Development, Implementation, and Testing of a Web Based Decision Aid for Facilitating Shared Decision Making for Disease Modifying Therapies for Sickle Cell Disease

Abstract Background Sickle cell disease (SCD) is associated with substantial morbidity, and premature mortality. Hydroxyurea (Hu), chronic blood transfusion and hematopoietic stem cell transplantation (HCT) can modify the course of this disease, reduce complications, and improve survival. These interventions are diverse in their therapeutic intent, but are all associated with substantial burden of care, signfiicant side effects and the potential for late complications. The complexity inherent in making decisons about these disease modifying therapies is compounded by the socioeconomic disadvantage experienced by this largely minority, underserved population. That despite proven efficacy in clinical trials, uptake and adherence with HU remains poor, and that only a small proportion of eligible patients undergo HCT underscores the difficulty in making these decisions. The objective of this study was to use a theory based systematic approach to develop, implement and test a web based decision aid to support patients and caregivers in shared decision making regarding disease modifying therapies for SCD.The theoretical basis for this project is the Ottawa decision support framework( ODSF), an evidence-based, practical, mid-range theory for guiding patients making health or social decisions which uses a three-step process to assess client and practitioner determinants of decisions to identify decision support needs; provide decision support tailored to client needs and evaluate the decision making process and outcomes. Methods Following the ODSF, we conducted qualitative interviews of patients with SCD, their caregivers, policymakers, community advocates and healthcare providers and other stakeholders. Subjects were recruited at multiple regional and national SCD conferences which draw a mix of patients and professional audience. Interviews lasted 30-40 minutes and were transcribed verbatim, transcripts were coded using QSR NVivo 10 and analyzed using qualitative mixed methods. Themes from qualitative interviews were incorporated into the each of the following phases of the project: Phase 1: Qualitative interviews for needs assessment to facilitate the description of the participants' experiences in seeking information about and making decisions related to SCD and utilizing both open and closed-ended questions. Phase 2: Data synthesis, and construction of a storyboard, draft content, draft design and format for the decision aid. Phase 3: Alpha testing for quality and error correction. Extensive modifications were carried out systematically incorporating the recommendations received. Phase 4: Iterative cylces of Beta testing for feasibility, comprehensibility and usability with qualitative interviews and observations and incorporated recommendations. Phase5: Peer-review of the finalized decision aid by stakeholders who had not participated in the development of the instrument and had not previously examined the website. Results Needs assessment qualitative interviews with 205 individuals yielded information on decisional needs, preferences regarding content, presentation and ease of use as well as a distinct preference to learn from the experience of other patients and guided the devlopemnt of the decision aid. Alpha testing for quality and error correction was conducted with 51 patients / family members, clinicians, health educators and policy makers. Beta testing for feasiblity, comprehensibilty, and usability was completed by a total 111 participants. Peer review by 60 providers, patients and stakeholders of the final decision aid (www.sickleoptions.org) indicated a high level of satisfaction with the content, presentation, ease of use, use of graphics and the use of patient testimonials. We have enrolled and are gathering data on 120 subjects in a randomized clinical trial to evaluate the impact of the decion aid on clinical decision making. Conclusions This stiudy provides empirical evidence about the successful process of creating, implementing and testing a web based decision aid for patients to guide shared decision making in disease modifying therapy for SCD. It provides evidence of favorable patient and physician perceptions about the comprehensivility and usability of the decision aid. Results of an ongoing randomized clinical trial will generate additional information about the impact of the decision on clinical decision making. Disclosures No relevant conflicts of interest to declare.