Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001172796
Ethics application status
Approved
Date submitted
10/08/2022
Date registered
29/08/2022
Date last updated
29/08/2022
Date data sharing statement initially provided
29/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility and acceptability of the MedsCheck Plus service amongst community pharmacists and home-dwelling people living with dementia
Scientific title
Investigating the impact of a community pharmacy-based service on medication management amongst home-dwelling people living with dementia: a pilot study
Secondary ID [1] 306553 0
Nil known
Universal Trial Number (UTN)
U1111-1275-0863
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 325447 0
Cognitive Impairment 325448 0
Condition category
Condition code
Neurological 322827 322827 0 0
Dementias
Neurological 322828 322828 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The first step of the intervention is the recruitment of the pharmacists. Industry contacts were utilised to gather expressions of interest. From this pool, the pharmacists were then recruited to participate in the pilot trial.
The second step of the intervention involves the pilot pharmacists completing 3-hour Dementia Friendly Pharmacy Course, followed by a 2-hour case study scenario assessment. The Dementia Friendly Pharmacy course is a readily available resource through Dementia Training Australia and is available at https://dta.com.au/online-courses/dementia-friendly-pharmacy/.
The MedsCheck Plus training component will involve an interactive learning management system which include short video scenarios (approx. 2 videos of 10 minutes each), videos (ie Dementia support services and pharmacy patient-centred care) along with learning content on ‘What is dementia’, ‘Types of dementia’, ‘Dementia in Australia’, ‘Identifying signs of dementia’, ‘What is patient-centred care’, ‘Applying a patient-centred approach to dementia care’, ‘Interpret the individual needs of the patient’, ‘MedsCheck Plus patient journey’, ‘Interacting appropriately with a PLWD’, ‘Role of caregiver in dementia care’, ‘Knowledge of support services’, ‘Identifying available services for dementia assessment’, ‘Arranging follow-ups’ and ‘Developing further knowledge in the area of dementia’. A combination of the 2 case study scenarios, learning content, interaction components (i.e. match the words, multiple choice) will make up the 2 hours of learning.
Pharmacists will be given one month to complete the provided training material This will ensure that only pharmacists who have completed the required training will be eligible to participate in this study. Training and assessment records will be recorded in Pharmaceutical Society of Australia’s (PSA) Learning Management System (LMS). Pharmacists are also encouraged to record completion of training in their personal training record.
The third step of the intervention will involve the trained pharmacist providing the initial face-to-face MedsCheck Plus to the participant. The steps in the patient journey are as follows:
• Identifying the need for MedsCheck Plus by initiating a MedsCheck service
• Determining eligibility and obtaining consent for a MedsCheck Plus
• Reconciliation of patient medication including all prescription, non-prescription and complementary and alternative medication.
The family carer may be required to assist with completing this part of the process in collaboration with the patient. The medication profile should be confirmed with the patient’s prescriber/s, and a copy of the completed medication profile will be provided to the patient’s prescriber. The patient and +/- carer should also be provided with the medication profile.
• Medication counselling involving a two-way discussion with the patient and +/- carer to ensure that medications are used appropriately and safely. The pharmacist, patient and +/- carer will also agree to any follow up actions and who is responsible. This should be documented in action plan, with dates agreed upon for a follow-up discussion to review the patient’s progress. The patient, caregiver (if present), prescribers and, if relevant, support services, health and/or community care professionals will be provided with copies of the documentation.
For the delivery of the intervention, the medication reconciliation and medication counselling process will occur within the initial session. It is anticipated that the length of this session will be 30-60 minutes in length. From this, an additional follow up session will be arranged based on the discretion of the pharmacist depending on the need (recommended at least 4 weeks following). This includes a review of strategies recommended including Webster Packs, complex medication regimes and starting a new dementia medication.
The final step of the intervention will involve the pharmacist providing a follow-up MedsCheck Plus consultation. At this time, the pharmacist will monitor the progress of actions identified and agreed upon in the action plan. The timeframe for the follow-up consultation will be at the discretion of the reviewing pharmacist, based on their perception of clinical need and individual patient circumstances. Given the targeted nature of follow-up consultations, it is expected that the normal duration of the consultation would be considerably less than the initial MedsCheck Plus, depending on the complexity and number of issues being followed up.
The adherence to the intervention will be qualitatively assessed during the focus group discussions with the participating pharmacists at the conclusion of the study.
Intervention code [1] 322984 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332211 0
The feasibility of MedsCheck Plus as an in-pharmacy review service. The outcomes will be assessed as a composite primary outcomes with acceptability. The patient outcome will be assessed using the 'Consumer Survey'. The pharmacist outcome will be assessed using the 'Pharmacist survey' and focus group discussion using the 'Stage 2 Focus Group Discussion Guide'. The focus groups will be conducted online via Microsoft Teams with a maximum of 5 participants. The focus group discussion will be undertaken by three members of the research team. The session will be audiotaped, transcribed, analysed and stored using the qualitative data management program NVivo. The questions will be sufficiently flexible to accommodate the natural flow of conversation within each group and pre-empting of questions by participants.
Timepoint [1] 332211 0
4 months post-intervention commencement
Primary outcome [2] 332395 0
The acceptability of MedsCheck Plus as an in-pharmacy review service. The outcomes will be assessed as a composite primary outcomes with feasibility. The patient outcome will be assessed using the 'Consumer Survey'. The pharmacist outcome will be assessed using the 'Pharmacist survey' and focus group discussion using the 'Stage 2 Focus Group Discussion Guide'. The focus groups will be conducted online via Microsoft Teams with a maximum of 5 participants. The focus group discussion will be undertaken by three members of the research team. The session will be audiotaped, transcribed, analysed and stored using the qualitative data management program NVivo. The questions will be sufficiently flexible to accommodate the natural flow of conversation within each group and pre-empting of questions by participants.
Timepoint [2] 332395 0
4 months post-intervention commencement
Secondary outcome [1] 412550 0
Nil
Timepoint [1] 412550 0
Nil

Eligibility
Key inclusion criteria
Consumers with mild cognitive impairment, diagnosed or suspected dementia and home dwelling in the Perth metropolitan area. The inclusion criteria is also extended to the family carer if appropriate.

Pharmacists are to be community pharmacists with access to current Medscheck services in the Perth metropolitan area. The pharmacists will be currently registered to practise with the Australian Health Practitioner Regulation Agency.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pharmacists working only from aged care or hospitals are excluded from the study. Pharmacists outside of the Perth Metropolitan area or interstate will not be eligible for the study.

Consumers no longer able to provide consent due to their cognitive impairment. Consumers currently residing in an aged care facility will be excluded from the study. Consumers residing outside of the Perth Metropolitan area or interstate will not be eligible for the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2022
Actual
Date of last participant enrolment
Anticipated
24/10/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310888 0
University
Name [1] 310888 0
University of New South Wales (UNSW)
Country [1] 310888 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
High Street,
KENSINGTON NSW 2052
Country
Australia
Secondary sponsor category [1] 312165 0
None
Name [1] 312165 0
Address [1] 312165 0
Country [1] 312165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310448 0
Curtin University Human Research Ethics Office
Ethics committee address [1] 310448 0
Research Office
Curtin University
Kent St
BENTLEY WA 6102
Ethics committee country [1] 310448 0
Australia
Date submitted for ethics approval [1] 310448 0
23/11/2021
Approval date [1] 310448 0
10/12/2021
Ethics approval number [1] 310448 0
HRE2021-0763

Summary
Brief summary
For many people who live with dementia, managing their daily medicines is a complex and difficult task. Whilst medicines are used to improve health, their incorrect use may cause unintended consequences that range from minor symptoms to serious events that require hospitalisation. The role that community pharmacists have in optimising medicine safety is well-recognised, and several generic programs have been developed for pharmacists to help people living in the community use their medicines more safely and easily.
Using one of these programs as a basis, our project will develop an in-pharmacy service to meet the specific needs of people living with dementia. The service is called MedsCheck Plus. This will involve the pharmacist holding structured meetings with a person living with dementia (and their family carers if appropriate), so that any medicine-related issues can be identified and overcome. The project will first develop a model for MedsCheck Plus, then train community pharmacists to do them. Finally, twenty people living with dementia will be provided with MedsCheck Plus, and the experiences of the consumers and pharmacists will be studied.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117706 0
Dr Andrew Stafford
Address 117706 0
Curtin Medical School
Curtin University
Kent St,
BENTLEY WA 6102
Country 117706 0
Australia
Phone 117706 0
+61 8 9266 2531
Fax 117706 0
+61 8 9266 2769
Email 117706 0
andrew.stafford@curtin.edu.au
Contact person for public queries
Name 117707 0
Mrs Holly Radford
Address 117707 0
Curtin Medical School
Curtin University
Kent St,
BENTLEY WA 6102
Country 117707 0
Australia
Phone 117707 0
+61 419 506 657
Fax 117707 0
+61 8 9266 2769
Email 117707 0
holly.radford@curtin.edu.au
Contact person for scientific queries
Name 117708 0
Dr Andrew Stafford
Address 117708 0
Curtin Medical School
Curtin University
Kent St,
BENTLEY WA 6102
Country 117708 0
Australia
Phone 117708 0
+61 8 9266 2531
Fax 117708 0
+61 8 9266 2769
Email 117708 0
andrew.stafford@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive information


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16495Study protocol    383662-(Uploaded-29-08-2022-10-05-32)-Study-related document.docx
16496Informed consent form    383662-(Uploaded-03-08-2022-16-35-13)-Study-related document.docx
16497Ethical approval    383662-(Uploaded-03-08-2022-16-35-36)-Study-related document.pdf
16813Other    Surveys PIFs Post-pilot focus group discussion g... [More Details] 383662-(Uploaded-24-08-2022-12-57-01)-Study-related document.docx
16814Informed consent form    383662-(Uploaded-29-08-2022-16-03-35)-Study-related document.docx
16815Other    Surveys PIFs Post-pilot focus group discussion g... [More Details] 383662-(Uploaded-24-08-2022-12-59-46)-Study-related document.docx
16816Other    Surveys PIFs Post-pilot focus group discussion g... [More Details] 383662-(Uploaded-29-08-2022-16-04-38)-Study-related document.docx
16817Other    Surveys PIFs Post-pilot focus group discussion g... [More Details] 383662-(Uploaded-24-08-2022-13-01-34)-Study-related document.docx
16818Other    Surveys PIFs Post-pilot focus group discussion g... [More Details] 383662-(Uploaded-29-08-2022-10-08-34)-Study-related document.docx
16819Other    Surveys PIFs Post-pilot focus group discussion g... [More Details] 383662-(Uploaded-03-08-2022-16-38-17)-Study-related document.docx
17018Ethical approval    383662-(Uploaded-24-08-2022-13-03-23)-Study-related document.pdf
17019Ethical approval    383662-(Uploaded-24-08-2022-13-03-40)-Study-related document.pdf



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.