 0
[email protected]
Contact person for public queries
Name 114555 0
Natalie Lott
Address 114555 0
John Hunter Hospital,
Division of Surgery
Locked Bag No 1
Hunter Region Mail Centre
NSW 2310 Australia
Country 114555 0
Australia
Phone 114555 0
+61 0418215968
Fax 114555 0
+61 2 4921 4274
Email 114555 0
[email protected]
Contact person for scientific queries
Name 114556 0
Natalie Lott
Address 114556 0
John Hunter Hospital,
Division of Surgery
Locked Bag No 1
Hunter Region Mail Centre
NSW 2310 Australia
Country 114556 0
Australia
Phone 114556 0
+61 0418215968
Fax 114556 0
+61 2 4921 4274
Email 114556 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
Still to be determined


What supporting documents are/will be available?




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.