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 [version 1; peer review: 2 approved]
Introduction: Polypharmacy 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 evi...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2022-11-01
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| Series: | NIHR Open Research |
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| Online Access: | https://openresearch.nihr.ac.uk/articles/2-54/v1 |
| _version_ | 1797780083150159872 |
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| author | Chris Salisbury Rupert A. Payne Barbara Caddick Peter S. Blair Tobias Dreischulte Carolyn A. Chew-Graham Bruce Guthrie Lorna J. Duncan Roxanne M. Parslow Cindy Mann Katrina M. Turner Jeff Round Deborah McCahon Nicholas L. Turner |
| author_facet | Chris Salisbury Rupert A. Payne Barbara Caddick Peter S. Blair Tobias Dreischulte Carolyn A. Chew-Graham Bruce Guthrie Lorna J. Duncan Roxanne M. Parslow Cindy Mann Katrina M. Turner Jeff Round Deborah McCahon Nicholas L. Turner |
| author_sort | Chris Salisbury |
| collection | DOAJ |
| description | Introduction: Polypharmacy 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. Methods: This 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 dissemination: The 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 Registration: 90146150 (28/03/2019) |
| first_indexed | 2024-03-12T23:39:30Z |
| format | Article |
| id | doaj.art-37c21efb932a41a99952b69341ee5021 |
| institution | Directory Open Access Journal |
| issn | 2633-4402 |
| language | English |
| last_indexed | 2024-03-12T23:39:30Z |
| publishDate | 2022-11-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | NIHR Open Research |
| spelling | doaj.art-37c21efb932a41a99952b69341ee50212023-07-15T00:00:00ZengF1000 Research LtdNIHR Open Research2633-44022022-11-01214406Improving 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 [version 1; peer review: 2 approved]Chris Salisbury0https://orcid.org/0000-0002-4378-3960Rupert A. Payne1https://orcid.org/0000-0002-5842-4645Barbara Caddick2https://orcid.org/0000-0002-3032-0430Peter S. Blair3Tobias Dreischulte4Carolyn A. Chew-Graham5https://orcid.org/0000-0002-9722-9981Bruce Guthrie6https://orcid.org/0000-0003-4191-4880Lorna J. Duncan7https://orcid.org/0000-0002-9629-030XRoxanne M. Parslow8Cindy Mann9Katrina M. Turner10Jeff Round11Deborah McCahon12Nicholas L. Turner13Centre for Academic Primary Care, University of Bristol, Bristol, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKBristol Trials Centre, University of Bristol, Bristol, UKInstitute of General Practice and Family Medicine, Medical Center of the Ludwig-Maximilians-University, Munich, GermanySchool of Medicine, Keele University, Keele, UKAdvanced Care Research Centre, University of Edinburgh, Edinburgh, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKInstitute of Health Economics, Edmonton, Alberta, CanadaCentre for Academic Primary Care, University of Bristol, Bristol, UKBristol Trials Centre, University of Bristol, Bristol, UKIntroduction: Polypharmacy 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. Methods: This 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 dissemination: The 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 Registration: 90146150 (28/03/2019)https://openresearch.nihr.ac.uk/articles/2-54/v1polypharmacy clinical trial medicines optimisation general practiceeng |
| spellingShingle | Chris Salisbury Rupert A. Payne Barbara Caddick Peter S. Blair Tobias Dreischulte Carolyn A. Chew-Graham Bruce Guthrie Lorna J. Duncan Roxanne M. Parslow Cindy Mann Katrina M. Turner Jeff Round Deborah McCahon Nicholas L. Turner 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 [version 1; peer review: 2 approved] NIHR Open Research polypharmacy clinical trial medicines optimisation general practice eng |
| title | 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 [version 1; peer review: 2 approved] |
| title_full | 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 [version 1; peer review: 2 approved] |
| title_fullStr | 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 [version 1; peer review: 2 approved] |
| title_full_unstemmed | 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 [version 1; peer review: 2 approved] |
| title_short | 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 [version 1; peer review: 2 approved] |
| title_sort | 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 version 1 peer review 2 approved |
| topic | polypharmacy clinical trial medicines optimisation general practice eng |
| url | https://openresearch.nihr.ac.uk/articles/2-54/v1 |
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