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Trial registered on ANZCTR


Registration number
ACTRN12624000901505p
Ethics application status
Submitted, not yet approved
Date submitted
25/06/2024
Date registered
24/07/2024
Date last updated
24/07/2024
Date data sharing statement initially provided
24/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ENgaginG older people Across transitions of care to improve medication manaGEment – Developing and Testing Co-designed Strategies
Scientific title
ENgaginG older people Across transitions of care to improve medication manaGEment (The ENGAGE Project) – Developing and Testing Co-designed Strategies
Secondary ID [1] 312306 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The ENGAGE Project – Developing and Testing Co-designed Strategies
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medication management 334051 0
transitions of care 334052 0
older patient engagement 334053 0
family engagement 334054 0
Condition category
Condition code
Public Health 330724 330724 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Feedback events and co-design group workshops will be conducted to develop strategies aimed at optimising medication management with older people across transitions of care.

Feedback events are group or individual interviews conducted with health professionals, patients and families. Either a researcher or PhD student will conduct the individual interviews, while two individuals comprising a combination of researchers or PhD students, are likely to be involved in the conduct of group interviews. Group interviews will involve patients or families in conversations, or health professionals in conversations. These participants will identify possible engagement strategies that can be used in actual practice. Included hospitals for feedback events are the Monash Medical Centre, Dandenong Hospital, Casey Hospital, Kingston Centre, Austin Hospital, and Heidelberg Repatriation Hospital. About 180 individuals will participate in feedback events. For each hospital, about 5-10 patients, 5-10 family members and 5-10 health professionals will participate. These sessions will occur face to face or online. Individual or group interviews will be about 30 minutes in duration.

Co-design group panels will be conducted with health professionals, patients and families together to prioritise strategies identified from feedback events, and to devise practical ways in how strategies are implemented. Included hospitals for co-design panels, are the Monash Medical Centre, Dandenong Hospital, Casey Hospital, Kingston Centre, Austin Hospital, and Heidelberg Repatriation Hospital. About 108 individuals will participate in co-design panels. about 4-6 patients, about 4-6 family members or advocates, and about 4-6 health professionals will participate in each co-design panel. It is anticipated there will be one co-design panel for each hospital. Each panel will meet about 2-4 times over a 6-8 month period for about 60 minutes. These panels will be conducted face to face, online or a mixture of the two approaches. While it is possible for participants in the feedback events will be also participating in co-design panels, the aim is to have a wide diversity of individuals taking part.

A feasibility and acceptability trial will be undertaken using strategies developed from feedback events and co-design panels. Included hospitals for the conduct of the feasibility and acceptability trial are the Monash Medical Centre and Austin Hospital, with two wards at each hospital selected for feasibility and acceptability testing. About 20 intervention patients and 20 usual care patients will participate in each of the two hospitals. In addition, about 20 family members, and 20 health professionals will participate from each hospital. In all, about 160 individuals will participate in the feasibility and acceptability trial, which will include patients, family members and health professionals.

The intervention will be delivered to patients during their hospitalisation. All patients will receive usual care in relation to their hospitalisation. For patients randomised to the intervention group, they will also receive the intervention during the same time period. The intervention will focus on three key types of strategies: information seeking, decision-making, and managing medications.

The information seeking type of strategy will include giving patients a list of questions developed from the co-design groups about seeking information relating to their medications. This information will relate the purpose of their medications, how to take their medications, how the medications work and what side effects they produce.

The decision making type of strategy will comprise providing patients and families with questions to query why the medications are needed, especially if changes have been made, and if any alternative treatments can be used instead, such as non-medication treatments.

The managing medications type of strategy will focus on helping patients to understand and to carry out their medication regimens. Depending on the co-design panels, patients will be provided with medication management applications (apps), and practical prompts to use in assisting with medication-taking activities.

One of the researchers will deliver the intervention to patients. This researcher will provide patients with details about the intervention following recruitment and consent. Patients in the intervention group will be able to contact this researcher if they have any queries arising from using the strategies of the intervention, such as issues they may have in accessing the materials. This researcher will periodically remind each patient about using the strategies. Another researcher will check at hospital discharge about the proportion of patients who state that they referred to the strategies underpinning the intervention.
Intervention code [1] 328779 0
Behaviour
Intervention code [2] 329034 0
Prevention
Comparator / control treatment
All patients will receive usual care in relation to their hospitalisation. For patients randomised to the intervention group, they will receive the intervention during the same time period.

Usual care comprises any medication conversations during routine tasks with doctors, nurses or pharmacists. These conversations may include bedside handover and ward round communication, and consultations on admission and discharge.
Control group
Active

Outcomes
Primary outcome [1] 338482 0
Feasibility of the study in relation to fidelity
Timepoint [1] 338482 0
At the end of the recruitment period
Primary outcome [2] 338483 0
Feasibility of the study in relation to fidelity
Timepoint [2] 338483 0
Just prior to hospital discharge
Primary outcome [3] 338785 0
Acceptability of intervention
Timepoint [3] 338785 0
Data collection will occur just prior to hospital discharge with patients and families
Data collection from health professionals will occur after the intervention has been in operation for about 2-3 weeks in a hospital ward
Secondary outcome [1] 436108 0
Patient activation (secondary outcome)
Timepoint [1] 436108 0
At baseline
Just prior to patient discharge
At 7-10 days post discharge
Secondary outcome [2] 436109 0
Shared decision-making (secondary outcome)
Timepoint [2] 436109 0
At baseline
Just prior to patient discharge
At 7-10 days post discharge
Secondary outcome [3] 436110 0
Readmission to hospital (secondary outcome)
Timepoint [3] 436110 0
At 30 days post-discharge
At 3 months post-discharge
Secondary outcome [4] 436111 0
Presentation to emergency department (secondary outcome)
Timepoint [4] 436111 0
At 30 days post-discharge
At 3 months post-discharge
Secondary outcome [5] 437472 0
Feasibility of the study (primary outcome)
Available population
Timepoint [5] 437472 0
By the end of the recruitment period
Secondary outcome [6] 437473 0
Feasibility of the study (primary outcome)
Eligibility to meet selection criteria
Timepoint [6] 437473 0
By the end of the recruitment period
Secondary outcome [7] 437474 0
Feasibility of the study (primary outcome)
Agreement to participate from families
Timepoint [7] 437474 0
At the end of the recruitment period
Secondary outcome [8] 437475 0
Feasibility of the study (primary outcome)
Agreement to participate from health professionals
Timepoint [8] 437475 0
At the end of the recruitment period
Secondary outcome [9] 437476 0
Feasibility of the study (primary outcome)
Commencement of intervention as intended
Timepoint [9] 437476 0
At the end of the recruitment period
Secondary outcome [10] 437477 0
Feasibility of the study in relation to retention
Timepoint [10] 437477 0
At 7-10 days post discharge
Secondary outcome [11] 437478 0
Feasibility of the study (primary outcome)
Presence of missing data
Timepoint [11] 437478 0
At baseline, just prior to discharge, at 7 to 10 days post discharge, at 30 days post discharge and at 3 months post discharge
Secondary outcome [12] 437479 0
Feasibility of the study (primary outcome)
Contamination of intervention
Timepoint [12] 437479 0
Just prior to hospital discharge

Eligibility
Key inclusion criteria
Patients: individuals who are aged 65 years or older with any condition, and have at least one medication prescribed and are admitted to the hospital study sites.

Family members: anyone who identifies as a relative or friend of an older patient aged 65 years or older.

For feedback sessions and co-design panels, older patients and their families may also be recruited through the hospitals’ consumer advisory groups or registers, or from consumer health organisations, such as the Australian Patients Association.

Health professionals: comprise qualified nurses, doctors, and pharmacists who work in any capacity at the study sites.

Note that minimum age for patient participation is 65 years. There are no age restrictions for participation by family members and health professionals.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients: those with severe cognitive impairment, severe dementia, haemodynamic instability, or at end of life.

Family members: no exclusion criteria.

Health professionals: no exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be undertaken conducted by an independent academic staff member of the School of Nursing and Midwifery at Monash University who is not involved in the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive data analysis will be performed for patient demographics, feasibility and acceptability and clinical outcome data. Mean and standard deviation results will be calculated for continuous variables, and frequencies and percentages will be calculated for categorical variables.

An exploratory analysis of group differences will be undertaken. Analysis of survey data will occur using inferential statistics to explore changes in patient perceptions from baseline. Within-group and between-group comparisons will be undertaken in and across the study sites, and the entire cohort.

Data analysis of qualitative data will be undertaken using reflexive thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
448
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316699 0
Government body
Name [1] 316699 0
National Health and Medical Research Council
Country [1] 316699 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318899 0
Hospital
Name [1] 318899 0
Monash Health
Address [1] 318899 0
Country [1] 318899 0
Australia
Secondary sponsor category [2] 318900 0
Hospital
Name [2] 318900 0
Austin Health
Address [2] 318900 0
Country [2] 318900 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315478 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 315478 0
https://monashhealth.org/research/resources/resource-library/
Ethics committee country [1] 315478 0
Australia
Date submitted for ethics approval [1] 315478 0
18/03/2024
Approval date [1] 315478 0
Ethics approval number [1] 315478 0
Ethics committee name [2] 315479 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 315479 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [2] 315479 0
Australia
Date submitted for ethics approval [2] 315479 0
20/08/2024
Approval date [2] 315479 0
Ethics approval number [2] 315479 0

Summary
Brief summary
The aim of the study is to develop and test tailored co-designed strategies that are agreed upon between hospitalised older people, their families and health professionals in managing medications as patients move across transitions of care. Strategies developed from feedback events and co-design group workshops, will be tested in a feasibility and acceptability trial. The work will inform the future development and testing of a randomised controlled trial of co-designed engagement strategies.


Trial website
Trial related presentations / publications
Public notes
The ethics application has been submitted to the Monash Health Human Research Ethics Committee. Currently, site specific assessment is being completed for the Monash Health site. Subsequently, site specific assessment will be sought from the Austin Health Human Research Ethics Committee.

Contacts
Principal investigator
Name 134818 0
Prof Elizabeth Manias
Address 134818 0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Country 134818 0
Australia
Phone 134818 0
+61 3 99020806
Fax 134818 0
Email 134818 0
[email protected]
Contact person for public queries
Name 134819 0
Elizabeth Manias
Address 134819 0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Country 134819 0
Australia
Phone 134819 0
+61 3 99020806
Fax 134819 0
Email 134819 0
[email protected]
Contact person for scientific queries
Name 134820 0
Elizabeth Manias
Address 134820 0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Country 134820 0
Australia
Phone 134820 0
+61 3 99020806
Fax 134820 0
Email 134820 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


What supporting documents are/will be available?

No Supporting Document Provided



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.