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, Alexander Bamsey, Neil Carter, David Hughes, Adam Turner, Sue Jordan, Vera Logan, Alexander Bamsey, Neil Carter, David Hughes, Adam Turner, Sue Jordan

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 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.

Keywords: aging; drug-related side effects and adverse reactions; nurses; polypharmacy; primary health care; randomised controlled trial.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. S.J. developed the ADRe Profile but gained no financial advantages from its implementation or from the trial. Swansea university holds the copyright to the ADRe Profile. All other authors declare no conflict of interests. The funders had and will have no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Illustrating the complementary triangulation.
Figure 2
Figure 2
Example section of the ADRe Profile, demonstrating the supplementary information icons.

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