Overview

This trial is active, not recruiting.

Conditions hip osteoarthritis, knee osteoarthritis
Treatment new oa model
Sponsor Diakonhjemmet Hospital
Collaborator The Research Council of Norway
Start date January 2015
End date December 2016
Trial size 388 participants
Trial identifier NCT02333656, 229079

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose health services research
Arm
(No Intervention)
Usual care. The participants enrolled in the control period will receive OA treatment as it is currently offered in primary health care services.
(Experimental)
New OA model. Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration
new oa model
The general practitioners and the physiotherapists will attend an inter-active workshop and deliver osteoarthritis care in line with international recommendations for osteoarthritis treatment. The general practitioner will refer eligible patients to treatment by physiotherapists at "Healthy Living Center" or by physiotherapists in private practice. This treatment will include a standardized patient education program followed by structured exercise program with individual adjustments. The general practitioner will schedule a follow-up after the 12-week treatment and will receive a treatment report from the physiotherapist.

Primary Outcomes

Measure
Osteoarthritis Quality Indicator questionnaire
time frame: 6 months

Secondary Outcomes

Measure
Pain
time frame: 6 months
Joint stiffness
time frame: 6 months
Global function
time frame: 6 months
Patient global assessment of the OA disease
time frame: 6 months
Patient Acceptable Symptom State (PASS)
time frame: 6 months
Hip/knee function, quality of living subscale
time frame: 6 months
Physical activity level
time frame: 6 months
Daily sitting
time frame: 6 months
Satisfaction with the care provided
time frame: 6 months
Health related quality of life (EQ-5D)
time frame: 6 months
Self-reported body weight
time frame: 6 months
Health care use, medication use and sick leave
time frame: 6 months
Adverse events
time frame: Up to 1 year
Health professionals' knowledge, attitude and behavior in OA care
time frame: Pre- and post-workshop + 6 months post-workshop
Referrals to orthopaedic surgeons
time frame: Up to 1 year
Referrals to MRI
time frame: Up to 1 year
Number of referrals to physiotherapy treatment
time frame: Up to 1 year
Discharge reports from physiotherapists
time frame: Up to 1 year
Arthritis Self-efficacy Scale
time frame: 6 months

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

Official title Improved Management of Patients With Hip and Knee Osteoarthritis in Primary Health Care
Principal investigator Nina Østerås, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Diakonhjemmet Hospital.