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Management of Hip and Knee Osteoarthritis in Primary Health Care

Primary Purpose

Hip Osteoarthritis, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
New OA model
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hip Osteoarthritis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diakonhjemmet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

Usual care. The participants enrolled in the control period will receive OA treatment as it is currently offered in primary health care services.

New OA model. Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration

Outcomes

Primary Outcome Measures

Osteoarthritis Quality Indicator questionnaire
Patient reported achievement of quality indicators for osteoarthritis care

Secondary Outcome Measures

Pain
Pain level in hip/knee past week
Joint stiffness
Stiffness in the hip/knee past week
Global function
Hip/knee function in the past week
Patient global assessment of the OA disease
Patient Acceptable Symptom State (PASS)
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)
Physical activity level
An index based on self-reported frequency, intensity, duration of physical activity
Daily sitting
Daily hours in sitting position
Satisfaction with the care provided
Health related quality of life (EQ-5D)
Self-reported body weight
Health care use, medication use and sick leave
Adverse events
Health professionals' knowledge, attitude and behavior in OA care
Referrals to orthopaedic surgeons
Number of referrals to secondary care that does not lead to scheduled joint surgery
Referrals to MRI
Number of referrals to MRI for OA assessment
Number of referrals to physiotherapy treatment
Discharge reports from physiotherapists
Number of discharge reports from PTs at FLSs/ private practice to the referring GP
Arthritis Self-efficacy Scale

Full Information

First Posted
January 4, 2015
Last Updated
January 30, 2018
Sponsor
Diakonhjemmet Hospital
Collaborators
The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT02333656
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
The Research Council of Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care. The participants enrolled in the control period will receive OA treatment as it is currently offered in primary health care services.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
New OA model. Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration
Intervention Type
Other
Intervention Name(s)
New OA model
Intervention Description
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 Outcome Measure Information:
Title
Osteoarthritis Quality Indicator questionnaire
Description
Patient reported achievement of quality indicators for osteoarthritis care
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain
Description
Pain level in hip/knee past week
Time Frame
6 months
Title
Joint stiffness
Description
Stiffness in the hip/knee past week
Time Frame
6 months
Title
Global function
Description
Hip/knee function in the past week
Time Frame
6 months
Title
Patient global assessment of the OA disease
Time Frame
6 months
Title
Patient Acceptable Symptom State (PASS)
Time Frame
6 months
Title
Hip/knee function, quality of living subscale
Description
Function (Knee injury and Osteoarthritis Outcome Score ADL subscale/ Hip disability and Osteoarthritis Outcome Score OoL subscale (K/HOOS)
Time Frame
6 months
Title
Physical activity level
Description
An index based on self-reported frequency, intensity, duration of physical activity
Time Frame
6 months
Title
Daily sitting
Description
Daily hours in sitting position
Time Frame
6 months
Title
Satisfaction with the care provided
Time Frame
6 months
Title
Health related quality of life (EQ-5D)
Time Frame
6 months
Title
Self-reported body weight
Time Frame
6 months
Title
Health care use, medication use and sick leave
Time Frame
6 months
Title
Adverse events
Time Frame
Up to 1 year
Title
Health professionals' knowledge, attitude and behavior in OA care
Time Frame
Pre- and post-workshop + 6 months post-workshop
Title
Referrals to orthopaedic surgeons
Description
Number of referrals to secondary care that does not lead to scheduled joint surgery
Time Frame
Up to 1 year
Title
Referrals to MRI
Description
Number of referrals to MRI for OA assessment
Time Frame
Up to 1 year
Title
Number of referrals to physiotherapy treatment
Time Frame
Up to 1 year
Title
Discharge reports from physiotherapists
Description
Number of discharge reports from PTs at FLSs/ private practice to the referring GP
Time Frame
Up to 1 year
Title
Arthritis Self-efficacy Scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kåre Hagen, Prof.
Organizational Affiliation
Project administrator/Research director
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nina Østerås, PhD
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0319
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32284049
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.
Results Reference
derived
PubMed Identifier
31613885
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. Erratum In: PLoS Med. 2019 Dec 19;16(12):e1002993.
Results Reference
derived
PubMed Identifier
31075423
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.
Results Reference
derived
PubMed Identifier
26631224
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.
Results Reference
derived

Learn more about this trial

Management of Hip and Knee Osteoarthritis in Primary Health Care

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