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Trial registered on ANZCTR


Registration number
ACTRN12622001260718p
Ethics application status
Submitted, not yet approved
Date submitted
15/09/2022
Date registered
21/09/2022
Date last updated
21/09/2022
Date data sharing statement initially provided
21/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a co-designed consumer engagement intervention on medication safety in cancer services for ethnic minority consumer
Scientific title
Investigating the effect of a co-designed consumer engagement intervention on medication safety in cancer services for ethnic minority consumers: A protocol for a pilot feasibility and acceptability study
Secondary ID [1] 307959 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medication communication in cancer care 327616 0
medication literacy 327661 0
cancer 327662 0
Condition category
Condition code
Cancer 324729 324729 0 0
Any cancer
Public Health 324746 324746 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Making it Meaningful (MiM) Intervention
Making it Meaningful (MiM) is a co-designed paper-based medication management tool that aims to increase patient and family member’s ability to make contact with healthcare staff between appointments and following hospital discharge in order to raise concerns about their medications. The co-design process was conducted with staff and patients from the study site in late 2021.
The MiM is an adaptation of an existing medication management tool used in NSW cancer services that provides translated information about medication side effects, in plain language and using images in order to meet the needs of populations with low English language proficiency. The MIM provides clear information about common side effects tailored for the individual patient and who to contact, including contact details if certain side effects or concerns arise when the patient is not at the health service.
Participants will be randomly allocated to the intervention or control group. Participants in the intervention group will attend their usual hospital or clinic consultation or appointment. The health practitioner (nurse or medical practitioner) will use Make it Meaningful Tool (MIM) to facilitate communication at the individual appointment where medications are changed or at discharge from hospital. We do not anticipate that using the MIM will add any additional time to existing appointments. The health care practitioner will provide a paper copy of the MiM for the patient to take away from the appointment to inform the patient of appropriate contacts if concerns or side effects arise.
Intervention code [1] 324415 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will receive usual care from their health care practitioner, which includes communication about medications using the existing medication management tool available in the participating service at an appointment where medications are changed or at discharge from hospital. The current tool in use is a paper based medication chart printed in English and available at hospital discharge.
Control group
Active

Outcomes
Primary outcome [1] 332523 0
Patient knowledge of medications and their side effects will be measured using survey questions developed for this study as no appropriate validated measure could be located.


Timepoint [1] 332523 0
Patient survey at baseline,1 week and 4 weeks after intervention.
Primary outcome [2] 332549 0
Suitability of trial recruitment, retention and data collection materials and processes will be measure by semi-structured qualitative telephone interview with staff.
Timepoint [2] 332549 0
Practitioner interview at trial completion (12 months) or when practitioner leaves the study
Primary outcome [3] 332550 0
Patient knowledge of how to contact the health service regarding medication concerns will be measured using survey questions developed for this study as no appropriate validated measure could be located.
Timepoint [3] 332550 0
Baseline, 1 week and 4 weeks post intervention
Secondary outcome [1] 413813 0
Patient perceptions of the safety of their care will be measured survey questions developed for this study as no appropriate validated measure could be located.
Timepoint [1] 413813 0
Patient survey at baseline, 1 week and 4 weeks after intervention
Secondary outcome [2] 413879 0
Patient self-efficacy to contact the service about medication concerns will be measured usingsurvey questions developed for this study as no appropriate validated measure could be located.
Timepoint [2] 413879 0
Baseline, 1 week and 4 weeks post intervention
Secondary outcome [3] 413880 0
Patient engagement in medication management will be measured using survey questions developed for this study as no appropriate validated measure could be located.
Timepoint [3] 413880 0
baseline,1 week and 4 weeks post intervention
Secondary outcome [4] 414004 0
When administering final patient questionnaire via telephone, researchers will also give patients will also provide patients opportunity to reflect on the recruitment and data collection process. (primary outcome)
Timepoint [4] 414004 0
Patient data collection 4 weeks post intervention.

Eligibility
Key inclusion criteria
Inpatients and outpatients who are receiving treatment or care at participating cancer service and aged over 18 years will be eligible to take part. Through the co-design process to develop MiM, the participating service identified that people from Russian or Mandarin-speaking populations are those who commonly attend the participating service with low English language proficiency. These two language groups are therefore targeted in this pilot study. Patients who attend the service must identify their primary language as Russian or Mandarin to be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

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)
Participants will be randomised to group 1 (intervention) or group 2 (comparison) by the multilingual fieldworkers during the recruitment process using an online randomisation tool (randomiser.org).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be stratified by language group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A survey tool with closed and free text items will be administered verbally over the phone. The survey comprises of measures to capture a) demographic information, b) knowledge of medications and their side effects, c) knowledge of how to contact the health service regarding medication concerns, d) self-efficacy to contact the service about medication concerns, e) patient engagement in medication management and f) patient perceptions of the safety of their care. Free text items will be used in the final survey only in order to capture process information about the trial, including the feasibility of using MiM.
1) To investigate how patients and staff engage with MiM.
2) To assess the feasibility and acceptability of MiM.
3) To investigate the suitability of trial recruitment, retention and data collection materials and processes.
4) To explore barriers and enablers of implementing the MiM.
To address objectives 1-4, free text data from the final survey on the items regarding engaging with the MiM, its feasibility and acceptability, the study processes and factors influencing the implementation of MiM will be subject to thematic analysis. Two researchers will independently code data to generate themes regarding the experience of using MiM and its feasibility.
5) To gather evidence of the nature and frequency of medication management issues that lead to ED visits and readmissions to inform the sample size required for a full-scale trial.
6) To determine whether a full-scale effectiveness trial is warranted.
To address objective 6, data of the impacts of MiM on knowledge and self-efficacy regarding medications and their management, and of the impact of MiM on patient engagement and perceptions of safety will be subject to analysis of variance (ANOVA) using the Stata software package. We will seek to determine change in self-efficacy, patient engagement and patient perceived safety pre- and post-intervention, and between the intervention and control groups. Between groups analysis will explore differences between the control and intervention group participants in their reported medication management behaviour post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23149 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 38507 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 312227 0
Government body
Name [1] 312227 0
National Health and Medical research Council (NHMRC)
Country [1] 312227 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Centre for Health Systems and Safety Research Australian Institute of Health Innovation
Level 6, 75 Talavera Road, Macquarie Park 2113
Country
Australia
Secondary sponsor category [1] 313761 0
None
Name [1] 313761 0
Address [1] 313761 0
Country [1] 313761 0
Other collaborator category [1] 282422 0
Hospital
Name [1] 282422 0
Prince of Wales Hospital
Address [1] 282422 0
Hight St, Randwick, NSW 2031
Country [1] 282422 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311606 0
South East Sydney Local Health District HREC
Ethics committee address [1] 311606 0
Ethics committee country [1] 311606 0
Australia
Date submitted for ethics approval [1] 311606 0
06/09/2022
Approval date [1] 311606 0
Ethics approval number [1] 311606 0

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

Contacts
Principal investigator
Name 121690 0
A/Prof Reema Harrison
Address 121690 0
Australian Institute of Health Innovation |
Level 6, 75 Talavera Road
Faculty of Medicine, Health and Human Sciences
Macquarie University, NSW 2109, Australia
Country 121690 0
Australia
Phone 121690 0
+61 02 9850 2425
Fax 121690 0
Email 121690 0
reema.harrison@mq.edu.au
Contact person for public queries
Name 121691 0
Reema Harrison
Address 121691 0
Australian Institute of Health Innovation |
Level 6, 75 Talavera Road
Faculty of Medicine, Health and Human Sciences
Macquarie University, NSW 2109, Australia
Country 121691 0
Australia
Phone 121691 0
+61 02 9850 2425
Fax 121691 0
Email 121691 0
reema.harrison@mq.edu.au
Contact person for scientific queries
Name 121692 0
Reema Harrison
Address 121692 0
Australian Institute of Health Innovation |
Level 6, 75 Talavera Road
Faculty of Medicine, Health and Human Sciences
Macquarie University, NSW 2109, Australia
Country 121692 0
Australia
Phone 121692 0
+61 02 9850 2425
Fax 121692 0
Email 121692 0
reema.harrison@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication for 5 years.
Available to whom?
available to researchers on a case by case basis on request
Available for what types of analyses?
Any purpose
How or where can data be obtained?
On the University data storage platform upon enquiry to the Principle Investigator reema.harrison@mq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17110Study protocol  bronwyn.newman@mq.edu.au
17111Ethical approval  bronwyn.newman@mq.edu.au



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.