Hip Osteoarthritis, Osteoarthritis
Conditions
Keywords
Hip osteoarthritis, Patient decision aids, Person-centred care, Randomized controlled trial, Shared decision-making, Web-based intervention
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.
Interventions
OTHERPatient Decision Aid (PtDA)
Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
OTHERBrochure 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
Sponsors
Fundación Canaria de Investigación Sanitaria
Hospital Universitario de Canarias
Hospital San Juan de Dios Tenerife
Avedis Donabedian Research Institute
Gerencia de Atención Primaria del Área de Salud de Tenerife
Servicio Canario de Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Values about characteristics of treatments | Immediately after the intervention | 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. |
| Treatment preference | Immediately after the intervention | Patients will be asked the treatment they prefer: physiotherapy, medication, intra-articular injections, arthroplasty, not sure |
| Intention to undergo the preferred treatment | Immediately after the intervention | Assessed with one item ranging 0 (not sure) to 5 (completely sure) |
| Knowledge of the disease and treatments | Before and immediately after the intervention | A 7-item scale will be udes to assess patients' knowledge of the disease and treatments |
| Decision quality about arthroplasty | Immediately after the intervention | Binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance. |
| Satisfaction with the decision making process scale | Immediately after the intervention | 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. |
| Concordance between values and intention to undergo arthroplasty vs. conservative treatments | Immediately after the intervention | Binary variable (yes/no) derived from the association between values and intention to undergo arthroplasty (see statistical analysis). |
Countries
Spain
Outcome results
None listed