Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders

Objectives VICTORION-Spirit was a hybrid study designed to assess the feasibility of implementing inclisiran, a novel cholesterol-lowering treatment and behavioural support within primary care centres in England. This process evaluation aimed to evaluate the implementation of inclisiran for patients...

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Main Authors: Peter Bower, Samantha Dixon, Paul Wilson, Amy Mathieson, Rebecca Elvey, Martin Gibson, Tracey Vell
Format: Article
Language:English
Published: BMJ Publishing Group 2025-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/2/e083441.full
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author Peter Bower
Samantha Dixon
Paul Wilson
Amy Mathieson
Rebecca Elvey
Martin Gibson
Tracey Vell
author_facet Peter Bower
Samantha Dixon
Paul Wilson
Amy Mathieson
Rebecca Elvey
Martin Gibson
Tracey Vell
author_sort Peter Bower
collection DOAJ
description Objectives VICTORION-Spirit was a hybrid study designed to assess the feasibility of implementing inclisiran, a novel cholesterol-lowering treatment and behavioural support within primary care centres in England. This process evaluation aimed to evaluate the implementation of inclisiran for patients with elevated low-density lipoprotein cholesterol and atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (n=900), from the perspectives of key stakeholders.Design VICTORION-Spirit was a phase IIIb, multicentre, randomised, controlled study. We followed a process evaluation strategy to collate the views of stakeholders via semistructured interviews and to gain insights on the ‘implementability’ of inclisiran in primary care. Data were generated via interviews with patients, healthcare providers and research nurses and analysed using a qualitative rapid analysis approach.Setting Primary care in Greater Manchester, UK.Participants 84 participants were interviewed, including patients (n=56), professionals at participating practices in VICTORION-Spirit (n=13), health advisors (n=4) and research nurses (n=11).Results Interim findings suggest the process of receiving and providing inclisiran during the study was ‘straightforward’, and the behavioural support provided to some patients was generally viewed favourably. Beyond the trial, patients and healthcare providers thought the delivery of inclisiran could work well as a practice nurse-provided service. Barriers to implementing inclisiran were generally related to workforce and workload pressures in primary care, and an incentive structure to support delivery was recommended.Conclusions Patients and healthcare providers supported implementing inclisiran in primary care. It was convenient for patients to receive inclisiran in general practice, and most providers felt that the intervention was a useful addition to existing lipid-lowering treatments. Several barriers to implementation were highlighted, including concerns relating to general practice resources and costs.Trial registration number NCT04807400.
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spelling doaj-art-2bf18bc2d38d47018654a081d65d08282025-08-20T03:11:25ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2023-083441Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholdersPeter Bower0Samantha Dixon1Paul Wilson2Amy Mathieson3Rebecca Elvey4Martin Gibson5Tracey Vell61 Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK4 Implementation Science, Novartis Pharmaceuticals UK, London, UK1 Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK1 Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK1 Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK2 North West EHealth, Manchester, UK3 Health Innovation Manchester, Manchester, UKObjectives VICTORION-Spirit was a hybrid study designed to assess the feasibility of implementing inclisiran, a novel cholesterol-lowering treatment and behavioural support within primary care centres in England. This process evaluation aimed to evaluate the implementation of inclisiran for patients with elevated low-density lipoprotein cholesterol and atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (n=900), from the perspectives of key stakeholders.Design VICTORION-Spirit was a phase IIIb, multicentre, randomised, controlled study. We followed a process evaluation strategy to collate the views of stakeholders via semistructured interviews and to gain insights on the ‘implementability’ of inclisiran in primary care. Data were generated via interviews with patients, healthcare providers and research nurses and analysed using a qualitative rapid analysis approach.Setting Primary care in Greater Manchester, UK.Participants 84 participants were interviewed, including patients (n=56), professionals at participating practices in VICTORION-Spirit (n=13), health advisors (n=4) and research nurses (n=11).Results Interim findings suggest the process of receiving and providing inclisiran during the study was ‘straightforward’, and the behavioural support provided to some patients was generally viewed favourably. Beyond the trial, patients and healthcare providers thought the delivery of inclisiran could work well as a practice nurse-provided service. Barriers to implementing inclisiran were generally related to workforce and workload pressures in primary care, and an incentive structure to support delivery was recommended.Conclusions Patients and healthcare providers supported implementing inclisiran in primary care. It was convenient for patients to receive inclisiran in general practice, and most providers felt that the intervention was a useful addition to existing lipid-lowering treatments. Several barriers to implementation were highlighted, including concerns relating to general practice resources and costs.Trial registration number NCT04807400.https://bmjopen.bmj.com/content/15/2/e083441.full
spellingShingle Peter Bower
Samantha Dixon
Paul Wilson
Amy Mathieson
Rebecca Elvey
Martin Gibson
Tracey Vell
Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders
BMJ Open
title Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders
title_full Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders
title_fullStr Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders
title_full_unstemmed Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders
title_short Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders
title_sort evaluating the implementation of inclisiran in primary care process evaluation interim findings from interviews with key stakeholders
url https://bmjopen.bmj.com/content/15/2/e083441.full
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