Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Engaging residents and families about managing psychotropic medicines in aged care facilities
Query!
Secondary ID [1]
312308
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
The EngageMeds Project
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Resident engagement
334057
0
Query!
Family engagement
334058
0
Query!
Managing psychotropic medicines in aged care facilities
334059
0
Query!
Medicines communication
334060
0
Query!
Condition category
Condition code
Public Health
330727
330727
0
0
Query!
Health service research
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
328781
0
Behaviour
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
338487
0
Recruitment in the study
Query!
Assessment method [1]
338487
0
Recruitment: the proportion of eligible residents who agree to participate in the project, identified by review of recruitment records collected by the researchers
Query!
Timepoint [1]
338487
0
At the end of the recruitment period
Query!
Primary outcome [2]
338488
0
Feasibility of the study in relation to fidelity
Query!
Assessment method [2]
338488
0
Proportion of participating residents who complete the intervention, identified by residents who state that they refer to the documented strategies
Structured, one-on-one, face-to-face interview with a member of the research team
Query!
Timepoint [2]
338488
0
At four to six weeks after delivery
Query!
Primary outcome [3]
338780
0
Acceptability of the study
Query!
Assessment method [3]
338780
0
Theoretical Framework of Acceptability (TFA) Questionnaire to be completed by residents in the intervention group
Theoretical Framework of Acceptability (TFA) Questionnaire to be completed by aged care workers
Short interviews with residents in intervention and usual care groups (about 15 min)
Short interviews with aged care workers (about 10 min)
Short interviews with families of residents (about 10 min)
Structured, one-on-one, face-to-face interviews with a member of the research team for residents
Structured, one-on-one, face-to-face or remote interviews with a member of the research team for aged care workers
Structured, one-on-one, face-to-face or remote interviews with a member of the research team for families of residents
Query!
Timepoint [3]
338780
0
At four to six weeks after delivery of the intervention
Query!
Secondary outcome [1]
436113
0
Perceived involvement in care (secondary outcome)
Query!
Assessment method [1]
436113
0
Perceived Involvement in Care Scale to be completed by residents in intervention and usual care groups
Query!
Timepoint [1]
436113
0
To be completed at baseline and at four to six weeks after delivery of intervention
Query!
Secondary outcome [2]
436114
0
Decisional conflict (secondary outcome)
Query!
Assessment method [2]
436114
0
Decisional Conflict Scale to be completed by residents and families in intervention and usual care groups
Decisional Conflict Scale to be completed by family members of residents in intervention and usual care groups
Query!
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
Query!
Secondary outcome [3]
436115
0
Psychotropic medicine use (secondary outcome)
Query!
Assessment method [3]
436115
0
Review by researcher of resident medical records of psychotropic medicines prescribed and administered
Query!
Timepoint [3]
436115
0
At baseline, one month, three months and six months after intervention delivery
Query!
Secondary outcome [4]
436116
0
Hospital admission (secondary outcome)
Query!
Assessment method [4]
436116
0
Review of resident medical record by researcher
Query!
Timepoint [4]
436116
0
At one month, three months and six months after delivery of intervention
Query!
Secondary outcome [5]
436117
0
Emergency department presentation (secondary outcome)
Query!
Assessment method [5]
436117
0
Review of resident medical records by researcher
Query!
Timepoint [5]
436117
0
At one month, three months and six months after delivery of intervention
Query!
Secondary outcome [6]
437411
0
Feasibility of the study (primary outcome)
Query!
Assessment method [6]
437411
0
Available population: the number of available residents within each aged care facility, identified by aged care facility records and discussions with the nurse-in-charge of a specific shift
Query!
Timepoint [6]
437411
0
By the end of the recruitment period
Query!
Secondary outcome [7]
437412
0
Feasibility of the study (primary outcome)
Eligibility to meet selection criteria
Query!
Assessment method [7]
437412
0
Eligibility: the proportion (and number) of residents who meet the eligibility criteria
Query!
Timepoint [7]
437412
0
By the end of the recruitment period
Query!
Secondary outcome [8]
437413
0
Feasibility of the study (primary outcome)
Provision of valid outcome data
Query!
Assessment method [8]
437413
0
Proportion of the residents who provide valid outcome data following delivery of the intervention
Participation in completion of surveys
Structured, one-on-one, face-to-face interviews with a member of the research team
Query!
Timepoint [8]
437413
0
At four to six weeks after delivery
Query!
Secondary outcome [9]
437414
0
Feasibility of the study (primary outcome)
Agreement to participate from families
Query!
Assessment method [9]
437414
0
Recruitment: the proportion of family members who visit residents who agree to participate in the project, identified by medical records and discussions with the nurse-in-charge of a specific shift
Query!
Timepoint [9]
437414
0
At the end of the recruitment period
Query!
Secondary outcome [10]
437418
0
Feasibility of the study (primary outcome)
Agreement to participate from aged care workers
Query!
Assessment method [10]
437418
0
Recruitment: the proportion of aged care workers employed who agree to participate in the project, identified by aged care facility records and discussions with the nurse-in-charge of a specific shift
Query!
Timepoint [10]
437418
0
At the end of the recruitment period
Query!
Secondary outcome [11]
437419
0
Feasibility of the study (primary outcome)
Commencement of intervention as intended
Query!
Assessment method [11]
437419
0
Fidelity: the proportion of participating residents who start the intervention as intended, identified by one researcher checking with residents about their use of the intervention following recruitment and consent
Query!
Timepoint [11]
437419
0
At the end of the recruitment period
Query!
Secondary outcome [12]
437420
0
Feasibility of the study (primary outcome)
Presence of missing data
Query!
Assessment method [12]
437420
0
Missing data: collection of data during conduct of study, identified by review of medical records, participation in completion of surveys, and participation in structured, one-on-one face-to-face interviews
Query!
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
Query!
Secondary outcome [13]
437421
0
Feasibility of the study (primary outcome)
Contamination of intervention
Query!
Assessment method [13]
437421
0
Contamination: usual care residents receiving the intervention
Residents in the intervention group and the usual care group will be asked which group they believe they were allocated to during the study period
Structured, one-on-one face-to-face interview with a member of the research team
Query!
Timepoint [13]
437421
0
At four to six weeks after delivery of intervention
Query!
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.
Query!
Minimum age
65
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/08/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/07/2027
Query!
Actual
Query!
Date of last data collection
Anticipated
31/10/2027
Query!
Actual
Query!
Sample size
Target
760
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Funding & Sponsors
Funding source category [1]
316701
0
Government body
Query!
Name [1]
316701
0
Australian Research Council
Query!
Address [1]
316701
0
Query!
Country [1]
316701
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Monash University
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
318903
0
Hospital
Query!
Name [1]
318903
0
Barwon Health Aged Care
Query!
Address [1]
318903
0
Query!
Country [1]
318903
0
Australia
Query!
Secondary sponsor category [2]
318910
0
Charities/Societies/Foundations
Query!
Name [2]
318910
0
Uniting AgeWell
Query!
Address [2]
318910
0
Query!
Country [2]
318910
0
Australia
Query!
Secondary sponsor category [3]
318911
0
Commercial sector/Industry
Query!
Name [3]
318911
0
Ryman Healthcare
Query!
Address [3]
318911
0
Query!
Country [3]
318911
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315481
0
Barwon Health HREC
Query!
Ethics committee address [1]
315481
0
http://www.barwonhealth.org.au/research/column-1/regi
Query!
Ethics committee country [1]
315481
0
Australia
Query!
Date submitted for ethics approval [1]
315481
0
25/03/2024
Query!
Approval date [1]
315481
0
05/07/2024
Query!
Ethics approval number [1]
315481
0
Query!
Summary
Brief summary
This project aims to investigate resident and family engagement in communicating about psychotropic medicines by developing and testing creative strategies in aged care facilities. Psychotropic medicines affect the mind, emotions and behaviour of individuals. The project will involve the conduct of interviews and observations, which will help to inform the conduct of co-design panels. Strategies developed from co-design panels will be evaluated in a feasibility and acceptability trial. Knowledge dissemination of the results will occur with audio scenario interviews, development of infographics and workshops at the aged care sites.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
134826
0
Prof Elizabeth Manias
Query!
Address
134826
0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Query!
Country
134826
0
Australia
Query!
Phone
134826
0
+61 3 99020806
Query!
Fax
134826
0
Query!
Email
134826
0
[email protected]
Query!
Contact person for public queries
Name
134827
0
Elizabeth Manias
Query!
Address
134827
0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Query!
Country
134827
0
Australia
Query!
Phone
134827
0
+61 3 99020806
Query!
Fax
134827
0
Query!
Email
134827
0
[email protected]
Query!
Contact person for scientific queries
Name
134828
0
Elizabeth Manias
Query!
Address
134828
0
Monash University, School of Nursing and Midwifery, Wellington Road, Clayton, Victoria 3800
Query!
Country
134828
0
Australia
Query!
Phone
134828
0
+61 3 99020806
Query!
Fax
134828
0
Query!
Email
134828
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF