NCT04837053

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,092 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Knee Osteoarthritis
• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
OTHER	Digital decision aid for physicians and patients	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.
OTHER	Routine care	Care as usual within the included study sites.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-02-28
• Completion: 2024-04-30
• First posted: 2021-04-08
• Last updated: 2024-08-07

Locations

1 site across 1 country: Germany