Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial

Nina Østerås, Leti van Bodegom-Vos, Krysia Dziedzic, Tuva Moseng, Eline Aas, Øyvor Andreassen, Ibrahim Mdala, Bård Natvig, Jan Harald Røtterud, Unni-Berit Schjervheim, Thea Vliet Vlieland, Kåre Birger Hagen, Nina Østerås, Leti van Bodegom-Vos, Krysia Dziedzic, Tuva Moseng, Eline Aas, Øyvor Andreassen, Ibrahim Mdala, Bård Natvig, Jan Harald Røtterud, Unni-Berit Schjervheim, Thea Vliet Vlieland, Kåre Birger Hagen

Abstract

Background: Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model.

Methods/design: A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER).

Discussion: The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care.

Trial registration: ClinicalTrials.gov NCT02333656.

Figures

Fig. 1
Fig. 1
Timeline for the SAMBA project. *Dark cells represent intervention periods, and blank cells represent control periods. The inclusion of patients will start on January 15th 2015 and end on June 15th 2016. The last six month follow-up will be in December 2016 and the last 12-month follow-up will be in June 2017. #The 6 municipalities will switch from control phase to intervention phase in a randomized order

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