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Completed

NCT Number: NCT02333656

Management of 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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonhjemmet Hospital

Oslo, 0319, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New OA model

Other

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

  1. Osteoarthritis Quality Indicator questionnaire

    Time frame: 6 months

    Patient reported achievement of quality indicators for osteoarthritis care

Secondary outcomes

  1. Pain

    Time frame: 6 months

    Pain level in hip/knee past week

  2. Joint stiffness

    Time frame: 6 months

    Stiffness in the hip/knee past week

  3. Global function

    Time frame: 6 months

    Hip/knee function in the past week

  4. Patient global assessment of the OA disease

    Time frame: 6 months

  5. Patient Acceptable Symptom State (PASS)

    Time frame: 6 months

  6. 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)

  7. Physical activity level

    Time frame: 6 months

    An index based on self-reported frequency, intensity, duration of physical activity

  8. Daily sitting

    Time frame: 6 months

    Daily hours in sitting position

  9. Satisfaction with the care provided

    Time frame: 6 months

  10. Health related quality of life (EQ-5D)

    Time frame: 6 months

  11. Self-reported body weight

    Time frame: 6 months

  12. Health care use, medication use and sick leave

    Time frame: 6 months

  13. Adverse events

    Time frame: Up to 1 year

  14. Health professionals' knowledge, attitude and behavior in OA care

    Time frame: Pre- and post-workshop + 6 months post-workshop

  15. Referrals to orthopaedic surgeons

    Time frame: Up to 1 year

    Number of referrals to secondary care that does not lead to scheduled joint surgery

  16. Referrals to MRI

    Time frame: Up to 1 year

    Number of referrals to MRI for OA assessment

  17. Number of referrals to physiotherapy treatment

    Time frame: Up to 1 year

  18. Discharge reports from physiotherapists

    Time frame: Up to 1 year

    Number of discharge reports from PTs at FLSs/ private practice to the referring GP

  19. Arthritis Self-efficacy Scale

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2015
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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