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Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

Payne, Rupert A; Blair, Peter S; Caddick, Barbara; Chew-Graham, Carolyn A; Dreischulte, Tobias; Duncan, Lorna J; Guthrie, Bruce; Mann, Cindy; Parslow, Roxanne M; Round, Jeff; Salisbury, Chris; Turner, Katrina M; Turner, Nicholas L; McCahon, Deborah

Authors

Rupert A Payne

Peter S Blair

Barbara Caddick

Tobias Dreischulte

Lorna J Duncan

Bruce Guthrie

Cindy Mann

Roxanne M Parslow

Jeff Round

Chris Salisbury

Katrina M Turner

Nicholas L Turner

Deborah McCahon



Abstract

IntroductionPolypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting.MethodsThis trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care.Ethics and disseminationThe protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers.Isrctn registration90146150 (28/03/2019).

Citation

Payne, R. A., Blair, P. S., Caddick, B., Chew-Graham, C. A., Dreischulte, T., Duncan, L. J., …McCahon, D. (in press). Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care. NIHR Open Research, 2, 54. https://doi.org/10.3310/nihropenres.13285.1

Journal Article Type Article
Acceptance Date Nov 8, 2022
Online Publication Date Nov 8, 2022
Deposit Date Jan 19, 2024
Publicly Available Date Jan 19, 2024
Journal NIHR open research
Print ISSN 2633-4402
Electronic ISSN 2633-4402
Publisher Taylor and Francis
Peer Reviewed Peer Reviewed
Volume 2
Pages 54
DOI https://doi.org/10.3310/nihropenres.13285.1
Keywords General Practice, Clinical Trial, Polypharmacy, Medicines Optimisation
PMID 37881305

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