Clinical trial NCT04241978: Development and Evaluation of a Web Based Decision Aid for Patients With Hip Osteoarthritis
Official title: The Effectiveness of a Web-based Decision Aid for Patients With Hip Osteoarthritis: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Osteoarthritis
Keywords: Hip osteoarthritis
Patient decision aids
Person-centred care
Randomized controlled trial
Shared decision-making
Web-based intervention
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: Fundación Canaria de Investigación Sanitaria
name: Hospital Universitario de Canarias
name: Hospital San Juan de Dios Tenerife
name: Avedis Donabedian Research Institute
name: Gerencia de Atención Primaria del Área de Salud de Tenerife
First posted: 2020-01-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Decisional conflict regarding the treatment for Hip Osteoarthritis, measured by the Decisional Conflict Scale (DCS)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Knowledge of the disease and treatments
timeFrame: Before and immediately after the intervention
measure: Values about characteristics of treatments
timeFrame: Immediately after the intervention
measure: Treatment preference
timeFrame: Immediately after the intervention
measure: Intention to undergo the preferred treatment
timeFrame: Immediately after the intervention
measure: Concordance between values and intention to undergo arthroplasty vs. conservative treatments
timeFrame: Immediately after the intervention
measure: Decision quality about arthroplasty
timeFrame: Immediately after the intervention
measure: Satisfaction with the decision making process scale
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Evaluation Unit. Canary Islands Health Service
state: Santa Cruz Tenerife
Study officials:
affiliation: Servicio de Evaluación de. Servicio Canario de Salud
name: Lilisbeth Perestelo Perez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perestelo-Perez L, Alvarez-Perez Y, Rivero-Santana A, Ramos-Garcia V, Duarte-Diaz A, Torres-Castano A, Toledo-Chavarri A, Herrera-Perez M, Pais-Brito JL, Del Castillo JC, Vazquez JR, Orrego C, Serrano-Aguilar P. The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial. Trials. 2020 Aug 24;21(1):736. doi: 10.1186/s13063-020-04661-z.