- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02333656
Management of Hip and Knee Osteoarthritis in Primary Health Care
30. januar 2018 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
393
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Oslo, Norge, 0319
- Diakonhjemmet Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Osteoarthritis Quality Indicator questionnaire
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pain
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
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6 months
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Patient Acceptable Symptom State (PASS)
Tidsramme: 6 months
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6 months
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Hip/knee function, quality of living subscale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
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6 months
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Health related quality of life (EQ-5D)
Tidsramme: 6 months
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6 months
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Self-reported body weight
Tidsramme: 6 months
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6 months
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Health care use, medication use and sick leave
Tidsramme: 6 months
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6 months
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Adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 1 year
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Up to 1 year
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Discharge reports from physiotherapists
Tidsramme: 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
Tidsramme: 6 months
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6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Kåre Hagen, Prof., Project administrator/Research director
- Hovedetterforsker: Nina Østerås, PhD, Researcher
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2015
Primær fullføring (Faktiske)
1. oktober 2017
Studiet fullført (Faktiske)
1. oktober 2017
Datoer for studieregistrering
Først innsendt
4. januar 2015
Først innsendt som oppfylte QC-kriteriene
5. januar 2015
Først lagt ut (Anslag)
7. januar 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. februar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 229079
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