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A study testing a new pharmacist-led service to improve medicine use in older adults.

A cluster randomised controlled trial to evaluate a pharmacist-led intervention addressing inappropriate polypharmacy and its impact on medication use outcomes in older adults

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000984594
Enrollment
256
Registered
2024-08-13
Start date
2025-07-01
Completion date
2025-07-29
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Older adults often take more medicines, increasing the risk of unsafe medicine use that can lead to poor outcomes such as side effects and hospitalisation. Clinical pharmacists are medicine experts who collaborate with doctors, nurses, and other healthcare professionals to ensure the safety and appropriateness of the medicines that people are taking. A new service named PolyCare has been developed, which utilises clinical pharmacists to support doctors and nurses in reducing unsafe medicine use for older adults who are taking multiple daily medicines. The purpose of this study is to test whether implementing the PolyCare service in general practice can improve outcomes for older adults. The study hypothesises that PolyCare can effectively reduce harmful medicine use for older adults.

Interventions

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 m

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.

Sponsors

Lisheng Liu - University of Auckland
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026