Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement  (Preprint)

Abstract

BACKGROUND Informed consent has considerable clinical, ethical, and legal implications for patient safety and liability. Little information is available about the use of multimedia patient decision aids (PtDA) in the consent process for therapeutic invasive procedures such as the peripherally inserted central venous catheter (PICC). In addition, none of the available studies have designed their multimedia PtDAs based on the Agency for Healthcare Research and Quality’s (AHRQ) comprehensive guide for informed consent. OBJECTIVE This paper describes a patient-centered, systematic, multidisciplinary approach to develop, implement, and alpha test a multimedia PtDA to reform the informed consent process of a PICC for patients in 10 acute and intensive care units. METHODS The development, implementation, and evaluation processes of the PtDA followed the phases in the Multimedia Production Framework: preproduction, production, and postproduction. Within this framework, we applied the criteria for judging the quality of PtDAs, the AHRQ’s Health Literacy Universal Precautions Toolkit, and the AHRQ’s Patient Education Materials Assessment Tool Guide. The methodology was guided by the Interprofessional Shared Decision-Making Model and the AHRQ’s Making Informed Consent an Informed Choice guide. In the preproduction phase, we (1) reviewed the current consent form; (2) observed 18 consent processes; (3) surveyed the vascular access team (N=6 nurses) about their perception of the current process; (4) surveyed 30 patients for knowledge recall and retention, overall satisfaction, and attitude toward using a multimedia PtDA; and (5) wrote and reviewed the script for the multimedia program. The production phase focused on filming the PtDA in English and Spanish languages. The postproduction phase included integrating the multimedia programs into the care processes, developing a modified workflow for the consent process, and alpha testing of the English and Spanish PtDAs by (1) a group of 5 patients for clarity and understandability of the information; (2) nurses using the AHRQ’s Patient Education Materials Assessment Tool Audio and Video; and (3) by the multidisciplinary change team. RESULTS Based on the alpha testing, patients indicated that the content was easy to follow and read; nurses provided positive feedback, and their comments were mainly related to the changes in the workflow in the consent process of the PICC after using the PtDA; and the multidisciplinary change team suggested edits related to changing a few scenes. The final multimedia program consisted of 7 min and 37 s demonstrating detailed information about the PICC. CONCLUSIONS A systematic development of PtDAs for nonurgent invasive procedures may eliminate many limitations of the conventional consent process by ensuring comprehensive, standardized, and easy-to-comprehend information and providing sufficient time for the patients to reflect on the information. To be effective, PtDAs should follow a systematic, patient-centered, evidence-based, and rigorous approach in the development, implementation, and evaluation processes. INTERNATIONAL REGISTERED REPOR RR1-10.2196/10709