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Trial registered on ANZCTR


Registration number
ACTRN12624000902594
Ethics application status
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 residents and families about managing psychotropic medicines in aged care facilities
Scientific title
Engaging residents and families about managing psychotropic medicines in aged care facilities
Secondary ID [1] 312308 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The EngageMeds Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resident engagement 334057 0
Family engagement 334058 0
Managing psychotropic medicines in aged care facilities 334059 0
Medicines communication 334060 0
Condition category
Condition code
Public Health 330727 330727 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this project, interviews and observations will be undertaken of how communication occurs about psychotropic medicines management in six aged care facilities. In total, about 72 interviews (about 12 in each facility) and about 90 hours of observations (about 15 hours in each facility) will be completed. The duration of interviews will be about half an hour.

This work obtained from interviews and observations will be used in the conduct of co-design panels to identify strategies for testing. There will be about 6 to 8 participants taking part in each of the co-design panels, involving residents, families and aged care workers. Participants will meet for about 60 minutes for up to two or three occasions, It should be noted that it is possible that participants from the interviews and observations will also be involved in the co-design panel, although attempts will be made to ensure wide diversity of involvement by participants.

All participants will receive usual care, in addition to the intervention. For this study there will be two different groups of participants - one group will receive the intervention (as well as usual care of the aged care facility) and one group will receive usual care only during the same time span of the study.

The intervention will involve delivery of a combination of strategies developed from the co-design panels. Residents will be recruited for the intervention group (about n=15), and residents will be recruited for the usual care group (about n=15) at three aged care facilities.

Strategies to be tested in the intervention will involve encouraging residents and families to ask questions about the psychotropic medicines prescribed for the resident. Examples of questions include how the medicines will help the resident, if they really need the medicines, and whether alternatives to psychotropic medicines could be used to fit with the residents’ activities. One of the researchers will deliver the intervention to participants.

Strategies will be documented on a laminated sheet or in a digital format for mobile phones, i-pads or tablets, depending on the residents’ and families’ preferences. The strategies will be translated into the residents' or families' preferred language if necessary. The duration of the intervention will be about four to six weeks.

The researcher will check every one to two days with resident participants to monitor adherence to the intervention through self report.

Recruited residents will be asked not to talk about resources they have been provided with, in relation to participation in the intervention or the usual care group.
Intervention code [1] 328781 0
Behaviour
Comparator / control treatment
All participants will receive usual care.

Usual care comprises:
- Medicines conversations during routine tasks with aged care workers.
- Conversations may occur during nursing handover and health care team communication.
- Pharmacist consultations may occur with residents, their families and other aged care workers.

Recruited residents will be asked not to talk about resources they have been provided with, in relation to participation in the intervention or the usual care group.
Control group
Active

Outcomes
Primary outcome [1] 338487 0
Recruitment in the study
Timepoint [1] 338487 0
At the end of the recruitment period
Primary outcome [2] 338488 0
Feasibility of the study in relation to fidelity
Timepoint [2] 338488 0
At four to six weeks after delivery
Primary outcome [3] 338780 0
Acceptability of the study
Timepoint [3] 338780 0
At four to six weeks after delivery of the intervention
Secondary outcome [1] 436113 0
Perceived involvement in care (secondary outcome)
Timepoint [1] 436113 0
To be completed at baseline and at four to six weeks after delivery of intervention
Secondary outcome [2] 436114 0
Decisional conflict (secondary outcome)
Timepoint [2] 436114 0
To be completed at baseline before delivery of intervention and usual care, and at four to six weeks after delivery of intervention
Secondary outcome [3] 436115 0
Psychotropic medicine use (secondary outcome)
Timepoint [3] 436115 0
At baseline, one month, three months and six months after intervention delivery
Secondary outcome [4] 436116 0
Hospital admission (secondary outcome)
Timepoint [4] 436116 0
At one month, three months and six months after delivery of intervention
Secondary outcome [5] 436117 0
Emergency department presentation (secondary outcome)
Timepoint [5] 436117 0
At one month, three months and six months after delivery of intervention
Secondary outcome [6] 437411 0
Feasibility of the study (primary outcome)
Timepoint [6] 437411 0
By the end of the recruitment period
Secondary outcome [7] 437412 0
Feasibility of the study (primary outcome)
Eligibility to meet selection criteria
Timepoint [7] 437412 0
By the end of the recruitment period
Secondary outcome [8] 437413 0
Feasibility of the study (primary outcome)
Provision of valid outcome data
Timepoint [8] 437413 0
At four to six weeks after delivery
Secondary outcome [9] 437414 0
Feasibility of the study (primary outcome)
Agreement to participate from families
Timepoint [9] 437414 0
At the end of the recruitment period
Secondary outcome [10] 437418 0
Feasibility of the study (primary outcome)
Agreement to participate from aged care workers
Timepoint [10] 437418 0
At the end of the recruitment period
Secondary outcome [11] 437419 0
Feasibility of the study (primary outcome)
Commencement of intervention as intended
Timepoint [11] 437419 0
At the end of the recruitment period
Secondary outcome [12] 437420 0
Feasibility of the study (primary outcome)
Presence of missing data
Timepoint [12] 437420 0
At baseline, at one month after delivery, at four to six weeks after delivery, at three months after delivery, and at six months after delivery
Secondary outcome [13] 437421 0
Feasibility of the study (primary outcome)
Contamination of intervention
Timepoint [13] 437421 0
At four to six weeks after delivery of intervention

Eligibility
Key inclusion criteria
Residents: will comprise individuals who are aged 65 years or older, and have at least one medicine prescribed.

Family members: will comprise anyone who identifies as a relative or friend of a resident.

Aged care workers: will comprise those who have a legal authority, duty of care or direct responsibility for managing medicines for the residents.

Note that the minimum age noted below relates to the age of residents.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents: will comprise those with severe dementia, severe cognitive impairment, haemodynamic instability, or at end of life.

Family members: there are no exclusion criteria.

Aged care workers: there are 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 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 (i.e. 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 resident 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 resident 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
31/07/2027
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
760
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316701 0
Government body
Name [1] 316701 0
Australian Research Council
Country [1] 316701 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318903 0
Hospital
Name [1] 318903 0
Barwon Health Aged Care
Address [1] 318903 0
Country [1] 318903 0
Australia
Secondary sponsor category [2] 318910 0
Charities/Societies/Foundations
Name [2] 318910 0
Uniting AgeWell
Address [2] 318910 0
Country [2] 318910 0
Australia
Secondary sponsor category [3] 318911 0
Commercial sector/Industry
Name [3] 318911 0
Ryman Healthcare
Address [3] 318911 0
Country [3] 318911 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315481 0
Barwon Health HREC
Ethics committee address [1] 315481 0
Ethics committee country [1] 315481 0
Australia
Date submitted for ethics approval [1] 315481 0
25/03/2024
Approval date [1] 315481 0
05/07/2024
Ethics approval number [1] 315481 0

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

Contacts
Principal investigator
Name 134826 0
Prof Elizabeth Manias
Address 134826 0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Country 134826 0
Australia
Phone 134826 0
+61 3 99020806
Fax 134826 0
Email 134826 0
Elizabeth.Manias@monash.edu
Contact person for public queries
Name 134827 0
Elizabeth Manias
Address 134827 0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Country 134827 0
Australia
Phone 134827 0
+61 3 99020806
Fax 134827 0
Email 134827 0
Elizabeth.Manias@monash.edu
Contact person for scientific queries
Name 134828 0
Elizabeth Manias
Address 134828 0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Country 134828 0
Australia
Phone 134828 0
+61 3 99020806
Fax 134828 0
Email 134828 0
Elizabeth.Manias@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


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.