Getting creative with informed consent strategies
Getting your informed consent strategies right is vital step in your recruitment process. Informed consent is one of the mainstays of clinical research, but it’s also one of the main reasons why pharma companies struggle to find enough people to take part in clinical trials. When the consent given is not based on the right criteria, participants often don’t make it through the initial pre-screening. Even when they do, they often drop out mid-trial because of issues they didn’t fully understand or can’t remember agreeing to in their informed consent.
Time to find a new way to improve your informed consent strategies
These problems mean it’s time for pharmaceutical companies to find new approaches to their informed consent strategies, so that they don’t face the same challenges in recruiting and retaining people to the end of the trials. Here are some creative ways to recruit trial subjects, that make the most of informed consent for the success of the trial:
#1 Target the right audience
People who take part in clinical trials come from all walks of life, and their levels of health literacy depend to a large degree on their age, gender, educational level and other factors. To reach a diverse group of potential trial participants, you need to take all these factors into account and make sure you are speaking to all the people you want.
Some of the problems associated with understanding informed consent include documents that are too long, which use complex language at reading levels that are too high for many of the target audience. Being able to bring their family members or friends with them to the pre-screening interview often enables them to understand the information better, and can help them to feel more comfortable.
#2 Use video and digital storytelling methods
You can translate informed consent documents into any language you want to, but it takes more than that. People with low levels of health literacy might respond better to “teach-to-goal” methods, which use multimedia, animation and visual images to explain more clearly than screeds of text do.
Video, for example, isn’t only faster to use, but also appeals to a wider, more diverse range of people, so it helps you to reach different population groups. This was done successfully in the U.S. when a pharmaceutical provider used tablets in some of its locations, to show an 8-minute video that featured real people speaking about the study to prospects.
The results showed locations using video started recruiting almost a month earlier than those using traditional methods, and also managed to attract a wider, more diverse group than the others.
Digital storytelling also uses various multimedia options to present a visual story that explains the situation better than reading a text-book style copy would. Using these methods gives recruiters the chance to generate better reasoning, since the person no longer needs to concentrate as much to understand. These methods work particularly well for the elderly, ethnic minorities, children and those with learning disabilities.
#3 Use software and apps
Giving informed consent online might sound like an anomaly, but studies have shown e-consent can work very well. This is particularly good for improving the understanding of the trial process for people with low health literacy or learning disabilities.
In one instance, online software was used to explain the study and what taking part would involve, and provided the official informed consent documents to sign. The site included links to additional information and pop-ups that explained unfamiliar terms, followed by interactive quizzes to see how much the readers had understood, and provide them with the right information.
The use of the interactive features helped viewers understand and remember the key facts, better than they did with paper forms. These interactive methods, along with similar mobile options for smartphones, are ideal for younger, tech-savvy and web-literate people.
#4 Make it competitive
Gamification is when you use the principles of game design in other digital applications. We see this used in healthcare on a daily basis, such as setting daily targets on Fitbits and other wearable technology. By using interactive, gamified-technology you can mimic the benefits of taking part in a trial. The U.S. National Heart, Lung, and Blood Institute uses this approach in its role-playing game called “The Paper Kingdom” – a game that helps children and their parents overcome fear about taking part in the trial. This kind of competitive approach is ideal for people who are familiar with gaming, as well as those who don’t respond to other methods of getting informed consent.
Make a difference with your informed consent strategies
Using these informed consent strategies to obtain consent can make a tremendous difference to the success of your trials, as well as improve understanding about the treatments and overcome the issues related to low health literacy. You’ll get more people applying to be in your trials, keep more of them in the trial until the end, and improve their overall satisfaction with the process.
Download our white paper on the Informed Consent process for more information and ideas about how to get creative with your recruitment strategies.