Patients are usually accustomed to using technology as a means of communication and information sharing. Yet tech can be too much of a good thing. Patients are also wary of tech use and in some cases suffering from tech fatigue.
Patients’ hesitancy to use technology can undermine clinical trial teams’ ability to collect data in decentralized trials. Implementing tools that streamline the process can help reduce friction in patient data collection.
Addressing Tech Fatigue in Decentralized Trials
The COVID-19 pandemic made remote communication commonplace, but it has also introduced a new level of fatigue and burnout. A KFF analysis of U.S. Census Bureau data found that approximately 40 percent of American adults now report symptoms of anxiety or depression, compared to 10 percent before the pandemic.
Patients face risks of additional tech fatigue when tools aren’t designed with their use or needs in mind. “A lot of the new decentralized technologies are patient-led or patient-directed. It’s a patient entering data,” says Clare Grace, chief patient officer at Parexel. Tools that aren’t designed with that patient perspective in mind are more likely to generate friction that increases fatigue and reduces patient participation, imperiling data collection.
Patient attitudes both cause and result from challenges in the data collection process. In a study of home- and remote-based medical testing (H/RMT) in Spain and Brazil, Simón Lalanza and fellow researchers found a “general distrust in the logistical management” of remote medical testing among patients. Most patients said that the convenience of remote testing didn’t affect their willingness to participate in clinical trials. Use of remote testing did, however, appear to boost patients’ participation in long-term follow-up programs.
Decentralized clinical trials offer opportunities to make clinical trial research more equitable. That’s because the technology used, such as digital tools, can reach more patients than trials based on in-person attendance only. Similarly, remote feedback can help develop therapies that are effective for a wider range of the patient population.
Still, patient tech fatigue remains a challenge for clinical trial teams. “Respondent burden needs to be carefully considered and addressed to avoid high rates of missing data and poor reporting of [patient-reported outcome] results, which may lead to poor quality data for regulatory decision making and/or clinical care,” Olalekan Lee Aiyegbusi and fellow researchers write in an 2022 article in Nature Communications.
Reduce Friction: Make It Easier for Patients to Enter Their Data
A first step to improving patients’ ability to enter data in decentralized trials is to ensure they have the right tools to do so.
Many medical wearables will interface with smartphone apps, for example. Smartphone ownership rates have continued to rise over the past decade. Yet smartphone ownership remains lowest among those ages 65 and older, according to a Pew Research Center study.
Even patients who regularly use their smartphone may face friction when using it as part of a clinical trial data collection, writes Oliver Eden, a business unit director at Jabil Healthcare. For example:
- Patients and caregivers still require training on the use of particular devices and apps.
- Patients and caregivers must have the skills to download an app, log in, and pair the phone with a medical device.
- Medical devices and smartphones must often be in close proximity for data transfer to occur.
- The clinical trial team must provide access to technical support.
- Push notifications and app use remind patients their behavior is being monitored, which can result in changes to behavior that wouldn’t otherwise occur.
Technology can also create a barrier to inclusion in the study itself. Patients who don’t own smartphones may be excluded from the study cohort even if they are otherwise qualified and willing to participate, unless the clinical trial team provides a smartphone. Patients who receive their phones as part of the study may require additional training and tech support as they learn to use both the smartphone and their medical device, notes Eden.
In a study of patient perspectives on tracking symptoms of motor neuron disease through digital technology, Jochem Helleman and fellow researchers found that while most study participants welcomed the opportunity to use remote monitoring tools, “fifteen percent of patients indicates they would not wish to perform home-measurements; reporting concerns about the burden and distress of home-monitoring, privacy and data security.”
Focusing on the patient experience can help reduce friction and improve patient use of data collection tools. One option is to use artificial intelligence (AI) to streamline the patient experience, writes Scott Pearson, chief product officer at research platform THREAD.
Pearson gives an example of using AI to streamline the login process. Easier logins reduce friction by lowering the effort it takes a clinical trial participant to access the app for data transfer. Autofill or predictive text tools can also make it easier for patients to enter data consistently.
Choosing Patient Data Collection Tools
Patients’ primary friction points in decentralized clinical trial data collection include:
- Challenges in learning new tech tools and software, including apps, and access to learning or technical support.
- Fatigue in entering data, particularly when data is repetitive, which may increase the risk of errors.
- Access to devices that can interface with the data collection app or software.
- Concerns about data privacy and security.
Tools like Anju’s TrialMaster focus on reducing friction at each of these points. TrialMaster’s built-in ePRO (Patient-Reported Outcomes) tools allow patients to access the system from any internet-connected device, reducing their need to learn how to use a new device. TrialMaster’s incorporated ePRO provides a simple, consistent interface that can help users enter data more effectively and accurately — and gives trial teams immediate access to that data, so that trial teams can respond promptly if needed. The system also provides robust data privacy and security support.
TrialMaster lets clinical trial teams use either the built-in ePRO or their own ePRO system. Patients can stay with the ePRO they already know through their trial participation even as clinical trial teams transition to TrialMaster use.
Using robust, intuitive data collection tools during clinical trials has other benefits as well.
The right tools help clinical trial teams connect with patients during the recruitment phase. “Having the ability to connect more patients with active trials will be a huge win,” says Carol Riley, practice administrator with St. Louis Cancer Care. Reduced friction in patient data collection also helps enrolled patients complete clinical trials more easily, enhancing the quality of collected data and potentially improving patient outcomes.
“Real-world data, as well as exploitation of digital apps and structured observational registries, and the utilization of machine learning and/or artificial intelligence, may further accelerate knowledge acquisition,” write researchers Elena Fountzilas, Apostolia M. Tsimberidou,Henry Hiep Vo, and Razelle Kurzrock in a 2022 article in Genome Medicine.
To gather patient-specific real-world data, clinical trial teams will need to smooth the process of patient data collection. Choosing the right digital platform can help.
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