将辅导嵌入随机对照试验中，以支持脑卒中幸存者职业康复的试验过程和实施保真度。
Embedding mentoring to support trial processes and implementation fidelity in a randomised controlled trial of vocational rehabilitation for stroke survivors.
机构信息
Rehabilitation & Ageing Research Group, Injury, Inflammation and Recovery Sciences, School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK.
School of Population Health & Environmental Sciences, King's College London, Addison House, London, SE1 1UL, UK.
出版信息
BMC Med Res Methodol. 2021 Oct 3;21(1):203. doi: 10.1186/s12874-021-01382-y.
BACKGROUND
Little guidance exists regarding how best to upskill and support those delivering complex healthcare interventions to ensure robust trial outcomes and implementation fidelity. Mentoring was provided to occupational therapists (OTs) delivering a complex vocational rehabilitation (VR) intervention to stroke survivors. This study aimed to explore mentors' roles in supporting OTs with intervention delivery and fidelity, and to describe factors affecting the mentoring process and intervention delivery.
METHODS
Quantitative data (duration, mode and total time of mentoring support) was extracted from mentoring records and emails between mentors and OTs, alongside qualitative data on barriers and facilitators to intervention delivery. Semi-structured interviews with mentors (n = 6) and OTs (n = 19) explored experiences and perceptions of intervention training, delivery and the mentoring process. Mean total and monthly time spent mentoring were calculated per trial site. Qualitative data were analysed thematically.
RESULTS
Forty-one OTs across 16 sites were mentored between March 2018 and April 2020. Most mentoring was provided by phone or Microsoft Teams (range: 88.6-100%), with the remainder via email and SMS (Short Message Service) text messages. Mentors suggested strategies to enhance trial recruitment, improved OTs' understanding of- and adherence to trial processes, intervention delivery and fidelity, and facilitated independent problem-solving. Barriers to mentoring included OT non-attendance at mentoring sessions and mentors struggling to balance mentoring with clinical roles. Facilitators included support from the trial team and mentors having protected time for mentoring.
CONCLUSIONS
Mentoring supported mentee OTs in various ways, but it remains unclear to what extent the OTS would have been able to deliver the intervention without mentoring support, or how this might have impacted fidelity. Successful implementation of mentoring alongside new complex interventions may increase the likelihood of intervention effectiveness being observed and sustained in real-life contexts. Further research is needed to investigate how mentors could be selected, upskilled, funded and mentoring provided to maximise impact. The clinical- and cost-effectiveness of mentoring as an implementation strategy and its impact on fidelity also requires testing in a future trial.
TRIAL REGISTRATION
ISRCTN, ISRCTN12464275 . Registered on 13th March 2018.
背景
在确保复杂医疗干预措施的试验结果稳健和实施保真度方面，如何最好地提高和支持那些提供复杂医疗干预措施的人员方面，指导意见很少。本研究对职业治疗师（OT）进行了辅导，以提供一项复杂的职业康复（VR）干预措施给中风幸存者。本研究旨在探讨导师在支持 OT 进行干预和保真度方面的角色，并描述影响辅导过程和干预交付的因素。
方法
从导师和 OT 之间的辅导记录和电子邮件中提取辅导支持的定量数据（辅导时间、模式和总时间），以及有关干预交付的障碍和促进因素的定性数据。对导师（n=6）和 OT（n=19）进行半结构化访谈，探讨干预培训、交付和辅导过程的经验和看法。计算每个试验点的平均总辅导时间和每月辅导时间。对定性数据进行主题分析。
结果
2018 年 3 月至 2020 年 4 月期间，对 16 个地点的 41 名 OT 进行了辅导。大多数辅导通过电话或 Microsoft Teams（范围：88.6-100%）进行，其余通过电子邮件和短信（SMS）文本消息进行。导师提出了一些策略，以提高试验招募，提高 OT 对试验过程、干预交付和保真度的理解和遵守，并促进独立解决问题。辅导的障碍包括 OT 不参加辅导课程，以及导师难以平衡辅导和临床角色。促进因素包括试验团队的支持和导师有时间进行辅导。
结论
辅导以各种方式支持被辅导的 OT，但尚不清楚如果没有辅导支持，OT 能否提供干预措施，以及这将如何影响保真度。在现实环境中，成功实施辅导和新的复杂干预措施可能会增加观察和维持干预效果的可能性。需要进一步研究，以探讨如何选择、提高技能、资助和提供辅导，以最大限度地发挥影响。辅导作为实施策略的临床和成本效益及其对保真度的影响也需要在未来的试验中进行测试。
试验注册
ISRCTN，ISRCTN84420144。于 2018 年 3 月 13 日注册。
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