Effectiveness of a Decision Aid for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254771
• Other study ID #: PI15-01264
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2020
• Source: Servicio Canario de Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Decision aid
Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health

Locations

Country	Name	City	State
Spain	Servicio de Evaluación de. Servicio Canario de Salud -	Santa Cruz de Tenerife

Sponsors (3)

Lead Sponsor	Collaborator
Servicio Canario de Salud	Hospital de Basurto, Hospital Donostia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)