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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

Status

Fullført

Intervensjon / Behandling

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

      • Oslo, Norge, 0319
        • Diakonhjemmet Hospital

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

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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.

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

Andre studie-ID-numre

  • 229079

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