Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Management of Hip and Knee Osteoarthritis in Primary Health Care

30. januar 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

393

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Norge
      • Oslo, Norge, 0319
        • Diakonhjemmet Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: Intervention group
New OA model. Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Osteoarthritis Quality Indicator questionnaire
Tidsramme: 6 months
Patient reported achievement of quality indicators for osteoarthritis care
6 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Diakonhjemmet Hospital

Samarbejdspartnere

The Research Council of Norway

Efterforskere

  • Studieleder: Kåre Hagen, Prof., Project administrator/Research director
  • Ledende efterforsker: Nina Østerås, PhD, Researcher

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2015

Primær færdiggørelse (Faktiske)

1. oktober 2017

Studieafslutning (Faktiske)

1. oktober 2017

Datoer for studieregistrering

Først indsendt

4. januar 2015

Først indsendt, der opfyldte QC-kriterier

5. januar 2015

Først opslået (Skøn)

7. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 229079

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Knæ slidgigt

Kliniske forsøg med New OA model

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ukraine

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner