Online informed-consent resource enhances process

An Internet-based, multimedia informed-consent tool is on track to increase clinical-trial enrollment at the University of Pennsylvania (Philadelphia).

Acknowledging the confusing and tedious informed-consent process that patients are subjected to before enrolling in a study, James Metz, MD, and colleagues sought to increase patient recruitment for research on proton therapy, a new type of radiation treatment. They posted videos and Web-based documents on the University of Pennsylvania's Web site for cancer patients and providers, OncoLink (www.oncolink.org) to make the process easier to understand.

Metz, an associate professor and vice chair of the clinical division in the Perelman School of Medicine department of radiation oncology at the University of Pennsylvania, and colleagues created a video in which a principle investigator for a proton-therapy clinical trial talked the viewer through the traditional informed-consent process for such studies. Patients would be able to stop, start, and replay the video as many times as they desired. Although only those eligible for a clinical trial would be given access to the informed-consent media, they could play it for family members or others.

A PDF of the informed-consent document for proton-therapy clinical trials was also made available online.

Before the resource became available to patients, health care professionals were asked to review the Web tools and complete an anonymous survey about their experience using these materials. The 23 respondents included research coordinators (43%), radiation oncologists (31%), research nurses (13%), and other professionals (13%).

According to the survey results, which were presented at the annual meeting of the American Society for Radiation Oncology, held October 2-6, 2011, in Miami Beach, Florida, nearly all the health care professionals (94%) stated that they were pleased with the information presented in the informed-consent resource. Overall, they valued the resources as an enhancement, not a replacement, for the informed-consent process. A total of 75% thought these materials would expedite the informed-consent process, and 88% stated that it would greatly enhance the informed-consent process for the patient.

However, only 50% of the respondents agreed that the resource contained all the necessary information needed for a patient to consent.

In all, 75% of the respondents expressed the desire to have a multimedia consent resource created for their future clinical trials.

The multimedia resource has now been expanded to persons undergoing proton therapy at the University of Pennsylvania, and will be evaluated through patient-satisfaction surveys and an evaluation of impact on patient accrual to clinical trials.

 

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