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| Name | Class |
|---|---|
| Gemeinsamer Bundesaussschuss | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention cluster | Experimental | EKIT tool |
|
| Control Cluster | Active Comparator | routine care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital decision aid for physicians and patients | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decision quality | Decision quality measured by DQI-Knee Osteoarthritis v2.0 | immediately after the intervention/procedure/surgery |
| 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) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörg Lützner, MD | TU Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden | Dresden | Saxony | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34511058 | Background | Lange T, Deckert S, Beyer F, Hahn W, Einhart N, Roessler M, Sedlmayr M, Schmitt J, Lutzner J. 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. BMC Musculoskelet Disord. 2021 Sep 12;22(1):783. doi: 10.1186/s12891-021-04546-5. | |
| 39109409 |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010820 | Physicians |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design
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|
| Routine care | Other | Care as usual within the included study sites. |
|
Oxford Knee Score (0 worst to 48 best)
| 12 month |
| Derived |
| Lutzner J, Deckert S, Beyer F, Hahn W, Malzahn J, Sedlmayr M, Gunther KP, Schmitt J, Lange T; Value-based Total Knee Replacement Study Group. Evaluation of a Digital Decision Aid for Knee Replacement Surgery. Dtsch Arztebl Int. 2024 Aug 23;121(17):566-572. doi: 10.3238/arztebl.m2024.0152. |
| D012216 |
| Rheumatic Diseases |