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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 information initially 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]

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

Medicines optimisation

Health equity

Condition category

Condition code

Public Health

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Participant acceptability assessed through questionnaire, Questionnaire has been developed for the purposes of this study.

Timepoint [1]

4 weeks post-intervention

Primary outcome [2]

Whanau/family member acceptability assessed through questionnaire. Questionnaire has been developed for the purposes of this study.

Timepoint [2]

4 weeks post-intervention

Primary outcome [3]

Prescriber acceptability questionnaire. Questionnaire has been developed for the purposes of this study.

Timepoint [3]

After all interventions have been completed

Secondary outcome [1]

Medicines knowledge will be assessed using a tool developed for this study

Timepoint [1]

Baseline and 4 weeks post intervention

Secondary outcome [2]

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]

Baseline and immediately post-intervention (all assignment of medicines appropriateness completed post-intervention)

Secondary outcome [3]

Participant quality of life will be assessed using the SF-36 tool

Timepoint [3]

Baseline and 4 weeks post-intervention

Secondary outcome [4]

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]

Immediately post intervention

Secondary outcome [5]

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]

After all interventions and assessments have been completed

Secondary outcome [6]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010
Postal Address: PO Box 5541, Wellesley Street, Auckland 1141

Country [1]

New Zealand

Funding source category [2]

Government body

Name [2]

Waitemata District Health Board

Address [2]

1 Shea Terrace, Takapuna, Auckland, 0622

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee NZ

Ethics committee address [1]

Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

22/06/2019

Approval date [1]

18/07/2019

Ethics approval number [1]

19/NTB/106

Summary

Brief summary

Medicines review services describe an intentional review of medicines, carried out between health professionals and patients with the aim to agree on the best way to use medicines to improve the quality, safety and appropriate use in a particular patient. Pharmacist-facilitated medicines review services have been shown to improve the appropriate use of medicines in older adults.
Maori, in comparison to non-Maori, are more likely to experience drug related problems, less likely to be given information about their medicines, and less likely to be recruited into mainstream pilot medicine review services.
Pharmacist services, designed to be responsive to the needs of Maori older adults have the potential to improve medicines related health outcomes and contribute to achieving health equity.
Interviews with Maori older adults, health professionals and District Health Board staff have been undertaken in Waitemata and, along with other research, have been used to develop a medicines review service for community-dwelling Maori older adults.
The medicines review service will include:
1. a ‘medicines education’ session with the pharmacist. In addition to sharing information about medicines, the participant will have the opportunity to share their medicine and wellbeing goals.
2. an optional ‘medicines optimisation’ service where the participant, pharmacist and prescriber can all sit down together and discuss a medicines plan.
The aim of this study is to test the acceptability of this medicines reviews service to Maori older adults, their whanau and prescribers. The study is being undertaken within a kaupapa Maori framework and measures of success include whether patients feel more in control and empowered in their medicine treatment journey. Other outcomes to be measured include how easy it is to recruit to this service, the time taken to provide the service and the effect of this services on medicines knowledge and medicines appropriateness.

Trial website

Trial related presentations / publications

Hikaka J, Hughes C, Jones R, Connolly M, Martini N. (2019) A pharmacist-led medicines review intervention in community-dwelling Maori older adults– a feasibility study protocol. Res Social Adm Pharm. 2019 Dec 6. Doi:10.1016/j.sapharm.12.004 [Epub ahead of print].

Public notes

Contacts

Principal investigator

Name

Ms Joanna Hikaka

Address

School of Pharmacy
University of Auckland
Park Rd
Grafton
Auckland
1010

Country

New Zealand

Phone

+64 211304917

Fax

[email protected]

Contact person for public queries

Name

Joanna Hikaka

Address

School of Pharmacy
University of Auckland
Park Rd
Grafton
Auckland
1010

Country

New Zealand

Phone

+64 211304917

Fax

[email protected]

Contact person for scientific queries

Name

Joanna Hikaka

Address

School of Pharmacy
University of Auckland
Park Rd
Grafton
Auckland
1010

Country

New Zealand

Phone

+64 211304917

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Outside of the scope of ethics application

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
3273	Study protocol	[email protected]	378008-(Uploaded-25-07-2019-15-18-35)-Study-related document.docx
3274	Statistical analysis plan	[email protected]
3275	Informed consent form	[email protected]
3276	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Hikaka J, Hughes C, Jones R, Amende H, Connolly MJ... [More Details]
Study results article	Yes		Hikaka J, Jones R, Hughes C, Amende H, Connolly MJ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Clinical expertise, advocacy and enhanced autonomy - Acceptability of a pharmacist-facilitated medicines review intervention for community-dwelling Maori older adults.	2021	https://dx.doi.org/10.1016/j.rcsop.2021.100010
Embase	Feasibility of a pharmacist-facilitated medicines review intervention for community-dwelling Maori older adults.	2021	https://dx.doi.org/10.1016/j.rcsop.2021.100018

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added automatically