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

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

The main goal of this study is assess the effectiveness of a PtDA for patients with hip osteoarthritis

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Other: Patient Decision Aid (PtDA); Other: Brochure with general information about 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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lilisbeth Perestelo Perez, PhD; Phone Number: 922478321; Email: lilisbeth.peresteloperez@sescs.es

Study Locations

• Spain
  • Santa Cruz Tenerife
    • Santa Cruz De Tenerife, Santa Cruz Tenerife, Spain, 38109
      • Evaluation Unit. Canary Islands Health Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Servicio Canario de Salud
• Collaborators: Hospital Universitario de Canarias; Fundación Canaria de Investigación Sanitaria; Hospital San Juan de Dios Tenerife; Avedis Donabedian Research Institute; Gerencia de Atención Primaria del Área de Salud de Tenerife
• Investigators: Principal Investigator: Lilisbeth Perestelo Perez, PhD, Servicio de Evaluación de. Servicio Canario de Salud

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): April 3, 2023

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Web-based intervention; Randomized controlled trial; Shared decision-making; Person-centred care; Patient decision aids; Hip osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: PIFUN33/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No