Amundsen Pål André, Underwood Martin, Burton Kim, Grotle Margreth, Engedahl Martin Stav, Malmberg-Heimonen Ira, Irgens Pernille Marie Stähr, Højen Magnus, Kisa Adnan, Hagen Milada, Holmgard Thor Einar, Martinsen Amy, Lothe Jakob, Monsen Sølvi Spilde, Froud Robert
School of Health Sciences, Kristiana University College, PB 1190, 0107, Sentrum, Oslo, Norway.
Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Pilot Feasibility Stud. 2024 Aug 13;10(1):110. doi: 10.1186/s40814-024-01538-9.
Persistent pain is a frequent cause of sick leave and work disability in Norway. A return-to-work intervention featuring supported work placements, developed in the UK, demonstrated feasibility, and a return-to-work rate of 20% within 6 months was observed in the sample. We sought to adapt the intervention for delivery in Norway and to confirm feasibility prior to a full-scale trial.
In this internal pilot, we used a pragmatic cohort randomised controlled approach with national recruitment in Norway. We recruited people who were unemployed (for at least 1 month), having persistent pain (for at least 3 months), aged between 18 and 64, and wanting to return to work. We initially recruited people to an observational cohort study of the impact of being unemployed with persistent pain. After baseline measurement, we randomly sub-sampled participants to whom we offered the intervention, which featured individual case management and support, work-familiarisation sessions, and the offer of a 6-week part-time unpaid work placement. We assessed recruitment rates (aiming to recruit 66, and sub-sample 17 within 6 months); optimal recruitment pathways; intervention acceptance rates; the feasibility of data collection; using video links for work-familiarisation sessions and remote case manager support.
The pilot ran from June to November 2022. Of 168 people expressing interest, 94 consented. Recruitment posts on Facebook yielded the most 'expressions of interest' (66%, n = 111). After screening for eligibility, we included 55 participants. Of these, 19 were randomised to be offered the intervention. Of these, less than half (n = 8) consented to intervention participation. Remote case manager and work-familiarisation sessions appeared feasible. Following a delay in identifying placements, three participants received offers of work placements, with one starting and completing during the pilot period. Data collection methods were feasible, and no adverse events were reported.
Recruitment and logistical processes, such as remote management by video link, are feasible. However, delivery of the intervention is challenging. In particular, sourcing placements and the time required for identifying appropriate placements was more challenging than anticipated. A full-scale trial is feasible but will require improvements to the placement identification processes.
ISRCTN85437524 (Referring to the ReISE trial, of which this internal pilot was a part), Registered 31 of May 2022 https://doi.org/10.1186/ISRCTN85437524 TRIAL FUNDING: Norwegian Research Council.
在挪威,持续性疼痛是病假和工作残疾的常见原因。英国开发的一种以支持性工作安置为特色的重返工作岗位干预措施已证明具有可行性,且在样本中观察到6个月内重返工作岗位率为20%。我们试图对该干预措施进行调整以便在挪威实施,并在全面试验之前确认其可行性。
在这项内部试点研究中,我们在挪威采用了实用的队列随机对照方法并进行全国范围的招募。我们招募了失业(至少1个月)、患有持续性疼痛(至少3个月)、年龄在18至64岁之间且希望重返工作岗位的人群。我们最初将这些人招募到一项关于失业伴持续性疼痛影响的观察性队列研究中。在基线测量之后,我们随机抽取部分参与者并为其提供干预措施,该措施包括个案管理与支持、工作熟悉课程以及提供为期6周的无薪兼职工作安置机会。我们评估了招募率(目标是在6个月内招募66人并抽取17人作为子样本);最佳招募途径;干预接受率;数据收集的可行性;使用视频链接进行工作熟悉课程以及远程个案经理支持的情况。
该试点研究于2022年6月至11月进行。在168名表示感兴趣的人中,94人同意参与。在脸书上发布的招募帖子产生了最多的“感兴趣表达”(66%,n = 111)。在筛选合格性之后,我们纳入了55名参与者。其中,19人被随机分配接受干预措施。在这些人中,不到一半(n = 8)同意参与干预。远程个案经理和工作熟悉课程似乎可行。在确定工作安置出现延迟之后,三名参与者获得了工作安置机会,其中一人在试点期间开始并完成了工作安置。数据收集方法可行,且未报告不良事件。
招募和后勤流程,如通过视频链接进行远程管理,是可行的。然而,实施干预具有挑战性。特别是,寻找工作安置以及确定合适工作安置所需的时间比预期更具挑战性。全面试验是可行的,但需要改进工作安置确定流程。
ISRCTN85437524(参考ReISE试验,本内部试点研究是其一部分),于2022年5月31日注册https://doi.org/10.1186/ISRCTN85437524 试验资金:挪威研究理事会