Implementation of inclisiran in United Kingdom primary care for patients with atherosclerotic cardiovascular disease or its-risk equivalents: rationale and design of Victorion-spirit, a pragmatic phase IIIb, randomised controlled study

Paul M Wilson, Samantha Dixon, Tracey Vell, P. Bower, Linda Rootkin, Claire Williams, Adam Strong, D. Lawrence, R. Elvey, Owen Williams, N. Stein, J. M. Gibson
{"title":"Implementation of inclisiran in United Kingdom primary care for patients with atherosclerotic cardiovascular disease or its-risk equivalents: rationale and design of Victorion-spirit, a pragmatic phase IIIb, randomised controlled study","authors":"Paul M Wilson, Samantha Dixon, Tracey Vell, P. Bower, Linda Rootkin, Claire Williams, Adam Strong, D. Lawrence, R. Elvey, Owen Williams, N. Stein, J. M. Gibson","doi":"10.18203/2349-3259.ijct20231106","DOIUrl":null,"url":null,"abstract":"Background: Translational gaps exist in implementing health innovations rapidly in clinical practice. Pragmatic effectiveness and implementation studies, therefore, play a pivotal role in understanding how high-value health innovations could be deployed and delivered in healthcare systems to reduce barriers to adoption and provide more rapid patient benefit. Victorion-spirit is an ongoing pragmatic, 9-month, phase IIIb, open-label, multicentre, randomised controlled study evaluating the implementation, patient experience, and delivery of the subcutaneous lipid-lowering therapy, inclisiran sodium 300 mg, in participants with elevated low-density lipoprotein cholesterol (LDL-C) who are on established lipid-lowering medication, or have been recommended lipid-lowering therapy, but are unable to tolerate treatment.\nMethods: Victorion-spirit utilises a type 1 hybrid effectiveness-implementation design, where the primary objective is to demonstrate superiority of inclisiran with or without (±) behavioural support versus standard of care (SOC; e.g., statin and/or other lipid-lowering therapies) + behavioural support in terms of percentage reduction in LDL-C from baseline to Day 270 in a primary care setting. Secondary objectives will evaluate implementation of inclisiran ± behavioural support versus SOC + behavioural support through assessment of patient satisfaction and patient activation/empowerment after treatment at Day 90; adherence to cardiovascular disease self-management; and serious adverse event profile. Additionally, a process evaluation ascertaining the views of patients, providers and national health service (NHS) commissioners will explore barriers and enablers to integrating inclisiran within primary care.\nConclusions: The results of Victorion-spirit have potential to change our approach to lipid management and inform further implementation efforts in healthcare systems, such as the NHS.\nTrial registration: ClinicalTrials.gov NCT04087400.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"36 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18203/2349-3259.ijct20231106","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Translational gaps exist in implementing health innovations rapidly in clinical practice. Pragmatic effectiveness and implementation studies, therefore, play a pivotal role in understanding how high-value health innovations could be deployed and delivered in healthcare systems to reduce barriers to adoption and provide more rapid patient benefit. Victorion-spirit is an ongoing pragmatic, 9-month, phase IIIb, open-label, multicentre, randomised controlled study evaluating the implementation, patient experience, and delivery of the subcutaneous lipid-lowering therapy, inclisiran sodium 300 mg, in participants with elevated low-density lipoprotein cholesterol (LDL-C) who are on established lipid-lowering medication, or have been recommended lipid-lowering therapy, but are unable to tolerate treatment. Methods: Victorion-spirit utilises a type 1 hybrid effectiveness-implementation design, where the primary objective is to demonstrate superiority of inclisiran with or without (±) behavioural support versus standard of care (SOC; e.g., statin and/or other lipid-lowering therapies) + behavioural support in terms of percentage reduction in LDL-C from baseline to Day 270 in a primary care setting. Secondary objectives will evaluate implementation of inclisiran ± behavioural support versus SOC + behavioural support through assessment of patient satisfaction and patient activation/empowerment after treatment at Day 90; adherence to cardiovascular disease self-management; and serious adverse event profile. Additionally, a process evaluation ascertaining the views of patients, providers and national health service (NHS) commissioners will explore barriers and enablers to integrating inclisiran within primary care. Conclusions: The results of Victorion-spirit have potential to change our approach to lipid management and inform further implementation efforts in healthcare systems, such as the NHS. Trial registration: ClinicalTrials.gov NCT04087400.
在英国对动脉粥样硬化性心血管疾病或其风险相当的患者的初级保健中实施inclisiran: victoria -spirit的基本原理和设计,一项实用的IIIb期随机对照研究
背景:在临床实践中快速实施卫生创新存在转化差距。因此,务实的有效性和实施研究在了解如何在医疗保健系统中部署和交付高价值的卫生创新以减少采用障碍并更快地为患者提供益处方面发挥着关键作用。victoria -spirit是一项正在进行的为期9个月、开放标签、多中心、随机对照的IIIb期研究,评估皮下降脂疗法inclisiran钠300 mg的实施、患者体验和递送,用于低密度脂蛋白胆固醇(LDL-C)升高的患者,这些患者正在接受既定的降脂药物治疗,或已被推荐降脂治疗,但无法耐受治疗。方法:victoria -spirit采用1型混合有效性实施设计,其主要目标是证明具有或不具有(±)行为支持的inclisiran与标准护理(SOC;例如,他汀类药物和/或其他降脂疗法)+行为支持在初级保健环境中从基线到第270天LDL-C降低百分比。次要目标将通过在治疗后第90天评估患者满意度和患者激活/授权来评估inclisiran±行为支持与SOC +行为支持的实施情况;坚持心血管疾病自我管理;还有严重的不良事件。此外,一项确定患者、提供者和国家保健服务(NHS)专员意见的进程评估将探讨将包容性纳入初级保健的障碍和推动因素。结论:victoria -spirit的结果有可能改变我们的血脂管理方法,并为医疗保健系统(如NHS)的进一步实施工作提供信息。试验注册:ClinicalTrials.gov NCT04087400。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信