title: Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.
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
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02333656.
authors.affiliation: National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, 0319, Oslo, Norway. nina.osteras@medisin.uio.no.
authors.forename: Nina
authors.initials: N
authors.lastname: Østerås
authors.affiliation: Department of Medical Decision Making, Leiden University Medical Center, J10-S, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Leti
authors.initials: L
authors.lastname: van Bodegom-Vos
authors.affiliation: Arthritis Research UK, Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, ST5 5BG, UK.
authors.forename: Krysia
authors.initials: K
authors.lastname: Dziedzic
authors.affiliation: National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, 0319, Oslo, Norway.
authors.forename: Tuva
authors.initials: T
authors.lastname: Moseng
authors.affiliation: Department of Health Management and Health Economics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.
authors.forename: Eline
authors.initials: E
authors.lastname: Aas
authors.affiliation: Patient Research Panel, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, 0319, Oslo, Norway.
authors.forename: Øyvor
authors.initials: Ø
authors.lastname: Andreassen
authors.affiliation: Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Mdala
authors.affiliation: Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.
authors.forename: Bård
authors.initials: B
authors.lastname: Natvig
authors.affiliation: Department of Orthopaedic Surgery, Akershus University Hospital, Lørenskog, Norway.
authors.forename: Jan Harald
authors.initials: JH
authors.lastname: Røtterud
authors.affiliation: Health and Social Services, Nes Municipality, Norway.
authors.forename: Unni-Berit
authors.initials: UB
authors.lastname: Schjervheim
authors.affiliation: Department of Orthopaedics, Leiden University Medical Center, J11-S, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Thea Vliet
authors.initials: TV
authors.lastname: Vlieland
authors.affiliation: National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, PO Box 23, Vinderen, 0319, Oslo, Norway.
authors.forename: Kåre Birger
authors.initials: KB
authors.lastname: Hagen
mesh_terms: D001835:Body Weight; D002985:Clinical Protocols; D005081:Exercise Therapy / Q000379:methods*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009664:Norway; D015207:Osteoarthritis, Hip / Q000534:rehabilitation*; D020370:Osteoarthritis, Knee / Q000534:rehabilitation*; D010353:Patient Education as Topic / Q000458:organization & administration*; D017060:Patient Satisfaction; D059825:Physical Therapists; D017410:Practice Guidelines as Topic; D011320:Primary Health Care / Q000458:organization & administration*; D011787:Quality of Health Care / Q000458:organization & administration; D012107:Research Design