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一项旨在调查在基层医疗环境中招募慢性疼痛且失业的人群进行个体化安置和支持的未来随机对照试验的可行性的初步试验。

A pilot trial investigating the feasibility of a future randomised controlled trial of Individualised Placement and Support for people unemployed with chronic pain recruiting in primary care.

机构信息

MRC Versus Arthritis Centre for Musculoskeletal Health and Work, University of Southampton, Southampton, UK.

MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, UK.

出版信息

Prim Health Care Res Dev. 2022 Jul 22;23:e39. doi: 10.1017/S1463423622000342.

Abstract

BACKGROUND

We investigated the feasibility of recruiting patients unemployed for more than 3 months with chronic pain using a range of methods in primary care in order to conduct a pilot trial of Individual Placement and Support (IPS) to improve quality of life outcomes for people with chronic pain.

METHODS

This research was informed by people with chronic pain. We assessed the feasibility of identification and recruitment of unemployed patients; the training and support needs of employment support workers to integrate with pain services; acceptability of randomisation, retention through follow-up and appropriate outcome measures for a definitive trial. Participants randomised to IPS received integrated support from an employment support worker and a pain occupational therapist to prepare for, and take up, a work placement. Those randomised to Treatment as Usual (TAU) received a bespoke workbook, delivered at an appointment with a research nurse not trained in vocational rehabilitation.

RESULTS

Using a range of approaches, recruitment through primary care was difficult and resource-intensive (1028 approached to recruit 37 eligible participants). Supplementing recruitment through pain services, another 13 people were recruited (total = 50). Randomisation to both arms was acceptable: 22 were allocated to IPS and 28 to TAU. Recruited participants were generally not 'work ready', particularly if recruited through pain services.

CONCLUSION

A definitive randomised controlled trial is not currently feasible for recruiting through primary care in the UK. Although a trial recruiting through pain services might be possible, participants could be unrepresentative in levels of disability and associated health complexities. Retention of participants over 12 months proved challenging, and methods for reducing attrition are required. The intervention has been manualised.

摘要

背景

我们调查了在初级保健中使用多种方法招募失业超过 3 个月的慢性疼痛患者的可行性,以便开展个体安置和支持(IPS)试验,以改善慢性疼痛患者的生活质量结果。

方法

本研究由慢性疼痛患者提供信息。我们评估了失业患者的识别和招募的可行性;就业支持工作者的培训和支持需求,以整合到疼痛服务中;随机分组、通过随访保留和适合确定性试验的适当结果测量的可接受性。随机分配到 IPS 的参与者接受就业支持工作者和疼痛职业治疗师的综合支持,以准备并接受工作安置。随机分配到常规治疗(TAU)的参与者接受定制的工作簿,由未接受职业康复培训的研究护士在预约时提供。

结果

通过初级保健采用多种方法进行招募非常困难且资源密集(共接触 1028 人,仅招募到 37 名符合条件的参与者)。通过疼痛服务补充招募,又招募了 13 人(总计 50 人)。两种治疗方案的随机分组都可以接受:22 人被分配到 IPS,28 人被分配到 TAU。招募的参与者通常没有“准备好工作”,特别是通过疼痛服务招募的参与者。

结论

在英国,通过初级保健进行确定性随机对照试验目前不可行。尽管通过疼痛服务招募试验可能是可行的,但参与者在残疾程度和相关健康复杂性方面可能没有代表性。12 个月以上的参与者保留证明具有挑战性,需要减少流失的方法。干预措施已被规范化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db10/9309751/433f825f4c7d/S1463423622000342_fig1.jpg

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