Hall Amanda, Richmond Helen, Bursey Krystal, Hansen Zara, Williamson Esther, Copsey Bethan, Albury Charlotte, Asghari Shabnam, Curran Vernon, Pike Andrea, Etchegary Holly, Lamb Sarah
Primary Healthcare Research Unit, Memorial University of Newfoundland Faculty of Medicine, St. John's, Newfoundland and Labrador, Canada
Primary Healthcare Research Unit, Memorial University of Newfoundland Faculty of Medicine, St. John's, Newfoundland and Labrador, Canada.
BMJ Open. 2020 Nov 30;10(11):e040834. doi: 10.1136/bmjopen-2020-040834.
There is global recognition that low back pain (LBP) should be managed with a biopsychosocial approach. Previous implementation of this approach resulted in low uptake and highlighted the need for ongoing support. This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation.
A pragmatic cluster RCT with embedded qualitative study with physiotherapists treating LBP in publicly funded physiotherapy departments in Newfoundland and Labrador, Canada. Participants will complete a previously developed online training course to equip them to deliver a biopsychosocial intervention for LBP. Clusters randomised to the intervention arm will receive additional support from a champion. A minimum champion training package has been developed based on known barriers in the literature. This includes strategies to target barriers relating to group-based scheduling issues, lack of managerial support, perceived patient factors such as addressing patient expectations for other types of treatments or selecting which patients might be best suited for this intervention, and anxiety about delivering something new. This package will be further codeveloped with study champions based on identified implementation barriers using the Behaviour Change Wheel. Clusters will be monitored for 6 months to assess champion and physiotherapist recruitment and retention, acceptability and implementation of the champion training, and the viability of conducting a cluster RCT in this setting. A purposive sample of physiotherapists will be interviewed from both arms.
This study was approved by Newfoundland and Labrador Health Research Ethics Authority in December 2018. Results will be disseminated to academic audiences through conferences and peer reviewed publications; to all study participants, their clinical leads, and patients with LBP.
ClinicalTrials.gov Identifier: NCT04377529; Memorial University of Newfoundland Protocol Record 20190025; Pre-results.
全球都认识到，下背痛（LBP）应采用生物心理社会方法进行管理。此前实施这种方法的效果不佳，采用率较低，这凸显了持续支持的必要性。本研究旨在探讨以下方面的可行性：（i）培训并利用倡导者来支持实施；（ii）采用整群随机对照试验（RCT）；（iii）在加拿大公共医疗环境中收集患者报告的结局指标，并确定实施过程中的背景障碍。
在加拿大纽芬兰与拉布拉多省由公共资金资助的物理治疗部门中，对治疗下背痛的物理治疗师进行一项务实的整群随机对照试验，并嵌入定性研究。参与者将完成一个先前开发的在线培训课程，使其有能力为下背痛提供生物心理社会干预。随机分配到干预组的整群将获得倡导者的额外支持。基于文献中已知的障碍，已制定了一个最低限度的倡导者培训包。这包括针对与基于群体的排班问题、缺乏管理支持、感知到的患者因素（如满足患者对其他类型治疗的期望或选择哪些患者可能最适合这种干预）以及对提供新事物的焦虑等相关障碍的策略。将根据使用行为改变轮确定的实施障碍，与研究倡导者进一步共同制定这个培训包。将对整群进行6个月的监测，以评估倡导者和物理治疗师的招募与留存情况、倡导者培训的可接受性和实施情况，以及在这种环境中进行整群随机对照试验的可行性。将从两组中选取有目的的物理治疗师样本进行访谈。
本研究于2018年12月获得纽芬兰与拉布拉多省健康研究伦理委员会批准。研究结果将通过会议和同行评审出版物传播给学术受众；传播给所有研究参与者、他们的临床负责人以及下背痛患者。
ClinicalTrials.gov标识符：NCT04377529；纽芬兰纪念大学方案记录20190025；预结果。
