Clinical trial NCT02333656: Management of Hip and Knee Osteoarthritis in Primary Health Care
Official title: Improved Management of Patients With Hip and Knee Osteoarthritis in Primary Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2015-01-07
Enrollment: 393
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Previous research has shown that the osteoarthritis care for persons with hip or knee osteoarthritis in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. This study will determine if a new model for integrated osteoarthritis (OA) care in primary health care will result in improved quality of osteoarthritis care and health benefits for the patients (reduced pain and body weight, increased function and activity level) among patients with hip and/or knee osteoarthritis. Further, this study will examine if the new model reduce the number of unnecessary referrals to Magnetic Resonance Imaging (MRI) and to orthopaedic surgeons in secondary care, and if it increases the number of referrals to physiotherapy treatment and the number of discharge reports from the physiotherapists to the referring general practitioner.

Detailed description: A new model for integrated care for patients with hip and/or knee osteoarthritis (OA) in primary care will be developed and implemented. The purpose of the model is to improve quality of OA care in primary health care services by increasing the collaboration between health care professionals and across health care levels, providing an integrated care and a patient pathway, and facilitating an active and healthy lifestyle among individuals with OA. This implementation study represents a collaborative study between six municipalities and a hospital department aiming to fulfill the intentions of the Norwegian Health Care Coordination Reform. The main aim of the present study is to implement and perform process and effect evaluations of this new model for integrated OA care. The study design will be a cluster randomized controlled trial with a stepped wedge design. Six neighboring municipalities will constitute the six clusters, which will switch from control (current OA care) to intervention phase (new OA model) in a randomized order. All municipalities start the trial simultaneously and act as controls until the point in time they are randomized to crossover from control to intervention, and all municipalities have implemented the intervention by the end of inclusion. The method consists of two parts; 1) Identification of barriers/facilitators + development of the model and interventions, 2) Implementation of the new model (interactive workshops) with process and effect evaluations. Participants will be general practitioners and physiotherapists in primary care as well as people with hip or knee OA.

Eligibility criteria: Inclusion Criteria:

* Activity-related hip and/or knee pain/complaints AND
* Clinical signs and symptoms corresponding to hip and/or knee OA OR radiologically diagnosed OA OR Registered in the medical journal with the ICPC codes L89 (osteoarthritis of the hip), L90 (osteoarthritis of knee), L91 (osteoarthritis not classified elsewhere), L13 (hip symptoms/complaints), L15 (knee symptoms/complaints) and/or L20 (joint symptoms/complaints not classified elsewhere).

Exclusion Criteria:

* Total hip or knee replacement in the actual joint(s) and no pain/complaints in the other hip or knee joint(s)
* Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
* Malignant illness or other major conditions (i.e unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended OA treatment
* Do not understand the Norwegian language

Primary outcomes:
measure: Osteoarthritis Quality Indicator questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Pain
timeFrame: 6 months
measure: Joint stiffness
timeFrame: 6 months
measure: Global function
timeFrame: 6 months
measure: Patient global assessment of the OA disease
timeFrame: 6 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 6 months
measure: Hip/knee function, quality of living subscale
timeFrame: 6 months
measure: Physical activity level
timeFrame: 6 months
measure: Daily sitting
timeFrame: 6 months
measure: Satisfaction with the care provided
timeFrame: 6 months
measure: Health related quality of life (EQ-5D)
timeFrame: 6 months
measure: Self-reported body weight
timeFrame: 6 months
measure: Health care use, medication use and sick leave
timeFrame: 6 months
measure: Adverse events
timeFrame: Up to 1 year
measure: Health professionals' knowledge, attitude and behavior in OA care
timeFrame: Pre- and post-workshop + 6 months post-workshop
measure: Referrals to orthopaedic surgeons
timeFrame: Up to 1 year
measure: Referrals to MRI
timeFrame: Up to 1 year
measure: Number of referrals to physiotherapy treatment
timeFrame: Up to 1 year
measure: Discharge reports from physiotherapists
timeFrame: Up to 1 year
measure: Arthritis Self-efficacy Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Project administrator/Research director
name: Kåre Hagen, Prof.
role: STUDY_DIRECTOR
affiliation: Researcher
name: Nina Østerås, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moseng T, Dagfinrud H, van Bodegom-Vos L, Dziedzic K, Hagen KB, Natvig B, Rotterud JH, Vlieland TV, Osteras N. 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. BMC Musculoskelet Disord. 2020 Apr 13;21(1):236. doi: 10.1186/s12891-020-03235-z.
citation: Osteras N, Moseng T, van Bodegom-Vos L, Dziedzic K, Mdala I, Natvig B, Rotterud JH, Schjervheim UB, Vlieland TV, Andreassen O, Hansen JN, Hagen KB. Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial. PLoS Med. 2019 Oct 15;16(10):e1002949. doi: 10.1371/journal.pmed.1002949. eCollection 2019 Oct.
citation: Moseng T, Dagfinrud H, Osteras N. Implementing international osteoarthritis guidelines in primary care: uptake and fidelity among health professionals and patients. Osteoarthritis Cartilage. 2019 Aug;27(8):1138-1147. doi: 10.1016/j.joca.2019.03.010. Epub 2019 May 8.
citation: Osteras N, van Bodegom-Vos L, Dziedzic K, Moseng T, Aas E, Andreassen O, Mdala I, Natvig B, Rotterud JH, Schjervheim UB, Vlieland TV, Hagen KB. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial. Implement Sci. 2015 Dec 2;10:165. doi: 10.1186/s13012-015-0353-7.