Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001070123
Ethics application status
Approved
Date submitted
19/07/2019
Date registered
31/07/2019
Date last updated
22/12/2021
Date data sharing statement initially provided
31/07/2019
Date results provided
22/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pharmacist-led medicines review intervention in community-dwelling Maori older adults– a feasibility study.
Scientific title
A pharmacist-led medicines review intervention in community-dwelling Maori older adults– a feasibility study.
Secondary ID [1] 298787 0
Nil known
Universal Trial Number (UTN)
U1111-1234-2170
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adult health 313736 0
Medicines optimisation 313738 0
Health equity 313739 0
Condition category
Condition code
Public Health 312139 312139 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Pharmacist-led medicines review service with 2 components: a) medicines education and b) medicines optimisation (optional).
Intervention
Intervention Content and Delivery

Medicines education preparation
The lead investigator will be the pharmacist delivering the intervention. The pharmacist will access the participant’s medicines dispensing history prior to medicines education meeting (unless the participant has specified they do not want the pharmacist to access this level of information prior to the medicines education component). For medicines education to be able to be delivered, an accurate list of participant’s medicines is required. Obtaining an accurate list of medicines taken is known as the process of medicines reconciliation and requires use at least two sources, one of which can be the list of dispensed medicines. A list of dispensed medicines will be obtained by accessing the dispensing history on Testsafe™(accessed via the WDHB Clinical Portal) which is an online repository which includes dispensed medicines. All community pharmacies who dispense medicines to patients in WDHB send information through to this repository. The pharmacist has access to this system via employment with WDHB. The second source for medicines reconciliation will be the participant during the medicines education component.

Medicines education component
The pharmacist and participant will discuss medicines that the participant is taking as well as medicine-related needs and goals for overall well-being. The inclusion of discussions relating to goals allows the participant to identify areas that may be relevant in regards to tailoring the education and also allows for whanaungatanga (development of connections) between the participant and the pharmacist. The pharmacist will schedule a time for this component either at the time of consent or via telephone or email correspondence. It is intended that this will happen as soon as practicable after consent is gained (but after baseline data has been collected by the independent research assistant).
Interactions will be governed by principles of kaupapa Maori research with a focus on exerting the participant’s right to rangatiratanga (self-determination and control). The session will centre on allowing time and space to talk about medicines and to improve the participants’ understanding of what the medicines are used for, potential side effects and likely length of treatment as well as improving the lead investigator’s understanding of what is important to the participant. Participants will be asked to bring their medicines along to the education session to guide discussions.
It is intended that the discussions will be guided by what the patient identifies as priority areas for discussion. This component will include tasks to the level of Medicines Use Review (MUR) in the PSNZ NZ National Pharmacist Services Framework. It may additionally include aspects described under Medicines Therapy Assessment (MTA) in relation to identifying participant concerns relating to medicines effectiveness or ADRs and discussion of medicines in the context of participant-identified goals of therapy.
Information relevant to the medicines education component will be collected on the Medicines Education Data Collection Form. Information will be summarised and sent as a narrative summary to the participant’s primary prescriber and community pharmacy either via post or secure electronic mail. This aspect of the intervention allows for connected communication between those involved in provision of health care to the participant.

Medicines Optimisation Preparation (optional)
Prior to the meeting the Pharmacist will access the participant’s clinical information via the WDHB Clinical Portal which is an online repository allowing access to medicine dispensing data, laboratory investigations, secondary care referrals and appointments, inpatient clinical observations, allied health assessments and publicly-funded hospital discharge summaries and outpatient clinic letters. This information, in addition to the conversation had both in the medicines education component and the medicines optimisation meeting will be used to review medicines appropriateness in relation to the individual participant. The information will be collected on the Medicines Optimisation Component Form. In the Phase 1b interviews, Maori older adults and health professional participants had mixed views on whether clinicians whom ‘patient’ participants had not met, should access their clinical information. As rangatiratanga (self-determination, control) is one of the aspects important in the proposed service model, it was decided to place the clinical history preparation after medicines education component (as the participant has met with the pharmacist).

Medicines Optimisation Component (optional)
The pharmacist will arrange a time to meet with the participant and primary prescriber (likely to be a GP but may include nurse practitioners or other designated prescribers). The medicines optimisation component will be delivered in line with the medicines management services described under Medicines Therapy Assessment (MTA) and Comprehensive Medicines Management (CMM) in the PSNZ Pharmacist Services Framework and the guidance set out in the Royal Pharmaceutical Society of Great Britain’s Medicines Optimisation good practice guidance.

If the prescriber is unable to be present at the medicines optimisation meeting then the pharmacist and prescriber will arrange a way to communicate the discussion (i.e. face-to-face at another point in time, over telephone or secure electronic transfer of information). The participant will be informed that the alternative route of communication is to be used. For example, the pharmacist may send a written communication to the prescriber, detailing the discussion with the participant and recommendations arising from the medicines optimisation component of the intervention. The prescriber and participant would then be able to arrange a time to discuss this further. The final output of the medicines optimisation component will be the development of a medicines management plan that has been agreed by the participant, prescriber and pharmacist. To clarify, the medicines optimisation component of the intervention will be deemed ‘completed’ once the medicines management plan has been agreed upon – either during the medicines optimisation meeting or after the fact if the prescriber was unable to attend. The pharmacist will not be following up on responses to the recommendations as part of the intervention. The final decision for changes in medicines therapy will rest with the participant and prescriber.
Participants will also be able to invite whanau (family) and/or support people to be present at these sessions.

The pharmacist delivering the intervention (also the lead investigator of this research proposal) is a Maori pharmacist (Ngaruahine) with 15+ years experiencing in medicines optimisation, the majority focusing on older adult medicine, working in both secondary and primary care (mainly Residential Aged care and Retirement Village) settings. She has held governance positions in Maori health organisations, including a member of the Executive Committee of Nga Kaitiaki o Te Puna Rongoa Maori o Aotearoa (The Maori Pharmacists’ Association) for over 8 years including 3 years as President. This work is being undertaken as part of her PhD work, funded by the Health Research Council of NZ under a Clinical Research Training Fellowship. She is a Named Investigator on The National Science Challenge – Ageing Well funded project: Older People in Retirement Village: Unidentified Need and Intervention Research Project.

Medicines education
Mode of delivery: Face to face with pharmacist
Location: Participants choice eg: home, community centre, GP practice
Number of times: 1 x one hour

Medicines optimisation (optional)
Mode of delivery: pharmacist + prescriber
Location: GP practice
Number of times: 1 x 15-30min (2-3 weeks after medicines education session)
Intervention code [1] 315058 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320790 0
Participant acceptability assessed through questionnaire, Questionnaire has been developed for the purposes of this study.

Timepoint [1] 320790 0
4 weeks post-intervention
Primary outcome [2] 320833 0
Whanau/family member acceptability assessed through questionnaire. Questionnaire has been developed for the purposes of this study.
Timepoint [2] 320833 0
4 weeks post-intervention
Primary outcome [3] 320835 0
Prescriber acceptability questionnaire. Questionnaire has been developed for the purposes of this study.
Timepoint [3] 320835 0
After all interventions have been completed
Secondary outcome [1] 372857 0
Medicines knowledge will be assessed using a tool developed for this study
Timepoint [1] 372857 0
Baseline and 4 weeks post intervention
Secondary outcome [2] 372858 0
Medicines appropriateness will be assessed using the STOPP/START criteria. This will be completed by the lead investigator using clinical information available throughout the intervention period. Participants medicines lists will be assessed for two different time points in time – medicines reconciliation at point of ‘medicines education’ component and medicines list immediately after medicines optimisation component (this list will take into account changes agreed as part of the medicines optimisation meeting).
Timepoint [2] 372858 0
Baseline and immediately post-intervention (all assignment of medicines appropriateness completed post-intervention)
Secondary outcome [3] 372859 0
Participant quality of life will be assessed using the SF-36 tool
Timepoint [3] 372859 0
Baseline and 4 weeks post-intervention
Secondary outcome [4] 372860 0
Time required to deliver intervention Time taken to deliver intervention will be recorded. This will be further categorised by non-contact and participant-contact time.
Prescriber time will be requested to estimate their time input in relation to the intervention as part of the Prescriber acceptability questionnaire.
Timepoint [4] 372860 0
Immediately post intervention
Secondary outcome [5] 372861 0
The feasibility of applying assessment tools relating to medicines knowledge, QoL and medicines appropriateness in this population will be assessed, including their use in informing further service/intervention development. The medicines knowledge tool has been developed for this study whilst the SF-36 and STOPP/START criteria have been widely validated although not in this population setting and intervention type.
Time taken for the independent research assistant to perform the various assessments will also be noted to inform future studies. [Composite outcome]
Timepoint [5] 372861 0
After all interventions and assessments have been completed
Secondary outcome [6] 372993 0
Recruitment methods detailed including time taken, cost (e.g. postage) recorded in log book. Approaches for participation by those not eligible will also be noted and with the potential to suggest changes to eligibility criteria for future studies. [composite outcome]
Timepoint [6] 372993 0
End of recruitment

Eligibility
Key inclusion criteria
Maori ethnicity (self – identified) AND
Community dwelling (not resident in rest home, private hospital or hospice) AND
55 years of age or older AND
Enrolled in a GP practice in Waitemata DHB AND
Taking four or more regular medicines for at least three months
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent

Study design
Purpose of the study
Treatment
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
Efficacy
Statistical methods / analysis
Although sample size justification is important, sample size calculation may not be appropriate in feasibility studies. A variety of methods for justification of sample size have been utilised in feasibility studies. There are various methods used to calculate appropriate sample sizes for feasibility studies. The majority of these are ‘rule of thumb’ methods which are regarded as ‘flat’ methods as they do not account for the potential size of main trial. Using the ‘rule of thumb’ methods, recommended sample sizes range from 12-70. A recent paper suggests that if rule of thumb methods are to be used, they should at least vary according to standardised difference in outcome measures; smaller standardised differences require a larger sample size and vice versa.
For our study we will use the SF-36 as a basis for sample size justification. The SF-36 has been widely validated across a range of clinical contexts including pharmaceutical care services. A meta-analysis of the effect of pharmaceutical care interventions on SF-36 showed a standardised mean difference of 0.39 for general health. Theoretical modelling of sample side calculation has been performed for pilot randomised trials. Based on the standardised mean difference of 0.39, if a randomised pilot were to be undertaken, using this approach, each treatment arm for a 90% powered trial should have 21 or 33 participants for a 80% or 95% upper confidence level respectively. Although this feasibility study is not randomised or controlled, these figures can be used as an estimation in our work. We aim to recruit and deliver the intervention to 30 participants.
Results from this feasibility study will be used to guide sample size calculations in future studies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2019
Actual
26/11/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
20/02/2020
Date of last data collection
Anticipated
29/02/2020
Actual
26/05/2020
Sample size
Target
30
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 21700 0
New Zealand
State/province [1] 21700 0
Auckland

Funding & Sponsors
Funding source category [1] 303341 0
Government body
Name [1] 303341 0
Health Research Council of New Zealand
Country [1] 303341 0
New Zealand
Funding source category [2] 303346 0
Government body
Name [2] 303346 0
Waitemata District Health Board
Country [2] 303346 0
New Zealand
Primary sponsor type
University
Name
School of Pharmacy, University of Auckland
Address
85 Park Rd, Grafton, Auckland, NZ, 1010
Country
New Zealand
Secondary sponsor category [1] 303367 0
None
Name [1] 303367 0
Address [1] 303367 0
Country [1] 303367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303870 0
Health and Disability Ethics Committee NZ
Ethics committee address [1] 303870 0
Ethics committee country [1] 303870 0
New Zealand
Date submitted for ethics approval [1] 303870 0
22/06/2019
Approval date [1] 303870 0
18/07/2019
Ethics approval number [1] 303870 0
19/NTB/106

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

Contacts
Principal investigator
Name 95090 0
Ms Joanna Hikaka
Address 95090 0
School of Pharmacy
University of Auckland
Park Rd
Grafton
Auckland
1010
Country 95090 0
New Zealand
Phone 95090 0
+64 211304917
Fax 95090 0
Email 95090 0
j.hikaka@auckland.ac.nz
Contact person for public queries
Name 95091 0
Joanna Hikaka
Address 95091 0
School of Pharmacy
University of Auckland
Park Rd
Grafton
Auckland
1010
Country 95091 0
New Zealand
Phone 95091 0
+64 211304917
Fax 95091 0
Email 95091 0
j.hikaka@auckland.ac.nz
Contact person for scientific queries
Name 95092 0
Joanna Hikaka
Address 95092 0
School of Pharmacy
University of Auckland
Park Rd
Grafton
Auckland
1010
Country 95092 0
New Zealand
Phone 95092 0
+64 211304917
Fax 95092 0
Email 95092 0
j.hikaka@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Outside of the scope of ethics application


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3273Study protocol  j.hikaka@auckland.ac.nz 378008-(Uploaded-25-07-2019-15-18-35)-Study-related document.docx
3274Statistical analysis plan  j.hikaka@auckland.ac.nz
3275Informed consent form  j.hikaka@auckland.ac.nz
3276Ethical approval  j.hikaka@auckland.ac.nz



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinical expertise, advocacy and enhanced autonomy - Acceptability of a pharmacist-facilitated medicines review intervention for community-dwelling Maori older adults.2021https://dx.doi.org/10.1016/j.rcsop.2021.100010
EmbaseFeasibility of a pharmacist-facilitated medicines review intervention for community-dwelling Maori older adults.2021https://dx.doi.org/10.1016/j.rcsop.2021.100018
N.B. These documents automatically identified may not have been verified by the study sponsor.