- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02333656
Management of Hip and Knee Osteoarthritis in Primary Health Care
30 janvier 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
393
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Oslo, Norvège, 0319
- Diakonhjemmet Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
45 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune 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.
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Expérimental: Intervention group
New OA model.
Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Osteoarthritis Quality Indicator questionnaire
Délai: 6 months
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Patient reported achievement of quality indicators for osteoarthritis care
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain
Délai: 6 months
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Pain level in hip/knee past week
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6 months
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Joint stiffness
Délai: 6 months
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Stiffness in the hip/knee past week
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6 months
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Global function
Délai: 6 months
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Hip/knee function in the past week
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6 months
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Patient global assessment of the OA disease
Délai: 6 months
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6 months
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Patient Acceptable Symptom State (PASS)
Délai: 6 months
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6 months
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Hip/knee function, quality of living subscale
Délai: 6 months
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Function (Knee injury and Osteoarthritis Outcome Score ADL subscale/ Hip disability and Osteoarthritis Outcome Score OoL subscale (K/HOOS)
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6 months
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Physical activity level
Délai: 6 months
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An index based on self-reported frequency, intensity, duration of physical activity
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6 months
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Daily sitting
Délai: 6 months
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Daily hours in sitting position
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6 months
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Satisfaction with the care provided
Délai: 6 months
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6 months
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Health related quality of life (EQ-5D)
Délai: 6 months
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6 months
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Self-reported body weight
Délai: 6 months
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6 months
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Health care use, medication use and sick leave
Délai: 6 months
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6 months
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Adverse events
Délai: Up to 1 year
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Up to 1 year
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Health professionals' knowledge, attitude and behavior in OA care
Délai: Pre- and post-workshop + 6 months post-workshop
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Pre- and post-workshop + 6 months post-workshop
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Referrals to orthopaedic surgeons
Délai: Up to 1 year
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Number of referrals to secondary care that does not lead to scheduled joint surgery
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Up to 1 year
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Referrals to MRI
Délai: Up to 1 year
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Number of referrals to MRI for OA assessment
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Up to 1 year
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Number of referrals to physiotherapy treatment
Délai: Up to 1 year
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Up to 1 year
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Discharge reports from physiotherapists
Délai: Up to 1 year
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Number of discharge reports from PTs at FLSs/ private practice to the referring GP
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Up to 1 year
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Arthritis Self-efficacy Scale
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Kåre Hagen, Prof., Project administrator/Research director
- Chercheur principal: Nina Østerås, PhD, Researcher
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2015
Achèvement primaire (Réel)
1 octobre 2017
Achèvement de l'étude (Réel)
1 octobre 2017
Dates d'inscription aux études
Première soumission
4 janvier 2015
Première soumission répondant aux critères de contrôle qualité
5 janvier 2015
Première publication (Estimation)
7 janvier 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 février 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 janvier 2018
Dernière vérification
1 janvier 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 229079
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