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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis of the Hip or Knee
• Intervention / Treatment: Behavioral: Implementation of a guideline-based model of care for hip and knee osteoarthritis

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Riikka T Holopainen, PhD; Phone Number: +358401696566; Email: riikka.holopainen@movedoc.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients participating GLA:D program
GLA:D -trained physiotherapists	Behavioral: Implementation of a guideline-based model of care for hip and knee osteoarthritis; Guideline-based model of care including GLA:D (Good Life with osteoArthritis from Denmark) -program that includes training for physiotherapists and group based education and exercise for patients with hip and knee OA.
Registry data from national registries (pre); Data of people with hip or knee OA from national registries from all Wellbeing Services Counties in Finland before the implementation of new model of care.
Registry data from national registries (post); Data of people with hip or knee OA from national registries from all Wellbeing Services Counties in Finland after the implementation of new model of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of OA care	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.	1 (primary endpoint), 3 and 5 years after implementation compared to baseline 2018-2024
Reach: Proportion of patients directed according to the model of care	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	1 (primary endpoint) 3 and 5 years after implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of trained GLA:D trainers and physiotherapists	Number of trained GLA:D trainers and physiotherapists in Finland, recorded in GLA:D Finland database by PI.	1, 3 and 5 years after implementation
Participation of patients in GLA:D program	Number of participants in GLA:D groups	1, 3 and 5 years after implementation
Problems walking due to knee /hip	yes / no	Baseline, 3 months, 1, 3 and 10 years
Fear of movement	Are you afraid that your joints will be damaged from physical activity and exercise? yes / no	Baseline, 3 months, 1, 3 and 10 years
Use of painkillers	Yes / no, and type of pain killers	Baseline, 3 months, 1, 3 and 10 years
Current employment	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	Baseline, 3 months, 1, 3 and 10 years
Sick leave because of knee / hip during last year	no / yes, under 1 month, yes 1-3 months, yes more than 3 months	Baseline, 3 months, 1, 3 and 10 years
Number of education and exercise sessions competed (face to face / online)	Numeral value	3 months
Falls over the last year	Number of falls	Baseline, 3 months, 1, 3 and 10 years
Compliance in GLA:D program	Number of participated GLA:D sessions / participant.	3 months
Numbers of sites training / implementing GLA:D -program	Number of sites training / implementing GLA:D -program in Finland. In numbers, based on documentation on GLA:D database by PI.	1, 3 and 5 years after implementation
Number of GLA:D groups running	Number of active GLA:D groups running, numbers, based on documentation on GLA:D Finland database by PI.	1, 3 and 5 years after implementation
Modifications in the Model of care	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.	1, 3 and 5 years after implementation
Pain intensity during last week, numerical rating scale	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	Baseline, 3 months, 1, 3 and 10 years
UCLA activity score	UCLA activity score, 1= wholly inactive (worse outcome), 10 = regularly participate in impact sports (better outcome)	Baseline, 3 months, 1, 3 and 10 years
EQ-5D-5L	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.	Baseline, 3 months, 1, 3 and 10 years
K/HOOS-12	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.	Baseline, 3 months, 1, 3 and 10 years
Global perceived effect	Much worse, an important worsening - much better an important improvement. 7-point likert scale, where a higher score indicates a better outcome.	3 months, 1, 3 and 10 years
Satisfaction with GLA:D	1-5 Not at all satisfied - very satisfied, higher score indicates a better outcome.	3 and 12 months
How often do you use what you've learned in GLA:D?	Never (1), every month (2), every week (3), every day (4), several times a day (5), a higher score indicates a better outcome.	3 months, 1, 3 and 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Male / female / other	Baseline
Age	in years	Baseline
Living situation	Living alone or with others	Baseline
Educational level	Basic and vocational education	Baseline
Medical comorbidities	High blood pressure and high cholesterol, Musculoskeletal conditions, Cardiovascular and blood diseases, Neurological diseases, Hormonal diseases, urinary diseasses, Gastrointestinal and liver diseases, Lung diseases, Cancer, Mental conditions, Diseases in the skin and other chronic diseases	Baseline
Smoking	Smoking status	Baseline
Duration of joint symptoms	Duration of joint symptoms in months / years	Baseline
Most affected joint	Most affected joint (right/left hip, right/left knee)	Baseline, 1, 3 and 10 years
Other affected joints	Other affected joints (right/left hip, right/left knee)	Baseline, 3 months, 1, 3 and 10 years
Previous injury knee /hip	Previous injury that cuaused the person consult a doctor	Baseline
Previous X-rays of affected joints	No / yes, more than 6 months ago / yes, within last 6 months / don't know	Baseline
Osteoarthritis checklist	Knee: load related pain, reduced functional capacity, morning stiffness, crepitus, reduced knee movement, bony enlargement, age, sex, overweight, previous joint injury, occupational / recreational overuse / family members with osteoarthritis Hip: hip pain, stiffness after inactivity, reduced functional capacity, reduced hip flexion, reduced internal hip rotation, painful internal hip rotation, age, sex, overweight, previous joint injury, occupational / recreational overuse / family members with osteoarthritis	Baseline
Previous and planned surgery of knee and hip	Type and time of surgery	Baseline (previous and planned surgery), 3 months, 1, 3 and 10 years (planned surgery)
Expectations on GLA:D program	1-5 1= very large / complete improvement, 5 = Very small or no improvement	Baseline
The Determinants of Implementation Behaviour Questionnaire	The multiprofessional version of Determinants of Implementation Behaviour Questionnaire (DIBQ-mp) Clinician reported determinants of implementation of guideline-based model of care and GLA:D program, designed according to the Theoretical Domains Framework. The items will be scored each separately on 7-point likert scale, where a lower score indicates that item being a barrier (worse outcome) and higher score towards facilitator (better outcome).	after delivering first GLA:D program and at 12 months
Short form of Orebro musculoskeletal pain screening questionnaire	0-100 points, higher score indicates a higher risk (<40 points = low risk, 40-50 points = medium risk, >50 points = high risk)	Baseline, 3 months, 1, 3 and 10 years

Collaborators and Investigators

• Sponsor: University of Jyvaskyla
• Collaborators: University of Helsinki; University of Southern Denmark; Tampere University; University of Limerick; University of Oulu

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: osteoarthritis; care pathway; implementation; benchmarking controlled trial; model of care
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: 263/13.00.04.00/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No