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

Not yet recruiting

• Conditions: Osteoarthritis of the Hip or Knee

• Registration Number: NCT06904885
• Lead Sponsor: University of Jyvaskyla

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-31
• Study Start: 2025-04-01
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-01
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cost of OA care	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	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

Secondary Outcome Measures

Name	Time	Method
Number of trained GLA:D trainers and physiotherapists	1, 3 and 5 years after implementation	Number of trained GLA:D trainers and physiotherapists in Finland, recorded in GLA:D Finland database by PI.
Participation of patients in GLA:D program	1, 3 and 5 years after implementation	Number of participants in GLA:D groups
Pain intensity during last week, numerical rating scale	Baseline, 3 months, 1, 3 and 10 years	Numerical rating scale (NRS) 0-10, where 0 means no pain (better outcome) and 10 worst possible pain (worse outcome). a) worst pain b) average pain
Problems walking due to knee /hip	Baseline, 3 months, 1, 3 and 10 years	yes / no
UCLA activity score	Baseline, 3 months, 1, 3 and 10 years	UCLA activity score, 1= wholly inactive (worse outcome), 10 = regularly participate in impact sports (better outcome)
Fear of movement	Baseline, 3 months, 1, 3 and 10 years	Are you afraid that your joints will be damaged from physical activity and exercise? yes / no
Use of painkillers	Baseline, 3 months, 1, 3 and 10 years	Yes / no, and type of pain killers
Current employment	Baseline, 3 months, 1, 3 and 10 years	Employed / student / unemployed / on sick leave full time / on sick leave part time / early retirement due to low ability to work / self-imposed early retirement / retired
Sick leave because of knee / hip during last year	Baseline, 3 months, 1, 3 and 10 years	no / yes, under 1 month, yes 1-3 months, yes more than 3 months
EQ-5D-5L	Baseline, 3 months, 1, 3 and 10 years	Mobility (1-5), self-care (1-5), usual activities (1-5), pain/ discomfort (1-5), anxiety / depression (1-5), eq-vas (0-100). Lower scores indicate a worse outcome.
K/HOOS-12	Baseline, 3 months, 1, 3 and 10 years	KOOS-12 asked if most affected joint is knee and HOOS-12 asked is most affected joint is hip. Scale 1-4 for each item, a lower score indicates a better outcome.
Global perceived effect	3 months, 1, 3 and 10 years	Much worse, an important worsening - much better an important improvement. 7-point likert scale, where a higher score indicates a better outcome.
Satisfaction with GLA:D	3 and 12 months	1-5 Not at all satisfied - very satisfied, higher score indicates a better outcome.
How often do you use what you've learned in GLA:D?	3 months, 1, 3 and 10 years	Never (1), every month (2), every week (3), every day (4), several times a day (5), a higher score indicates a better outcome.
Number of education and exercise sessions competed (face to face / online)	3 months	Numeral value
Falls over the last year	Baseline, 3 months, 1, 3 and 10 years	Number of falls
Compliance in GLA:D program	3 months	Number of participated GLA:D sessions / participant.
Numbers of sites training / implementing GLA:D -program	1, 3 and 5 years after implementation	Number of sites training / implementing GLA:D -program in Finland. In numbers, based on documentation on GLA:D database by PI.
Number of GLA:D groups running	1, 3 and 5 years after implementation	Number of active GLA:D groups running, numbers, based on documentation on GLA:D Finland database by PI.
Modifications in the Model of care	1, 3 and 5 years after implementation	Descriptive qualitative reporting based on research diary: When and how modifactions in the Model of Care and Care pathways occured, whether it was unplanned or planned, reasons and goals for modification.