Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000984594p
Ethics application status
Submitted, not yet approved
Date submitted
25/07/2024
Date registered
13/08/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
13/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study testing a new pharmacist-led service to improve medicine use in older adults.
Scientific title
A cluster randomised controlled trial to evaluate a pharmacist-led intervention addressing inappropriate polypharmacy and its impact on medication use outcomes in older adults
Secondary ID [1] 311032 0
Nil known
Universal Trial Number (UTN)
U1111-1300-9210
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problematic polypharmacy 332149 0
Condition category
Condition code
Public Health 328870 328870 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating general practice clinics will be selected as the unit for allocation. Patient participants from general practice clinics assigned to the intervention group will receive the PolyCare intervention, which aims to improve medicine use and reduce inappropriate prescribing in older adults with polypharmacy.

The stages of the PolyCare intervention include:
1) Utilising PolyScan, a novel information technology tool to identify eligible patients aged 65 years or older, prescribed five or more medicines, and with potentially inappropriate medicines (PIMs).
PolyScan was developed based on 21 indicators from a New Zealand criteria of PIMs to correct for older adults with polypharmacy, which was programed into a set of implementable definitions. The tool is automatically linked to New Zealand hospital, emergency department, and pharmaceutical collection databases to classify whether each indicator is present at an individual patient level, and then triage individuals based on the number of indicators met [1]. Clinics and clinical pharmacists will access the PolyScan report electronically using their unique password encryption.

2) Enlisting clinical pharmacists to provide educational outreach to general practice clinics. A clinical pharmacist will meet with general practice clinicians as a group to:
- Review and discuss the findings from the PolyScan report.
- Discuss strategies to reduce problematic polypharmacy, advocating for rational and environmentally conscious prescribing.
- Detail the pharmacist's role in providing medicine reviews for clinic patients over the four-week intervention period.
- Request a clinic team member to facilitate the pharmacist's integration into the team and assist in resolving encountered difficulties.
Educational outreach (education package) will be conducted one month prior to conducting the first medicine review for patient participants (see step 3).

3) Enlisting clinical pharmacists to conduct medicine reviews for patient participants in collaboration with doctors and nurses.
Patient participants will be provided a one off, individualised, 60-minute, free appointment with a pharmacist to review their medicines. The medicine review will be conducted face-to-face, either at the patient's general practice clinic or in their home. The procedures for the medicine review are detailed below:
- Meeting with the patient to discuss their health and medicine background.
- Evaluating patient characteristics such as literacy level which may affect their health or medicine outcomes.
- Evaluating whether any patient symptoms could be attributed to the adverse effects or interactions from their medicines.
- Interpreting, assessing and monitoring patient laboratory results.
- Assessing, detecting, and prioritising patient medicine concerns including inappropriate polypharmacy, inappropriate medicines, dosage or regimens, adverse effects, contraindications, or interactions.
- Working with the patient to develop a mutually agreed plan to resolve identified medicine issues.
- Providing patients with medicine education and training.
- Communicating recommendations to the patient's general practitioner/nurse practitioner (GP/NP) and other clinicians through messages in the clinic's electronic patient management system.
The doctor/nurse will make the final decision regarding the pharmacist’s recommendations.

4) Monitoring and following up with patient participants post-medicine review.
Clinical pharmacists will monitor and follow-up with patient participants at 3-months and 6-months following the medicine review.

Clinical pharmacists delivering the PolyCare intervention must hold a current New Zealand annual practicing certificate and have experience practicing within general practice clinics.

A package has been developed to support clinical pharmacists to deliver the study. This package includes materials such as terms of reference, goals and objectives, role descriptions and purposes, contribution descriptions and responsibilities, boundaries, timelines, leadership structure, decision-making policy and authority, communication channels, the implementation framework, policy guidelines, patient eligibility criteria, patient information sheet/brochure, consent form, workflow and care pathway considerations, suggested solutions to potential implementation barriers, as well as resources such as Grimes and Barnett et al.'s patient-centered consultation skills program for pharmacy practice [2], and Lacey et al.'s 'Hui Process' framework for patient consultations [3].

The research team will develop a compulsory online training programme for all pharmacists to complete before delivering the study. The training programme will include multiple choice, matching, and true or false self-check questions, which provide small summative self-evaluations at the end of each topic section. After the training, an assessment comprising multiple choice, matching, true or false, and short answer questions will be used test competency. Each pharmacist would be required to complete the training and achieve a set passing grade in the assessment before delivering the study. Lastly, an evaluation form based on Sadler et al.’s research is included for pharmacists to evaluate the training using a five-point Likert scale [4]. An estimated six hours will be required to complete the online training.

Regarding intervention adherence, the clinical pharmacist delivering the intervention will inform the research team any patient participants that do not complete the medicine review in it's entirety.

Reference
1. Liu L, Alate R, Harrison J. Development and validation of PolyScan, an information technology triage tool for older adults with polypharmacy: a healthcare informatics study. J Prim Health Care. 2023;15(3):215-223.
2. Grimes L, Barnett N. Consultation skills for pharmacy practice: taking a patient-centred approach. Manchester: Centre for Pharmacy Postgraduate Education. 2014.
3. Lacey C, Huria T, Beckert L, et al. The Hui process: a framework to enhance the doctor-patient relationship with Maori. N Z Med J. 2011;124(1347):72–78.
4. Sadler S, Rodgers S, Howard R, et al. Training pharmacists to deliver a complex information technology intervention (PINCER) using the principles of educational outreach and root cause analysis. Int J Pharm Pract. 2014;22(1):47-58.
Intervention code [1] 327491 0
Treatment: Other
Comparator / control treatment
The patient participants from clinics assigned to the control group will receive usual clinic care. Usual care may include general practice services such as preventive care, diagnostic evaluations, the management of chronic conditions, and other standard primary care services. However, usual care will exclude pharmacist-led educational outreach and medicine review offered by the PolyCare intervention.

Following completion of the study, the researchers will offer support to control group patients and clinics. Control group clinics will be provided with a PolyScan report, which identifies the patients who have received PIMs for follow-up and review. Additionally, an accompanying research paper by Liu and Harrison will be provided, which explains the significance of each PIM for older adults with polypharmacy [1]. Disseminating this information will be passed to the practice manager or another delegate.

Reference
1. Liu L, Harrison J. Development of explicit criteria identifying potentially inappropriate polypharmacy in older adults in New Zealand primary care: a mixed-methods study. J Prim Health Care. 2023;15(1):38-47.
Control group
Active

Outcomes
Primary outcome [1] 336693 0
The study will focus on a set of 21 PIM indicators from the New Zealand Criteria, which New Zealand expert clinicians have recognised as crucial to correct for older adults with polypharmacy [1].

The primary outcome will assess the change in the mean number of PIM indicators per patient participant, as identified in the New Zealand Criteria.

Reference:
1. Liu L, Harrison J. Development of explicit criteria identifying potentially inappropriate polypharmacy in older adults in New Zealand primary care: a mixed-methods study. JPHC. 2023; doi:10.1071/HC22135
Timepoint [1] 336693 0
Data collection time-points will be at study baseline (primary time-point), three months, and six months after the intervention period.
Secondary outcome [1] 429381 0
Patient-reported outcome measure.
Timepoint [1] 429381 0
Data collection time-points will be at baseline, three months, and six months after the intervention period.
Secondary outcome [2] 429382 0
Economic evaluation.
Timepoint [2] 429382 0
Data collection time-point will be six months after the intervention period.
Secondary outcome [3] 429383 0
Process evaluation.
Timepoint [3] 429383 0
Data collection time-points will be at baseline, three months, and six months after the intervention period.
Secondary outcome [4] 436979 0
Environmental impact evaluation
Timepoint [4] 436979 0
Data collection time-point will be at six months after the intervention period.
Secondary outcome [5] 438282 0
Patient-reported outcome measure.
Timepoint [5] 438282 0
Data collection time-points will be at baseline, three months, and six months after the intervention period.

Eligibility
Key inclusion criteria
Patients can qualify to take part in the study if they meet the following criteria:
- They are 65 years of age or older.
- Their current daily medicine regimen includes five or more medicines.
- They are presently prescribed one or more PIM indicators, as identified by the PolyScan tool.
- They can provide written informed consent, either by the patient or their welfare guardian/enduring power of attorney.
- They are registered at a general practice clinic that is participating in the study.

Pharmacists can qualify to take part in the study if they meet the following criteria:
- They possess a current Annual Practising Certification from the Pharmacy Council of New Zealand.
- They possess at least one year experience practising within general practice clinics.

GPs and NPs can qualify to take part in the study if they meet the following criteria:
- They are based in New Zealand.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients will be excluded if:
- They underwent a pharmacist-led medicine review within the last six months.
- They are unable to meet the requirements of the inclusion criteria.

Pharmacists, NPs/GPs will be excluded if:
- They are unable to meet the requirements of the inclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Procedure for enrolling patient participants:

The research team will meet with clinics to introduce the study. For those interested, consent will be requested from the chief executive officer or designated representative and indicated by signing a consent form.

For each clinic, the PolyScan IT tool will be used to identify older adults with polypharmacy who have been prescribed a PIM. A clinic staff member will be delegated to screen these patients against the eligibility criteria and contact eligible patients to introduce the study. Eligible patients interested in participating will be referred to the study pharmacist. The pharmacist will discuss the study with patients, and provide them with a participant information sheet and consent form to sign and return before recruitment.

Clinics will be selected as the unit for allocation. After clinics and patients have been recruited into the study, the researchers will stratify participating clinics based on the size of their enrolled population into three groups: 1) less than 5,000 patients, 2) between 5,000 and 10,000 patients, and 3) more than 10,000 patients. For each group, an "off-site" independent statistician, who has no interaction with clinics, will generate the randomisation sequence using a computerised randomisation table, and allocate clinics to the intervention or control group.

Allocation is concealed as it cannot be known which group a clinic is allocated to during recruitment, as allocation will only occur after clinics and patients have been recruited into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participating general practice clinics will be stratified according to their number of enrolled patients, dividing them into three groups: 1) fewer than 5,000 patients, 2) between 5,000 and 10,000 patients, and 3) exceeding 10,000 patients.

For each strata, an independent statistician will be tasked with generating an allocation sequence using a randomisation table created by computer software. Sequence generation will involve labeling each clinic cluster, using computer software to generate a randomisation sequence, creating the randomisation table, and assigning each cluster to a treatment group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
29/07/2025
Actual
Date of last data collection
Anticipated
29/01/2026
Actual
Sample size
Target
256
Accrual to date
Final
Recruitment outside Australia
Country [1] 26003 0
New Zealand
State/province [1] 26003 0

Funding & Sponsors
Funding source category [1] 315293 0
Government body
Name [1] 315293 0
Health Research Council
Country [1] 315293 0
New Zealand
Primary sponsor type
Individual
Name
Lisheng Liu - University of Auckland
Address
The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland
Country
New Zealand
Secondary sponsor category [1] 317386 0
Individual
Name [1] 317386 0
Jeff Harrison - University of Auckland
Address [1] 317386 0
The University of Auckland Faculty of Medical and Health Sciences. M&HS Building 505 - Bldg 505, 85 Park Road, Grafton, Auckland, 1023
Country [1] 317386 0
New Zealand
Secondary sponsor category [2] 317387 0
Individual
Name [2] 317387 0
Trudi Aspden - University of Auckland
Address [2] 317387 0
The University of Auckland Faculty of Medical and Health Sciences. M&HS Building 505 - Bldg 505, 85 Park Road, Grafton, Auckland, 1023
Country [2] 317387 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314252 0
New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 314252 0
Ethics committee country [1] 314252 0
New Zealand
Date submitted for ethics approval [1] 314252 0
01/09/2024
Approval date [1] 314252 0
Ethics approval number [1] 314252 0

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

Contacts
Principal investigator
Name 130818 0
Mr Lisheng Liu
Address 130818 0
The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland
Country 130818 0
New Zealand
Phone 130818 0
+64 7 270 1871
Fax 130818 0
Email 130818 0
[email protected]
Contact person for public queries
Name 130819 0
Lisheng Liu
Address 130819 0
The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland
Country 130819 0
New Zealand
Phone 130819 0
+64 7 270 1871
Fax 130819 0
Email 130819 0
[email protected]
Contact person for scientific queries
Name 130820 0
Lisheng Liu
Address 130820 0
The University of Auckland Faculty of Medical and Health Sciences. 8 Grafton Road, Auckland Central, 1010, Auckland
Country 130820 0
New Zealand
Phone 130820 0
+64 7 270 1871
Fax 130820 0
Email 130820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study participants will give informed consent with the understanding that their individual participant-level data will not be publicly accessible.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24012Informed consent form    386940-(Uploaded-01-07-2024-15-09-57)-participant-information-sheet-consent-form-template-v5.0april2023.doc



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.