Research and Innovation, Sint Maartenskliniek, Nijmegen, The Netherlands
Department of Primary and Community Care, Radboudumc, Nijmegen, The Netherlands.
BMJ Open. 2024 Nov 20;14(11):e083496. doi: 10.1136/bmjopen-2023-083496.
Despite recommendations, non-surgical treatment modalities in knee and/or hip osteoarthritis (KHOA) are underused. An information campaign was developed targeting patients with early stage KHOA and healthcare professionals (HCPs) to optimise timing of referral to secondary care. This protocol describes the development and design of this information campaign and a randomised controlled trial (RCT) on its effectiveness in impacting healthcare utilisation.
The behaviour change wheel was used as a theoretical framework for the campaign design. After an inventory of the literature, a selection was made of factors influencing healthcare use. Effectiveness will be evaluated with a cluster RCT. The study aims to recruit 300 patients in 24 general practices, randomly allocated to intervention or usual care (ratio 1:1). General practitioners and affiliated HCPs are invited to participate in the trial and recruit patients. Patients are eligible to participate if they are Dutch speaking, aged 50-75 years, registered with KHOA at the general practice, without joint replacement nor having considerable walking impairment. The main end point is the difference in rate of referral to hospital care as reported by patients over a period of 18 months. Secondary parameters include quality of care, beliefs about KHOA treatment modalities, physical activity, self-management behaviour and referral rates to secondary care. Patients receive online questionnaires at baseline, 6, 12 and 18 months. Online questionnaires are sent to HCPs at baseline and after 12 months to assess (changes in) beliefs about KHOA treatment modalities.
All methods are carried out in accordance with relevant guidelines and regulations and ethical approval was waived by the Dutch medical research ethical committee of Arnhem-Nijmegen (file number 2020-7246). Trial results will be communicated to participants and patient representatives via news letters, the public via the Sint Maartenskliniek website and journals of patient organisations and HCPs via congresses and international scientific journals.
NL9140.
尽管有相关建议，但膝关节和/或髋关节骨关节炎（KHOA）的非手术治疗方法仍未得到充分应用。本研究开发了一项针对早期 KHOA 患者和医疗保健专业人员（HCP）的信息宣传活动，以优化向二级保健机构转诊的时机。本方案描述了该信息宣传活动的开发和设计，以及一项评估其对医疗保健利用影响的随机对照试验（RCT）。
该活动的设计采用行为改变轮作为理论框架。在对文献进行清查后，选择了影响医疗保健使用的因素。有效性将通过一项聚类 RCT 进行评估。本研究旨在招募 300 名来自 24 家普通诊所的患者，随机分配到干预组或常规护理组（比例为 1:1）。邀请全科医生及其附属 HCP 参与试验并招募患者。如果患者为荷兰语，年龄在 50-75 岁之间，在普通诊所登记患有 KHOA，没有接受过关节置换手术，也没有明显的行走障碍，则有资格参与研究。主要终点是患者在 18 个月内报告的转诊至医院治疗的比率差异。次要参数包括护理质量、对 KHOA 治疗方法的信念、身体活动、自我管理行为和向二级保健机构的转诊率。患者在基线、6、12 和 18 个月时接受在线问卷调查。在基线和 12 个月时向 HCP 发送在线问卷，以评估（对）KHOA 治疗方法的信念变化。
所有方法均按照相关指南和规定进行，荷兰阿纳姆-尼美根的医学研究伦理委员会已豁免本研究的伦理批准（文件编号 2020-7246）。试验结果将通过通讯、公共网站和患者组织的期刊以及会议和国际科学期刊告知参与者和患者代表。
NL9140。
