Effectiveness of a Decision Aid for Knee Osteoarthritis

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Decision aid

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 Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz de Tenerife, Spain, 38004
    • Servicio de Evaluación de. Servicio Canario de Salud -

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; In the control group, the usual explanation about the disease and the possibilities of treatment will be followed
Experimental: Intervention group; 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.	Other: Decision aid; Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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
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)

Collaborators and Investigators

• Sponsor: Servicio Canario de Salud
• Collaborators: Hospital Donostia; Hospital de Basurto
• Investigators: Study Chair: Amado Rivero Santana, PhD, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Arthroplasty; Knee ostheoartritis; Clinical trial; Decision aids
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PI15-01264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No