Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis (Value-based TKR)

Study Overview
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Brief Summary
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The aim of this trial is to investigate the effect of a medical decision aid (EKIT-Tool) on decision quality for knee arthroplasty.

Detailed Description
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The tool will guide the SDM process and support the consultation, providing a systematic presentation of individual patient and disease-specific information and the fulfilment of indication criteria. Furthermore, it will present health information about knee replacement to empower the patient. To investigate the effect of the tool on decision quality, we choose a prospective multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT) design.

Official Title
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An Individualized Decision Aid for Physicians and Patients for Total Knee Replacement in Osteoarthritis (Value-based TKR): Study Protocol for a Multi-center, Stepped Wedge, Cluster Randomized Controlled Trial

Conditions
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Knee Osteoarthritis, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Other: Digital decision aid for physicians and patients
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with knee osteoarthritis who are candidates for knee replacement capacity to consent understanding of the German language (written and oral) age of 18 years or older informed consent Exclusion criteria: meeting not all inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention cluster<br>EKIT tool | Other: Digital decision aid for physicians and patients<br>* The intervention consists of three parts: (1) the EKIT tool provides a systematic presentation of individual patient and disease-specific information; (2) it visualizes the fulfilment of the indication criteria recommanded in corresponding german guideline; (3) it presents health information about total knee replacement.<br>|
| Active Comparator: Control Cluster<br>routine care | Other: Routine care<br>* Care as usual within the included study sites.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision quality | Decision quality measured by DQI-Knee Osteoarthritis v2.0 | immediately after the intervention/procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fulfillment of patient expectations | Fulfillment of patient expectations measured by a 5-point Likert-scale (not at all, no, unsure, yes partially, yes completely) | 12 months | 
| Oxford Knee Score (OKS) | Oxford Knee Score (0 worst to 48 best) | 12 month |