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Trial registered on ANZCTR


Registration number
ACTRN12618001869268p
Ethics application status
Not yet submitted
Date submitted
18/10/2018
Date registered
16/11/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient power: Feasibility of a notepad-based intervention to encourage patients to ask questions about their care
Scientific title
Patient power: Feasibility study of a notepad-based intervention to encourage joint replacement surgery patients to ask questions about their care
Secondary ID [1] 296267 0
None
Universal Trial Number (UTN)
U1111-1221-7153
Trial acronym
na
Linked study record
na

Health condition
Health condition(s) or problem(s) studied:
Post-operative care 309945 0
Health literacy 310421 0
Condition category
Condition code
Surgery 308718 308718 0 0
Other surgery
Musculoskeletal 308719 308719 0 0
Other muscular and skeletal disorders
Public Health 309136 309136 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of providing patients undergoing hip or knee replacements with a notepad designed to help patients identify and feel comfortable asking questions about their care. The notepads will be provided to patients when they check in to have their surgery completed. The notepad is designed to be placed in reaching distance of their bed, durable, easy for patients to use, and to help patients record questions when no-one is around so they don't forget. It will provide patients with example questions, and will provide a place for patients to record their questions as they think of them. The example questions will be the same for both hip and knee replacements, and indicatively include questions such as, 'Are there any problems with how the wound is healing?', 'Is my joint movement progressing appropriately?', and, 'What are the signs of infection?'.

Compliance with the intervention will be assessed at the end of the trial by comparing the total number of patients with the number of notebooks collected.
Intervention code [1] 312603 0
Behaviour
Intervention code [2] 312605 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307695 0
Number of questions recorded in notepad, as counted by researchers.
Timepoint [1] 307695 0
On discharge. Participating patients will leave completed notepad pages with research staff when they leave the hospital.
Primary outcome [2] 307696 0
Types of questions recorded in notepad. These will be generated by conducting thematic analysis on the questions recorded in notepads. If non-English language questions are recorded, these will be translated prior to analysis.
Timepoint [2] 307696 0
On discharge. Participating patients will leave completed notepad pages with the researchers when they leave the hospital.
Primary outcome [3] 307697 0
Self-reported measures of patients' perceptions about the notepad (e.g. liked the notepad, found it useful, felt it helped them to feel more able to ask questions). Survey questions designed specifically for this study. These survey items will be analysed using exploratory factor analysis prior to analysis and, where possible, composite multi-item scale(s) will be computed that measure each of the factors identified.
Timepoint [3] 307697 0
On discharge. Participating patients will be asked to complete a survey immediately before leaving the hospital.
Secondary outcome [1] 352593 0
Adapted Brief Health Care Climate Questionnaire scores.

Reference: Shumway, D., Griffith, K. A., Jagsi, R., Gabram, S. G., Williams, G. C., & Resnicow, K. (2015). Psychometric properties of a brief measure of autonomy support in breast cancer patients. BMC Medical Informatics and Decision Making, 15(1), 51.
Timepoint [1] 352593 0
On discharge. Participating patients will be asked to complete a survey immediately before leaving the hospital.
Secondary outcome [2] 353062 0
Clinicians' feedback on the notepad tool. This outcome will be captured qualitatively using open-ended survey questions specifically designed for this study.
Timepoint [2] 353062 0
Survey to be completed by clinicians immediately after the trial period.
Secondary outcome [3] 353992 0
Clinicians' perceptions about how, if at all, the notepad tool influence care. This outcome will be captured qualitatively using open-ended survey questions specifically designed for this study.
Timepoint [3] 353992 0
Survey to be completed by clinicians immediately after the trial period.

Eligibility
Key inclusion criteria
All patients undergoing hip or knee replacement surgery at the trial hospital will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not have sufficient mental capacity to consent will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable; this is not a randomised controlled trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a pragmatic uncontrolled feasibility study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For quantitative outcomes, descriptive statistics will be reported. For qualitative outcomes, thematic analysis will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12113 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 24281 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 300861 0
Government body
Name [1] 300861 0
Victorian Managed Insurance Authority
Address [1] 300861 0
161 Collins St, Melbourne, Victoria, 3000
Country [1] 300861 0
Australia
Primary sponsor type
University
Name
Monash University
Address
8 Scenic Blvd, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 300417 0
Hospital
Name [1] 300417 0
Frankston Hospital
Address [1] 300417 0
2 Hastings Rd, Frankston, Victoria, 3199
Country [1] 300417 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301636 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 301636 0
Office for Research
Peninsula Health
PO Box 52
Frankston VIC 3199
Ethics committee country [1] 301636 0
Australia
Date submitted for ethics approval [1] 301636 0
29/10/2018
Approval date [1] 301636 0
Ethics approval number [1] 301636 0
Ethics committee name [2] 301646 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 301646 0
Monash Research Office
26 Sports Walk
Monash University
Wellington Road
Clayton, Victoria, 3800
Ethics committee country [2] 301646 0
Australia
Date submitted for ethics approval [2] 301646 0
26/11/2018
Approval date [2] 301646 0
Ethics approval number [2] 301646 0

Summary
Brief summary
Patient engagement can result in the improvement of health outcomes, reduced healthcare costs and increased patient satisfaction. However, shortcomings in communication of care processes, treatment expectations and possible side effects from health professionals to patients persist. This project aims to test a behaviour change strategy involving the use of a specialised notepad to enhance the patient voice in early post-operative wound care. The notepad will be co-designed by patients, researchers, and hospital clinicians, It will provide patients with example questions, and will provide a place for patients to record their questions as they think of them, It will be provided to patients undergoing hip or knee replacement surgery at Frankston Hospital in Victoria, Australia.
Trial website
na
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87614 0
Dr Breanna Wright
Address 87614 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 87614 0
Australia
Phone 87614 0
+61 4 2231 6401
Fax 87614 0
Email 87614 0
breanna.wright@monash.edu
Contact person for public queries
Name 87615 0
Dr Breanna Wright
Address 87615 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 87615 0
Australia
Phone 87615 0
+61 4 2231 6401
Fax 87615 0
Email 87615 0
breanna.wright@monash.edu
Contact person for scientific queries
Name 87616 0
Dr Nicholas Faulkner
Address 87616 0
BehaviourWorks Australia, 8 Scenic Blvd, Monash University, Clayton, Victoria, 3800
Country 87616 0
Australia
Phone 87616 0
+61 3 99052712
Fax 87616 0
Email 87616 0
nicholas.faulkner@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient notepad data will not be made publicly available due to the high risk of it containing identifiable and sensitive personal information.

Patient survey data will be made publicly available, but any identifiable information provided in open-ended questions will be redacted.

Clinician survey data will be made publicly available.
What supporting documents are/will be available?
Study protocol
Attachments/websites
Type [1] 266 0
Study protocol
URL/details/comments [1] 266 0
A protocol is being prepared for publication.
Attachment [1] 266 0
Summary results
Not applicable