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Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial

Vera Logan Orcid Logo, Alex Bamsey, Neil Carter, David Hughes, Adam Turner Orcid Logo, Sue Jordan Orcid Logo

Pharmacy, Volume: 10, Issue: 3, Start page: 52

Swansea University Authors: Vera Logan Orcid Logo, Alex Bamsey, Neil Carter, David Hughes, Adam Turner Orcid Logo, Sue Jordan Orcid Logo

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Abstract

(1) Aims: Adverse drug reactions (ADRs) particularly affect older people prescribed multiple medicines. The professional bodies of nursing, medicine and pharmacy have issued guidelines on identification and management of ADRs; however, ADRs continue to account for ~10% unplanned hospital admissions...

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Published in: Pharmacy
ISSN: 2226-4787
Published: MDPI AG 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa59925
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The professional bodies of nursing, medicine and pharmacy have issued guidelines on identification and management of ADRs; however, ADRs continue to account for ~10% unplanned hospital admissions in the UK. Current methods of ADR identification and management could be improved by multidisciplinary collaboration involving nurses. The aim of this study is to examine the impact of implementing the nurse-led Adverse Drug Reaction (ADRe) Profile in UK primary care. (2) Design: A pragmatic cluster-randomised controlled trial (RCT) followed by qualitative interviews in a sequential mixed-methods study. (3) Methods: For the cluster RCT, 60 patients aged &#x2265;65 prescribed &#x2265;5 regular medicines for long-term conditions will be recruited, 10 in each of 6 general practices. The intervention arm (n = 30) will complete the ADRe Profile, whilst the control participants (n = 30) continue to receive usual, standard care. Primary outcomes will include clinical impact on patients, benefit and prescription changes. On completion of the RCT, participants will be invited to semi-structured qualitative interviews, to evaluate the impact of the ADRe Profile from stakeholders&#x2019; perspectives, and to describe the contextual factors relevant to ADRe implementation. (4) Results: The findings of this study will evaluate the effectiveness of the ADRe Profile in identifying and resolving potential ADRs in primary care. Trial registration: This study was registered in ClinicalTrials.gov, registration number NCT04663360, date of registration&#x2014;29 November 2021 (date of initial registration: 26 November 2020), protocol version 2, dated 8 January 2021</abstract><type>Journal Article</type><journal>Pharmacy</journal><volume>10</volume><journalNumber>3</journalNumber><paginationStart>52</paginationStart><paginationEnd/><publisher>MDPI AG</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>2226-4787</issnElectronic><keywords>drug-related side effects and adverse reactions; polypharmacy; primary health care; aging; nurses; randomised controlled trial</keywords><publishedDay>28</publishedDay><publishedMonth>4</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-04-28</publishedDate><doi>10.3390/pharmacy10030052</doi><url/><notes>Study Protocol. 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spelling 2022-05-18T13:39:47.0891290 v2 59925 2022-04-29 Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial 89a4cb1af023b1d80dce90a417a94585 0000-0001-7437-0272 Vera Logan Vera Logan true false 543ab96bafd16bb557dff6584389e629 Alex Bamsey Alex Bamsey true false 9a3f8cbd9ad25966c489e44fabed844f Neil Carter Neil Carter true false f1fbd458e3c75d8b597c0ac8036f2b88 David Hughes David Hughes true false 486394f1fb20386cbf02509e4a70ddd4 0000-0002-0721-7662 Adam Turner Adam Turner true false 24ce9db29b4bde1af4e83b388aae0ea1 0000-0002-5691-2987 Sue Jordan Sue Jordan true false 2022-04-29 HNU (1) Aims: Adverse drug reactions (ADRs) particularly affect older people prescribed multiple medicines. The professional bodies of nursing, medicine and pharmacy have issued guidelines on identification and management of ADRs; however, ADRs continue to account for ~10% unplanned hospital admissions in the UK. Current methods of ADR identification and management could be improved by multidisciplinary collaboration involving nurses. The aim of this study is to examine the impact of implementing the nurse-led Adverse Drug Reaction (ADRe) Profile in UK primary care. (2) Design: A pragmatic cluster-randomised controlled trial (RCT) followed by qualitative interviews in a sequential mixed-methods study. (3) Methods: For the cluster RCT, 60 patients aged ≥65 prescribed ≥5 regular medicines for long-term conditions will be recruited, 10 in each of 6 general practices. The intervention arm (n = 30) will complete the ADRe Profile, whilst the control participants (n = 30) continue to receive usual, standard care. Primary outcomes will include clinical impact on patients, benefit and prescription changes. On completion of the RCT, participants will be invited to semi-structured qualitative interviews, to evaluate the impact of the ADRe Profile from stakeholders’ perspectives, and to describe the contextual factors relevant to ADRe implementation. (4) Results: The findings of this study will evaluate the effectiveness of the ADRe Profile in identifying and resolving potential ADRs in primary care. Trial registration: This study was registered in ClinicalTrials.gov, registration number NCT04663360, date of registration—29 November 2021 (date of initial registration: 26 November 2020), protocol version 2, dated 8 January 2021 Journal Article Pharmacy 10 3 52 MDPI AG 2226-4787 drug-related side effects and adverse reactions; polypharmacy; primary health care; aging; nurses; randomised controlled trial 28 4 2022 2022-04-28 10.3390/pharmacy10030052 Study Protocol. This article belongs to the Special Issue 10th Anniversary of Pharmacy—Advances in Pharmacy Education and Practice. Academic Editor: David Wright. COLLEGE NANME Nursing COLLEGE CODE HNU Swansea University SU College/Department paid the OA fee This research was funded by Swansea University (Research Excellence Scholarship), sponsor reference RIO 034-20 and received support from Health and Care Research Wales (ID 49076). 2022-05-18T13:39:47.0891290 2022-04-29T14:33:52.8550269 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Vera Logan 0000-0001-7437-0272 1 Alex Bamsey 2 Neil Carter 3 David Hughes 4 Adam Turner 0000-0002-0721-7662 5 Sue Jordan 0000-0002-5691-2987 6 59925__23935__64b2e18522294e1f90165a334f9170a8.pdf 59925.VOR.pdf 2022-04-29T14:43:38.6169963 Output 930506 application/pdf Version of Record true Copyright: © 2022 by the authors. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. true eng https:// creativecommons.org/licenses/by/ 4.0/
title Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
spellingShingle Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
Vera Logan
Alex Bamsey
Neil Carter
David Hughes
Adam Turner
Sue Jordan
title_short Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
title_full Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
title_fullStr Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
title_full_unstemmed Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
title_sort Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial
author_id_str_mv 89a4cb1af023b1d80dce90a417a94585
543ab96bafd16bb557dff6584389e629
9a3f8cbd9ad25966c489e44fabed844f
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486394f1fb20386cbf02509e4a70ddd4
24ce9db29b4bde1af4e83b388aae0ea1
author_id_fullname_str_mv 89a4cb1af023b1d80dce90a417a94585_***_Vera Logan
543ab96bafd16bb557dff6584389e629_***_Alex Bamsey
9a3f8cbd9ad25966c489e44fabed844f_***_Neil Carter
f1fbd458e3c75d8b597c0ac8036f2b88_***_David Hughes
486394f1fb20386cbf02509e4a70ddd4_***_Adam Turner
24ce9db29b4bde1af4e83b388aae0ea1_***_Sue Jordan
author Vera Logan
Alex Bamsey
Neil Carter
David Hughes
Adam Turner
Sue Jordan
author2 Vera Logan
Alex Bamsey
Neil Carter
David Hughes
Adam Turner
Sue Jordan
format Journal article
container_title Pharmacy
container_volume 10
container_issue 3
container_start_page 52
publishDate 2022
institution Swansea University
issn 2226-4787
doi_str_mv 10.3390/pharmacy10030052
publisher MDPI AG
college_str Faculty of Medicine, Health and Life Sciences
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hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description (1) Aims: Adverse drug reactions (ADRs) particularly affect older people prescribed multiple medicines. The professional bodies of nursing, medicine and pharmacy have issued guidelines on identification and management of ADRs; however, ADRs continue to account for ~10% unplanned hospital admissions in the UK. Current methods of ADR identification and management could be improved by multidisciplinary collaboration involving nurses. The aim of this study is to examine the impact of implementing the nurse-led Adverse Drug Reaction (ADRe) Profile in UK primary care. (2) Design: A pragmatic cluster-randomised controlled trial (RCT) followed by qualitative interviews in a sequential mixed-methods study. (3) Methods: For the cluster RCT, 60 patients aged ≥65 prescribed ≥5 regular medicines for long-term conditions will be recruited, 10 in each of 6 general practices. The intervention arm (n = 30) will complete the ADRe Profile, whilst the control participants (n = 30) continue to receive usual, standard care. Primary outcomes will include clinical impact on patients, benefit and prescription changes. On completion of the RCT, participants will be invited to semi-structured qualitative interviews, to evaluate the impact of the ADRe Profile from stakeholders’ perspectives, and to describe the contextual factors relevant to ADRe implementation. (4) Results: The findings of this study will evaluate the effectiveness of the ADRe Profile in identifying and resolving potential ADRs in primary care. Trial registration: This study was registered in ClinicalTrials.gov, registration number NCT04663360, date of registration—29 November 2021 (date of initial registration: 26 November 2020), protocol version 2, dated 8 January 2021
published_date 2022-04-28T04:17:36Z
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