Development and Validation of Patient-Centered Knowledge Scale for LVAD Placement

Abstract

Purpose: Incorporating patient values and beliefs into shared medical decision-making is a central tenet of patient-centered, culturally-competent healthcare advocated by the Institute of Medicine and the American Medical Association. Achievement of this goal is currently constrained by a lack of operationalized methodologies for measuring patient knowledge and values. This paper presents the results of a replicable methodology for developing a culturally-informed and patient-centered measure of knowledge about Left Ventricular Assist Device (LVAD) therapy. The LVAD Knowledge Scale was designed to facilitate discussion and measure of candidate understanding of treatment options, two key components of the informed consent process. Methods: Using structured interviews and free-listing techniques (n= 45), we identified top patient values and decisional needs, and provider's perspectives on essential knowledge needs for informed consent. From this list, we generated 20 Knowledge Scale question items that were further refined in cognitive interviews with patient consultants. A finalized 20-item LVAD Knowledge Scale was alpha tested among a stratified sample of 40 LVAD patients, candidates, and decliners. Results: Results of cognitive interviewing and alpha testing demonstrated that these methodologies were effective in creating a measure to capture and assess patient beliefs, understandings and values about treatment options. The scale showed good internal consistency (Cronbach's alpha = .89) and was significantly correlated with both the Decisional Regret Scale (r= .89, p< .05) and the Montreal Cognitive Assessment (MOCA) tool (r= .76, p< .05). Further, the scale takes only 10-15 to administer. Conclusion: Our results show that the inductive methodologies outlined in this paper can be effectively applied across settings and other clinical treatment areas to create valid and robust measures of knowledge that are responsive to individual patient preferences, needs and values, and help to ensure that patient values guide clinical decision-making.