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

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 (i.e. behavioral support, nicotine replacement therapy and/or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness. OBJECTIVE A fully automated online DA (called ‘VISOR’) that includes both an implicit and explicit value-clarification exercise was developed that helps smokers to choose evidence-based cessation assistance. This DA will be tested in a randomized controlled trial (RCT). METHODS The development of the DA ’VISOR’ was based on the International Patient Decision Aid Standards (IPDAS) guidelines. Viewpoints of both end users (collected through 20 interviews with current smokers) and clinical & scientific experts (assessed using a Delphi study 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 (usability) in December 2019; feedback was incorporated and resulted in a final DA version. The DA combines intuitive and deliberate decision-making processes to facilitate both decision-making styles. An RCT will be conducted to assess the DA’s (cost-)-effectiveness. Within this RCT the DA will be compared to a DA that will not include the explicit value clarification exercise. RESULTS Data regarding the effect of the VISOR DA is currently being collected, expecting conclusion 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 effect of the DA on decision-making and smoking outcomes is currently being studied. CLINICALTRIAL The trial is registered in the Netherlands Trial Register (NL8270).