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

Abstract

Background Decision 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. Objective We 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. Methods The 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. Results Data regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021. Conclusions By 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 Registration Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 International Registered Report Identifier (IRRID) DERR1-10.2196/21772

Informed decision making on the uptake of evidence-based smoking cessation assistance: A needs assessment among end users and experts to inform decision aid development

“…Based on the results from the needs assessment described in this paper and on previous findings from risk communication studies, we therefore decided to make icon arrays for our DA (using the website Iconarray.com (Risk Science Center and Center for Bioethics and Social Sciences in Medicine, University of Michigan, n.d.)) to convey information regarding the effectiveness of different smoking cessation assistance tools. More information on the application of this method can be found in our paper describing the DA (Gültzow, Smit, Hudales, Knapen, et al, 2020) .…”

“…However, developers have to ensure that 'core functions' and the most important information that the DA aims to convey should be retained. We ourselves have used various options to deal with this in the smoking cessation DA developed as part of the associated broader project (Gültzow, Smit, Hudales, Knapen, et al, 2020), e.g., we have chosen to enable users (1) to receive in-depth information regarding options that they are interested in while ensuring that all users receive the necessary information to make a decision, and (2) to skip certain functionalities that are not regarded as necessary but as attractive by some users (e.g., a knowledge quiz).…”

“…A semi-structured interview guide was developed which was used to gather information for the larger project (Gültzow, Smit, Hudales, Knapen, et al, 2020) and this study, and therefore also included questions that were beyond the scope and objectives of this study (see the entire interview guide on the OSF, https://osf.io/6dg7r/?view_only=98e511e58fcd4870a583c2071430e526). The relevant questions for this study were related to: (1) Knowledge, (2) values related to cessation assistance tools, (3) the proposed DA (e.g., personal needs regarding functional aspects, device compatibility, usage duration and the layout of the DA).…”

“…On the other hand, very specific tailoring in the form of tailored advice based on identified values might help DA-users to make value-consistent choices (Witteman et al, 2020). In our own DA, we therefore aimed for a synergistic approach: Throughout the majority of the DA users were able to customize the information they were receiving (i.e., we used customization as opposed to system-driven tailoring as described in Potential end users (i.e., individuals motivated to quit smoking)), but we also provided them with system-tailored advice at the end (Gültzow, Smit, Hudales, Knapen, et al, 2020). This shows that it is possible to integrate dissenting expert opinions, in future studies it should be assessed if this approach is effective as well.…”

“…Which is why we are currently testing if a smoking cessation DA is more effective if users are supported in identifying smoking cessation assistance tools that reflect their values and preferences (Gültzow, Smit, Hudales, Knapen, et al, 2020).…”