Effectiveness of a Decision Aid for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Decision aid

• Registration Number: NCT03254771
• Lead Sponsor: Servicio Canario de Salud

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.

Study Timeline

• Study First Submitted: 2017-06-05
• Study Start: 2017-08-16
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-18
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Decision aid	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Servicio de Evaluación de. Servicio Canario de Salud -; 🇪🇸 Santa Cruz de Tenerife, Spain