Online Decision Aid Research Articles

Do online decision aids reflect new prenatal screening and testing options? An environmental scan and content analysis.

Decision aids have been developed to help prospective parents make informed, shared decisions about medical tests, but these options are rapidly changing. This study aimed to identify and evaluate publicly available decision aids written in English for prospective parents seeking prenatal test information. A systematic review process was followed using 3 sources: known decision aid repositories, fetal medicine organisations and Google. The search, screening process, quality assessment, and data extraction was performed by two independent researchers. The quality assessment of the decision aids was based on the International Patient Decision Aids Standards (IPDAS v.4.0). We identified 13 decision aids, which varied in the screening and diagnostic tests that they discussed. No decision aid met all the IPDAS v.4.0. criteria and no decision aid reported updated risk of miscarriage for amniocentesis and chorionic villus sampling (CVS). There was a lack of decision aids for some common decisions in the prenatal context. We identified outdated content in current prenatal decision aids. The findings will inform healthcare professionals of the quality of current prenatal decision aids, which may facilitate their patients' informed decision-making about prenatal tests. Considerations for improving future decision aids are outlined.

Medical decision-making for adolescents with depression: A bibliometric study and visualization analysis via CiteSpace.

This study focussed on evaluating the status of recent research on medical decision-making for adolescents with depression and identifying research hotspots and frontiers via CiteSpace. We extracted studies that were concerned with medical decision-making for adolescents with depression from the Web of Science Core Collection (WoSCC), covering the period from 1 January 1999 to 20 September 2022. We used CiteSpace to generate online maps of worldwide cooperation among countries, institutions, and authors. Hotspots and frontiers were systematically summarized. A total of 368 papers related to medical decision-making for adolescents with depression were obtained from WoSCC. The most prolific author was Nick Midgley (seven papers). The United States and University College London were the leading country and institution in this research area, with 177 and 17 papers, respectively. Countries, institutions, and authors all actively collaborated. Main recent research trends include the preference or attitude towards medical treatment in adolescents with depression; approaches for adolescents with depression to seeking medical help; and the key role of parent, family, and primary care in medical decision-making for adolescents. Thus, further attention should be paid to determining how to promote the role of parents, families, and primary care in the decision-making process and create appropriate online help-seeking tools and decision aids to facilitate shared decision-making in the future.

The development of a decision aid for shared decision making in the Dutch implantable cardioverter defibrillator patient population: A novel approach to patient education.

BackgroundCounseling of Implantable Cardioverter-defibrillator (ICD) patients with regard to individual risks and benefits is challenging. An evidence-based decision aid tailored to the needs of Dutch ICD patients is not yet available. The objective of this pilot project was to structurally evaluate the current clinical practice in The Netherlands and the ICD patient experience, in order to develop an online decision aid to facilitate shared decision making in ICD procedures.MethodsBetween June 2016 and December 2017, a Dutch web-based decision aid was developed according to the Patient Decision Aid Standards (IPDAS) using the RAND-UCLA/multi-stepped Delphi model. Development process consisted of 5 stages in which the Dutch clinical practice was reviewed (stage 1), patients’ needs and their history of decision making was structurally assessed (stages 2A and B) and a modified Delphi consensus process was performed with an expert panel consisting of representatives from different medical fields (stage 3). Results from stages 1–3 were used to design and structure the content of an online-based decision aid (stage 4) which was finally evaluated in a usability testing by patients in stage 5.Results and conclusionThis study describes the evidence-based approach to the development of the Dutch ICD decision aid. In our population, levels of shared decision-making experience were low. The ICD decision aid was structurally developed for the Dutch ICD patient population. Our upcoming multicenter stepped wedge clustered randomized trial will further evaluate the ICD decision aid in clinical practice.

The effects of an online decision aid to support the reproductive decision-making process of genetically at risk couples-A pilot study.

Couples at risk of transmitting a genetic disease to their offspring may experience doubts about their reproductive options. This study examines the effects of an online decision aid (DA) on the (joint) reproductive decision-making process of couples (not pregnant at time of inclusion) at risk of transmitting a genetic disease to their offspring. The primary outcome is decisional conflict, and secondary outcomes are knowledge, realistic expectations, deliberation, joint informed decision-making, and decisional self-efficacy. These outcomes were measured with a pretest-posttest design: before use (T0), after use (T1), and 2 weeks after use (T2) of the decision aid (DA). Usability of the DA was assessed at T1. Paired sample t-tests were used to compute differences between baseline and subsequent measurements. The comparisons of T0-T1 and T0-T2 indicate a significant reduction in mean decisional conflict scores with stronger effects for participants with high baseline decisional conflict scores. Furthermore, use of the DA led to increased knowledge, improved realistic expectations, and increased levels of deliberation, with higher increase in participants with low baseline scores. Decision self-efficacy only improved for participants with lower baseline scores. Participants indicated that the information in the DA was comprehensible and clearly organized. These first results indicate that this online DA is an appropriate tool to support couples at risk of transmitting a genetic disease and a desire to have (a) child(ren) in their reproductive decision-making process.

Effect of the Airblast Settings on the Vertical Spray Profile: Implementation on an On-Line Decision Aid for Citrus Treatments

Airblast sprayers are widely used for the application of plant protection products (PPP) in citrus. Adaptation of the vertical distribution of the spray cloud to the canopy (density, shape and size), is essential to deposit an adequate amount of PPP on the target and to reduce losses (drift, runoff). Vertical spray profiles of three air-assisted axial fan hydraulic sprayers with different configurations and settings were obtained to evaluate the effect of these settings on the vertical spray profile. From the analysis of the empirical results, the impact of operational settings (nozzle, air volume and flow rate) on treatment efficiency is assessed. The empirical database generated in this work has been employed to feed the Citrus VESPA model, a highly intuitive, web-based decision aid tool that helps farmers to easily estimate the vertical spray profiles generated by their particular sprayers and settings and how these influence deposition and potential drift. The tool can also be used to determine the effect and importance of adequately selecting, orienting and opening/closing nozzles and optimizing volume application rate and fan speed, in order to adjust the application to the actual vegetation, with the aim of saving resources and reducing risks to humans and the environment.

My Contraceptive Choice: A Decision Support Tool for College Women.

We developed an online decision aid, My Contraceptive Choice (MCC), for college women to select the appropriate birth control methods. MCC consists of a short quiz, customized recommendations, and educational resources. Evaluations from a focus group, an online survey, and test cases showed that the tool is accurate, usable, and useful. Future work is required to further improve MCC's compliance with user needs/preferences and to include additional resources to make it more useful.

"Is it time to stop driving?": A randomized clinical trial of an online decision aid for older drivers.

Many older adults face the difficult decision of when to stop driving. We sought to test whether an online driving decision aid (DDA) would improve decision quality. This prospective two-arm randomized trial enrolled English-speaking licensed drivers (age ≥70 years) without significant cognitive impairment but with ≥1 diagnosis associated with increased likelihood of driving cessation; all participants received primary care in clinics associated with study sites in three states. The intervention was the online Healthwise® DDA for older adults addressing "Is it time to stop driving?"; control was web-based information for older drivers only. The primary outcome was decision conflict as estimated by the Decisional Conflict Scale (DCS; lower scores indicate higher quality). Secondary outcomes were knowledge and decision self-efficacy about driving decisions. We examined postrandomization differences in primary and secondary outcomes by study arm using generalized linear mixed-effects models with adjustment for site and prerandomization scores. Among 301 participants (mean age: 77.1 years), 51.2% identified as female and the majority as non-Hispanic (99.0%) and white (95.3%); 98.0% lived in an urban area. Participant characteristics were similar by study arm but differed across sites. Intervention participants had a lower mean DCS score (12.3 DDA vs 15.2 control; adjusted mean ratio [AMR] 0.76, 95%CI 0.61-0.95; p=0.017). Intervention participants had higher mean knowledge scores (88.9 DDA vs. 79.9 control; OR 1.13, 95%CI 1.01-1.27, p=0.038); there was no difference between groups in self-efficacy scores. The DDA had high acceptability; 86.9% of those who viewed it said they would recommend it to others in similar situations. The online Healthwise® DDA decreased decision conflict and increased knowledge in this sample of English-speaking, older adults without significant cognitive impairment, although most chose to continue driving. Use of such resources in clinical or community settings may support older adults as they transition from driving to other forms of mobility. ClinicalTrials.gov identifier "Advancing Understanding of Transportation Options (AUTO)" NCT04141891.

Development and pilot testing of an online decision aid for women considering risk-stratified breast screening.

Development and pilot testing of an online decision aid for women considering risk-stratified breast screening.

Development of decision aid on health help-seeking for medical students.

Rates of mental health problems are increasing among medical students, who have added pressures compared with non-medical students. Medical student populations exhibit low rates of help-seeking and often struggle with disclosing health conditions due to the barriers experienced and concerns over negative repercussions. This study aimed to create and test the feasibility and potential efficacy of an online decision aid (DA) tool that provides medical students with resources for disclosing and help-seeking for their health concerns. The research used mixed methods, comprising two rounds of testing, the first used the Think-Aloud method to identify modifications needed, and both of which measured feasibility and assessed decision making outcomes pre and post use of the DA utilizing O'Connor's Decisional Conflict Scale (DCS) (2010) and Stage of Decision Making (SDM) (2003) measures. Results showed good feasibility of the DA. The mean DCS total score decreased from 32 to 16.75, (Wilcoxon signed-rank tests Z = -3.06, P < 0.05). There was no significant change in the SDM. The results suggest that the DA may reduce decisional conflict, improving their certainty and confidence in decision making, but had no immediate impact on their SDM, consistent with some other DAs. Further longitudinal research would be beneficial.

The Usability of an Online Tool to Promote the Use of Evidence-Based Smoking Cessation Interventions.

To increase usage of evidence-based smoking cessation interventions (EBSCIs) among smokers, an online decision aid (DA) was developed. The aims of this study were (1) to conduct a usability evaluation; (2) to conduct a program evaluation and evaluate decisional conflict after using the DA and (3) to determine the possible change in the intention to use EBSCIs before and directly after reviewing the DA. A cross-sectional study was carried out in September 2020 by recruiting smokers via the Internet (n = 497). Chi-squared tests and t-tests were conducted to test the differences between smokers who differed in the perceived usability of the DA on the program evaluation and in decisional conflict. The possible changes in intention to use EBSCIs during a cessation attempt before and after reviewing the DA were tested using t-tests, McNemar’s test and χ2 analysis. The participants evaluated the usability of the DA as moderate (MU; n = 393, 79.1%) or good (GU; n = 104, 20.9%). GU smokers rated higher on all the elements of the program evaluation and experienced less decisional conflict, but also displayed a higher intention to quit. After reviewing the DA, the participants on average had a significantly higher intention to use more EBSCIs, in particular in the form of eHealth. Recommendations to make the DA more usable could include tailoring, using video-based information and including value clarification methods. Furthermore, a hybrid variant in which smokers can use the DA independently and with the guidance of a primary care professional could aid both groups in choosing a fitting EBSCI option.

Preferences for More or Less Health Care and Association With Health Literacy of Men Eligible for Prostate-Specific Antigen Screening in Australia

Understanding personal factors that influence diverse responses to health care information, such as preferences for more or less health care, might be beneficial to more effective communication and better involvement in health care choices. To determine whether individuals' preferences for more or less health care are associated with informed choice and understanding of overdiagnosis in routine prostate cancer screening and to examine associations among preferences, educational status, and health literacy. This survey study included a community-based sample of men in Australia aged 45 to 60 years eligible for prostate-specific antigen (PSA) screening, recruited via an international social research company. Survey data were collected online from June 27 to July 26, 2018. Data were analyzed in April 2020. Participants were randomized to 1 of 2 versions of an online decision aid (full-length or abbreviated) about PSA screening and completed an online survey that included a measure of preference for more or less health care, the Medical Maximizer-Minimizer Scale (MMS), in which higher score indicates preference for more health care. The primary outcome was informed choice; knowledge, attitudes, and intentions about screening for prostate cancer were also measured. Of 3722 participants who began the survey, 2993 (80.4%) completed it (mean [SD] age, 52.15 [6.65] years). Stronger preferences for more heath care were observed in those without tertiary education (mean difference, 0.15; 95% CI, 0.09-0.22; P < .001) and with inadequate health literacy (mean difference, 0.16; 95% CI, 0.09-0.22; P < .001). After controlling for health and demographic variables, a 1-unit increase in MMS score was associated with reduced relative risk (RR) of making an informed choice (RR, 0.78; 95% CI, 0.74-0.82; P < .001) and of having adequate conceptual knowledge (RR, 0.87; 95% CI, 0.84-0.90; P < .001), correct numerical knowledge (RR, 0.93; 95% CI, 0.89-0.97; P = .001), and correct understanding of overdiagnosis (RR, 0.84; 95% CI, 0.79-0.90; P < .001). A 1-unit increase in MMS score was associated with a more positive attitude toward screening (RR, 1.18; 95% CI, 1.15-1.21; P < .001) and more positive intention to screen (RR, 1.20; 95% CI, 1.16-1.25; P < .001) after adjusting for control variables. This survey study examined associations between preferences for more or less health care and knowledge about overdiagnosis and informed choice among men in Australia. These results may motivate clinicians to elicit individual patient preferences to facilitate tailored discussions with patients about low-value care, such as prostate cancer screening, for which benefit is uncertain.

Shared Decision Making With Young People at Ultra High Risk of Psychotic Disorder.

Introduction: While the majority of young people who meet the criteria for being considered at increased risk of psychosis do not go on to develop a psychotic disorder, young people are currently being identified and treated in early intervention services. Ethical concerns have been raised concerning the decision about whether or not to provide treatment, and if so, what type of treatment. This study sought to support young people themselves to make these decisions with support from their clinician through a shared decision-making approach, facilitated by an online decision aid.Methods: This project used the International Patient Decision Aid Standards (IPDAS) to guide the development and piloting of an online decision aid across two phases: (1) qualitative, semi-structured focus groups with young people who were past clients and clinicians from an early psychosis service; and (2) pilot testing of the decision aid with clinicians and young people who were current clients to finalize the development.Results: Issues discussed by clinicians in the focus group were grouped into three main areas: (1) engagement phase; (2) assessment and priorities for treatment; and (3) initial and ongoing decision making. Clients focused on the context in which the decisions were made, including as they experienced initial feelings of resistance, and then acceptance of efforts made to describe and treat their mental health challenges. Clients highlighted the need for collaboration between themselves and their clinician, and the need to be equipped with the knowledge and tools to take care of themselves. These focus group data were used to refine the online decision aid. Pilot testing revealed that while it was overall useful and relevant, important limitations were noted by both clients and clinicians.Discussion: The use of a decision aid to facilitate shared decision making (SDM) in this area is feasible and has utility for both clients and clinicians. Use of such a tool can help to address the need to uphold the rights of young people as decision makers about their own care. Future efforts should embed decision aids within complex SDM interventions, and research to understand issues relating to implementation of these interventions.

Enhancing Specific Health Literacy with a Digital Evidence-Based Patient Decision Aid for Hypertension: A Randomized Controlled Trial.

IntroductionHealth literacy is an important competency to make informed, shared decisions in line with patient’s preferences. On the other hand, lower health literacy is associated with poorer health outcomes. Evidence-based patient decision aids (EbPDA) are validated instruments to support informed medical decisions and empower patients for relevant involvement in their care. This study aimed to investigate the effect of a digital EbPDA for hypertension on health literacy.MethodsIn a randomized controlled trial, 124 participants were presented with a web-based scenario related to a newly diagnosed condition of arterial hypertension. The intervention group was provided with an online decision aid, while the control group was prompted to search for related information without support. Specific health literacy for hypertension was operationalized based on the European survey for health literacy (HLS-EU-Q47).ResultsThe intervention group showed a statistically significant increase in subjectively perceived overall specific health literacy regarding hypertension (p=0.02, Cohen’s d=0.44). The effect was also statistically significant for the subcategories understanding, appraising, and applying health-related information (all p<0.05). At least equal results could be shown for participants with a lower level of education compared to participants with a high level.ConclusionThe findings suggest that digital EbPDAs can be an effective and easily scalable instrument to improve populations’ specific health literacy. A possible advantage of the measure could be that patients are addressed concerning important and pressing personal decisions, fostering awareness of the individual’s need for health literacy to reflect one’s options and preferences. EbPDAs may also be a promising approach to target vulnerable populations, as the investigated EbPDA seems to perform equally in less versus more educated individuals. For future research, it may be interesting to investigate whether EbPDAs have effects on general health literacy that go beyond the disease specifically addressed.

DNA-based screening and personal health: a points to consider statement for individuals and health-care providers from the American College of Medical Genetics and Genomics (ACMG)

DNA-based screening and personal health: a points to consider statement for individuals and health-care providers from the American College of Medical Genetics and Genomics (ACMG)

Evaluating quality in adolescent mental health services: a systematic review

ObjectivesTo evaluate the quality of adolescent mental health service provision globally, according to the WHO Global Standards of adolescent mental health literacy, appropriate package of services and provider competencies.Design and...

Outcomes of a regional suicide prevention systems intervention study: Suicide prevention by monitoring and collaborative care (SUPREMOCOL) in noord-brabant in the netherlands

IntroductionSince 2007, suicide rates increased in the Netherlands and the province of Noord-Brabant ranked second nationally with a 64% increase. 60% of people who died by suicide did not receive treatment at the time of their death. Gap analysis showed 1) lack of expertise to explore suicide risk in health care or community settings where persons at risk presented; 2) lack of swift access to specialist care addressing suicidality; 3) lack of oversight of the care process and 4) lack of follow up.ObjectivesWe developed a regional suicide prevention systems intervention with chain partners at community, general health and mental health care level to address these gaps in Noord-Brabant, aiming at a 20% decrease in the number of suicides.MethodsThe project started October 2016 and lasted 4 years. The intervention has four pillars: 1) Online decision aid for health care professionals to assess suicidal risk and to communicate with chain partners; 2) swift access to care; 3) facilitation of care through the care chain by a dedicated nurse; and 4) 12 months follow up monitoring if the patient still receives appropriate care. We examined the effect of SUPREMOCOL on suicides in a pre-post design.ResultsDuring the implementation year of the intervention, suicides in Noord-Brabant dropped 17% whereas nationally they dropped 5%, and this effect was sustained after one year.ConclusionsThis suicide prevention systems intervention is effective in reducing suicide rates. Long-term follow-up and implementation is warranted.DisclosureNo significant relationships.

Evaluation of a shared decision-making strategy with online decision aids in surgical and orthopaedic practice: study protocol for the E-valuAID, a multicentre study with a stepped-wedge design

BackgroundInguinal hernia repair, gallbladder removal, and knee- and hip replacements are the most commonly performed surgical procedures, but all are subject to practice variation and variable patient-reported outcomes. Shared decision-making (SDM) has the potential to reduce surgery rates and increase patient satisfaction. This study aims to evaluate the effectiveness of an SDM strategy with online decision aids for surgical and orthopaedic practice in terms of impact on surgery rates, patient-reported outcomes, and cost-effectiveness.MethodsThe E-valuAID-study is designed as a multicentre, non-randomized stepped-wedge study in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis in six surgical and six orthopaedic departments. The primary outcome is the surgery rate before and after implementation of the SDM strategy. Secondary outcomes are patient-reported outcomes and cost-effectiveness. Patients in the usual care cluster prior to implementation of the SDM strategy will be treated in accordance with the best available clinical evidence, physician’s knowledge and preference and the patient’s preference. The intervention consists of the implementation of the SDM strategy and provision of disease-specific online decision aids. Decision aids will be provided to the patients before the consultation in which treatment decision is made. During this consultation, treatment preferences are discussed, and the final treatment decision is confirmed. Surgery rates will be extracted from hospital files. Secondary outcomes will be evaluated using questionnaires, at baseline, 3 and 6 months.DiscussionThe E-valuAID-study will examine the cost-effectiveness of an SDM strategy with online decision aids in patients with an inguinal hernia, gallstones, knee or hip osteoarthritis. This study will show whether decision aids reduce operation rates while improving patient-reported outcomes. We hypothesize that the SDM strategy will lead to lower surgery rates, better patient-reported outcomes, and be cost-effective.Trial registration: The Netherlands Trial Register, Trial NL8318, registered 22 January 2020. URL: https://www.trialregister.nl/trial/8318.

Long-term effectiveness of an online decision aid for female cancer patients regarding fertility preservation: Knowledge, attitude, and decisional regret.

The decision, whether to undergo fertility preservation or not is highly demanding for cancer patients. Decision aids may act as an additional source of support. So far, only a limited number of decision aids regarding fertility preservation for female cancer patients exist and have been evaluated systematically. This paper presents the results of secondary analyses of the first randomized controlled trial evaluating an online decision aid for female cancer patients affected by different types of cancer. It focuses on fertility-related knowledge, attitude toward fertility preservation, and long-term effectiveness regarding decisional regret. Young female cancer patients between 18 and 40years of age were recruited after fertility counseling with a reproductive specialist. They were assigned to either the control group (counseling only) or the intervention group (counseling followed by the additional use of the decision aid). Both groups had to complete a questionnaire after counseling as well as 1 and 12months later, covering topics such as fertility-related knowledge, attitude towards fertility preservation, decisional conflict and regret. Recruitment was ongoing during 18months in eight fertility centers located in Switzerland and Germany. Mean age of participating women was 29.31years (SD 4.57). Of the entire sample (n=51) 53% were affected with breast cancer, 27.4% with lymphoma, and 19.6% with various other types of cancer. Knowledge regarding the most common fertility preservation methods was high and comparable in both groups. Positive attitude significantly exceeded negative attitude among all participants (p=0.001). Although the altogether low scores for decisional regret were on a higher level in the control group (T2: mean=19.00, SD=13.24; T3: mean=22.0, SD=20.67) than in the intervention group (T2: mean=14.12, SD=11.07; T3: mean=12.94, SD=13.24), there were no statistically significant differences between and within both groups. There was a positive association between decisional conflict and decisional regret at T3 (p=0.001, r=0.510). This decision aid was suitable as an additional source of knowledge and may positively impact decisional regret in the long term. Results suggest that the provision of an online decision aid as a complement to fertility counseling may facilitate decision-making.

Navigate: a study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners

BackgroundActive surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We developed Navigate, an online decision aid to help men and their partners make management decisions consistent with their values. The aims are to evaluate the impact of Navigate on uptake of AS; decision-making preparedness; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life and anxiety. In addition, the healthcare cost impact, cost-effectiveness and patterns of use of Navigate will be assessed. This paper describes the study protocol.MethodsThree hundred four men and their partners are randomly assigned one-to-one to Navigate or to the control arm. Randomisation is electronically generated and stratified by site. Navigate is an online decision aid that presents up-to-date, unbiased information on LRPC tailored to Australian men and their partners including each management option and potential side-effects, and an interactive values clarification exercise. Participants in the control arm will be directed to the website of Australia’s peak national body for prostate cancer. Eligible patients will be men within 3 months of being diagnosed with LRPC, aged 18 years or older, and who are yet to make a treatment decision, who are deemed eligible for AS by their treating clinician and who have Internet access and sufficient English to participate. The primary outcome is self-reported uptake of AS as the first-line management option. Secondary outcomes include self-reported preparedness for decision-making; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life. Uptake of AS 1 month after consent will be determined through patient self-report. Men and their partners will complete study outcome measures before randomisation and 1, 3 and 6 months after study consent.DiscussionThe Navigate online decision aid has the potential to increase the choice of AS in LRPC, avoiding or delaying unnecessary radical treatments and associated side effects. In addition, Navigate is likely to reduce patients’ and partners’ confusion and distress in management decision-making and increase their quality of life.Trial registrationAustralian and New Zealand Clinical Trial Registry ACTRN12616001665426. Registered on 2 December 2016. All items from the WHO Trial Registration Data set can be found in this manuscript.

An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial.

BackgroundDecision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness.ObjectiveWe describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice.MethodsThe development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness.ResultsData regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021.ConclusionsBy making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes.Trial RegistrationNetherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270International Registered Report Identifier (IRRID)DERR1-10.2196/21772