跳至主要内容
临床试验/NCT02333656
NCT02333656已完成不适用

Improved Management of Patients With Hip and Knee Osteoarthritis in Primary Health Care

Diakonhjemmet Hospital2 个研究点 分布在 1 个国家目标入组 393 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
393
试验地点
2
主要终点
Osteoarthritis Quality Indicator questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

研究组 & 干预措施

Control group

No Intervention

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

Intervention group

Experimental

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

干预措施: New OA model (Other)

结局指标

主要结局

Osteoarthritis Quality Indicator questionnaire

时间窗: 6 months

Patient reported achievement of quality indicators for osteoarthritis care

次要结局

  • Hip/knee function, quality of living subscale(6 months)
  • Pain(6 months)
  • Patient global assessment of the OA disease(6 months)
  • Joint stiffness(6 months)
  • Global function(6 months)
  • Patient Acceptable Symptom State (PASS)(6 months)
  • Physical activity level(6 months)
  • Satisfaction with the care provided(6 months)
  • Health related quality of life (EQ-5D)(6 months)
  • Health care use, medication use and sick leave(6 months)
  • Health professionals' knowledge, attitude and behavior in OA care(Pre- and post-workshop + 6 months post-workshop)
  • Discharge reports from physiotherapists(Up to 1 year)
  • Daily sitting(6 months)
  • Self-reported body weight(6 months)
  • Adverse events(Up to 1 year)
  • Arthritis Self-efficacy Scale(6 months)
  • Referrals to orthopaedic surgeons(Up to 1 year)
  • Referrals to MRI(Up to 1 year)
  • Number of referrals to physiotherapy treatment(Up to 1 year)

研究者

发起方
Diakonhjemmet Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina Osteras

Researcher

Diakonhjemmet Hospital

研究点 (2)

Loading locations...

相似试验