Development and validation of a patient-centered knowledge scale for left ventricular assist device placement

Abstract

Background: A central tenet of patient-centered health care advocated by the Institute of Medicine and the American Medical Association is to enhance informed decision-making in a way that incorporates patient values, knowledge and beliefs. Achievement of this goal is constrained by a lack of validated measures of patients' knowledge needs.

Methods: In this study we present a comprehensive and valid methodology for developing a clinically informed and patient-centered measure of knowledge about left ventricular assist device (LVAD) therapy to facilitate discussion and measure candidate understanding of treatment options. Using structured interviews with patients, caregivers, candidates for LVAD treatment (New York Heart Association Class III and IV) and expert clinicians (n = 71), we identified top patient decisional needs and perspectives on essential knowledge needs for informed decision-making. From this list, we generated 20 knowledge scale question items to refine in cognitive interviews (n = 5) with patients and patient consultants.

Results: Good internal consistency and reliability of the knowledge scale (Cronbach's α = 0.81) was seen in 30 LVAD patients and candidates. Knowledge was higher among patients currently with LVADs than candidates, regardless of receiving standard education (with education: 69.9 vs 50.1, adjusted p = 0.02; without education: 69.9 vs 37.6, adjusted p < 0.001).

Conclusion: The LVAD knowledge scale may be useful in clinical settings to identify gaps in knowledge among patient candidates considering LVAD treatment, and to better tailor education and discussion with patients and their caregivers, and to enhance informed decision-making before treatment decisions are made.

Trial registration: ClinicalTrials.gov NCT02248974.

Keywords: CV surgery; cardiology; cardiomyopathy; heart failure; transplantation; ventricular assistance.

Conflict of interest statement

Disclosure statement

J.D.E. and M.L. receive consultant and research support from Thoratec Corporation. The remaining authors have no conflicts of interest to disclose. This research was supported by a grant (CDR-1306-01769) from the Patient Centered Outcomes Research Institute (PCORI; ClinicalTrials.gov Identifier: NCT02248974). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its board of governors or methodology committee. The corporation had no role in the funding or writing of this article.

Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

LVAD knowledge scale scores by study participant type.