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

Abstract

BackgroundPrevious 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/designA 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).DiscussionThe 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 registrationClinicalTrials.gov NCT02333656Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-015-0353-7) contains supplementary material, which is available to authorized users.

Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated osteoarthritis care model: secondary analyses from a cluster-randomised stepped-wedge trial

“…The study protocol has been published previously [4]. The study is reported according to the CONSORT checklist (Additional file 2).…”

“…The PTs received access to a database with recommended exercises and dose recommendations. The exercises were selected from the exercise programmes of the Swedish BOA and Danish GLA:D OA management programmes and previously published well-recognized, effective exercise programmes to impact hip and knee OA symptoms [4,17,18] . The group-based patient education programme lasted 3 h and was based on a standardized template (Power-Point with optional manuscript).…”

“…We have conducted a cluster randomized controlled stepped-wedge trial to evaluate the effectiveness of implementing a structured model of integrated OA care in six Norwegian municipalities [4]. The previously reported primary outcome: patient-reported quality of care and associated hypotheses showed greater quality of care and satisfaction with care, more patients referred to physiotherapy and fewer to orthopedic surgeons, and more patients who fulfilled physical activity criteria in the intervention group compared to the usual care group after 6 months [5].…”

“…The direct relationship between exercise adherence and patient-reported outcomes has not yet been investigated in any of the previous OA management programmes. [4] The aim of the current secondary analyses (as predefined in the study protocol) was to explore patientreported response to treatment between the intervention and control group including application of the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) at 3 and 6 months follow-up combined. Additionally, we aimed to further explore the intervention group by: i) Comparing the proportion of OMERACT-OARSI responders among participants completing the exercise programme (exercise for ≥2 times per week for ≥8 weeks) vs. the proportion among the non-completers; ii) Examine demographic and baseline patient-reported measures for associations with completing the exercise programme.…”

Osteoarthrosis in general practice

“…lekarzy rodzinnych, ortopedów, lekarzy rehabilitacji medycznej, niekiedy także lekarzy udzielają-cych świadczeń w ramach Poradni Leczenia Bólu i poradniach specjalistycznych zajmujących się leczeniem choroby podstawowej mogącej być przyczyną zmian zwyrodnieniowych w obrębie stawów) i oprzeć go na znajomości różnorodnych metod mających na celu złagodzenie dolegliwości zgłaszanych przez pacjenta, a także w miarę możliwości usprawnienie go (rehabilitacja -kinezyterapia i fizykoterapia, masaż leczniczy, zasady racjonalnego leczenia przeciwbólo-wego, odpowiednie zaopatrzenie ortopedyczne itp.). Celem niniejszej pracy jest zebranie najistotniejszych z punktu widzenia lekarza rodzinnego wiadomości dotyczących ChZS, by w swojej praktyce mógł on, współpracując z lekarzami innych dziedzin, poprowadzić pacjenta we wstępnej diagnostyce, wspomóc proces terapeutyczny, a także stanowić wsparcie medyczne w razie braku dostępności lub długiego okresu oczekiwania na konsultację specjalistyczną [1].…”