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A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

ABSTRACT: BACKGROUND:Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial. OBJECTIVE:We describe the design and development process of a tablet-based decision support tool. METHODS:Our development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles. RESULTS:We used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice. CONCLUSIONS:The informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources. TRIAL REGISTRATION:ClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW).

SUBMITTER: Furberg RD

PROVIDER: S-EPMC6010840 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

Furberg Robert D RD Ortiz Alexa M AM Moultrie Rebecca R RR Raspa Melissa M Wheeler Anne C AC McCormack Lauren A LA Bailey Donald B DB

JMIR research protocols 20180606 6

<h4>Background</h4>Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial.<h4>Objective</h4>We describe the design and development process of a tablet-based decision support tool.< ...[more]

PMID: 29875084

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Project description:BackgroundInformed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient's 'presumed will', but these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have been developed to improve informed consent processes for research, including a number of decision aids, however there are no interventions for proxies who are faced with more complex decisions. This article outlines the development of a novel decision aid to support families making decisions about research participation on behalf of an adult who lacks capacity to consent.MethodsDecision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed with the involvement of lay advisors and relevant stakeholders.ResultsPrevious research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy's role and utilises a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid to ensure that it would be acceptable for use.ConclusionsFrameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users. Feasibility testing and outcome measure development is required prior to any evaluation of its effectiveness.

Project description:BACKGROUND:Chronic conditions present major health problems, affecting an increasing number of individuals who experience a variety of symptoms that impact their health related quality of life. Digital tools can be of support in chronic conditions, potentially improving patient-provider communication, promoting shared decision making for treatment and care, and possibly even improving patient outcomes. This study aimed to develop a digital tool for patient-provider communication in chronic health care settings and describes the data collection and subsequent content and software development of the InvolveMe tool. InvolveMe will provide patients with the opportunity to report symptoms and preferences to their health care providers (HCP), and to use secure messaging to interact with the HCPs. METHOD:The study employed a combination of interviews with patients with chronic conditions and focus groups with HCPs, examining experiences with chronic conditions and the potential use of a digital tool for support. Participants were recruited from two outpatient clinics at a university hospital. Data collected from interviews and focus groups were analysed using thematic analysis. Content and software development was informed by the data collection and by tool development workshops. RESULTS:Analyses from interviews with patients (n?=?14) and focus groups with HCPs (n?=?11) generated three main themes: 1) Making symptoms and challenges visible, 2) Mastering a new life, and 3) Digital opportunities for follow-up. Each main theme generated separate subthemes. Theme 1 and 2 gave input for content development of the symptom and needs assessment part of the tool, while theme 3 provided ideas for the software development of the InvolveMe tool. Tool development workshops with patients (n?=?6) and HCPs (n?=?6) supplemented the development. CONCLUSIONS:A digital tool such as InvolveMe has the potential to support shared decision making for patients with chronic health conditions. Through integration with an existing patient portal such a tool can provide opportunities for meaningful interactions and communication between patients and HCP's, particularly with regards to symptoms, needs and preferences for care.

Project description:Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. The recent availability of direct oral anticoagulants (DOACs) with comparable efficacy and improved safety compared with warfarin alters the balance between risk factors for stroke and benefit of anticoagulation. Our objective was to examine the impact of DOACs as an alternative to warfarin on the net benefit of oral anticoagulant therapy (OAT) in a real-world population of AF patients.This is a retrospective cohort study of patients with paroxysmal or persistent nonvalvular AF. We updated an Atrial Fibrillation Decision Support Tool (AFDST) to include DOACs as treatment options. The tool generates patient-specific recommendations based upon individual patient risk factor profiles for stroke and major bleeding using quality-adjusted life-years (QALYs) calculated for each treatment strategy by a decision analytic model. The setting included inpatient and ambulatory sites in an academic health center in the midwestern United States. The study involved 5,121 adults with nonvalvular AF seen for any ambulatory visit or inpatient hospitalization over the 1-year period (January through December 2016). Outcome measure was net clinical benefit in QALYs.When DOACs are a therapeutic option, the AFDST recommends OAT for 4,134 (81%) patients and no antithrombotic therapy or aspirin for 489 (9%). A strong recommendation for OAT could not be made in 498 (10%) patients. When warfarin is the only option, OAT is recommended for 3,228 (63%) patients and no antithrombotic therapy or aspirin for 973 (19%). A strong recommendation for OAT could not be made in 920 (18%) patients. In total, 1,508 QALYs could be gained if treatment were changed to that recommended by the AFDST.Availability of DOACs increases the proportion of patients for whom oral anticoagulation therapy is recommended in a real-world cohort of AF patients and increased projected QALYs by more than 1,500 when all patients are receiving thromboprophylaxis as recommended by the AFDST compared with current treatment.

Project description:BackgroundSurrogate decision makers of stroke patients are often unprepared to make critical decisions on life-sustaining treatments. We describe the development process and key features for the Understanding Stroke web-based decision support tool.MethodsWe used multiple strategies to develop a patient-centered, tailored decision aid. We began by forming a Patient and Family Advisory Council to provide continuous input to our multidisciplinary team on the development of the tool. Additionally, focus groups consisting of nurses, therapists, social workers, physicians, stroke survivors, and family members reviewed key elements of the tool, including prognostic information, graphical displays, and values clarification exercise. To design the values clarification exercise, we asked focus groups to provide feedback on a list of important activities of daily living. An ordinal prognostic model was developed for ischemic stroke and intracerebral hemorrhage using data taken from the Virtual International Stroke Trials Archive Plus, and incorporated into the tool.ResultsFocus group participants recommended making numeric prognostic information optional due to possible emotional distress. Pie charts were generally favored by participants for graphical presentation of prognostic information, though a horizontal stacked bar chart was also added due to its prevalence in stroke literature. Plain language descriptions of the modified Rankin Scale were created to accompany the prognostic information. A values clarification exercise was developed consisting of a list of 13 situations that may make an individual consider comfort measures only. The final version of the web based tool (which can be viewed on tablets) included the following sections: general introduction to stroke, outcomes (prognostic information and recovery), in-hospital and life-sustaining treatments, decision making and values clarification, post-hospital care, tips for talking to the health care team, and a summary report. Preliminary usability testing received generally favorable feedback.ConclusionWe developed Understanding Stroke, a tailored decision support tool for surrogate decision makers of stroke patients. The tool was well received and will be formally pilot tested in a group of stroke surrogate decision makers.Trial registrationClinicalTrials.gov ( NCT03427645 ).

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A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

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A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

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