- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333656
Management of Hip and Knee Osteoarthritis in Primary Health Care
January 30, 2018 updated by: Nina Osteras, Diakonhjemmet Hospital
Improved Management of Patients With Hip and Knee Osteoarthritis in Primary Health Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
393
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0319
- Diakonhjemmet Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Usual care.
The participants enrolled in the control period will receive OA treatment as it is currently offered in primary health care services.
|
|
Experimental: Intervention group
New OA model.
Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Osteoarthritis Quality Indicator questionnaire
Time Frame: 6 months
|
Patient reported achievement of quality indicators for osteoarthritis care
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 6 months
|
Pain level in hip/knee past week
|
6 months
|
Joint stiffness
Time Frame: 6 months
|
Stiffness in the hip/knee past week
|
6 months
|
Global function
Time Frame: 6 months
|
Hip/knee function in the past week
|
6 months
|
Patient global assessment of the OA disease
Time Frame: 6 months
|
6 months
|
|
Patient Acceptable Symptom State (PASS)
Time Frame: 6 months
|
6 months
|
|
Hip/knee function, quality of living subscale
Time Frame: 6 months
|
Function (Knee injury and Osteoarthritis Outcome Score ADL subscale/ Hip disability and Osteoarthritis Outcome Score OoL subscale (K/HOOS)
|
6 months
|
Physical activity level
Time Frame: 6 months
|
An index based on self-reported frequency, intensity, duration of physical activity
|
6 months
|
Daily sitting
Time Frame: 6 months
|
Daily hours in sitting position
|
6 months
|
Satisfaction with the care provided
Time Frame: 6 months
|
6 months
|
|
Health related quality of life (EQ-5D)
Time Frame: 6 months
|
6 months
|
|
Self-reported body weight
Time Frame: 6 months
|
6 months
|
|
Health care use, medication use and sick leave
Time Frame: 6 months
|
6 months
|
|
Adverse events
Time Frame: Up to 1 year
|
Up to 1 year
|
|
Health professionals' knowledge, attitude and behavior in OA care
Time Frame: Pre- and post-workshop + 6 months post-workshop
|
Pre- and post-workshop + 6 months post-workshop
|
|
Referrals to orthopaedic surgeons
Time Frame: Up to 1 year
|
Number of referrals to secondary care that does not lead to scheduled joint surgery
|
Up to 1 year
|
Referrals to MRI
Time Frame: Up to 1 year
|
Number of referrals to MRI for OA assessment
|
Up to 1 year
|
Number of referrals to physiotherapy treatment
Time Frame: Up to 1 year
|
Up to 1 year
|
|
Discharge reports from physiotherapists
Time Frame: Up to 1 year
|
Number of discharge reports from PTs at FLSs/ private practice to the referring GP
|
Up to 1 year
|
Arthritis Self-efficacy Scale
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Kåre Hagen, Prof., Project administrator/Research director
- Principal Investigator: Nina Østerås, PhD, Researcher
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: PLoS Med. 2019 Dec 19;16(12):e1002993.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
January 4, 2015
First Submitted That Met QC Criteria
January 5, 2015
First Posted (Estimate)
January 7, 2015
Study Record Updates
Last Update Posted (Actual)
February 1, 2018
Last Update Submitted That Met QC Criteria
January 30, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 229079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Novartis PharmaceuticalsRecruitingSymptomatic Knee OsteoarthritisUnited States, Spain, Hungary, Argentina, Germany, Slovakia, Czechia, Belgium, Romania
-
University of BathUniversity of Oxford; 3D Metal Printing Ltd; Versus ArthritisRecruitingMedial Knee OsteoarthritisUnited Kingdom
-
Max Biocare Pty. Ltd.Completed
Clinical Trials on New OA model
-
University of PittsburghCompletedPatient Centered CareUnited States
-
Sheba Medical CenterJuvenile Diabetes Research FoundationCompleted
-
University Hospital, GenevaFondation Privée des HUG; IF International FoundationNot yet recruitingRecovery | Psychiatric Hospitalization | CoercionSwitzerland
-
St. Petersburg State Pavlov Medical UniversityPirogov Russian National Research Medical University; Ministry of Health, Russian... and other collaboratorsUnknownStroke | Total Hip Replacement | AMIRussian Federation
-
Oasis Pharmaceuticals, LLCMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases...RecruitingNonalcoholic Steatohepatitis | Nonalcoholic Fatty LiverUnited States
-
Hospital District of Helsinki and UusimaaUniversity of Turku; Karlstad UniversityCompletedArthroplasties, Hip Replacement | Arthroplasties, Knee ReplacementFinland
-
Seno Medical Instruments Inc.Completed
-
University of Southern DenmarkDanish Cancer Society; Region of Southern DenmarkRecruitingEmpowerment, Cervical Cancer, Endometrial Cancer, Follow-up, Nurse-led, PROMDenmark
-
Albert Einstein College of MedicineMJHS Institute for Innovation in Palliative CareRecruitingDementia | Alzheimer DiseaseUnited States
-
Duke UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedOsteoarthritisUnited States