Abstract 176: Variation in the Content and Timing of Informed Consent in Cardiovascular Procedures: An Opportunity to Improve Decision-making
Authors: Shahu Andi , Spatz Erica S , Schwartz Jennifer , Searfoss Rana , Perez Mallory , Eddy Elizabeth , Schroeder Lori M , Bernheim Susannah M , Krumholz Harlan M 
Published: July 2021

Background:
Informed consent, when effectively implemented, provides a powerful opportunity to build trust between the patient and clinician; support patient autonomy; and enable high-quality decision-making. Yet despite being legally and ethically mandated, consistent quality standards for informed consent are lacking, resulting in varied laws and practices. We examined variation in the quality of informed consent among three cardiovascular procedures - cardiac catheterization (CC), transesophageal echocardiography (TEE), and implantable cardioverter defibrillator (ICD) - at a single institution.

Methods:
We conducted a chart review of elective outpatient CCs, TEEs, and ICDs performed from April 1 to June 30, 2014, evaluating: presence of consent form; content (documentation of purpose of procedure, benefits, risks, risk probabilities, and alternatives); legibility (assessed subjectively); and timing of consent prior to start of procedure. We also assessed documentation of procedure-specific risks (CC: bleeding, infection, heart attack, stroke, arrhythmia, vessel damage, heart damage, kidney injury, contrast allergy, adverse reaction, death; TEE: oral damage, esophageal damage, arrhythmia, blood pressure changes, breathing changes, aspiration pneumonia, death; ICD: pneumothorax, vessel damage, cardiac puncture, bleeding, infection, arrhythmia, adverse reaction, lead failure, death).

Results:
A generic consent document was used for all procedures (79 CCs, 39 TEEs, 36 ICDs); however, personalized, hand-written information was heterogeneous. Some documents did not specify the procedure’s purpose (CC: 19% [15 of 79]; TEE: 8% [3 of 39]; ICD: 6% [2 of 36]). Description of procedure-specific risks varied, and in some cases no risks were specified (CC: 32% [25 of 79]; TEE: 18% [7 of 39]; ICD: 42% [15 of 36]); only 8 total documents cited risk probabilities. Alternatives were never listed, and benefits were frequently not specified (CC: 100% [79 of 79]; TEE: 100% [39 of 39]; ICD: 86% [31 of 36]). Written documentation was often illegible (CC: 41% [32 of 79]; TEE: 31% [12 of 39]; ICD: 28% [10 of 36]). Timing of consent prior to procedure varied (median time: 32 min for CC, 29 min for TEE, and 1.6 days for ICD). Last, 43% (34 of 79 CCs), 49% (19 of 39 TEEs), and 3% (1 of 36 ICDs) were consented less than 30 minutes prior to start time.

Conclusion:
We observed notable variation in the content, legibility and timing of informed consent documents within and across procedures. These components are necessary, though may not be sufficient, to support a high-quality informed consent process. Our results highlight opportunities for improving informed consent. Standardization of content and increased time for patients to consider the risks, benefits, and alternatives of elective procedures may result in higher quality decision-making and facilitate patient autonomy.