Examination of the Informed Consent Process as Experienced by Patients Who Underwent a De Novo Transjugular Intrahepatic Portosystemic Shunt, Chemoembolization or Radioembolization Procedure

Abstract

The purpose of this study is to examine the informed consent (IC) procedure as it was experienced by patients who had undergone a de novo transjugular intrahepatic portosystemic shunt (TIPS), chemoembolization (TACE), or radioembolization (TARE) procedure in an Interventional Radiology (IR) Department. The three main study aims and a fourth exploratory aim are as follows: (1) Describe how patients who underwent a de novo TIPS, TACE, or TARE procedure in an IR Department described the IC procedure; (2) Describe what information patients who underwent a de novo TIPS, TACE, or TARE procedure in an IR Department recalled being told during the IC procedure; (3) Describe the satisfaction of patients who underwent a de novo TIPS, TACE, or TARE procedure in an IR Department with the IC procedure; and (4) Explore how the IC experiences of patients who underwent a de novo TIPS, TACE, or TARE procedure in an IR Department differed according to their levels of health literacy. Using a qualitative descriptive design, participants were recruited from an IR department that performed these procedures. A total of 14 participants were interviewed about their IC experiences and the Newest Vital Sign (NVS) Health Literacy assessment was administered. The participants described the IC procedure by discussing the staff they encountered, their feelings during the visit, the support persons who accompanied them, and the decisions they made about the procedure. The participants recalled being told about how their procedure would be performed, the care they would need, and the benefits and risks of the procedure. Most were satisfied with the information received during the IC procedure and found the information consistent with how they experienced the procedure. A few participants would have liked more visual materials, addition details about the procedure, simpler language, or more explanation of the medical terminology. No apparent differences in the IC experience could be attributed to health literacy. These findings suggest that persons’ experiences during the IC process are multi-faceted and affected by their emotions and concerns and the nature of their encounters with their healthcare providers.