During the Covid-19 pandemic, America’s 53 million family caregivers gained some long overdue recognition for their vital role as unpaid extenders of an under-resourced health care workforce. The clinical trial enterprise, however, has yet to appreciate caregivers — and fully engage them — as critical partners in recruiting and supporting people who are older, disabled, or have Alzheimer’s disease, cancer, or other chronic medical conditions for research studies.
There are many reasons why people — patients and caregivers alike — may want to participate in clinical trials. Some are motivated by the hope of finding a cure or a life-extending treatment for themselves; others seek to help others, even if there is little hope for themselves or their loved ones. For caregivers, there is the assurance of getting the best possible care for their loved ones, typically for free or at reduced cost, as well as the opportunity to become more knowledgeable about their loved ones’ condition and treatment.
Despite these potential benefits, researchers often find it difficult to recruit and retain people who are eligible for their trial, particularly among underrepresented populations.
Because caregivers are typically the person closest to the participant, they can be crucial allies in both increasing and diversifying clinical trial participation. They can also speed research and reduce research expenses by keeping participants from dropping out of trials while caring for them, supporting their treatment, transporting them to and from study sides, and providing researchers with essential data and observations that participants may not be aware of or may not be able to convey.
One of us (S.I.) once cared for a hospitalized patient who became very ill during a study. Though she was responsible for conducting patient interviews, she decided one day not to burden this patient with an interview due to the severity of his illness. But as she passed by his room, the patient’s wife spotted her and followed her down the hallway, demanding that she do the interview.
“Participating in your study is the number one priority of his life right now! Contributing to the research is his legacy,” the woman said of her sick husband. “Please don’t pass by his room again!”
The other of us (J.R.) has worked closely with caregiver advocates like Yvonne Latty, who testified before Congress on the importance of clinical research participation to addressing her mother’s Alzheimer’s disease while acknowledging how difficult it was. As she said, “I was thrilled that she was going to be a part of [a trial], and hopeful that it could help her. But it was grueling.”
Engaged and committed caregivers can be key not only to getting people into clinical trials but to keeping them in trials for all the follow-up visits, interviews, and procedures, which typically can last for several years.
To integrate caregivers into clinical trials, researchers must treat them as partners. Even without the extra work of a trial, caregivers lead stressful lives, caring for people with serious illnesses or disabilities often while working full- or part-time. Inviting them into a research study means offering them an opportunity — but it also means asking them to do more work.
That needs to be factored in from the beginning by designing research in a way that recognizes caregivers’ critical contributions. Researchers must consider how their study designs and decisions enable or inhibit caregiver participation. How long will the trial last? What are the transportation commitments? Do participants need to make multiple visits to multiple sites? Will caregivers need to take time off from work to enable the person they care for to participate?
Answers to these and other questions must inform thinking about how caregivers are compensated, as well as how to provide needed supports like transportation, childcare, and respite care. Lessons learned from the quick shift to virtual care during the early phase of the Covid-19 pandemic can inform when it is possible — even preferable — to collect data remotely, reducing or eliminating travel to trial sites.
Some of these issues are referenced in a recent report from the National Academies of Sciences, Engineering, and Medicine, which we helped write as members of the committee.
We recommend co-enrolling caregivers with patients in research studies once the patient consents. In studies on delirium and functional decline in hospitalized older adults that one of us (S.I.) leads, researchers are trained how to educate participants and family caregivers alike on study participation and address their questions. They walk caregivers through the orientation just as they do the participants, so everyone knows what’s involved up front and what to expect. Recruiting participants and their caregivers into research should be a dual process that engages caregivers as partners and addresses any barriers they may face to participation.
In short, the foundation for successful caregiver engagement needs to be in place before recruitment begins. Caregivers shouldn’t be pulled into a system that’s unable to support them. That means making efforts to incorporate patient and caregiver perspectives into the earliest phases of research, including the development of research questions, study protocol designs, and data collection strategies.
The clinical trial enterprise could reap numerous benefits from engaging family caregivers in studies: improved participant representation, better compliance with protocols, reduced drop-out rates, and even higher-quality data. But engagement goes hand in hand with support. Many family caregivers are ready and willing to be partners in research — if they are treated as partners right from the start.
Sharon Inouye is a geriatrician, director of the Aging Brain Center at the Hinda and Arthur Marcus Institute for Aging Research in Boston, and professor of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center. Jason Resendez is the president and CEO of the National Alliance for Caregiving.