Patient Decision Aid Standards Collaboration Research Articles

Development of an Electronic Decision Aid Tool to Facilitate Mainstream Genetic Testing in Ovarian Cancer Patients.

Multigene panel testing is an important component of cancer treatment plans and risk assessment, but there are many different panel options and choosing the most appropriate panel can be challenging for health care providers and patients. Electronic tools have been proposed to help patients make informed decisions about which gene panel to choose by considering their preferences and priorities. An electronic decision aid (DA) tool was developed in line with the International Patient Decision Aids Standards collaboration. The multidisciplinary project team collaborated with an external health care communications agency and the MGH Cancer Center Patient and Family Advisory Council (PFAC) to develop the DA. Surveys of genetic counselors and patients were used to scope the content, and alpha testing was used to refine the design and content. Surveys of genetic counselors (n = 12) and patients (n = 228) identified common themes in discussing panel size and strategies for helping patients decide between panels and in identifying confusing terms for patients and distribution of patients' choices. The DA, organized into 2 major sections, provides educational text, graphics, and videos to guide patients through the decision-making process. Alpha testing feedback from the PFAC (n = 4), genetic counselors (n = 3) and a group of lay people (n = 8) identified areas to improve navigation, simplify wording, and improve layout. The DA developed in this study has the potential to facilitate informed decision-making by patients regarding cancer genetic testing. The distinctive feature of this DA is that it addresses the specific question of which multigene panel may be most suitable for the patient. Its acceptability and effectiveness will be evaluated in future studies.

Views of Multiple Sclerosis Patients About Key Elements for a Decision Aid: A Qualitative Study.

BACKGROUND: Patients with multiple sclerosis (MS) may experience decisional conflict during treatment choice. Shared decision making (SDM), whereby patients and health professionals, primarily nurses, collaborate in making decisions, reduces this decisional conflict. It requires understanding large amounts of information and may be complex, especially when decisions affect patients' autonomy and quality and prolongation of life. Patient decision aids are tools in facilitating SDM. This study aimed to identify the key elements from the perspective of patients with relapsing-remitting MS to create a patient decision aid in the Spanish sociocultural context. METHODS: This is a qualitative study using focus groups led by a clinical nurse specialist. Semistructured interviews included healthcare needs and demands, the SDM process, and general characteristics of a peer support program. After the transcription of interview recordings, data were analyzed by thematic analysis and a constructivist naturalistic approach. RESULTS: Patients with MS (27) from Spain participated in 4 focus groups of 90 to 120 minutes each. Three overarching themes were identified: information access to sufficient high-quality data; knowledge of available treatment options, including efficacy, adverse effects, frequency, administration route, and the impact on daily life; decision-making role, engaged versus nonengaged patients. The former require support in facilitating their active involvement in decisions, whereas the latter prefer more passive health models. CONCLUSION: The needs identified by patients with relapsing-remitting MS regarding treatment choice in the Spanish setting align with those reported by other studies. The identified themes provide valuable information to design and develop a virtual patient decision aid jointly by clinical MS nurses and patients according to the International Patient Decision Aid Standards Collaboration criteria. This aid will help improve understanding between nurses and patients during SDM and facilitate the process.

Effectiveness of Interactive Digital Decision Aids in Prenatal Screening Decision-making: Systematic Review and Meta-analysis.

Increasing prenatal screening options and limited consultation time have made it difficult for pregnant women to participate in shared decision-making. Interactive digital decision aids (IDDAs) could integrate interactive technology into health care to a facilitate higher-quality decision-making process. The objective of this study was to assess the effectiveness of IDDAs on pregnant women's decision-making regarding prenatal screening. We searched Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO, World Health Organization International Clinical Trials Registry Platform, Google Scholar, and reference lists of included studies until August 2021. We included the randomized controlled trials (RCTs) that compared the use of IDDAs (fulfilling basic criteria of International Patient Decision Aid Standards Collaboration and these were interactive and digital) as an adjunct to standard care with standard care alone and involved pregnant women themselves in prenatal screening decision-making. Data on primary outcomes, that is, knowledge and decisional conflict, and secondary outcomes were extracted, and meta-analyses were conducted based on standardized mean differences (SMDs). Subgroup analysis based on knowledge was performed. The Cochrane risk-of-bias tool was used for risk-of-bias assessment. Eight RCTs were identified from 10,283 references, of which 7 were included in quantitative synthesis. Analyses showed that IDDAs increased knowledge (SMD 0.58, 95% CI 0.26-0.90) and decreased decisional conflict (SMD -0.15, 95% CI -0.25 to -0.05). Substantial heterogeneity in knowledge was identified, which could not be completely resolved through subgroup analysis. IDDAs can improve certain aspects of decision-making in prenatal screening among pregnant women, but the results require cautious interpretation.

Development of the Tool to Empower Parental Telling and Talking (TELL Tool): A digital decision aid intervention about children's origins from donated gametes or embryos.

This study aimed to create and develop a well-designed, theoretically driven, evidence-based, digital, decision Tool to Empower Parental Telling and Talking (TELL Tool) prototype. This developmental study used an inclusive, systematic, and iterative process to formulate a prototype TELL Tool: the first digital decision aid for parents who have children 1 to 16 years of age and used donated gametes or embryos to establish their families. Recommendations from the International Patient Decision Aids Standards Collaboration and from experts in decision aid development, digital health interventions, design thinking, and instructional design guided the process. The extensive developmental process incorporated researchers, clinicians, parents, children, and other stakeholders, including donor-conceived adults. We determined the scope and target audience of the decision aid and formed a steering group. During design work, we used the decision-making process model as the guiding framework for selecting content. Parents' views and decisional needs were incorporated into the prototype through empirical research and review, appraisal, and synthesis of the literature. Clinicians' perspectives and insights were also incorporated. We used the experiential learning theory to guide the delivery of the content through a digital distribution plan. Following creation of initial content, including storyboards and scripts, an early prototype was redrafted and redesigned based on feedback from the steering group. A final TELL Tool prototype was then developed for alpha testing. Detailing our early developmental processes provides transparency that can benefit the donor-conceived community as well as clinicians and researchers, especially those designing digital decision aids. Future research to evaluate the efficacy of the TELL Tool is planned.

Ensuring High-Quality Shared Decision-making for Lung Cancer Screening

This Viewpoint discusses the role of the International Patient Decision Aid Standards Collaboration in emphasizing the importance of shared decision-making facilitated by trained individuals and the use of decision aids that meet minimal quality standards when counseling patients for lung cancer screening.

The development of a patient decision aid to reduce decisional conflict about antidepressant use in pregnancy

BackgroundPeople with moderate to severe depression in pregnancy must weigh potential risks of untreated or incompletely treated depression against the small, but uncertain risks of fetal antidepressant drug exposure. Clinical support alone appears insufficient for helping individuals with this complex decision. A patient decision aid (PDA) has the potential to be a useful tool for this population. The objective of our work was to use internationally recognized guidelines from the International Patient Decision Aids Standards Collaboration to develop an evidence-based PDA for antidepressant use in pregnancy.MethodsA three-phased development process was used whereby, informed by patient and physician perspectives and evidence synthesis, a steering committee commissioned a web-based PDA for those deciding whether or not to start or continue antidepressant treatment for depression in pregnancy (Phase 1). A prototype was developed (Phase 2) and iteratively revised based on feedback during field testing based on a user-centred process (Phase 3).ResultsWe developed a web-based PDA for people deciding whether to start or continue antidepressant use for depression in pregnancy. It has five interactive sections: (1) information on depression and treatment; (2) reasons to start/continue an antidepressant and to start/stop antidepressant medication; (3) user assessment of values regarding each issue; (4) opportunity to reflect on factors that contribute to decision making; and (5) a printable PDF that summarizes the user’s journey through the PDA.ConclusionsThis tool, which exclusively focuses on depression treatment with Selective Serotonin Reuptake Inhibitors and Serotonin–Norepinephrine Reuptake Inhibitors, can be used by individuals making decisions about antidepressant use to treat depression during pregnancy. Limitations of the PDA are that it is not for other conditions, nor other medications that can be used for depression, and in its pilot form cannot be used by women who do not speak English or who have a visual impairment. Pending further study, it has the potential to enhance quality of care and patient experience.

Facilitators and barriers to living donor kidney transplantation

Facilitators and barriers to living donor kidney transplantation

P–496 Alpha test results: Towards developing a digital prototype intervention to support parents’ disclosure about donor conception in the United States

Abstract Study question The objective of the study was to determine the usability, comprehensibility, and acceptability of a digital, decision-support aid prototype supporting parental disclosure of donor conception. Summary answer: This mixed methods design maximized participant feedback about the digital, decision-support aid prototype yielding rich insight about the prototype while minimizing participant and investigator burden. What is known already Although a paradigm shift is underway to remove the secrecy that has historically shrouded the practice of gamete donation, little is known about best practices that can support parents in disclosing the conceptional origins to their children. To address this gap, we created a decision-support aid prototype to facilitate parental disclosure post-treatment. In doing so, we followed the International Patient Decision Aid Standards Collaboration for developing decision-support aids, which recommends that Alpha testing (i.e., usability, comprehensibility, and acceptability) be completed to improve the quality of newly created decision-support interventions prior to Beta (i.e., real world) testing. Study design, size, duration A mixed-methods, triangulation design was used. Participants/materials, setting, methods Sixteen participants were purposefully selected based on desired characteristics and the needs of the study. Participants were asked to: (1) follow investigator prepared instructions for accessing the digital, decision-support aid; (2) complete a quantitative rating form about each slide within the decision-support aid prototype; and (3) participate in a qualitative, cognitive interview or focus group. Descriptive statistics and qualitative content analysis guided the iterative analysis. Main results and the role of chance The sample was composed of 10 parents that used donated sperm (n = 3), oocytes (n = 4), or embryos (n = 2) to conceive children and 8 clinicians; 2 participants were both donor recipient parents and clinicians. The interviews (n = 14) and one focus group (2 participants) ranged in length from 25 to 70 minutes (M = 47 minutes). Usability: Participants suggested refining the instructions for accessing the decision-support aid and upgrading the technology used to deliver the content. Common concerns were the inconsistent volume of the audio recordings and a need for higher quality images. Comprehensibility: Feedback obtained from the participants’ rating forms and in the interviews and focus group were consistently high about the ability to understand the content and the scope of the information presented. Acceptability: Participants noted the aid would resonate with parents. They recommended shortening the length of the aid, changing specific wording, modifying some of the video content, refining specific content for individual slides and the four modules. Unintended recommendations about how the aid might be used to provide clinician education or in international research were also reported. Limitations, reasons for caution Alpha testing is not designed to obtain all possible technological or content issues. Rather, it is a useful and recommended step in intervention development to mitigate existing technological bugs and key content issues prior to implementation of Beta testing of a decision-support aid. Wider implications of the findings: Other investigators that develop digital decision-support aids may consider the use of both quantitative and qualitative data collection methods during Alpha testing to refine digital interventions efficiently. The use of mixed methods not only captures rich and insightful feedback but also minimizes the burden on participants and investigators. Trial registration number Not applicable

Patients' and Providers' Needs and Preferences When Considering Fertility Preservation Before Cancer Treatment: Decision-Making Needs Assessment.

BackgroundAs cancer treatments continue to improve, it is increasingly important that women of reproductive age have an opportunity to decide whether they want to undergo fertility preservation treatments to try to protect their ability to have a child after cancer. Clinical practice guidelines recommend that providers offer fertility counseling to all young women with cancer; however, as few as 12% of women recall discussing fertility preservation. The long-term goal of this program is to develop an interactive web-based patient decision aid to improve awareness, access, knowledge, and decision making for all young women with cancer. The International Patient Decision Aid Standards collaboration recommends a formal decision-making needs assessment to inform and guide the design of understandable, meaningful, and usable patient decision aid interventions.ObjectiveThis study aims to assess providers’ and survivors’ fertility preservation decision-making experiences, unmet needs, and initial design preferences to inform the development of a web-based patient decision aid.MethodsSemistructured interviews and an ad hoc focus group assessed current decision-making experiences, unmet needs, and recommendations for a patient decision aid. Two researchers coded and analyzed the transcripts using NVivo (QSR International). A stakeholder advisory panel guided the study and interpretation of results.ResultsA total of 51 participants participated in 46 interviews (18 providers and 28 survivors) and 1 ad hoc focus group (7 survivors). The primary themes included the importance of fertility decisions for survivorship, the existence of significant but potentially modifiable barriers to optimal decision making, and a strong support for developing a carefully designed patient decision aid website. Providers reported needing an intervention that could quickly raise awareness and facilitate timely referrals. Survivors reported needing understandable information and help with managing uncertainty, costs, and pressures. Design recommendations included providing tailored information (eg, by age and cancer type), optional interactive features, and multimedia delivery at multiple time points, preferably outside the consultation.ConclusionsDecision making about fertility preservation is an important step in providing high-quality comprehensive cancer care and a priority for many survivors’ optimal quality of life. Decision support interventions are needed to address gaps in care and help women quickly navigate toward an informed, values-congruent decision. Survivors and providers support developing a patient decision aid website to make information directly available to women outside of the consultation and to provide self-tailored content according to women’s clinical characteristics and their information-seeking and deliberative styles.

Decision Aids for Preventive Treatment Alternatives for BRCA1/2 Mutation Carriers: a Systematic Review

Introduction Women with a pathogenic BRCA1/2 mutation have a markedly increased lifetime risk of developing breast and/or ovarian cancer. The current preventive treatment alternatives that are offered are an intensified breast cancer screening programme and risk-reducing operations. Before deciding on one option, medical and personal factors such as life situation and individual preferences must be weighed carefully. Decision aids are used internationally to support BRCA1/2 mutation carriers during their decision-making process. In this study these are analysed structurally for the first time and their applicability to the German context is examined. Material and Methods A systematic literature search in five electronic databases and a manual search were performed. The identified decision aids were evaluated with regard to formal criteria, medical content and quality. The qualitative assessment used the criteria of the International Patient Decision Aid Standards Collaboration (IPDASi v4.0), which examined various dimensions (e.g., information, probabilities, values). Results Twenty decision aids, which were published between 2003 and 2019 in Australia (n = 4), the United Kingdom (n = 3), Canada (n = 2), the Netherlands (n = 2) and the USA (n = 9), were included. Nine focus on BRCA1/2 mutation carriers and eleven include other risk groups. Eighteen include risk-reducing operations as decision options, 14 list screening methods for breast and/or ovarian cancer, and 13 describe the possibility of pharmacological prevention by means of selective oestrogen receptor modulators or aromatase inhibitors. Nine of the 20 decision aids meet fundamental quality criteria (IPDASi v4.0 qualification criteria). Conclusion International decision aids can serve formally as a basis for a German decision aid for BRCA1/2 mutation carriers. Some of them differ markedly in content from the recommendations of German guidelines. Only a few achieve a high quality.

Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development.

More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients' perspectives on conflicts of interest? We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research. Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included. Most evidence on the effects of conflict of interest management strategies pertained only to subsequent compliance with the management strategy. This evidence highlighted substantial noncompliance with prevailing requirements. Evidence on patient perspectives on conflicts of interest offered several insights, including the existence of diverse views on the acceptability of conflicts of interest, the salience of conflict of interest type and monetary value to patients, and the possibility that conflict of interest disclosure could have unintended effects. We identified no published research on the effects of IPDAS Collaboration conflict of interest quality standards on patient decision making or outcomes. Because we did not conduct a systematic review, we may have missed some evidence relevant to our review questions. In addition, our team did not include patient partners. The findings of this review have implications for the management of conflicts of interest not only in patient decision aid development but also in clinical practice guideline development, health and medical research reporting, and health care delivery.

Guidance and/or Decision Coaching with Patient Decision Aids: Scoping Reviews to Inform the International Patient Decision Aid Standards (IPDAS).

In 2005, the International Patient Decision Aid Standards (IPDAS) collaboration identified guidance and decision coaching as important dimensions of patient decision aids (PtDAs) and developed a set of quality criteria. We sought to update definitions, theoretical rationale, and evidence for guidance and/or decision coaching used within or alongside PtDAs for the IPDAS update 2.0. We conducted 2 scoping reviews on guidance and decision coaching, including systematic searches and a hand search of the Cochrane Review on PtDAs. Eligible studies were randomized controlled trials (RCTs) on guidance or decision coaching used with/alongside PtDAs. Data, including conceptual models, were summarized narratively and with meta-analyses when appropriate. Of 1022 citations, we found no RCTs that evaluated guidance in PtDAs. The 2013 definition for guidance was endorsed, and we made minimal changes to the description of guidance. Of 3039 citations, we identified 21 RCTs on decision coaching informed by 5 conceptual models stating that people exposed to decision coaching are more likely to progress in making informed decisions consistent with their values. Compared to usual care, decision coaching with PtDAs led to improved knowledge mean difference [MD], 19.5/100; 95% confidence interval [CI], 10.0-29.0; 5 RCTs). Compared to decision coaching alone, PtDAs led to a small improvement in knowledge (MD, 3.6/100; 95% CI, 1.0-6.3; 3 RCTs). There were variable effects on other outcomes. We simplified the decision coaching definition slightly and defined minimal decision coaching elements. We found no evidence on which to propose changes in guidance in IPDAS. Decision coaching is continuing to be used alongside PtDAs, but there is inadequate evidence on the added effectiveness compared to PtDAs alone. The decision coaching definition was updated with minimal elements.

Tomada de decisão compartilhada na saúde: aproximações e distanciamentos entre a ajuda decisional e os apoios de tomada de decisão

Objetivo: analisar as ajudas decisionais e os apoios de tomada de decisão, enquanto ferramentas da tomada de decisão compartilhada, enfocando suas aproximações e dessemelhanças. Metodologia: trata-se de pesquisa teórica baseada no referencial do International Patient Decision Aids Standards Collaboration, quanto às ajudas decisionais, e, em relação aos apoios de tomada de decisão, adotou-se as pesquisas de Shogren, Wehmeyer, Martinis, e Blanck e o Quality Rights. Resultados: a ajuda decisional e os apoios de tomada de decisão são instrumentos centrais na efetivação da tomada de decisão compartilhada. sendo assim, a ajuda decisional e os apoios de tomada de decisão convergem para a promoção da autonomia pessoal do paciente e a sua participação efetiva como agente efetivo da decisão em saúde. Conclusão: ambos instrumentos incrementam o controle do paciente sobre as decisões que são tomadas sobre seus cuidados em saúde na medida em que promovem o direito à autodeterminação do paciente.

What Works in Implementing Patient Decision Aids in Routine Clinical Settings? A Rapid Realist Review and Update from the International Patient Decision Aid Standards Collaboration.

BackgroundDecades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting.AimThis review was conducted in response to the IPDAS Collaboration’s evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings.MethodsRapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research.ResultsWe developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve.ConclusionsWe recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

Development of a patient decision aid for the management of superficial basal cell carcinoma (BCC) in adults with a limited life expectancy

BackgroundBasal cell carcinoma (BCC) is a slow-growing, rarely lethal skin cancer that affects people 65 years or older. A range of treatment options exist for BCC, but there is little evidence available to guide patients and providers in selecting the best treatment options.ObjectivesThis study outlines the development of a patient decision aid (PDA) for low-risk BCC that can be used by patients and providers to assist in shared decision-making.MethodsIn accordance with the International Patient Decision Aids Standards (IPDAS) Collaboration framework, feedback from focus groups and semi-structured interviews with patients and providers, an initial prototype of the PDA was developed. This was tested using cognitive interviews and iteratively updated.ResultsWe created eighteen different iterations using feedback from 24 patients and 34 providers. The key issues identified included: 1) Addressing fear of cancer; 2) Communicating risk and uncertainty; 3) Values clarification; and 4) Time lag to benefit.LimitationsThe PDA does not include all possible treatment options and is currently paper based.ConclusionsOur PDA has been specifically adapted and designed to support patients with a limited life expectancy in making decisions about their low risk BCC together with their doctors.

Development and evaluation of a patient decision aid for patients considering ongoing medical or surgical treatment options for ulcerative colitis using a mixed-methods approach: protocol for DISCUSS study

IntroductionApproximately 20%–30% of patients with ulcerative colitis (UC) require surgery, the majority of these being elective due to chronic symptoms refractory to medical treatment. The decision for surgery is difficult...

Development of a Participatory Patient Decision Aid for Patients with Multiple Myeloma

Shared- Decision Making (SDM) is an important aspect of patient engagement in which the healthcare provider invites the patient and caregiver to collaborate on healthcare decisions. Patient decision aids (PDAs) following criteria set forth by the International Patient Decision Aid Standards (IPDAS) Collaboration have been shown to improve the quality of care delivered and health outcomes (1,2) and foster SDM by preparing patients to understand their condition, clarify values, and discuss priorities with their healthcare provider.

Do Women With High eHealth Literacy Profit More From a Decision Aid on Mammography Screening? Testing the Moderation Effect of the eHEALS in a Randomized Controlled Trial.

Background: Our decision aid on mammography screening developed according to the criteria of the International Patient Decision Aids Standards Collaboration increases knowledge compared to usual care. However, it remains unclear whether this decision aid is more effective in women with higher eHealth literacy. Our objective was to test whether the positive effect of the decision aid on knowledge is moderated by eHealth literacy.Methods: A total of 1,206 women aged 50 from Westphalia-Lippe, Germany, participated (response rate of 16.3%) in our study and were randomized to usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. eHealth literacy was assessed at baseline with the Electronic Health Literacy Scale (eHEALS); knowledge was assessed at baseline and post-intervention. First, we compared the 2-factor model of the German eHEALS (information-seeking and information-appraisal) found in previous research and the 3-factor model we hypothesized for decision aid use to the originally proposed 1-factor model. Second, we modeled the measurement model according to the superior factor model found in step one and tested whether the eHEALS moderated the effect of the decision aid on knowledge.Results: The 3-factor model of the eHEALS had a better model fit than the 1-factor or 2-factor model. Both information-seeking, information-appraisal, and information-use had no effect on knowledge post-intervention. All three interactions of the decision aid with information-seeking, information-appraisal, and information-use were not significant. Equally, neither education nor its interaction with the decision aid had an effect on knowledge post-intervention.Conclusion: The decision aid developed in this project increases knowledge irrespective of level of eHealth literacy. This means that not only women with high eHealth literacy profit from the decision aid but that the decision aid has been successfully conceptualized as a comprehensible information tool that can be used by women of varying eHealth literacy levels.Trial registration: German Clinical Trials Register DRKS00005176 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005176).

Modified Delphi survey for the evidence summarisation of patient decision aids: Study protocol

IntroductionInformation included in a patient decision aid (PDA) can significantly influence patients’ decisions and is, therefore, expected to be evidence-based and rigorously selected and summarised. PDA developers have not yet...

A Multisite Randomized Controlled Trial of a Patient-Centered Ventricular Assist Device Decision Aid (VADDA Trial)

Studies indicate that decision making and informed consent among patients considering left ventricular assist device (LVAD) support for advanced heart failure could be improved. In the VADDA (Ventricular Assist Device Decision Aid) trial, we tested a patient-centered decision aid (DA) to enhance the quality of decision making about LVAD therapy. After an extensive user-centered design process, we conducted a multisite randomized trial of the DA compared with standard education (SE) among inpatients considering LVAD treatment for advanced heart failure The main outcome was LVAD knowledge at 1 week and 1 month after administration of the DA versus the SE, according to a validated scale. Secondary measures included prespecified quality decision making measures recommended by the International Patient Decision Aid Standards collaboration. Of 105 eligible patients, 98 consented and were randomly assigned to the DA and SE arms. Patients receiving the VADDA exhibited significantly greater LVAD knowledge than the SE group at 1 week of follow-up (P = .01) but not at 1 month (P = .47). No differences were found between DA and SE patients in rates of acceptance versus decline of LVAD treatment (85% vs 78%; P = .74). Recipients in the DA arm reported greater satisfaction with life after implantation compared with nonrecipients (28 vs 23 out of 30; P = .008), although both arms reported high satisfaction. Patients rated the DA high in acceptability and usability. The VADDA enhances LVAD knowledge, particularly in the short term (1 week) during the peak period of decision making. The DA does not encourage decision direction and reflects patient, caregiver, and physician preferences for content and format. https://clinicaltrials.gov/ct2/show/NCT02248974. The trial is registered with clinicaltrials.gov (NCT02248974).