Perestelo-Pérez et al. Trials (2020) 21:736 https://doi.org/10.1186/s13063-020-04661-z STUDY PROTOCOL Open Access The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial Lilisbeth Perestelo-Pérez1,2,3*, Yolanda Álvarez-Pérez4, Amado Rivero-Santana2,3,4, Vanesa Ramos-García4, Andrea Duarte-Díaz4, Alezandra Torres-Castaño4, Ana Toledo-Chávarri2,4, Mario Herrera-Perez5, José Luis País-Brito2,5, José Carlos del Castillo6, José Ramón Vázquez7, Carola Orrego2,8 and Pedro Serrano-Aguilar1,2,3 Abstract 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-centered care. 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, and (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. Trial registration: ClinicalTrials.gov NCT04241978. Registered on 24 January 2020. Keywords: Hip osteoarthritis, Patient decision aids, Person-centered care, Shared decision-making, Web-based intervention, Randomized controlled trial * Correspondence: lilisbeth.peresteloperez@sescs.es 1 Evaluation Unit of the Canary Islands Health Service (SESCS), Camino Candelaria, s/n. 38109, El Rosario, S/C de Tenerife, Spain 2 Health Services Research on Chronic Patients Network (REDISSEC), Tenerife, Spain Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Perestelo-Pérez et al. Trials (2020) 21:736 Page 2 of 8 Background separate analyses for them [15, 16]. Because hip OA has Osteoarthritis (OA) is one of the most prevalent chronic its own characteristics and given the existing shortages diseases [1], which affects more than 70% of people older in this field, the aim of this study is to develop a PtDAs than 50 years, and its prevalence clearly increases with for hip OA and evaluate its effectiveness on the im- age until 70 years old [2]. It can affect any joint, but pref- provement of patients’ decisional process. erably affects the knee, hands, hip, and spine [3]. Pain, stiffness, and loss of functionality caused by OA have an Methods/design important impact in the quality of life of patients [4, 5]. This clinical trial protocol follows the Standard Protocol Furthermore, OA represents a high economic burden Items: Recommendations for Interventional Trials (SPIR for society, due to its direct and indirect health costs [6]. IT) 2013 statement [17] (see Additional file 1). Flow of As a chronic disease, OA is associated with long-term participants are presented in Fig. 1 and the schedule of multicomorbidity and polymedication. enrollment, intervention, and assessments is shown in Conservative therapeutic options for hip OA include Fig. 2. Any future protocol modification will be regis- exercise, weight loss, and walking aids, as well as drugs tered in the ClinicalTrials.gov database and communi- and corticosteroids injections in more advanced stages. cated to the Scientific and Ethics Committee of the When these options fail to improve symptoms, a surgical University Hospital Nuestra Señora de la Candelaria intervention called arthroplasty or joint replacement is (Tenerife, Spain). recommended, with some variations depending on the damaged joint. This technique has been shown to be Study design safe and effective [7], although like any other surgical The general design of the study consists of two phases: procedure, it implies risks such as infection, thrombo- (1) development of a web-based PtDA for hip OA pa- embolism, or the need for re-intervention due to prob- tients and (2) assessment of its effectiveness in a ran- lems in the prosthesis [8]. Indication for arthroplasty is domized controlled trial (RCT). not straightforward, since subjective symptoms are not highly correlated with the cartilage deterioration ob- Phase 1: Development of a web-based PtDA served in radiographic images [9]. This fact, along with The procedure for the development of the PtDA will the existing uncertainty about the absolute and relative consist of the following steps: efficacy of conservative treatments, makes OA a preference-sensitive condition, in which patients’ values 1) We performed two systematic reviews to identify and preferences regarding the benefits and risks associ- evidence on hip OA treatments’ effectiveness ated with different treatment options should play a de- (search strategy: “hip osteoarthritis AND treatment” cisive role when making treatment decisions [10]. A in the title), on one side, and decision support shared decision-making (SDM) process thus seems a ne- interventions for hip and knee OA patients, on the cessary approach in this health condition, providing pa- other. We consulted the databases Medline, tients with reliable information and promoting their Embase, and WOS on January 2019. For OA involvement in decision-making, according to the princi- treatments, we only included clinical practice ples of the patient-centered care model [11]. guidelines and systematic reviews with meta- Patient decision aids (PtDAs) are one of the most used analysis, prioritizing those more recent with enough interventions to promote SDM and help patients to de- quality. For the second review, we included all type cide between different treatments options [12]. They of empirical studies which applied a PtDA for hip provide information on a specific health problem and its and knee OA patients, with the only aim of identify- available treatments, including quantitative information ing the PtDAs and try to access to its content. about their risks and benefits, and other characteristics 2) The Project Management Group will be composed relevant for making a decision. They also addresses pa- of a scientific team (researchers and clinical experts) tient’s values and preferences regarding those character- with expertise in assessing the quality of the istics and potential consequences, implicitly or explicitly evidence presented to the Advisory Committee, and promoting reflection about those own values/prefer- in its interpretation, and a technical team (web ences. PtDAs have shown to improve patients’ know- developers and designers). An Advisory Committee ledge about the disease and treatments, their decisional will also be created with 6–8 external primary and conflict, the concordance between patients’ preferences specialized care professionals (i.e., traumatology, and their actual choices, or their involvement in rheumatology, physiotherapy, rehabilitation) with decision-making, among other variables [13]. In the field experience in hip OA management, and/or patient of OA, the few existing studies have been focused on decision-making, and 3–4 individuals living with knee OA [14] or included hip patients but did not report hip OA and their families and/or caregivers. Perestelo-Pérez et al. Trials (2020) 21:736 Page 3 of 8 Fig. 1 Flow of participants 3) Evidence synthesis and prototype of the PtDA: the Committee. Content and presentation issues will scientific team will analyze and discuss the evidence be reviewed and refined, in an iterative process on the efficacy and safety of the different treatment that will result in a second version of the PtDA. options, based on the results of the systematic The review will be through virtual or face-to- review, and a first draft of the PtDA contents and face meetings, according to the availability of structure will be developed following the the members of Advisory Committee. There is International Patients Decision Aid Standards not a predefined number of review cycles, and it (IPDAS) [12]. Along with the technical team, will depend on the time schedule of the project format and presentation issues will be discussed. At and the consensus reached in the successive the end of this phase, a first version of the PtDA reviews. will be prepared. 5) Field testing: this new version of the PtDA will be 4) Review and evaluation of contents: the PtDA tested in individual interviews with 10 hip OA will be sent to all members of the Advisory patients (with and without previous arthroplasty), Perestelo-Pérez et al. Trials (2020) 21:736 Page 4 of 8 Fig. 2 Schedule of enrolment, interventions, and assessments (SPIRIT checklist) who will evaluate its acceptability in terms of Eligibility criteria content (quantity, clarity and usefulness of Adult patients with a diagnosis of hip OA, eligible for ei- information), structure, format, and navigability. ther surgical or non-surgical management, and with flu- Qualitative and quantitative information will be ency to read, write, and speak Spanish will be included collected. After modifying those aspects highlighted in the trial. Exclusion criteria will be as follows: previous by patients in order to improve the PtDA, it will be hip arthroplasty, patients with terminal illnesses, be par- ready to evaluate its effectiveness. ticipating in other trials, or mental or sensory alterations that impede or hinder the response to the measurement instruments or do not have the capacity to make Phase 2: Assessment of effectiveness decisions. Study design and setting A parallel, multicenter, superiority RCT will be car- Randomization and allocation concealment ried out in hospitals and primary and specialty care Computer-based randomization with Stata® 15.0 will be centers of Tenerife (Spain). Patients will be randomly performed centrally by an independent researcher (allo- allocated to intervention (web-based PtDA) or control cation rate 1:1). Randomization will be stratified by pa- group (general information about OA). tient inclusion in waiting list for arthroplasty (yes/no). Perestelo-Pérez et al. Trials (2020) 21:736 Page 5 of 8 Sealed envelopes with each patient’ allocation will be treatment: mode of administration, improvement in prepared, which will be opened only after the patient pain and function, risk of mild and serious adverse sign the informed consent for participation in the study. effects, time until symptoms’ improvement, duration The nature of the intervention makes impossible to of benefits, and in the case of arthroplasty, period of blind patients and researchers to group allocation. rehabilitation and risk of needing surgery revision. – Treatment preference (physiotherapy, medication, Recruitment and procedure intra-articular injections, arthroplasty, not sure). Eligible patients will be identified through the review of – Intention to undergo the preferred treatment: participating centers’ clinical charts. A member of the assessed with one item ranging 0 (not sure) to 5 research team will contact them by telephone to explain (completely sure). the study and invite them to participate. Those who – Concordance between values and intention to agree will complete the baseline assessment in the same undergo arthroplasty vs. conservative treatments: phone call, and an appointment will be scheduled with a binary variable (yes/no) derived from the association researcher at their referral primary healthcare center or between values and intention to undergo hospital. There, patients will be asked to read the project arthroplasty (see the “Statistical analysis” section). information sheet, which will explain in detail what their – Decision quality about arthroplasty: binary variable participation will consist of, and to sign the informed (yes/no) defined as a combination of adequate consent. Then, patients allocated to the intervention knowledge (≥ 60% of correct responses) and group will review the PtDA accompanied by a re- concordance. searcher, who will give support in navigation if neces- – Satisfaction with the decision-making process: sary. Then, they will complete the questionnaires assessed with the 12-item questionnaire developed assessing the outcome measures, in the same web inter- by Barry et al. [23]. In a previous study with type 2 face. Patients in the control group will follow the same diabetes patients, we obtained a Cronbach alpha procedure, but instead of the PtDA, they will review gen- value of 0.90 [20]. eral information about OA of the hip, knee, ankle, and – Safety: patients will be asked whether participation foot, information included in a brochure delivered in in the study has produced any psychological primary care centers of the Canary Islands Health Ser- undesired outcome such as anxiety, mood changes, vice, which will be also presented in a web format. uncertainty, or any kind of concern. Outcome measures At baseline, in the telephone call to recruit patients, The primary outcome of this study will be decisional con- assessment will include the primary outcome (DCS), as flict regarding the treatment for OA, assessed with the De- well as the following control variables: sociodemographic cisional Conflict Scale (DCS) [18], immediately after (i.e., age, sex, education, living and job status) and clin- reviewing the PtDA. This is a 16-item self-reported scale ical data (i.e., comorbidities, affected hip, OA duration, widely used in PtDA research. It has 5 subscales: feeling previous and current treatments for OA, being in wait- informed, values clarity, feeling supported, uncertainty, ing list for arthroplasty); the Patient Activation Measure and effectiveness. Scores are transformed to a 0–100 scale, (PAM) [24]; and general health-related quality of life with higher scores indicating more conflict. In previous measured with the EuroQoL questionnaire (EQ-5D-5L) studies in other health conditions, we have obtained good [25]. Knowledge will be assessed just before the applica- internal consistency values (0.88–0.90) [19–21]. The sec- tion of the PtDA (or the OA general information in the ondary outcomes will include: control group). Immediately after the intervention, all the outcome measures will be assessed again. – Knowledge of the disease and treatments: assessed with a 7-item questionnaire previously used in stud- Sample size calculation ies of PtDA in OA, specifically adapted for hip OA Assuming type I and II errors of 0.05 and 0.20 respect- [22]. This instrument assesses patients’ objective ively, a total of 126 patients (63 per group) are needed in knowledge as an outcome of the information/deci- order to detect a medium effect size (Cohen’s d = 0.5) [26] sional process, and it does not measure the level of in the primary dependent variable (DCS). No losses are health literacy. Items have a “true/false/do not expected given that the post-intervention assessment will know” format. The percentage of correct responses take place immediately after the application of the PtDA. represents the total score. – Values about characteristics of treatments: patients Statistical analysis will be asked to rate in a 0–10 scale the importance Data will be analyzed on an intention-to-treat basis, al- they attribute to different characteristics of though given the nature of the intervention, we do not Perestelo-Pérez et al. Trials (2020) 21:736 Page 6 of 8 expect relevant protocol deviations. The baseline equiva- personal identifying information will be stored separately lence of the randomized groups will be assessed by from other study data and identified by code number. means of Student’s t test and χ2 test, for continuous and Access to files will be limited to research staff involved categorical variables, respectively. To analyze the effect in the study. The statistician performing the data ana- of the intervention on the primary outcome (DCS), lyses will receive depersonalized data where the partici- mixed linear regression model with intervention as inde- pants’ identifying information will be replaced by an pendent variable will be used, adjusting for DCS baseline unrelated sequence of numbers. scores and sociodemographic or clinical variables which show significant between-group differences at baseline. Dissemination policy Center will be included as a random intercept to control The results of this study will be published in a peer- for the potential intraclass correlation. The same analysis review journal and presented in international will be carried out for the remaining continuous out- conferences. comes. Treatment preference will be analyzed by means of χ2 test. Concordance between values and intention to Discussion undergo arthroplasty will be calculated by means of a Patient-centered care is currently advocated as the gold method similar to the one proposed by Sepucha et al. standard of health care, and SDM is one of its essential [27]: first, a binary variable will be created, with a value aspects. In order to encourage SDM, many interventions of 1 for participants who prefer arthroplasty and scored aimed at patients, health professionals, or both have 4 or 5 in intention to undergo it, and zero for the been developed, to be applied or used before and/or dur- remaining patients. Second, a mixed logistic regression ing the clinical encounter [13, 28]. Among them, PtDAs model will be performed with patients’ values as inde- have the strongest evidence favoring their efficacy in in- pendent variables and intention to undergo arthroplasty creasing patients’ knowledge, decreasing their decisional (vs. other treatments) as dependent variable. Significant conflict, and in general improving the decision-making predictors will be retained in the model and the pre- process and the quality of their health care decisions dicted score for each patient will be calculated. Patients (understood as being informed and concordant with with a predicted score equal or higher (lower) than 0.5 own values/preferences) [13, 28]. In the field of OA, and intention to (not) undergo arthroplasty will be clas- however, the number of available PtDAs is very scarce, sified as concordant, and the remaining ones as not con- and published RCTs are limited and their assessed out- cordant. Finally, the effect of the DA in the number of comes heterogeneous [13, 26, 29, 30]. Furthermore, they concordant patients, as well as the number who make a have included only patients with knee OA or have not quality decision, will be assessed with mixed logistic re- reported separated data for hip patients [15, 16, 31]. gression. For all outcomes, we will explore the inter- Therefore, this RCT will contribute to increase the action of the intervention with sex and education. current knowledge about the effectiveness of PtDAs in Analyses will be performed with Stata® 15.0. the field of hip OA, with the ultimate aim of improving the quality of care offered to these patients. No physical Data monitoring, management, and confidentiality or psychological risk is expected to result from participa- The project team at the Evaluation Unit at the Canary tion in this study. Participants allocated to the PtDA Islands Health Service (Tenerife, Spain) will serve as the group will access to updated information on the disease data coordinating center responsible for data collection and the risks and benefits of the various treatments for forms, coordination of data transfer, and data analysis. hip OA and will be encouraged to explicitly clarify their This is a minimal risk study and we do not expect harms values and preferences about those treatment options. derived from participation. Therefore, an independent safety data monitoring committee is not needed. None- Limitations and strengths theless, researches who will apply the intervention and In relation to the systematic review for the development collect outcomes data will asked for any undesired out- of the PtDA, it is expected to find limitations related to come and register any behavioral or verbal sign which the coverage and completeness of the information ob- could indicate discomfort, annoyance, or worry. tained, since the bibliographic search does not guarantee Study data will be stored on secure drives on a server’s the obtaining of the universe of articles. We will expand institution (Evaluation Unit at the Canary Island Health the search with consultation of other sources such as Service) and managed according to the General Registry specialized websites and institutions working in this area for the Protection of Personal Data (RGPD UE 679/ of research. 2016) and Spanish Organic Law 3/2018, of December 5, The main limitations of the effectiveness study are the on the Protection of Personal Data and Guarantee of impossibility of blinding participants to treatment alloca- Digital Rights. All documents that contain names or tion, and the absence of follow up, which precludes the Perestelo-Pérez et al. Trials (2020) 21:736 Page 7 of 8 assessment of patients’ subsequent interaction with their Abbreviations health care providers and their actual treatment choices. OA: Osteoarthritis; PCC: Person-centered care; PtDA: Patient decision aid; SDM: Shared decision-making We will try to mitigate the lack of blinding giving con- trol participants a brochure with general information Acknowledgements about OA. In the absence of data about patients’ actual Not applicable decisions, we will measure the intensity of their Authors’ contributions intention to undergo their prefer treatment. On the LPP conceived the study and participated in its design and collaborated in other side, we will only collect baseline data for the pri- the writing of the manuscript. AR and YA participated in its design and collaborated in the writing of the manuscript. VR, AD, AT, ATC, MHP, JLP, JRV, mary outcome and knowledge, in order to avoid over- CO, and PS collaborated in the writing of the manuscript and read and loading patients with too many questionnaires; approved the final manuscript. nonetheless, an adequate randomization and allocation process should overcome the influence of this limitation. Funding This project is funded by the Fundación Canaria Instituto de Investigación The strength of the study relies on its methodo- Sanitaria de Canarias (FIISC) (reference No. PIFUN33/18). FIISC has not any logical rigor, beginning with the development of the authority or role in decisions about study design, collection, management, PtDA based on recommended guidelines [12, 32], in- analysis, and interpretation of data, writing of the report, or the decision to submit it for publication. volving a wide number of researchers, clinical experts, and patients, and assessing its effectiveness in a RCT Availability of data and materials with adequate randomization, allocation concealment, The datasets used and analyzed during the current study will be available from the corresponding author on reasonable request. The PtDA will be and implementation of the intervention. Regarding available after the end of the study on the PyDeSalud website (https://www. the population, given the socioeconomic context (one pydesalud.com/). of the less developed regions of Spain) and the ad- Ethics approval and consent to participate vanced age of hip patients on average, it is expected The Scientific and Ethics Committee of the University Hospital Nuestra to include a considerable number of patients with low Señora de la Candelaria (Tenerife, Spain) approved the study protocol (file education level and/or health/digital literacy, enhan- number: CHUNSC_2018_59). The study will be performed in accordance with Good Clinical Practice standards, applicable local regulatory requirements, cing the current evidence about the effectiveness of and the recommendations of the Declaration of Helsinki. The informed PtDAs interventions in these vulnerable populations consent form for patients’ participation is shown in Additional file. [33, 34]. The developed PtDA promises to be a useful Consent for publication resource to help patients to improve their knowledge Not applicable. of treatment options for hip OA, to take a more ac- tive decisional role about their health care, and to Competing interests The authors declare that they have no competing interests. make decisions more aligned with their values and preferences. From the professionals’ perspective, it Author details 1 could help to improve the quality of their communi- Evaluation Unit of the Canary Islands Health Service (SESCS), Camino Candelaria, s/n. 38109, El Rosario, S/C de Tenerife, Spain. 2Health Services cation with patients, leading to a better understanding Research on Chronic Patients Network (REDISSEC), Tenerife, Spain. 3Center for of patients’ preferences, values, and concerns. Further- Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain. 4 more, the use of the PtDA should reduce the variabil- Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC), Tenerife, Spain. 5Hospital Universitario de Canarias (HUC), Tenerife, Spain. ity of practice in the information/decision process, 6 Hospital San Juan de Dios de Santa Cruz de Tenerife (HSJD), Tenerife, Spain. both within and across professionals. From the health 7 Gerencia de Atención Primaria de Tenerife del Servicio Canario de la Salud, system’s perspective, these tools could help to im- Tenerife, Spain. 8Avedis Donabedian Research Institute (FAD), Barcelona, Spain. prove the efficiency of health care for OA [35, 36]. Received: 6 April 2020 Accepted: 7 August 2020 Trial status The trial has been registered at ClinicalTrials.gov under References the identifier number NCT04241978 on 24 January 1. Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, et al. The global 2020. 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