合作伙伴参与 AIM-Back 试验中非药物护理途径的规划和开发。

Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial.

机构信息

Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, USA.

Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, NC, USA.

出版信息

Clin Trials. 2023 Oct;20(5):463-472. doi: 10.1177/17407745231178789. Epub 2023 Jun 2.

DOI:10.1177/17407745231178789

PMID:37269070

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10524642/

Abstract

BACKGROUND/AIMS: Embedded pragmatic clinical trials are increasingly recommended for non-pharmacological pain care research due to their focus on examining intervention effectiveness within real-world settings. Engagement with patients, health care providers, and other partners is essential, yet there is limited guidance for how to use engagement to meaningfully inform the design of interventions to be tested in pain-related pragmatic clinical trials. This manuscript aims to describe the process and impacts of partner input on the design of two interventions (care pathways) for low back pain currently being tested in an embedded pragmatic trial in the Veterans Affairs health care system.

METHODS

Sequential cohort design for intervention development was followed. Engagement activities were conducted with 25 participants between November 2017 and June 2018. Participants included representatives from multiple groups: clinicians, administrative leadership, patients, and caregivers.

RESULTS

Partner feedback led to several changes in each of the care pathways to improve patient experience and usability. Major changes to the sequenced care pathway included transitioning from telephone-based delivery to a flexible telehealth model, increased specificity about pain modulation activities, and reduction of physical therapy visits. Major changes to the pain navigator pathway included transitioning from a traditional stepped care model to one that offers care in a feedback loop, increased flexibility regarding pain navigator provider type, and increased specificity for patient discharge criteria. Centering patient experience emerged as a key consideration from all partner groups.

CONCLUSION

Diverse input is important to consider before implementing new interventions in embedded pragmatic trials. Partner engagement can increase acceptability of new care pathways to patients and providers and enhance uptake of effective interventions by health systems.

TRIAL REGISTRATION

NCT#04411420. Registered on 2 June 2020.

摘要

背景/目的：嵌入式实用临床试验越来越多地被推荐用于非药物性疼痛护理研究，因为它们侧重于在真实环境中检查干预措施的有效性。与患者、医疗保健提供者和其他合作伙伴的互动至关重要，但对于如何利用互动来为将要在与疼痛相关的实用临床试验中测试的干预措施的设计提供有意义的信息，指导有限。本文旨在描述在退伍军人事务医疗保健系统中进行的嵌入式实用临床试验中，对正在测试的两种干预措施（护理途径）的设计过程和合作伙伴投入的影响。

方法

采用干预措施开发的序贯队列设计。2017 年 11 月至 2018 年 6 月期间，与 25 名参与者进行了互动活动。参与者包括来自多个群体的代表：临床医生、行政领导、患者和护理人员。

结果

合作伙伴的反馈导致对每条护理途径进行了多项更改，以改善患者体验和可用性。对序贯护理途径的重大更改包括从基于电话的交付过渡到灵活的远程医疗模式、增加关于疼痛调节活动的具体性，以及减少物理治疗次数。对疼痛导航者途径的重大更改包括从传统的分级护理模式过渡到提供反馈循环中的护理模式、增加疼痛导航者提供者类型的灵活性，以及增加患者出院标准的具体性。患者体验被所有合作伙伴视为一个关键考虑因素。