Clinical trial NCT06904885: Implementing a Guideline-based Model of Care for Hip and Knee Osteoarthritis in Finland. A Benchmarking-controlled Trial (FIN-OA)
Official title: Implementing a Guideline-based Model of Care for Hip and Knee Osteoarthritis in Finland. A Benchmarking-controlled Trial (FIN-OA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis of the Hip or Knee
Keywords: osteoarthritis
implementation
benchmarking controlled trial
model of care
care pathway
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: University of Oulu
name: University of Helsinki
name: Tampere University
name: University of Limerick
First posted: 2025-04-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: National registry data: Patients with diagnosed OA from all Wellbeing Services Counties in Finland

GLA:D patient-reported outcome data: Patients who are participating in the GLA:D program, diagnosed with hip or knee osteoarthritis in any location that delivers GLA:D program.

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.

Eligibility criteria: Data from national registries:

* Patients with diagnosed OA (ICD-10 / ICPC2)
* age over 18 years

Collection of GLA:D patient-reported outcomes:

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

Primary outcomes:
measure: Cost of OA care
timeFrame: 1 (primary endpoint), 3 and 5 years after implementation compared to baseline 2018-2024
measure: Reach: Proportion of patients directed according to the model of care
timeFrame: 1 (primary endpoint) 3 and 5 years after implementation
Secondary outcomes:
measure: Number of trained GLA:D trainers and physiotherapists
timeFrame: 1, 3 and 5 years after implementation
measure: Participation of patients in GLA:D program
timeFrame: 1, 3 and 5 years after implementation
measure: Pain intensity during last week, numerical rating scale
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Problems walking due to knee /hip
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: UCLA activity score
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Fear of movement
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Use of painkillers
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Current employment
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Sick leave because of knee / hip during last year
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: EQ-5D-5L
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: K/HOOS-12
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Global perceived effect
timeFrame: 3 months, 1, 3 and 10 years
measure: Satisfaction with GLA:D
timeFrame: 3 and 12 months
measure: How often do you use what you've learned in GLA:D?
timeFrame: 3 months, 1, 3 and 10 years
measure: Number of education and exercise sessions competed (face to face / online)
timeFrame: 3 months
measure: Falls over the last year
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Compliance in GLA:D program
timeFrame: 3 months
measure: Numbers of sites training / implementing GLA:D -program
timeFrame: 1, 3 and 5 years after implementation
measure: Number of GLA:D groups running
timeFrame: 1, 3 and 5 years after implementation
measure: Modifications in the Model of care
timeFrame: 1, 3 and 5 years after implementation
Other outcomes:
measure: The Determinants of Implementation Behaviour Questionnaire
timeFrame: after delivering first GLA:D program and at 12 months
measure: Gender
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Living situation
timeFrame: Baseline
measure: Educational level
timeFrame: Baseline
measure: Medical comorbidities
timeFrame: Baseline
measure: Smoking
timeFrame: Baseline
measure: Duration of joint symptoms
timeFrame: Baseline
measure: Most affected joint
timeFrame: Baseline, 1, 3 and 10 years
measure: Other affected joints
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Previous injury knee /hip
timeFrame: Baseline
measure: Previous X-rays of affected joints
timeFrame: Baseline
measure: Osteoarthritis checklist
timeFrame: Baseline
measure: Previous and planned surgery of knee and hip
timeFrame: Baseline (previous and planned surgery), 3 months, 1, 3 and 10 years (planned surgery)
measure: Short form of Orebro musculoskeletal pain screening questionnaire
timeFrame: Baseline, 3 months, 1, 3 and 10 years
measure: Expectations on GLA:D program
timeFrame: Baseline
Locations:
Study officials:
References: