Since the start of the pandemic, researchers have faced additional challenges in participant recruitment and engagement. Safety and exposure concerns reduced in-person clinical contact and routine health visits, which left research sites scrambling to adopt digital means of outreach, enrollment, and data collection.
The sudden need for technology over these past two years drove many sites to adopt solutions without the time to consider impacts on accessibility or factor in ease of use. In doing so, is it possible that we now face new barriers?
Many participants still have unreliable means of traveling to sites for surveys or physical sample collection. While digital data collection can help to overcome these types of barriers, in truth, not every member of your community has consistent access to the internet or a smart device. Many still lack the technological literacy and confidence for using digital engagement.
But here technology can be a solution – in helping us to scale and improve the way that we serve these populations in research. Let’s explore three ways that digital tools can support the use of non-digital touchpoints to better support research participants:
- Computer Assisted Telephone Interviews
- Paper-Based Participation with Scanning
- Multiple Modes of Sample Collection
Computer Assisted Telephone Interviews (CATI)
Many studies rely on an initial, in-person visit but collect additional data through digital means, like self-completed electronic surveys. Additional approaches to support data collection are necessary to ensure data collection on your cohort is inclusive for all participants over time.
An important method in ensuring complete data collection among harder-to-reach participants is Computer Assisted Telephone Interviews (CATI). During a CATI session, a trained interviewer follows a script over a telephone call to collect answers from a participant.
The goal of using CATI is to increase levels of participation and retention for participants by providing the choice to allow survey completion over the phone. This approach is especially supportive for:
- Participants who do not have access to a digital device
- Participants with limited-or-no internet access
- Participants who need or want help using technology
- Participants with disabilities
- Participants with personal preference for phone-based engagement
- Older Participants
- Spanish speakers
- Participants who are unable or unwilling to do in-person appointments
Using CATI to Improve Participant Engagement: A Case Study
In understanding the value of using CATI to improve your access to study participants, let’s explore its use in an actual research project.
The National Institutes of Health’s (NIH) All of Us Research Program (All of Us) seeks to engage and enroll over one million people. The NIH has prioritized accessibility and diversity as one of its most important aims.
The Details about How CATI Works
All of Us adopted CATI as an important part of participant engagement, which is embedded in Vibrent’s platform.
Permission-based access
Participant permission is a critical part of success with CATI. Authenticated interviewer staff can access only a limited portion of a participant’s record during a telephone interview. They use their own secure login credentials and must secure verbal permission from the participant before moving forward.
Tailored interview script
The NIH delivers tailored access to the interview staff based on the program through restricted navigation on select pages. While the interviewer proceeds through the interview via the digital interface, the participant simply answers questions over the phone. This is especially helpful to those participants who need assistance in understanding questions or instructions within a survey or study module.
Full on-demand reporting
Everything the interviewer enters during the session is documented in the participant’s record – which creates a log that can be queried during security review. For the site, or the NIH, this additional level of internal documentation helps to protect the fidelity of data and ensures ongoing compliance.
CATI Supports a Comprehensive Approach to Diverse Patient Populations
All of Us to date has successfully completed over 12,000 CATI support sessions, which has resulted in 18,000 surveys being completed.
Of those sessions, research staff conducted 93 percent of them with participants in groups underrepresented in biomedical research. Additionally, 25 percent of these CATI sessions were conducted in Spanish.
Overall, the program saw a number of benefits to engagement. These include:
- Increased participation and retention levels
- Improved usability for participants with disabilities, low technical literacy, and limited device or internet access
- Higher satisfaction for some participants who prefer phone over computers
There is no doubt that CATI can make an impressive impact on overall data collection. Research staff can easily use CATI technology in a digital research platform like Research Cloud to conduct phone interviews with participants who want to interact with a human, or who need assistance completing study activities from home because of lifestyle or accessibility reasons.
Further, participant feedback indicates the CATI experience improves a participant’s knowledge of their own health history and the research in which they participate. One participant noted, “We covered lots of information and some of the conditions I had never even heard about, so I wrote those down.”
CATI sessions with participants in UBR categories:
- Overall = 95%
- Racial Identity = 75%
- Income = 43%
- Age = 33.0
- Education = 27%
- SGM = 7%
- Geography = 5%
- 30% of CATI sessions conducted in Spanish while only 5% of our research participant accounts have Spanish preference
- Organizations can effectively reach participants who are traditionally underrepresented in biomedical research via CATI.
Paper-Based Participation
Researchers today often overlook the importance of reaching cohorts through paper-based participation. Some populations may feel more comfortable with paper-based approaches including individuals who have low literacy levels and would prefer to have family members assist them remotely or due to a lack of comfort with technology.
The true benefit of using digital technology is when it enables researchers to use the methods that work for participants– while reducing the work effort and cost to combine offline and online data capture.
Supporting research participants by offering dual modes of participation provides benefits similar to using CATI:
- Increased participation and retention levels
- Reduced bias towards certain groups by including participants who are digitally underserved
Using Technology to Support Paper Collection for Research Participants
Let’s uncover some of the ways that technology, in this case the Research Cloud, pairs with direct mail.
Some techniques include:
- Integration with an on-demand direct mail service to distribute surveys and materials
- Targeted segmentation to further tailor materials for patient populations based on language, age, demographics, or location
- Using QR codes, vanity URLs, unique email addresses, and other tracking mechanisms to attribute the approach of outreach and gauge success across multiple campaigns
While there are great benefits to integrating paper responses in a digital research program, there are drawbacks, too.
Paper-based participation can create additional challenges to maintaining records. Check with governing bodies to determine if paper documentation must be saved after digitization and for how long following study closure.
Accurate data capture is essential to create meaningful inputs from these participants. There are many ways to streamline data entry but validating data should be a priority at time of entry.
Multiple Modes of Sample Collection (remote vs. in-person)
When face-to-face interaction between study staff and participants is not possible, there are alternative methods of collecting biospecimens and physical measures.
We can learn much from our clients who focus on infectious disease research, as an example. Those clients, as well as others who require biological samples for a study, can use digital research platforms like Vibrent’s Research Cloud to facilitate the distribution of testing and sample collection kits.
How Researchers Use Research Cloud to Enable Remote Testing Kits
Study staff use our digital research platform to order testing kits for participants who are unable or unwilling to visit a clinic for biological samples. Study participants can also self-order through the Vibrent Participant Experience Manager.
There are some unique benefits to the patient population in using remote testing processes.
Expanding access to participants:
- Support your patients regardless of their geographic location
- Increase accessibility to your patients who have limited or no transportation, limited mobility or chronic health conditions
Expanding data collection:
- Data can be collected any time of day or week and at participant’s convenience
- Tools can be used multiple times for data capture
- Devices provided by the study can be used for participant incentive and to benefit long-term health maintenance (e.g. measuring tape with a chart to understand relationship of waist to hip ratio on health, pulse oximeter, fitness tracker, blood pressure device, thermometer, etc.)
Are there Risks in Remote Specimen Collection?
Of course risks exist, especially if there is a mixed modal collection. For one, you must consider documentation of the method of collection, and explore the accuracy of the type of specimen you collect via these kits.
As an example, there could be a higher risk of failure in self-collection if your participants struggle to understand the instructions. This is one of the many reasons you must prioritize language and readability in the production of your study materials.
You must also explore if the interest in the health tool provided (if something besides a testing kit, e.g. a fitness tracker) could be seen as an external influence. Is it possible that the tool itself would drive enrollment and prevent authentic engagement in the study?
Also consider validation of specimen and other data, like EHR data, and association with the correct participant record. Thoroughly plan how to ensure the accuracy of this data entry when samples are received.
Finally, the expense of saliva kits vs. other collection methods (e.g. blood samples) is a necessary consideration. There could be added cost for shipping, processing, and lost/replaced assets that are not realized in lab or clinical collection.
Ensure you’ve reviewed all the risks, along with the benefits, as you determine the mix of approaches you will use to support a diverse population of study participants.
Use Technology to Reduce Digital Barriers in Your Research
Technology in health research can be used to create accessible, user-friendly experiences to those who need it most. And, surprisingly, technology is our best asset for addressing the digital divide and supporting data completeness across diverse groups of participants. The key is to consider your participant population along with your study goals, and tailor your approach accordingly.
CATI, paper processes, and remote data collection all have a role next to electronic data capture, wearables and future technology. And each of these plays a part in improving diversity in clinical trials and other research.
