Imagine this: Your elderly mother, who has dementia, is in a nursing home and COVID-19 vaccines are due to arrive in a week or two.
You think she should be vaccinated, having heard the vaccine is effective in generating an immune response in older adults. Your brother disagrees. He worries that development of the vaccine was rushed and doesn't want your mother to be among the first people to get it.
These kinds of conflicts are likely to arise as COVID vaccines are rolled out to long-term care facilities across the country.
"This is a highly politicized environment, not only with respect to vaccines but also over the existence of the virus itself," said Michael Dark, a staff attorney with California Advocates for Nursing Home Reform. "It's not hard to imagine disputes arising within families."
About 3 million people — most of them elderly — live in nursing homes, assisted living centers and group homes, where more than 105,000 residents have died of COVID-19. They should be among the first Americans to receive vaccines, along with health care workers, according to recommendations from the Centers for Disease Control and Prevention and various state plans.
But long-term care residents' participation in the fastest and most extensive vaccination effort in U.S. history is clouded by a significant complication: More than half have cognitive impairment or dementia.
This raises a number of questions. Will all older adults in long-term care understand the details of the vaccines and be able to consent to getting them? If individual consent isn't possible, how will families and surrogate decision-makers get the information they need on a timely basis?
And what if surrogates don't agree with the decision an elderly person has made and try to intervene?
"Imagine that the patient, who has some degree of cognitive impairment, says 'yes' to the vaccine but the surrogate says 'no' and tells the nursing home, 'How dare you try to do this?" said Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison Law School.
Addressing these issues will occur against a backdrop of urgency. Deaths in long-term care facilities are rising dramatically, with new estimates suggesting that 19 residents die of COVID-19 every hour. With viral outbreaks increasing, already-overwhelmed staffers may not have much time to sit down with residents to answer questions or have conversations with families over the phone.
Meanwhile, CVS and Walgreens, the companies operating vaccine programs at most long-term care facilities, have aggressive timetables. Both companies have said the large-scale rollout of the Pfizer-BioNTech vaccine — the first one that the Food and Drug Administration has authorized — will begin on Dec. 21.But facilities in some states may get supplies earlier. Altogether, there are more than 15,000 nursing homes and nearly 29,000 assisted living residences in the U.S.
At a meeting of the federal Advisory Committee on Immunization Practices early this month, Dr. Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, acknowledged the agency was "very concerned" that information about vaccines be adequately explained to long-term care residents. "It's very important for the frail elderly not only to ensure that they are understanding the vaccine that they're getting but also that their family members do," she said.
Each vaccine manufacturer will be required to prepare a fact sheet describing what's known about benefits and risks associated with a vaccine, what's not known, and making it clear that a vaccine has received "emergency use authorization" from the FDA — a conditional endorsement that falls short of full approval. A second vaccine, from Moderna, is poised to receive this kind of authorization after an FDA meeting on Thursday.
Something that will need to be made clear to residents: while vaccines have been tested on people age 65 and older, those tests did not include individuals living in long-term care, according to Dr. Sara Oliver, a CDC expert.
Some operators have crafted communication plans around the vaccines and already begun intensive outreach. Others may not be well prepared.
Juniper Communities operates 22 senior housing communities (a standalone nursing home, multiple memory care and assisted living facilities, and two continuing care retirement communities) in Colorado, New Jersey and Pennsylvania. This week, it is planning an hour-long town hall videoconferencing session for residents and families about coronavirus vaccines. Last week, it held a similar event for staffers.
Juniper has contracted with CVS, which is requiring that every resident and staff member fill out consent forms in triplicate before being inoculated. When written consent can't be obtained directly, verbal consent, confirmed independently, may substitute. Walgreens has similar requirements.
For residents with memory impairment, two Juniper nurses will reach out by phone to whomever has decision-making authority. "One will ask questions and obtain verbal consent; the other will serve as a witness," said Lynne Katzmann, Juniper's founder and chief executive officer. Separately, emails, blog posts and prerecorded voice messages about the vaccines have gone out to Juniper residents and staffers, starting at the end of November.
A key message is "we've done this before, not at this scale, mind you, and not at this level of import, but we do flu vaccinations annually," said Katzmann, who plans to be the first Juniper employee to get the Pfizer vaccine when it comes to New Jersey.
At Genesis Healthcare, crucial messages are "these vaccines have been studied thoroughly, tens of thousands of people have received them already, they're very, very effective, and no steps have been skipped in the scientific process," said Dr. Richard Feifer, executive vice president and chief medical officer. Genesis, the nation's largest long-term care company, operates more than 380 nursing homes and assisted living residences in 26 states, with about 45,000 employees and more than 30,000 residents.
Medical directors at each Genesis facility have been scheduling video conferences with families, residents and staffers during the past few weeks to address concerns. They've also distributed a letter and a question-and-answer document prepared by the Society for Post-Acute and Long-Term Care Medicine, in addition to getting information out through closed-circuit TV channels and social media.
In partnership with Brown University researchers, the company will monitor daily the side effects that its long-term care residents experience after getting coronavirus vaccines. Most reactions are expected to be mild or moderate and resolve within a few days. They include fatigue, pain at the injection site, headaches, body aches, fever and, rarely, allergic responses.
Administering the vaccine will occur over three visits for all long-term care facilities. At the first, all Genesis residents and staffers will get inoculations. At the second, three to four weeks later, those same people will get a second dose, and new staffers and residents will get a first dose. At the third, those who still qualify for a second vaccine dose will get one.
What will happen if lots of people experience uncomfortable side effects and employees don't come in for a couple of days while recovering? "It's a very difficult problem and we're making contingency plans to address it," Feifer said.
And what about continuing care retirement communities — also known as "life plan communities" — where residents in skilled nursing, assisted living and independent living can reside in close proximity?
That's the case at Bayview in Seattle, which houses 210 residents in a 10-story building. For the moment, independent living residents aren't on the priority list but "I know there will be a contingent of residents and staff who won't want to be vaccinated and we'll see if we can use those vaccines for our independent living people instead," said Joel Smith, Bayview's health services administrator.
Logistical challenges are sure to arise, but many operators have an acute sense of mission. "It is critical that we lead the way out of this crisis," Feifer of Genesis said. "Nursing homes need to go first and be the first ones to address vaccine hesitancy head-on and be successful at generating a high level of acceptance. There is no alternative, no Plan B right now. We have to be successful."