Osteoarthritis, Knee
Conditions
Keywords
Knee ostheoartritis, Arthroplasty, Clinical trial, Decision aids
Brief summary
The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART
Detailed description
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.
Interventions
OTHERDecision aid
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Sponsors
Hospital de Basurto
Hospital Donostia
Servicio Canario de Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict, measured by the Decisional Conflict Scale (DCS). | Immediately after the intervention; 6 months after the intervention (only non-operated patients) | The DCS measures patients' uncertainty about treatment choice. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of the disease and treatments | Immediately after the intervention; 6 months after the intervention (only non-operated patients) | A 7-item scale will be udes to assess patients' knowledge of the disease and treatments |
| Goals and concerns | Immediately after the intervention; 6 months after the intervention (only non-operated patients) | A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments |
| Treatment preference | Immediately after the intervention; 6 months (only non-operated patients) | Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty |
| Satisfaction with the decision making process | Immediately after the intervention; 6 months | The scale developed by Barry et al. (1997) will be used, composed of 12 items measuring patients' satisfaction with information and care provided |
| Decisional regret, measured by the Decisional Regret Scale (DRS) | 6 months (only operated patients) | The DRS contains five items measuring patients regret with the treatment decision |
Countries
Spain
Outcome results
None listed