Becoming Active in Beating osteoarthritiS: study protocol of a randomised controlled trial on the effectiveness of an information campaign in improving the management of osteoarthritis and quality of care in general practices in the Netherlands

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NL9140.

Keywords: hip; knee; primary prevention; public health; rheumatology; self-management.