PPhoCUs: Polypharmacy, Pharmacists and Clinical Uncertainty – Understanding how pharmacist decision making can be improved in the context of polypharmacy

ISRCTN	ISRCTN38879473
DOI	https://doi.org/10.1186/ISRCTN38879473
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	336527
Protocol serial number	UoE Sponsor number: 2022-23-31, CPMS 62607
Sponsor	University of Exeter
Funder	NIHR School for Primary Care Research

Submission date: 08/10/2024
Registration date: 15/10/2024
Last edited: 18/11/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study looks at how pharmacists in GP practices make decisions when helping patients who take many different medications. People who take more than 10 medicines are more likely to have serious health issues and need hospital care. The study aims to understand how pharmacists handle these complex situations and make decisions when the best course of action is unclear.

Who can participate?
Pharmacists working in GP practices and patients who have appointments with these pharmacists can participate in the study.

What does the study involve?
The study involves recording patient appointments with GP pharmacists to see how decisions are made. Both pharmacists and patients will also be invited to individual interviews to share their experiences. Pharmacists will discuss how they make decisions, and patients will talk about their experiences during their appointments.

What are the possible benefits and risks of participating?
Participants may benefit from contributing to research that could improve pharmacist training and patient care in the future. There are minimal risks, but participants might feel uncomfortable being recorded or interviewed.

Where is the study run from?
University of Exeter (UK)

When is the study starting and how long is it expected to run for?
June 2024 to September 2026

Who is funding the study?
The study is funded by the School for Primary Care Research within the National Institute for Health Research (UK)

Who is the main contact?
Tomazo Kallis, t.j.kallis@exeter.ac.uk

Contact information

Mr Tomazo Kallis
Public, Scientific, Principal investigator

JS01, Smeall Building
St Luke's Campus, 79 Heavitree Road
Exeter
EX2 4TH
United Kingdom

ORCID ID	0009-0005-1654-5464
Phone	+44 1392 661000
Email	t.j.kallis@exeter.ac.uk

Study information

Primary study design	Observational
Study design	Qualitative
Secondary study design	Qualitative study
Participant information sheet	46195 Patient Participation Information Sheet v2 19Jun24.pdf
Scientific title	PPhoCUs: Polypharmacy, Pharmacists and Clinical Uncertainty
Study acronym	PPhoCUs
Study objectives	How can clinical pharmacist decision-making be improved when delivering medication reviews in the context of polypharmacy and clinical uncertainty? 1. How do practice-based pharmacists approach clinical uncertainty when conducting reviews with patients who have complex polypharmacy? 2. What influences clinical pharmacists’ decision making when encountering clinical uncertainty in patients with complex polypharmacy? 3. In the context of clinical uncertainty, what is the patient’s experience of care and person-centred decision making delivered by clinical pharmacists in general practice? 4. In what way do the current education pathways for pharmacists in primary care meet the perceived learning needs for pharmacists managing clinical uncertainty in practice? 5. How might the standards for ongoing clinical education for pharmacists in GP practice settings (considering both clinical supervision and formal education) be further improved to support better patient-centred decision making in the context of clinical uncertainty?
Ethics approval(s)	Approved 27/06/2024, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 207 9722504; leedswest.rec@hra.nhs.uk), ref: 24/YH/0120
Health condition(s) or problem(s) studied	Polypharmacy (10 or more medicines)
Intervention	Phase 1: Observational audio recordings of structured medication reviews between pharmacists and patients Phase 2: Semi-structured interviews with pharmacists Phase 3: Semi-Structured interviews with patients Phase 4: Focus group sessions to develop new intervention targeting pharmacist management of clinical uncertainty when reviewing polypharmacy in primary care
Intervention type	Other
Primary outcome measure(s)	Perceptions and experiences of clinical uncertainty using audio recordings of naturalistic encounters where pharmacists review polypharmacy with patients in GP practice settings
Key secondary outcome measure(s)	1. Joint navigation of clinical uncertainty using audio recordings of naturalistic encounters where pharmacists review polypharmacy with patients in GP practice settings 2. Pharmacist perceptions of clinical uncertainty using qualitative interviews 3. Patient perceptions of pharmacist-delivered polypharmacy reviews, including shared decision making, using qualitative interviews
Completion date	30/09/2026

Eligibility

Participant type(s)	Health professional, Service user
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	For Pharmacists (in Phases 1 and 2): 1. Registered as a Pharmacist with the General Pharmaceutical Council 2. Employed in the primary care sector, based in either a general practice or primary care network setting 3. Currently delivering or able to deliver structured medication reviews For Patients (in Phases 1 and 3): 1. 18 years old or older 2. Prescribed 10 or more medications on repeat 3. Booked to have a structured medication review with a clinical pharmacist in primary care 4. Able to freely give informed consent
Key exclusion criteria	For Pharmacists: 1. Pharmacists working in secondary care or community pharmacy settings 2. Healthcare professionals who are not registered pharmacists 3. Pharmacists with no experience or ability to deliver SMRs For Patients: 1. Under 18 years of age 2. Patients who are unable to freely give consent or lack capacity 3. End of Life Care patients 4. Care Home Residents 5. Patients identified by the host research site as being unsuitable for participation by virtue of being acutely or significantly unwell, difficulties in communicating, safety issues (e.g. noted on patient records or have overtly declined to be contacted by the practice) or welfare issues
Date of first enrolment	30/09/2024
Date of final enrolment	31/07/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Exeter

Stocker Road
Exeter
EX4 4PY
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	for Patients version 2	19/06/2024	15/10/2024	No	Yes
Participant information sheet	for Pharmacists Phase 1 version 2	19/06/2024	15/10/2024	No	Yes
Participant information sheet	for Pharmacists Phase 2 version 2	19/06/2024	15/10/2024	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.1	19/06/2024	15/10/2024	No	No

Additional files

46195 336527_ PPhoCUs Protocol_v1.1_19Jun2024.pdf: Protocol file
46195 Patient Participation Information Sheet v2 19Jun24.pdf: for Patients
46195 Pharmacist Participation Information Sheet Phase1 v2 19Jun24.pdf: for Pharmacists Phase 1
46195 Pharmacist Participation Information Sheet Phase2 v2 19Jun24.pdf: for Pharmacists Phase 2

Editorial Notes

18/11/2025: The date of final enrolment was changed from 30/01/2026 to 31/07/2025.
06/11/2024: Internal review.
08/10/2024: Trial's existence confirmed by NHS HRA.