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多中心对照前后研究设计的创伤护理模式的有效性和成本效益研究:研究方案。

Effectiveness and cost-effectiveness of the Transmural Trauma Care Model investigated in a multicenter trial with a controlled before-and-after design: A study protocol.

机构信息

Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.

Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands.

出版信息

Physiother Res Int. 2021 Apr;26(2):e1894. doi: 10.1002/pri.1894. Epub 2021 Jan 21.

Abstract

OBJECTIVE

The rehabilitation of trauma patients in primary care is challenging, and there are no guidelines for optimal treatment. Also, the organization of care is not well-structured. The Transmural Trauma Care Model (TTCM) has been developed in the Netherlands, aiming to improve patient outcomes by optimizing the organization and the quality of the rehabilitation process in primary care. A recent feasibility study showed that implementation of the TTCM at a Dutch Level 1 trauma center was feasible, patient outcomes were improved, and costs were reduced. This study aims to assess the effectiveness and cost-effectiveness of the TTCM compared to the usual care in a multicenter trial.

METHODS

A multicenter trial with a controlled before-and-after design will be performed at 10 hospitals in the Netherlands. First, participating hospitals will include 322 patients in the control group, receiving usual care as provided in these specific hospitals. Subsequently, the TTCM will be implemented in all participating hospitals, and hospitals will include an additional 322 patients in the intervention group. The TTCM consists of a multidisciplinary team at the outpatient clinic (trauma surgeon and hospital-based physical therapist), an educated and trained network of primary care trauma physical therapists, and structural communication between them. Co-primary outcomes will investigate generic and disease-specific, health-related quality of life. Secondary outcomes will include pain, patient satisfaction, perceived recovery, and patient-reported physical functioning. For the economic evaluation, societal and healthcare costs will be measured. Measurements will take place at baseline and after 6 weeks, 3, 6, and 9 months. Analyses will be based on the intention-to-treat principle. Missing data will be handled using longitudinal data analyses in the effect analyses and by multivariate imputation in the economic evaluation.

CONCLUSION

This trial with a controlled before-and-after design will give insight into the effectiveness and cost-effectiveness of the TTCM in a multicenter trial.

摘要

目的

初级保健中创伤患者的康复具有挑战性,且目前尚无最佳治疗的指南。此外,护理组织也不完善。Transmural Trauma Care Model(TTCM)在荷兰已经开发出来,旨在通过优化初级保健中的组织和康复过程的质量来改善患者的预后。最近的一项可行性研究表明,在荷兰一级创伤中心实施 TTCM 是可行的,患者的预后得到改善,且成本降低。本研究旨在评估与常规护理相比,TTCM 在多中心试验中的有效性和成本效益。

方法

将在荷兰的 10 家医院进行一项多中心、对照前后设计的试验。首先,参与医院将在对照组中纳入 322 名患者,接受这些特定医院提供的常规护理。随后,TTCM 将在所有参与医院中实施,每家医院将在干预组中再纳入 322 名患者。TTCM 包括门诊的多学科团队(创伤外科医生和医院为基础的物理治疗师)、受过教育和培训的初级保健创伤物理治疗师网络,以及他们之间的结构性沟通。主要结局将评估通用和特定于疾病的健康相关生活质量。次要结局将包括疼痛、患者满意度、感知康复和患者报告的身体功能。对于经济评估,将测量社会和医疗保健成本。测量将在基线和 6 周、3 个月、6 个月和 9 个月时进行。分析将基于意向治疗原则。缺失数据将在效果分析中通过纵向数据分析处理,在经济评估中通过多元插补处理。

结论

这项对照前后设计的试验将为多中心试验中 TTCM 的有效性和成本效益提供见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea68/8047890/86be3419f809/PRI-26-e1894-g001.jpg

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