Rapid vaccine rollout at nursing homes raises concern.

Many questions remain regarding consent by elderly

As coronavirus vaccines arrive at California nursing homes and long-term care facilities, many residents will be eager to receive a vaccine that promises to finally ease the months of grief and isolation. Before that can happen, though, facilities must obtain consent from their residents, and a growing number of advocates are raising concerns that residents may not get their doubts and questions adequately addressed amid the rapid pace of the vaccination program and varied levels of information given from facility to facility.

“This is a huge trust exercise like nothing we’ve been through since probably the polio vaccine,” said Tracy Greene Mintz, a social worker and senior care consultant based in Redondo Beach.

In California, COVID-19 has infected nearly 36,000 nursing home residents, resulting in just over 5,300 deaths. Add in staffers who have died of the coronavirus and 35% of the state’s total COVID-19 deaths trace back to nursing homes and long-term care facilities. It is why residents in such facilities are among the first recipients of vaccines.

Mintz said many long-term care residents will have zero hesitancy giving consent. “They are like, ‘Sign me up, I want to see my family, let’s go go go,’ ” she said. But others will struggle to understand the risks, benefits and unknowns of a new vaccine. “You’re going to have residents who are blind or hard of hearing or don’t speak English, and they’ll need someone to interpret for them.”

Complicating consent even further, the rollout of covid vaccines is occurring in a highly charged political climate that often stokes skepticism about science and government. What’s more, about two-thirds of nursing home residents in the U.S. have some form of cognitive impairment. If residents have a medical proxy, facilities are supposed to reach out to them to get either verbal or written consent to deliver the vaccine, and then record the details of the conversation in the notes section of the consent form.

When there’s no family or legal representative to reach out to, an interdisciplinary team of social workers, nurses and doctors will make the call, Deborah Pacyna, director of public affairs for the California Association of Health Facilities, said. If it is determined that the resident has no cultural, religious or medical reason to avoid the vaccine, Pacyna said, chances are the team will approve giving the vaccine.

“As an ombudsman, I am wary of that process,” said Nicole Howell, executive director of Ombudsman Services of Contra Costa, So

lano and Alameda counties, a nonprofit watchdog group that monitors the care provided to 29,000 residents in nursing homes and other long-term care facilities in those counties. “I just always want to make sure an individual’s right to selfdetermination is respected and guarded as much as possible.”

Pfizer and Moderna, manufacturers of two coronavirus vaccines, report that in clinical trials their vaccines were about 95% effective in preventing coronavirus infections, and side effects like fever, soreness at the injection site and fatigue tended to be short-lived. But the vaccines, which were deemed safe and granted emergency use authorization by the FDA last month, were just recently developed. Longterm studies that could alleviate fears of unforeseen

complications down the line have yet to occur.

Over 1,200 skilled nursing facilities and 14,000 assisted living facilities in California are eligible to take part in a federal program that has contracted with Walgreens and CVS to administer the vaccines.

About 90% of skilled nursing facilities and 65% of assisted living facilities have signed up for the program so far, according to the California Department of Public Health. For those that did not sign up, local health departments are charged with helping to create a vaccination plan.

Some facilities are still in the dark about when they may receive vaccinations. But many already have received tentative vaccination dates and consent forms from Walgreens and CVS that must be completed before pharmacists appear toting vaccines in coolers.

Howell has reviewed the consent forms provided by Walgreens and CVS and feels confident that if inter

disciplinary teams are given the time to make thoughtful decisions and are not being rushed, that first step in the vaccination process should go smoothly. “I’m watching cautiously,” she said. The bigger issue may be that two pharmacies are tasked with vaccinating hundreds of thousands of residents in long-term care. “We need more hands on the pump,” she said, arguing that local health departments and large health facilities like Kaiser should assist in vaccinating.

California’s initial allotment of 327,000 doses of the Pfizer vaccine is set to be followed by hundreds of thousands more doses from both Pfizer and Moderna. The initial goal was to vaccinate 2 million health care workers and 400,000 residents by late winter, though it’s likely to take longer.

It is a momentous undertaking, and the vaccine itself is profoundly different than other vaccines. Rather than using a small dose of the virus, these vaccines de

liver a “shock protein” that messages the immune system to create antibodies that ward off coronavirus infection.

When it comes to getting consent for this vaccine, though, the process mimics that of more familiar injections, like the flu shot or shingles vaccine. Residents receive information on risks and benefits, and California law then requires that either the resident or their proxy agree or deny the injection.

The Centers for Disease Control and Prevention has recommended that residents or their representatives read a six-page fact sheet about the vaccine before consenting. Mike Dark, an attorney with California Advocates for Nursing Home Reform, argued that such an approach doesn’t take into account the pop

ulation in long-term care settings. “If you hand an 85-year- old resident a sixpage document, they’re going to say, ‘I need to talk to my family right now,’ ” he said. “And right now, it’s extremely hard for that supportive decision-making to take place.”

Dark would like to see families allowed into facilities under COVID-19 safety protocols to help residents who may be wrestling with the decision. He’d also like there to be more of a uniform consent process, ensuring residents in all facilities are given equal time and space to fully understand what they’re agreeing to, and not simply handed a fact sheet.

In an effort to address concerns about the vaccine, the CDC and other organizations have hosted webinars and created informational videos and educational PowerPoint presentations.

But Chis Laxton, executive director of the Society for Post-Acute and LongTerm Care Medicine, said that how much of this extra information facilities make available to residents is largely up to them. And though a more thorough, consistent approach to educating residents and gaining consent might be ideal, the priority is ending the crisis. “I think it’s more important to get people vaccinated,” he says. “We need needles in arms, and we needed that yesterday.”