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

Study 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.

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

Conditions
-----------------
Hip Osteoarthritis, Osteoarthritis

Intervention / Treatment
-----------------
* Other: Patient Decision Aid (PtDA)
* Other: Brochure with general information about osteoarthritis


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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)<br>* Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health<br>* Other names: Intervention;|
| Active Comparator: Control group<br>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<br>* 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<br>* Other names: Control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 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. | Immediately after the intervention | 
| Treatment preference | Patients will be asked the treatment they prefer: physiotherapy, medication, intra-articular injections, arthroplasty, not sure | Immediately after the intervention | 
| Intention to undergo the preferred treatment | Assessed with one item ranging 0 (not sure) to 5 (completely sure) | 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). | 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. | 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. | Immediately after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip osteoarthritis, Patient decision aids, Person-centred care, Randomized controlled trial, Shared decision-making, Web-based intervention