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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
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The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
| |
| Non Treatment Group | Placebo Comparator | Conventional information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline and Follow-up Surveys | Behavioral | (completed online) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decision quality | Hip and Knee Decision Quality Instrument (HK-DQI) | 40 to 52 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (generic) | Euroqol Five Dimensions Questionnaire (EQ-5D-5L) | 40 to 52 weeks after baseline |
| Quality of life (condition-specific) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton Bone and Joint Centre | Edmonton | Alberta | T5E 5R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30797238 | Derived | Bansback N, Trenaman L, MacDonald KV, Hawker G, Johnson JA, Stacey D, Marshall DA. An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2019 Feb 23;20(1):89. doi: 10.1186/s12891-019-2434-2. |
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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 |
|---|---|
| C074807 | BaseLine dental cement |
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| Patient Reported Outcome Measure informed Decision Aid | Other | (PROM-DA) |
|
| Pamphlet | Other | (usual care) |
|
| 40 to 52 weeks after baseline |
| Depression | The Patient Health Questionnaire (PHQ-9) | 40 to 52 weeks after baseline |
| Knowledge about total knee arthroplasty surgery | HK-DQI | Baseline |
| Values | HK-DQI | Baseline |
| Decisional conflict | Decisional Conflict Scale (SURE) | Baseline |
| Treatment Preference | Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks? Yes No Unsure | Baseline |
| Preference for involvement in decision making | Control Preferences Scale (CPS) | Baseline |
| Willingness to have surgery | Single item question: Based on your current understanding of the risks and benefits of knee replacement surgery of your knee arthritis, what is your current preference between having joint replacement surgery or non-surgical treatments? I would definitely consider having knee joint replacement surgery now. I would probably consider having knee joint replacement surgery now. I am not sure. I would probably not consider having knee joint replacement surgery now. I would definitely not consider having knee joint replacement surgery now. | Baseline |
| Patient-reported shared decision-making | CollaboRATE | 3 to 6 weeks after baseline |
| Decisional regret | Decision Regret Scale | 40 to 52 weeks after baseline |
| Satisfaction with knee replacement surgery | Three item questionnaire:
Responses from 'very dissatisfied' to ' very satisfied' | 40 to 52 weeks after baseline |
| Expectations | Single item question from Bourne et al. 2010. Clin Orthop Relat Res. related to whether expectations were met; not met; or whether they had no expectations. | 40 to 52 weeks after baseline |
| Surgical consult | Electronic Medical Records (EMR) | 1 to 4 weeks after baseline |
| Surgery | EMR | 27 to 30 weeks after baseline |
| Concordance | HK-DQI | 40 to 52 weeks after baseline |
| D012216 |
| Rheumatic Diseases |