Virtual-first care, or V1C, could increase the quality of healthcare and make it more patient-centric by letting patients combine in-person visits with virtual options such as video for seeing their care providers.
That’s the idea behind virtual-first care (V1C), a new care model centered on convenient, customized, high-quality care that integrates a full suite of services tailored directly to patients’ clinical needs and preferences. This package includes asynchronous communication such as texting; video and other live virtual modes; and in-person options.
V1C goes beyond what you might think of as standard “telehealth” by using evidence-based protocols and tools that include traditional and digital therapeutics and testing, personalized care plans, dynamic patient monitoring, and team-based approaches to care. This could include spit kits mailed for laboratory tests and complementing clinical care with health coaching. V1C also replaces some in-person exams with ongoing monitoring, using sensors for more ‘whole person’ care.
Amidst all this momentum, we have the opportunity to rethink the goals of healthcare innovation, but that means bringing together key stakeholders to demonstrate that sustainable V1C can redefine healthcare.
Established V1C healthcare providers such as Omada, Headspace, and Heartbeat Health, as well as emerging market entrants like Oshi, Visana, and Wellinks, work with a variety of patients who have complicated long-term conditions such as diabetes, heart failure, gastrointestinal illness, endometriosis, and COPD. V1C is comprehensive in ways that are lacking in digital health and its other predecessors: it has the potential to integrate multiple data streams, incorporate more frequent touches and check-ins over time, and manage a much wider range of chronic health conditions, improving lives and reducing disease burden now and in the future.
Recognizing the pandemic-driven interest in virtual care, significant energy and resources are already flowing fast toward V1C. Some of the world’s largest innovators jumped into V1C early on: Verily, Alphabet’s Life Sciences Company, launched Onduo in 2016 to disrupt the diabetes healthcare market, and is now well positioned to scale its solutions. Major insurers like Aetna and United now offer virtual-first plans to members, responding as organizations expand virtual options for employees. Amidst all this momentum, we have the opportunity to rethink the goals of healthcare innovation, but that means bringing together key stakeholders to demonstrate that sustainable V1C can redefine healthcare.
That was the immediate impetus for IMPACT, a consortium of V1C companies, investors, payers and patients founded last year to ensure access to high-quality, evidence-based V1C. Developed by our team at the Digital Medicine Society (DiMe) in collaboration with the American Telemedicine Association (ATA), IMPACT has begun to explore key issues that include giving patients more integrated experiences when accessing both virtual and brick-and-mortar care.
Digital Medicine Society
V1C is not, nor should it be, virtual-only care. In this new era of hybrid healthcare, success will be defined by how well providers help patients navigate the transitions. How do we smoothly hand a patient off from an onsite primary care physician to, say, a virtual cardiologist? How do we get information from a brick-and-mortar to a digital portal? How do you manage dataflow while still staying HIPAA compliant? There are many complex regulatory implications for these new models, as well as an evolving landscape in terms of privacy, security and interoperability. It will be no small task for groups like IMPACT to determine the best path forward.
None of these factors matter unless the industry can recruit and retain clinicians. Our field is facing an unprecedented workforce crisis. Traditional healthcare is making clinicians miserable, and COVID has only accelerated the trend of overworked, disenchanted healthcare workers leaving in droves. Clinicians want more interactions with patients, and fewer with computer screens – call it “More face time, less FaceTime.” No new model will succeed unless the industry can more efficiently deploy its talent – arguably its most scarce and precious resource. V1C can help with alleviating the increasing burden and frustration borne by individual physicians in today’s status quo.
In healthcare, new technological approaches inevitably provoke no shortage of skepticism. Past lessons from Silicon Valley-driven fixes have led to understandable cynicism. But V1C is a different breed of animal. By building healthcare around the patient, not the clinic, V1C can make healthcare work better for patients, payers and providers. We’re at a fork in the road: we can revert back to a broken sick-care system, or dig in and do the hard work of figuring out how this future-forward healthcare system gets financed, organized and executed. As a field, we must find the courage and summon the energy to embrace this moment, and make it a moment of change.
Jamie Rettinger with his now fiance Amie Purnel-Davis, who helped him through the clinical trial.
Melanoma is the deadliest form of skin cancer. About 85,000 people are diagnosed with it each year in the U.S. and more than 8,000 die of the cancer when it spreads to other parts of the body, according to the Centers for Disease Control and Prevention (CDC).
There are two peaks in diagnosis of melanoma; one is in younger women ages 30-40 and often is tied to past use of tanning beds; the second is older men 60+ and is related to outdoor activity from farming to sports. Light-skinned people have a twenty-times greater risk of melanoma than do people with dark skin.
"When I graduated from medical school, in 2005, melanoma was a death sentence" --Diwakar Davar.
Jamie had a follow up PET scan about six months after his surgery. A suspicious spot on his lung led to a biopsy that came back positive for melanoma. The cancer had spread. Treatment with a monoclonal antibody (nivolumab/Opdivo®) didn't prove effective and he was referred to the UPMC Hillman Cancer Center in Pittsburgh, a four-hour drive from his home in western Ohio.
An alternative monoclonal antibody treatment brought on such bad side effects, diarrhea as often as 15 times a day, that it took more than a week of hospitalization to stabilize his condition. The only options left were experimental approaches in clinical trials.
Early research
"When I graduated from medical school, in 2005, melanoma was a death sentence" with a cure rate in the single digits, says Diwakar Davar, 39, an oncologist at UPMC Hillman Cancer Center who specializes in skin cancer. That began to change in 2010 with introduction of the first immunotherapies, monoclonal antibodies, to treat cancer. The antibodies attach to PD-1, a receptor on the surface of T cells of the immune system and on cancer cells. Antibody treatment boosted the melanoma cure rate to about 30 percent. The search was on to understand why some people responded to these drugs and others did not.
At the same time, there was a growing understanding of the role that bacteria in the gut, the gut microbiome, plays in helping to train and maintain the function of the body's various immune cells. Perhaps the bacteria also plays a role in shaping the immune response to cancer therapy.
One clue came from genetically identical mice. Animals ordered from different suppliers sometimes responded differently to the experiments being performed. That difference was traced to different compositions of their gut microbiome; transferring the microbiome from one animal to another in a process known as fecal transplant (FMT) could change their responses to disease or treatment.
When researchers looked at humans, they found that the patients who responded well to immunotherapies had a gut microbiome that looked like healthy normal folks, but patients who didn't respond had missing or reduced strains of bacteria.
Davar and his team knew that FMT had a very successful cure rate in treating the gut dysbiosis of Clostridioides difficile, a persistant intestinal infection, and they wondered if a fecal transplant from a patient who had responded well to cancer immunotherapy treatment might improve the cure rate of patients who did not originally respond to immunotherapies for melanoma.
The ABCDE of melanoma detection
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Clinical trial
"It was pretty weird, I was totally blasted away. Who had thought of this?" Jamie first thought when the hypothesis was explained to him. But Davar's explanation that the procedure might restore some of the beneficial bacterial his gut was lacking, convinced him to try. He quickly signed on in October 2018 to be the first person in the clinical trial.
Fecal donations go through the same safety procedures of screening for and inactivating diseases that are used in processing blood donations to make them safe for transfusion. The procedure itself uses a standard hollow colonoscope designed to screen for colon cancer and remove polyps. The transplant is inserted through the center of the flexible tube.
Most patients are sedated for procedures that use a colonoscope but Jamie doesn't respond to those drugs: "You can't knock me out. I was watching them on the TV going up my own butt. It was kind of unreal at that point," he says. "There were about twelve people in there watching because no one had seen this done before."
A test two weeks after the procedure showed that the FMT had engrafted and the once-missing bacteria were thriving in his gut. More importantly, his body was responding to another monoclonal antibody (pembrolizumab/Keytruda®) and signs of melanoma began to shrink. Every three months he made the four-hour drive from home to Pittsburgh for six rounds of treatment with the antibody drug.
"We were very, very lucky that the first patient had a great response," says Davar. "It allowed us to believe that even though we failed with the next six, we were on the right track. We just needed to tweak the [fecal] cocktail a little better" and enroll patients in the study who had less aggressive tumor growth and were likely to live long enough to complete the extensive rounds of therapy. Six of 15 patients responded positively in the pilot clinical trial that was published in the journal Science.
Davar believes they are beginning to understand the biological mechanisms of why some patients initially do not respond to immunotherapy but later can with a FMT. It is tied to the background level of inflammation produced by the interaction between the microbiome and the immune system. That paper is not yet published.
Surviving cancer
It has been almost a year since the last in his series of cancer treatments and Jamie has no measurable disease. He is cautiously optimistic that his cancer is not simply in remission but is gone for good. "I'm still scared every time I get my scans, because you don't know whether it is going to come back or not. And to realize that it is something that is totally out of my control."
"It was hard for me to regain trust" after being misdiagnosed and mistreated by several doctors he says. But his experience at Hillman helped to restore that trust "because they were interested in me, not just fixing the problem."
He is grateful for the support provided by family and friends over the last eight years. After a pause and a sigh, the ruggedly built 47-year-old says, "If everyone else was dead in my family, I probably wouldn't have been able to do it."
"I never hesitated to ask a question and I never hesitated to get a second opinion." But Jamie acknowledges the experience has made him more aware of the need for regular preventive medical care and a primary care physician. That person might have caught his melanoma at an earlier stage when it was easier to treat.
Davar continues to work on clinical studies to optimize this treatment approach. Perhaps down the road, screening the microbiome will be standard for melanoma and other cancers prior to using immunotherapies, and the FMT will be as simple as swallowing a handful of freeze-dried capsules off the shelf rather than through a colonoscopy. Earlier this year, the Food and Drug Administration approved the first oral fecal microbiota product for C. difficile, hopefully paving the way for more.
An older version of this hit article was first published on May 18, 2021
