Mapping the informed consent process for left ventricular assist devices

Savitri E. Fedson; Kelly K. Mackenzie; Estevan D. Delgado; Mackenzie N. Abraham; Jerry D. Estep; Jennifer S. Blumenthal-Barby; Courtenay R. Bruce

doi:10.1097/MAT.0000000000000696

Mapping the informed consent process for left ventricular assist devices

Savitri E. Fedson, Kelly K. Mackenzie, Estevan D. Delgado, Mackenzie N. Abraham, Jerry D. Estep, Jennifer S. Blumenthal-Barby, Courtenay R. Bruce

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

Ethical, practical, and medical challenges affect decisions about left ventricular assist device (LVAD) implantation. The informed consent document (IC-Doc) is integral to the decision-making process and structures informed consent conversations. The objective of this study was to analyze IC-Docs to identify the information patients and their families receive about LVAD implantation to create a model IC-Doc. We requested IC-Doc for LVAD implantation from LVAD programs in the United States. We analyzed them in three areas: medical and technical content, patient knowledge gaps, and syntax. Nineteen IC-Docs representing all United Network of Organ Sharing regions were included. Seventeen (89.5%) mentioned the indications for LVAD implantation (bridge to transplant or destination therapy), and six indicated which category applied to the patient. Palliative care was mentioned as an alternative in nine (47.4%); no IC-Doc discussed nonsurgical palliative care. Eight forms (42.1%) specifically mentioned turning off the LVAD. Eighteen forms mention general bleeding, and four referred to long-term gastrointestinal bleeding. Two IC-Docs addressed driveline infections. One form was written at an 8th grade reading level. There is wide variation in LVAD IC-Docs and omission of some benefits and risks. We have written an IC-Doc that meets criteria for disclosure, fills many knowledge gaps, and has an acceptable readability score. ASAIO Journal 2018; 64:630-635.

Original language	English (US)
Pages (from-to)	630-635
Number of pages	6
Journal	ASAIO Journal
Volume	64
Issue number	5
DOIs	https://doi.org/10.1097/MAT.0000000000000696
State	Published - Jan 1 2018

Keywords

Informed Consent
Left Ventricular Assist Device
Readability
Shared-Decision Making

ASJC Scopus subject areas

Biophysics
Bioengineering
Biomaterials
Biomedical Engineering

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10.1097/MAT.0000000000000696

Cite this

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title = "Mapping the informed consent process for left ventricular assist devices",

abstract = "Ethical, practical, and medical challenges affect decisions about left ventricular assist device (LVAD) implantation. The informed consent document (IC-Doc) is integral to the decision-making process and structures informed consent conversations. The objective of this study was to analyze IC-Docs to identify the information patients and their families receive about LVAD implantation to create a model IC-Doc. We requested IC-Doc for LVAD implantation from LVAD programs in the United States. We analyzed them in three areas: medical and technical content, patient knowledge gaps, and syntax. Nineteen IC-Docs representing all United Network of Organ Sharing regions were included. Seventeen (89.5%) mentioned the indications for LVAD implantation (bridge to transplant or destination therapy), and six indicated which category applied to the patient. Palliative care was mentioned as an alternative in nine (47.4%); no IC-Doc discussed nonsurgical palliative care. Eight forms (42.1%) specifically mentioned turning off the LVAD. Eighteen forms mention general bleeding, and four referred to long-term gastrointestinal bleeding. Two IC-Docs addressed driveline infections. One form was written at an 8th grade reading level. There is wide variation in LVAD IC-Docs and omission of some benefits and risks. We have written an IC-Doc that meets criteria for disclosure, fills many knowledge gaps, and has an acceptable readability score. ASAIO Journal 2018; 64:630-635.",

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author = "Fedson, {Savitri E.} and Mackenzie, {Kelly K.} and Delgado, {Estevan D.} and Abraham, {Mackenzie N.} and Estep, {Jerry D.} and Blumenthal-Barby, {Jennifer S.} and Bruce, {Courtenay R.}",

note = "Funding Information: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (1306–01769). Publisher Copyright: Copyright {\textcopyright} 2017 by the ASAIO Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",

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AU - Estep, Jerry D.

AU - Blumenthal-Barby, Jennifer S.

AU - Bruce, Courtenay R.

N1 - Funding Information: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (1306–01769). Publisher Copyright: Copyright © 2017 by the ASAIO Copyright: Copyright 2019 Elsevier B.V., All rights reserved.

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Mapping the informed consent process for left ventricular assist devices

Abstract

Keywords

ASJC Scopus subject areas

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