Effectiveness of a Decision Aid for Knee Osteoarthritis

Study Overview
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Brief Summary
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The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART

Detailed Description
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The number of knee total arthroplasty (ART) interventions has increased in the last 10 years in European countries, partly due to the aging of the population and partly because of the increase in the use of these interventions to improve the quality of life among elderly patients. According to the Organization for Economic Cooperation and Development (OECD) 2012, from 2000 to 2010 in Spain the percentage of knee ART has doubled in recent years. . The role of citizens in decisions affecting their health is changing. Individual factors such as improving educational attainment and access to medical information, and collective factors such as training of patient groups and changes in legislation (informed consent, autonomy principle) have motivated the transition from a paternalistic model to a co-responsibility model. Shared decision-making (TDC) has been proposed in recent years as a model of care that promotes users' involvement in the decisions about their treatment, in those situations where there is uncertainty and / or the scientific evidence reports a balance between benefits and risks that is similar for two or more therapeutic options. Decision aids (DA) are tools designed to promote and facilitate patients' involvement in medical decisions concerning their health Objectives: To assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART Methodology: Randomized controlled trial to evaluate the effectiveness of the DA versus usual care in reducing decisional conflict, increasing knowledge of the disease/treatments, informed choice and the satisfaction with the decision making process, and decreasing decisional regret.

Official Title
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Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis of the knee Candidates for arthroplasty Exclusion Criteria: Patients who have already undergone knee arthroplasty Patients younger than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>In the control group, the usual explanation about the disease and the possibilities of treatment will be followed | |
| Experimental: Intervention group<br>In the Intervention group, the Decision Aid (DA) will be presented and explained to the patient by research personnel at a schedule previously agreed with the patient. The patient will be given a paper copy of the (DA) to take home, as well as a web link to the computer application, and oral and written instructions to review the material again and perform value clarification exercises. | Other: Decision aid<br>* Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict, measured by the Decisional Conflict Scale (DCS). | The DCS measures patients' uncertainty about treatment choice. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness | Immediately after the intervention; 6 months after the intervention (only non-operated patients) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of the disease and treatments | A 7-item scale will be udes to assess patients' knowledge of the disease and treatments | Immediately after the intervention; 6 months after the intervention (only non-operated patients) | 
| Goals and concerns | A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments | Immediately after the intervention; 6 months after the intervention (only non-operated patients) | 
| Treatment preference | Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty | Immediately after the intervention; 6 months (only non-operated patients) | 
| Satisfaction with the decision making process | The scale developed by Barry et al. (1997) will be used, composed of 12 items measuring patients' satisfaction with information and care provided | Immediately after the intervention; 6 months | 
| Decisional regret, measured by the Decisional Regret Scale (DRS) | The DRS contains five items measuring patients regret with the treatment decision | 6 months (only operated patients) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee ostheoartritis, Arthroplasty, Clinical trial, Decision aids