Clinical trial NCT03254771: Effectiveness of a Decision Aid for Knee Osteoarthritis
Official title: Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee ostheoartritis
Arthroplasty
Clinical trial
Decision aids
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: Hospital de Basurto
name: Hospital Donostia
First posted: 2017-08-18
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional conflict, measured by the Decisional Conflict Scale (DCS).
timeFrame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
Secondary outcomes:
measure: Knowledge of the disease and treatments
timeFrame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
measure: Goals and concerns
timeFrame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
measure: Treatment preference
timeFrame: Immediately after the intervention; 6 months (only non-operated patients)
measure: Satisfaction with the decision making process
timeFrame: Immediately after the intervention; 6 months
measure: Decisional regret, measured by the Decisional Regret Scale (DRS)
timeFrame: 6 months (only operated patients)
Other outcomes:
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Servicio de Evaluación de. Servicio Canario de Salud -
Study officials:
affiliation: Researcher
name: Amado Rivero Santana, PhD
role: STUDY_CHAIR
References: