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临床试验/NCT06904885
NCT06904885尚未招募不适用

Implementing a Guideline-based Model of Care for Hip and Knee Osteoarthritis in Finland. A Benchmarking-controlled Trial (FIN-OA)

University of Jyvaskyla0 个研究点目标入组 10,000 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
10,000
主要终点
Cost of OA care

研究概览

简要总结

This project aims to bridge the gap between guideline recommendations and clinical practice in osteoarthritis (OA) management. By implementing a systematic, evidence-based model of care, the project seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The project consists of three phases. In the first phase the current OA care is mapped through registry review and questionnaires and interviews of patients and healthcare professionals. In the second, implementation phase of the project, a plan will be created how to support healthcare professionals in delivering care according to the new model of care and training and support will be offered according to the plan. In the third phase of the project, the implementation success will be evaluated, and the costs of OA care evaluated and compared to baseline data. In addition, patient-reported data will be collected from those patients, who participate in the group-based exercise and education program.

详细描述

Osteoarthritis (OA) is a growing global health challenge, due to the significant increase in prevalence of knee and hip OA. In Finland, OA care costs are substantial, driven by diagnostic procedures, medical treatments, and indirect costs such as work absenteeism. The international guidelines recommend education, exercise, and weight management as first-line treatment options, but adherence to guidelines is inconsistent. This project aims to explore regional differences in OA care and beliefs and OA care practices in Finland. In addition, we will implement and evaluate a guideline-based model of care for hip and knee OA, that includes the Good Life with osteoarthritis from Denmark (GLA:D®) program as the preferred non-surgical management option in local care pathways. In addition, the aim is to share evidence-based OA knowledge and management skills nationwide.

This study is a hybrid type-3 benchmarking-controlled implementation trial. It is nested in primary healthcare in two Wellbeing Services Counties. The study includes three phases: pre-implementation, implementation, and evaluation. The pre-implementation activities include mapping the current OA care through registry review (healthcare utilization and costs from 2019-2024). In addition questionnaires and interviews of patients and healthcare professionals (beliefs and practices) will be conducted. Planned activities of the implementation phase include developing and integrating a new model of care (including GLA:D®) into local care pathways, and training physiotherapists to deliver it. Implementation theories and multifaceted implementation strategies will be used and adapted locally. The activities to evaluate the process include assessment of the implementation outcomes on healthcare professional and organizational levels, healthcare resource utilization and cost outcomes (1, 3 and 5 years) using registry data. In addition outcomes reported by patients participating in the GLA:D program will be collected at 3 months and 1, 3 and 10 years.

This project aims to bridge the gap between guideline-recommended OA-management and clinical practice. By implementing a systematic, evidence-based model of care, the study seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The findings will inform future OA care strategies and will be disseminated and adapted to other healthcare contexts in Finland and can be adapted also internationally. The findings will be published in peer-reviewed journals and presented in national and international conferences.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Patients who are participating in theGLA:D program, diagnosed with hip or knee osteoarthritis, fluent in finnish
  • age over 18 years

排除标准

  • Other than OA-related cause of symptoms
  • not able to answer the questionnaires in Finnish
  • no access to a computer or mobile device to answer the questionnaires

结局指标

主要结局

Cost of OA care

时间窗: 1 (primary endpoint), 3 and 5 years after implementation compared to baseline 2018-2024

Healthcare cost associated with the new care pathway incluing annual healthcare consultation prevalence, number and cost of hospitalizations, OA-related surgical interventions and primary and specialized healthcare and outpatient specialist visits. Filled prescriptions, number and duration of OA-related sick leaves and disability pensions. Costs will be analysed using data from national registers in pre and post implementation, both within the pilot Wellbeing Services Counties and between the pilot and other Wellbeing Services Counties.

Reach: Proportion of patients directed according to the model of care

时间窗: 1 (primary endpoint) 3 and 5 years after implementation

Proportion of patients with hip and knee related symptoms and OA who contact healthcare that are referred to direct access physiotherapy and to GLA:D program

次要结局

  • Number of trained GLA:D trainers and physiotherapists(1, 3 and 5 years after implementation)
  • Participation of patients in GLA:D program(1, 3 and 5 years after implementation)
  • Pain intensity during last week, numerical rating scale(Baseline, 3 months, 1, 3 and 10 years)
  • Problems walking due to knee /hip(Baseline, 3 months, 1, 3 and 10 years)
  • UCLA activity score(Baseline, 3 months, 1, 3 and 10 years)
  • Use of painkillers(Baseline, 3 months, 1, 3 and 10 years)
  • Fear of movement(Baseline, 3 months, 1, 3 and 10 years)
  • Current employment(Baseline, 3 months, 1, 3 and 10 years)
  • Sick leave because of knee / hip during last year(Baseline, 3 months, 1, 3 and 10 years)
  • EQ-5D-5L(Baseline, 3 months, 1, 3 and 10 years)
  • K/HOOS-12(Baseline, 3 months, 1, 3 and 10 years)
  • Global perceived effect(3 months, 1, 3 and 10 years)
  • Satisfaction with GLA:D(3 and 12 months)
  • How often do you use what you've learned in GLA:D?(3 months, 1, 3 and 10 years)
  • Number of education and exercise sessions competed (face to face / online)(3 months)
  • Falls over the last year(Baseline, 3 months, 1, 3 and 10 years)
  • Compliance in GLA:D program(3 months)
  • Numbers of sites training / implementing GLA:D -program(1, 3 and 5 years after implementation)
  • Number of GLA:D groups running(1, 3 and 5 years after implementation)
  • Modifications in the Model of care(1, 3 and 5 years after implementation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riikka Holopainen

Visiting researcher

University of Jyvaskyla

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