Development and Evaluation of a Web Based Decision Aid for Patients With Hip Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

The Effectiveness of a Web-based Decision Aid for Patients With Hip Osteoarthritis: Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241978
• Other study ID #: PIFUN33/18
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: April 3, 2023

Study information

• Verified date: December 2023
• 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 PtDA for patients with hip osteoarthritis

Description:

Background: Osteoarthritis (OA) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care (PCC). Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.

Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients' decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.

Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 3, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with diagnosis of hip Osteoarthritis

Exclusion Criteria:

• Patients younger than 18 years

• Previous hip arthroplasty

• Patients with terminal illnesses

• Non-fluent Spanish language

• Mental or sensory alterations that impede or hinder the response to the measurement instruments or do not have the capacity to make decisions.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• Patient Decision Aid (PtDA)
Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
• Brochure with general information about osteoarthritis
Participants of the control group will be given a brochure with general information about osteoarthritis of the hip, knee, ankle and foot instead of the PtDA

Locations

Country	Name	City	State
Spain	Evaluation Unit. Canary Islands Health Service	Santa Cruz De Tenerife	Santa Cruz Tenerife

Sponsors (6)

Lead Sponsor	Collaborator
Servicio Canario de Salud	Avedis Donabedian Research Institute, Fundación Canaria de Investigación Sanitaria, Gerencia de Atención Primaria del Área de Salud de Tenerife, Hospital San Juan de Dios Tenerife, Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS)	DCS is a 16-item self-reported scale widely used in PtDA research. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness. This is a 0-100 point scale, where a high score means more decisional conflict.	Immediately after the intervention
Secondary	Knowledge of the disease and treatments	A 7-item scale will be udes to assess patients' knowledge of the disease and treatments	Before and immediately after the intervention
Secondary	Values about characteristics of treatments	Patients will be asked to rate in a 0-10 scale the importance they attribute to different characteristics of treatment: mode of administration, improvement in pain and function, risk of mild and serious adverse effects, time until symptoms' improvement, duration of benefits, and in the case of arthroplasty, period of rehabilitation and risk of needing surgery revision.	Immediately after the intervention
Secondary	Treatment preference	Patients will be asked the treatment they prefer: physiotherapy, medication, intra-articular injections, arthroplasty, not sure	Immediately after the intervention
Secondary	Intention to undergo the preferred treatment	Assessed with one item ranging 0 (not sure) to 5 (completely sure)	Immediately after the intervention
Secondary	Concordance between values and intention to undergo arthroplasty vs. conservative treatments	Binary variable (yes/no) derived from the association between values and intention to undergo arthroplasty (see statistical analysis).	Immediately after the intervention
Secondary	Decision quality about arthroplasty	Binary variable (yes/no) defined as a combination of adequate knowledge (=60% of correct responses) and concordance.	Immediately after the intervention
Secondary	Satisfaction with the decision making process scale	The Satisfaction with Decision Scale (SWD) is a validated 12-item scale measuring participants' satisfaction with healthcare decision making. The SWD uses a 5-point Likert scale where 0 is "Strongly Disagree" and 4 is "Strongly Agree." This is a 0-100 point scale, where a high score means more satisfaction with the decision making process.	Immediately after the intervention