Management of Hip and Knee Osteoarthritis in Primary Health Care

Knee Osteoarthritis Clinical Trial

Official title:

Improved Management of Patients With Hip and Knee Osteoarthritis in Primary Health Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333656
• Other study ID #: 229079
• Status: Completed
• Phase: N/A
• First received: January 4, 2015
• Last updated: January 30, 2018
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoarthritis Quality Indicator questionnaire	Patient reported achievement of quality indicators for osteoarthritis care	6 months
Secondary	Pain	Pain level in hip/knee past week	6 months
Secondary	Joint stiffness	Stiffness in the hip/knee past week	6 months
Secondary	Global function	Hip/knee function in the past week	6 months
Secondary	Patient global assessment of the OA disease		6 months
Secondary	Patient Acceptable Symptom State (PASS)		6 months
Secondary	Hip/knee function, quality of living subscale	Function (Knee injury and Osteoarthritis Outcome Score ADL subscale/ Hip disability and Osteoarthritis Outcome Score OoL subscale (K/HOOS)	6 months
Secondary	Physical activity level	An index based on self-reported frequency, intensity, duration of physical activity	6 months
Secondary	Daily sitting	Daily hours in sitting position	6 months
Secondary	Satisfaction with the care provided		6 months
Secondary	Health related quality of life (EQ-5D)		6 months
Secondary	Self-reported body weight		6 months
Secondary	Health care use, medication use and sick leave		6 months
Secondary	Adverse events		Up to 1 year
Secondary	Health professionals' knowledge, attitude and behavior in OA care		Pre- and post-workshop + 6 months post-workshop
Secondary	Referrals to orthopaedic surgeons	Number of referrals to secondary care that does not lead to scheduled joint surgery	Up to 1 year
Secondary	Referrals to MRI	Number of referrals to MRI for OA assessment	Up to 1 year
Secondary	Number of referrals to physiotherapy treatment		Up to 1 year
Secondary	Discharge reports from physiotherapists	Number of discharge reports from PTs at FLSs/ private practice to the referring GP	Up to 1 year
Secondary	Arthritis Self-efficacy Scale		6 months