The Effectiveness of a Web-based Decision Aid for Patients With Hip Osteoarthritis: Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Osteoarthritis
- Sponsor
- Servicio Canario de Salud
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The main goal of this study is assess the effectiveness of a PtDA for patients with hip osteoarthritis
Detailed 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.
Investigators
Lilisbeth Perestelo-Perez
Health Services Researcher
Servicio Canario de Salud
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS)
Time Frame: Immediately after the intervention
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.
Secondary Outcomes
- Decision quality about arthroplasty(Immediately after the intervention)
- Treatment preference(Immediately after the intervention)
- Knowledge of the disease and treatments(Before and immediately after the intervention)
- Intention to undergo the preferred treatment(Immediately after the intervention)
- Satisfaction with the decision making process scale(Immediately after the intervention)
- Values about characteristics of treatments(Immediately after the intervention)
- Concordance between values and intention to undergo arthroplasty vs. conservative treatments(Immediately after the intervention)