An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial

Toni Lange, Stefanie Deckert, Franziska Beyer, Waldemar Hahn, Natascha Einhart, Martin Roessler, Martin Sedlmayr, Jochen Schmitt, Jörg Lützner, Toni Lange, Stefanie Deckert, Franziska Beyer, Waldemar Hahn, Natascha Einhart, Martin Roessler, Martin Sedlmayr, Jochen Schmitt, Jörg Lützner

Abstract

Background: Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative ("evidence and consensus based indication critera for total arthroplasty") developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality.

Methods: The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients' decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%.

Discussion: There is a high potential for transferring the intervention into routine practice if the evaluation is positive.

Trial registration: ClinicalTrials.gov: NCT04837053 . Registered on 08/04/2021.

Keywords: Decision quality; Patient-reported outcome measures; Shared decision making; Total knee arthroplasty.

Conflict of interest statement

The authors declare that they have no competing interests that could be considered as a potential conflict of interest for this study. However, outside this study JL has received research funds from Aesculap, Link, Mathys, Smith&Nephew and BiometZimmer and fees for lectures/workshops from Aesculap, Link, Mathys and Pfizer.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
The stepped wedge design as applied in Value-based TKR
Fig. 2
Fig. 2
Flow of study intervention and assessment

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