Bringing eConsent to the Intensive Care Unit

The following is a guest article by Karen Maduschke, Sr. Director & General Manager, Patient Consent at IQVIA.

In the United States alone, 5 million people are admitted annually to intensive care units (ICU), where they receive acute care and monitoring for active emergencies. If they are a fit with the inclusion criteria, many of these patients can be ideal candidates for receiving investigational treatments that may save their lives while providing insights to researchers that could help save the lives of countless future patients.

In acute care settings specifically, the urgency of medical action can be keenly felt by the patient, their families, and their care providers. For this reason, the ability to provide the option for electronic informed consent (eConsent) to join a trial in place of traditional paper-based process plays a pivotal role in quickly enrolling the patient so that they may receive critical intervention as quickly as possible. In turn, eConsent adoption can simultaneously enable better clinical research as well as rapid delivery of potentially life-saving cutting-edge treatments to patients with an immediate need.

The Challenge of Informed Consent in the ICU

Clinical research has long been highly valued within ICUs for researchers and patients. Still, obtaining informed consent to participate in a clinical trial in these scenarios can be challenging. Patients can be admitted to the ICU for any number of reasons, such as a stroke, heart attack, organ failure, infection, or a major trauma. Their need for care is time sensitive, meaning that getting rapid consent to provide potentially life-saving interventions is essential. However, acute care patients are often unable to provide consent on their own – for example if they are unconscious, physically, or mentally impaired – and need a Legally Authorized Representative (LAR) to step in on their behalf. 

The process can be fraught with emotion for family members already incredibly concerned about the well-being of their loved one. On the part of the principal investigator (PI), it’s imperative to balance the need to communicate medical information required to secure an informed consent with the empathy and compassion the people involved deserve – all with great haste.

Informed consent is not a “contract” to join a trial, but rather a process by which the PI and patient discuss the potential risks and benefits of trial participation and ensure all possible outcomes are fully understood. Traditionally, informed consent forms have been presented as lengthy paper documents filled with medical jargon that formally explains the execution of the clinical trial and the investigational intervention – such as a new procedure or medication. These concepts are then often explained verbally to the patient and/or legal LAR – who may not be onsite – and hence needs to be called – by a study doctor. 

Amidst high stress, high emotion, and haste, we can infer that this approach is less than ideal to ensure total absorption of complex but very important information about receiving an investigational treatment. Enter eConsent.

The Power of eConsent 

eConsent platforms digitized the informed consent process, translating all the information about receiving an investigational treatment into a more user-friendly, feature rich program that appeals to most learning styles while alleviating the paper-trail burden on site staff. Utilizing multimedia to convey important study information in a digestible way, eConsent makes it easier for patients – or their loved ones – to make decisions about their healthcare that they feel confident in. It also helps fulfill regulatory obligations more robustly by automatically generating an irrefutable audit trail that provides more understanding than a bottom-line signature.

eConsent focuses on showcasing the key elements of a trial under good clinical practice (GCP) guidelines so that every potential participant can understand the possible benefits and risks, the amount of time that will be required for the trial, how treatment will be administered, etc. Furthermore, it enables the facilitation of remote consent by an LAR who may be offsite and/or located far away from the ICU treating the patient.

Envisioning a World Beyond Paper-Based Informed Consent

What eConsent ultimately offers is the flexibility to gain consent safely and efficiently in challenging situations – a manner that better supports the patient and their LAR to make the best choice for them while advancing medical science. Despite the advantages, paper-based systems are still standard in most hospitals around the world. One reason for this is that many sites don’t understand how eConsent can be woven into the urgent care environment to save them time and help their patients. 

Let’s break down the process. Say that an unconscious patient is admitted to the emergency department and is a candidate for a clinical trial. The patient’s next of kin was unable to accompany the ambulance but is listed on the intake form. The study doctor calls this relative, confirms their status as LAR, and explains the situation. With paper consent, there is no way to get the document to the LAR right away, so verbal consent may be gathered on the phone, with an impartial witness from the hospital listening and the study doctor making notes in the patient file.  This is extremely difficult to coordinate, putting the LAR in the especially difficult position of making a quick decision based on minimal details, exposing the site to risk in an audit, and heightening the potential retraction of consent by the LAR. For this reason, many hospitals won’t even attempt to participate in clinical trials for certain emergency care indications. 

With eConsent however, the doctor can offer to send a link by email or text message to transmit a multimedia-enhanced consent that allows the LAR to watch a video further explaining the trial, read through the document and mark questions, and share with other members of the patient’s family. The study doctor offers to call back in 30 minutes or an hour to review questions and determine if the LAR is ready to provide informed consent. 

In the best cases, this consent is gathered by electronic signature and the entire process fully documented – making it much easier for sites and LARs. In the worst case, there may still need to be a wet ink signature on paper, and hence the site must document verbal consent if permissible by local regulation and have the paper ICF delivered by courier to the LAR. But at least there is already a secure audit trail of the phone conversation and document sharing. This opens an opportunity for more emergency care sites to participate in these trials and for more patients to be enrolled in these difficult circumstances. 

Realizing the Vision

Opening the floodgates of eConsent adoption is not a matter of need for innovation, but rather collaboration and communication as it relates to overcoming the blockers – both mental and regulatory – that keep sites using inadequate procedures. The technology we need to excel is already here and equipped to rapidly streamline the advancement of patient care and clinical research in the ICU setting. As an industry, it’s our responsibility to come together to set a new standard in which this vision can be fully realized.

About Karen Maduschke

Karen Maduschke, Sr. Director & General Manager, Patient Consent at IQVIA, is an energetic leader with over 25 years of experience driving strategic growth and delivering value in multinational settings. She is passionate about patient-centricity in clinical trial research and ensuring the integrity of the informed consent process.

   

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