Effectiveness of a Decision Aid for Knee Osteoarthritis

Servicio Canario de Salud

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Other: Decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT03254771

PI15-01264

Details and patient eligibility

About

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

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

193 participants in 2 patient groups

Control group

No Intervention group

Description:

In the control group, the usual explanation about the disease and the possibilities of treatment will be followed

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Decision aid