An interventional study of Patient Decision Aid (PtDA) and Brochure with general information about osteoarthritis in Hip Osteoarthritis and Osteoarthritis, sponsored by Servicio Canario de Salud. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Servicio Canario de Salud · Not applicable, Interventional, and Health services research
The main goal of this study is assess the effectiveness of a PtDA for patients with hip osteoarthritis
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.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
This study's enrollment of 130 is above the median of 90 across 458 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Servicio Canario de Salud is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
The participants will complete the baseline assessment and will be asked to read the project information sheet. Then, patients allocated to the intervention group will review the PtDA accompanied by the researcher and will complete the questionnaires assessing the outcome measures, in the same web interface.
Other: Patient Decision Aid (PtDA)
Patients in the control group will follow the same procedure, but they will be given a brochure with general information about osteoarthritis of the hip, knee, ankle and foot instead of the PtDA
Other: Brochure with general information about osteoarthritis
Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
Also known as: Intervention
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
Also known as: Control
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.
Time frame: Immediately after the intervention
Knowledge of the disease and treatments
A 7-item scale will be udes to assess patients' knowledge of the disease and treatments
Time frame: Before and immediately after the intervention
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.
Time frame: Immediately after the intervention
Treatment preference
Patients will be asked the treatment they prefer: physiotherapy, medication, intra-articular injections, arthroplasty, not sure
Time frame: Immediately after the intervention
Intention to undergo the preferred treatment
Assessed with one item ranging 0 (not sure) to 5 (completely sure)
Time frame: Immediately after the intervention
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).
Time frame: Immediately after the intervention
Decision quality about arthroplasty
Binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance.
Time frame: Immediately after the intervention
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.
Time frame: Immediately after the intervention
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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