Home Visits Are Trial Participants’ Least-Favored Decentralized Approach
Bringing the trial to the patient has become a critical focus in research, but it’s important that efforts stay grounded on what patients truly want. A new survey shows a reluctance toward home visits — a mainstay of decentralized trial approaches — particularly among underrepresented groups.
The survey, conducted by Velocity Clinical Research, received responses from 1,129 clinical trial-experienced Americans (split about one-third male and two-thirds female) on their perspectives and attitudes toward decentralization, the use of technology and other elements of trial participation.
Though the respondent pool was 85 percent White, the answers from Hispanic/Latin (5 percent), Black/African American (5 percent), Asian (2 percent) and American Indian/Alaska Native (2 percent) offer valuable insights into factors that can motivate or deter trial participation in underrepresented groups. In particular, the response to home visits stood out.
On paper, home visits sound like a strong solution to accessibility challenges for many patients, including underrepresented populations — but these latest findings suggest they may hurt more than they help. According to the survey, two-thirds of respondents under age 35 were against home visits, while just 45 percent over age 65 supported having healthcare staff come to their homes.
Overall, just half (51 percent) of respondents said they would be willing to allow at home visits as part of trial participation, making it by far the least supported decentralized methodology. And when given the choice between site visits and at home visits, 76 percent of respondents preferred the option to go to the clinic.
Interestingly, some groups were against home visits more than others, the researchers found. For example, no Black women selected home visits when asked to pick between them, virtual appointments and on-site appointments for future participation in trials, while 70 percent of Black women under age 35 and 90 percent of Black women age 55 to 64 said they wanted to do future trials at the site itself.
Similar preferences were seen among older women and younger respondents: 79 percent of women over age 65 and 82 percent of females under age 25 voiced their desires to go to a clinic for visits, while women age 45 to 54 showed the greatest support for more virtual visits (59 percent).
Hispanic women were more likely to allow home visits than women in other underrepresented groups, but they were not particularly enthusiastic about this approach. Specifically, 55 percent of Hispanic women age 35 to 54 said they would be open to allowing home visits, contrasting with just 35 percent of women from other diverse backgrounds.
“Some participants who may live in cramped conditions or in accommodation with lots of people might not have a private space to conduct a health visit from a practitioner. Equally, some people might not want other people in their household or community to know they are taking part in a clinical trial,” G. Paul Evans, chief executive and president of Velocity, told CenterWatch Weekly.
“When it comes to health care, people want human interaction. That’s why we think a hybrid model between brick-and-mortar sites combined with technology is going to be the premier solution for recruiting patients to trials, going forward,” he said.
Other decentralized methods fared better on the survey. A majority of respondents said they were comfortable with using various technologies for visits and data collection, although their acceptance varied considerably depending on the approach. Mobile eDiaries received the most support (82 percent), followed by telehealth (78 percent), wearables (75 percent) and self-collection of biosamples (64 percent). eDiary done on a desktop computer received less support than its mobile counterpart, coming in at 63 percent.
The survey offers a deeper look into patient attitudes toward these technologies. For example, there was a significant difference between acceptance of telehealth by age; older patients, except for those over age 65, were more supportive of this approach, while younger patients were significantly less interested. This was seen most profoundly in women age 55 to 64 (90 percent) vs. women age 18 to 34 (45 percent). Despite the current hesitancy revealed by the survey, Velocity predicts an increased acceptance of this approach in trials as it becomes more widely used in routine medical care.
Reluctance was also seen in certain subgroups when it came to wearable devices for tracking blood pressure, heart rate, glucose levels and other measurements. For instance, just 46 percent of African American men said they would want to use wearables in trials compared to 65 percent of African American females who said they’d be willing. And significant differences were again seen between age groups — 55 percent of participants over age 35 said they were comfortable using wearables in trials compared to a dismal 35 percent of participants age 18 to 35, suggesting younger patients aren’t experienced with the use of wearables in clinical research.
Remote technologies used in trials thus far have been “fairly elementary,” Velocity says, compared to commercial phone apps and digital devices and aren’t as widely used in clinical research as they may seem.
According to the survey, 43 percent of participants across all age groups had never encountered trial-related home visits, texts or even phone calls, while not even 3 percent of respondents over age 45 had experienced all three. Barely half (54 percent) had used an eDiary in a trial before despite their strong willingness to use it. Just one in five said they had used wearables in a trial, 17 percent used an eDiary on a computer, 17 percent gathered biosamples at home and 28 percent had not encountered any of these.
The survey shows decentralized approaches can be beneficial as long as they are designed and used in a patient-centric manner — and that the traditional medium of participation isn’t replaced along the way. “The use of technology in clinical trials is set to increase. The key is to give patients choices,” Evans said.
“If you have people between the ages of 35 and 45 filling out an eDiary, send push notifications at times of the day when they are less busy running a household. Millennials and Gen Zs, to a large degree, use fitness trackers, so why not build monitoring devices into something they already use?” he said. “Technology in clinical research has to be built along patient-centric lines. The overall design of protocols by sponsors must integrate the physical with the virtual and remove patient burden.”
Read the full survey report here: https://adobe.ly/3Mr2YKZ.