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新型综合护理干预对慢性肌肉骨骼疼痛患者的成本效果和成本效用:林堡网络疼痛康复实用试验方案。

The (cost-)effectiveness and cost-utility of a novel integrative care initiative for patients with chronic musculoskeletal pain: the pragmatic trial protocol of Network Pain Rehabilitation Limburg.

机构信息

Department of Rehabilitation Medicine, School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine and Life Sciences, Maastricht University, Universiteitssingel 40, 6229 ER Maastricht, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.

Centre of Expertise in Rehabilitation and Audiology, Adelante, Hoensbroek, The Netherlands.

出版信息

Health Qual Life Outcomes. 2020 Oct 1;18(1):320. doi: 10.1186/s12955-020-01569-9.

Abstract

BACKGROUND

Rehabilitation care for patients with chronic musculoskeletal pain (CMP) is not optimally organized. The Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) provides integrated care with a biopsychosocial approach and strives to improve the Quadruple Aim outcomes: pain-related disability of patients with CMP; experiences of care of patients with CMP; meaning in the work of healthcare professionals; and healthcare costs. Firstly, in this study, the effectiveness (with regard to the functioning and participation of patients) of primary care for patients with CMP will be assessed, comparing care organized following the NPRL2.0 procedure with usual care. Secondly, the cost-effectiveness and cost-utility with regard to health-related quality of life and healthcare costs will be assessed. And thirdly, the effect of duration of participation in a local network in primary care will be studied.

METHODS

In this pragmatic study, it is expected that two local networks with 105 patients will participate in the prospective cohort study and six local networks with 184 patients in the stepped-wedge based design. Healthcare professionals in the local networks will recruit patients.

INCLUSION CRITERIA

age ≥ 18 years; having CMP; willing to improve functioning despite pain; and adequate Dutch literacy.

EXCLUSION CRITERIA

pregnancy; and having a treatable medical or psychiatric disease. Patients will complete questionnaires at baseline (T1), 3 months (T2), 6 months (T3), and 9 months (T4). Questionnaires at T1 and T4 will include the Pain Disability Index and Short Form Health Survey. Questionnaires at T1, T2, T3, and T4 will include the EQ-5D-5L, and iMTA Medical Consumption and Productivity Cost Questionnaires. Outcomes will be compared using linear mixed-model analysis and costs will be compared using bootstrapping methods.

DISCUSSION

NPRL2.0 is a multidimensional, complex intervention, executed in daily practice, and therefore needing a pragmatic study design. The current study will assess NPRL2.0 with respect to the Quadruple Aim outcomes: patient health and costs. This will provide more information on the (cost-) effectiveness of the organization of care in a network structure regarding patients with CMP. The other two Quadruple Aim outcomes will be examined alongside this study. Trial registration Netherlands Trial Register: NL7643. https://www.trialregister.nl/trial/7643 .

摘要

背景

慢性肌肉骨骼疼痛(CMP)患者的康复护理组织得不尽人意。Network Pain Rehabilitation Limburg 2.0(NPRL2.0)提供了一种生物心理社会方法的综合护理,并努力改善四重目标的结果:CMP 患者的疼痛相关残疾;CMP 患者的护理体验;医疗保健专业人员的工作意义;以及医疗保健成本。首先,在这项研究中,将评估初级保健对 CMP 患者的有效性(就患者的功能和参与而言),将 NPRL2.0 程序组织的护理与常规护理进行比较。其次,将评估与健康相关的生活质量和医疗保健成本方面的成本效益和成本效用。第三,将研究在初级保健中参与当地网络的持续时间的效果。

方法

在这项务实的研究中,预计将有两个各有 105 名患者的当地网络参与前瞻性队列研究,以及六个各有 184 名患者的当地网络参与基于阶梯式楔形设计的研究。当地网络中的医疗保健专业人员将招募患者。

纳入标准

年龄≥18 岁;患有 CMP;愿意在疼痛的情况下改善功能;以及有足够的荷兰语读写能力。

排除标准

怀孕;以及患有可治疗的医学或精神疾病。患者将在基线(T1)、3 个月(T2)、6 个月(T3)和 9 个月(T4)时完成问卷。T1 和 T4 的问卷将包括疼痛残疾指数和简明健康调查问卷。T1、T2、T3 和 T4 的问卷将包括 EQ-5D-5L 和 iMTA 医疗消费和生产力成本问卷。使用线性混合模型分析比较结果,使用自举法比较成本。

讨论

NPRL2.0 是一种多维、复杂的干预措施,在日常实践中执行,因此需要一个务实的研究设计。目前的研究将根据四重目标的结果评估 NPRL2.0:患者的健康和成本。这将为网络结构中针对 CMP 患者的护理组织提供更多有关(成本)有效性的信息。其他两个四重目标结果将与本研究一起进行检查。

试验注册

荷兰试验注册处:NL7643。https://www.trialregister.nl/trial/7643。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a2/7528600/43fe62c3ea53/12955_2020_1569_Fig1_HTML.jpg

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