Author: dcridigital

Deep Dive: A Closer Look at the Impact of School and Childcare Changes on Healthcare Workers

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As the COVID-19 pandemic continues to grip the U.S., the HERO Registry is shining a light on many of the challenges healthcare workers are facing. Similar to the the general population, healthcare workers who are are female and/or Latino or Hispanic are facing extra challenges when it comes to balancing work with changes in schools and childcare facilities.

We recently asked HERO members to identify how recent school and childcare changes have affected their ability to work. Of the 2,000 members that responded, 28% acknowledged feeling more distracted at work; 25% said they were more anxious because of school changes; 15% said they were struggling to find and pay for childcare; and 10% said they were unable to work the number of hours they need to work.

But a deeper dive into this HERO survey data shows differences when it comes to race/ethnicity and gender. Hispanic and Latino healthcare workers responding to the survey said that they were not available to work all the hours they needed to work at more than double the rate of white healthcare workers. Across all measures, healthcare workers who are Hispanic and Latino were more likely to report struggling with childcare issues than any other group.

A closer look at the HERO data also shows that while male and female healthcare workers are showing similar rates of not being able to work all hours needed and struggling to find childcare, women were more likely to identify with being distracted and more anxious while working than men.

What’s Next?

We appreciate the input from the HERO Community who help inform our research by completing our Hot Topic survey. Your participation helps bring awareness to the challenges healthcare workers are facing.

If you are not a HERO member, please join today. You can contribute to what it is like to work on the front lines of COVID-19, receive opportunities to participate in research, and help to protect all people working in health care as well as their families and communities.

Pauses in Vaccine Trials Build Trust and Show the System is Working

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Adrian Hernandez, MD, MHS, HERO Research Program principal investigator, recently shared his opinion in STAT News on the recent pauses of three COVID-19 vaccine trials.

“Holds and pauses certainly aren’t restricted to COVID-19 trials in the clinical trials sphere,” says Hernandez. “I believe that these three pauses show that the system is working.”

The goals of vaccine trials are to show a therapy is safe and effective in preventing infection. And in the era of COVID-19, researchers need to prove this in an extremely compressed timeline. What would typically take several years is now happening over several months.

With an accelerated timeline, confidence in the regulatory approval process is critical to willingness by the public to get vaccinated. A recent STAT-Harris Poll shows that Americans are less willing now to get a COVID-19 vaccine than they were a few months ago. In mid-August, 69% of Americans said they would get a vaccine once available. Asked again in October, only 58% said they would get vaccinated. The lack of interest was especially evident in Black individuals — 65% were interested in the first poll but only 43% in the second poll.

Hernandez shares how these recent holds in vaccine trials can help establish trust in the research system and acceptance when a vaccine is approved.

“It tells the American public that everyone is committed not just to developing new treatments, but to developing ones that are safe and effective. It also reassures current and future participants about taking part in studies of these new treatments that everyone is treating safety as a primary concern.” To read Hernandez’s entire opinion, visit STAT News.

Dental Professionals are on the Front Lines of COVID-19 with High Exposure to the Virus

Posted on by dcridigital

October is National Dental Hygiene Month — a time to acknowledge and thank dental hygienists and their colleagues who strive to brighten our smiles during this global pandemic.

Dental professionals along with other healthcare workers are at high risk of exposure to COVID-19 due to proximity to patients as well as to other workers. Dental practices were initially shut down for routine practice at the start of the pandemic. But today, many dental professionals have returned to work.

Based on an article in The New York Times and occupational information from O Net, dental hygienists face high exposure to disease and infection and physical proximity to other people. Although slightly less than hygienists, dental assistants and dentists also face high daily exposure and proximity.

Why are dental professionals at so much risk?

If you have had your teeth cleaned, you are familiar with the variety of instruments used in a dental office. These instruments create sprays of tiny droplets and aerosols containing not only water, but saliva, which could contain high levels of the virus in infected people. These particles can stay in the air for hours, be transmitted to others, and land on hard surfaces. Combine this with the fact that dental professionals are in close proximity to their patient’s face, and you can easily understand how this group faces particularly high risk.

“I can’t express enough how dangerous it is in a dental office right now, we have the ability to be asymptomatic and spread this to other people as much as we’re looking out for our own safety,” said Cindi Roddan, a dental hygienist, in a NBC Bay Area Investigation, “Everything that we do in dentistry creates aerosols. It is so dangerous.”

Coming together to fight COVID-19

Dental professionals along with all people who work in health care are invited to join the HERO Registry. HERO members share what it is like to work and live during the COVID-19 pandemic and have opportunities to participate in research to help protect and support all healthcare workers during this pandemic.

Join HERO today, share this flyer, and invite your colleagues to do the same.

Understanding the Science: An Update on Vaccine Trials

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Susanna Naggie, MD, Vice Dean of Clinical Research at Duke University School of Medicine and Principal Investigator for the HERO-HCQ trial

Anne Friedland, MD, Infectious Disease Program Fellow, Duke University School of Medicine

Most health experts agree that a crucial part of the global response to the COVID-19 pandemic is a preventative vaccine. An effective vaccine could prevent thousands of deaths and will likely be necessary to return to some semblance of life as we knew it pre-COVID-19.

People worldwide are eagerly anticipating a vaccine and pressures are mounting to expedite vaccine approvals. However, it is important that crucial steps in vaccine development are not rushed in attempts to expedite vaccine approvals. Once approved, vaccines will be rapidly mass distributed to millions of healthy people. Due to the number of people who will require vaccination, the bar for safety is very high — even higher than for an investigational drug given for a life-threatening disease, where the risk-benefit balance favors treatment. To consider risk-benefit for a vaccine deployed across a population and given to millions of people, the efficacy (aka the benefit) must be known and the safety must be high. The World Health Organization recommends a vaccine of at least 50% efficacy (meaning it will prevent disease in at least half of the people vaccinated) to be considered for public use.

Vaccines go through many steps in development before being deemed safe for wide public distribution. Randomized clinical trials are considered the gold standard for proving that a vaccine, drug, or a medical approach works. In these types of trials, one group is assigned by chance to receive the investigational vaccine and another group is assigned to receive a placebo. A placebo looks exactly like the investigational vaccine, but contains no active ingredients.

In phase one human trials, a vaccine is given to dozens of individuals who are closely monitored for side effects. If there are no serious side effects, phase two trials are started. In this phase, the vaccine is given to hundreds of individuals who are monitored for safety, and more detailed observations are made. It is not until phase three trials involving tens of thousands of individuals that vaccine efficacy can be determined. In this stage, researchers are looking to understand if the vaccine prevents new infections or if people do become infected, does the vaccine help them control the infection so that it doesn’t become severe disease. To help expedite vaccine development while maintaining the critical steps for assessing safety and efficacy, researchers are blending phases two and three. During this final phase and prior to approval, it is also possible for researchers to identify rare adverse effects that may not have been detected in earlier phases when the vaccine was given to fewer people.

There have been some promising initial results from phase one and two trials during the COVID-19 vaccine development, and we now have multiple vaccine candidates in a phase three trial. Recently, the AstraZeneca vaccine candidate was placed on hold due to the development of a severe neurologic disease, transverse myelitis, in two of the trial participants. One of these cases was determined to be a new diagnosis of multiple sclerosis, a progressive disease that can present with transverse myelitis. To date, approximately 18,000 people have received the vaccine worldwide. Transverse myelitis is diagnosed in approximately 1 in 236,000 Americans per year. Thus, this would be a rare complication, if it is deemed related to the vaccine.

The hold on the AstraZeneca vaccine highlights the potential risk of investigational vaccines and underscores the importance of large phase three studies to ensure safety and efficacy before widespread distribution. The pause also shows us the system of reviewing interim trial data to monitor the safety of participants is working.

As we await safety and efficacy data from vaccine trials, we must continue to emphasize consistent practices we know help to prevent transmission: universal masking, social distancing, avoiding large crowds, and hand washing. We also must continue to investigate other prevention strategies that may serve as a bridge until vaccines are available, or that may be used as part of an armamentarium to prevent SARS-CoV-2 transmission, which will be particularly important if vaccines are not highly effective. Oral antivirals and monoclonal antibodies are under investigation currently for prevention of COVID-19.  

The HERO-HCQ trial continues to enroll healthcare workers to test whether hydroxychloroquine (HCQ, brand name Plaquenil®) can prevent COVID-19 infection in healthcare workers. 

Learn more about HERO-HCQ and sign up to join the HERO Registry. HERO members are linked to opportunities to participate in HERO-HCQ and other clinical trials and research opportunities.

We Asked, You Answered: How School Changes are Affecting Healthcare Workers

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For the 40% of all U.S. households with children under 18, the pandemic is posing significant challenges as schools and daycares close, change schedules, or switch to virtual formats. But for healthcare workers, these changes in school schedules and formats can cause extra challenges and make the balancing act between work and home even harder.

We asked HERO members how school changes were affecting their lives. More than 2,000 members replied to our questions reporting that 28% feel more distracted at work, 25% are feeling more anxious because of school changes. In addition, 15% are struggling to find and pay for childcare, and 10% are not able to work the number of hours they need to work.

This chart shows how school or daycare has impacted a healthcare workers ability to work during the pandemic.

But even those who do not have children at home report that they are affected through extra shifts, feeling at risk caring for grandchildren, or managing their teams.

One HERO member said: “I don’t have children, but as a nursing executive I see the impact it has on the staff and our ability to staff our units. The core staff are more stressed, and our per diem staff are hesitant to pick up time because they don’t know if the schools will be making last minute changes and sending the kids home. It’s very challenging for the staff and the managers who want to support their staff but also need to meet the operational needs of their departments.”

Another added, “I am not a parent or caregiver; however, I am responsible for taking on extra responsibilities that my coworkers with children are less able to. While I’m trying to help, it’s adding to my burnout.”

There’s another hidden toll as many clinician-parents are trying to help their friends and fellow parents navigate the pandemic as well.

“As both a parent and a medical professional, I am completely exhausted by the dozens of ‘just one quick question’ calls I am getting from fellow parents who desperately want and need advice and reliable information, but don’t have a functional relationship with a healthcare provider of their own. Trying to find a healthy balance between keeping my work professional, maintaining boundaries for my own well-being, and supporting my community is a HUGE source of exhaustion, anxiety, distress, burnout and constant self-doubt in my life,” reported one HERO member.

For those who are able to have a full-time parent present to take care of school and daycare closures, loss of income or opportunity is another challenge: “Because my husband lost his job due to COVID-19, childcare isn’t an issue, but I am seriously stressed about the loss of income,” one HERO member said.

Many reported having less time for themselves as they rearrange work schedules to be home with children:

  • “I am working nights and weekends to help my children with e-learning and I am exhausted.”
  • “I have to now work nearly every weekend in order to be home during the week for virtual schooling.”
  • “I have to rearrange my work schedule to be home more during the week. I am working every weekend for the next ten weeks, at a minimum.”

For those who are not able to change their schedule, finding a work-life balance is hard as well: “I feel guilty that I’m not able to provide emotional and educational support for my child because I am working full time and longer days than ever. I’m a manager as well, so I am very stressed about my staff’s ability to work due to their children’s educational issues,” said one HERO member.

Many families of healthcare workers are struggling financially to manage school changes: “We have significant increases in childcare and education costs as we both are unable to work from home. To avoid loss of income and leave from work we have transferred our school age children into private school so they can attend in-person and are paying significantly more for childcare arrangements after school,” said one HERO member.

For those healthcare workers living in places where schools did not change schedules, the fear of change is significant and the normal schedule can cause disruption as well: “My wife has stopped watching our school-aged grandchild due to fear of them contracting COVID-19 from her since she is with other children in the classroom,” said one HERO member.

Many respondents said that while they do not have school aged children, they face other challenges such as caring for special-needs adults and children managing remote college.

These stressors are not unique to HERO members of course, but they do put extra stress on an already overly burdened healthcare system.

“A major goal of the HERO Registry is to listen to our members and give a larger voice to their experiences during the pandemic. School and child care changes are affecting all workers with young children at home,” said Emily O’Brien, principal investigator for the HERO Registry. “But for healthcare workers, these struggles may have a larger impact on the overall healthcare system. It’s important for leaders to hear these perspectives and understand their impact.”

As the nation heads into flu season on top of the COVID-19 pandemic, a strong healthcare workforce will depend on finding answers to safely provide childcare.

We appreciate the input from HERO Registry members who completed this survey. Your feedback helps bring awareness to the challenges healthcare workers are facing and guide future research needs. Our next topic will be on the financial impact of the pandemic.

If you have not joined HERO, sign-up today. Together through research we can identify solutions to help protect healthcare workers.

Perseverance in COVID-19 times: Why HERO-HCQ matters based on the results and learnings from the Minnesota HCQ pre-exposure prophylaxis study

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Results from the Pre-exposure Prophylaxis (PrEP) for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial for COVID-19 in healthcare workers study was published this week as preprint.

Researchers from the University of Minnesota conducted this randomized, double-blind, placebo-controlled clinical trial with 1,483 healthcare workers from across the U.S. and in the Canadian province of Manitoba. Participants were randomized to either 400 mg of HCQ once or twice weekly or a placebo for 12 weeks. The primary endpoint was confirmed or probable COVID-19-compatible illness. The HERO Research leadership commends the Minnesota research team for making their results available.

It is important to note that this paper has not been reviewed by experts in this area and that results from this study should not guide clinical practice. But, the results do provide additional evidence that HCQ is safe and generally well tolerated in the prevention setting. The study researchers concluded pre-exposure prophylaxis with HCQ once or twice weekly did not significantly reduce laboratory-confirmed COVID-19 or COVID-19-compatible illness among healthcare workers.

The research team acknowledged several study limitations: (1) the study was originally powered to detect a 50% relative effect size with a goal of enrolling 1,050 participants per arm (3,150 total), but it was stopped early (~495 per arm) due to slow enrollment and (2) the doses of HCQ studied were low (400 mg weekly or twice weekly) and resulted in low systemic exposures to HCQ. With these limitations in mind, the study reported that the primary outcome event rate was the same for both HCQ arms (5.9%), which was numerically lower than the event rate in the placebo arm (7.9%). This difference between the HCQ and placebo arms suggests those participants receiving HCQ had a 28% (weekly dosing) and 26% (twice weekly dosing) lower risk of confirmed or probable COVID-19-compatible illness than those receiving placebo. This difference did not meet statistical significance. When the arms of HCQ were combined, there was a 27% lower risk of COVID-19-compatible illness with a confidence interval ranging from 52% lower risk to 9% higher risk. 

What does this all mean? First, due to the early closure, this study is underpowered and thus cannot provide a definitive answer on the role of HCQ for prevention. The similar effect sizes in the HCQ arms and a trend towards significance when compared to placebo either alone or in combination underscores the need for a powered study to definitively answer this question.

Additional limitations of the study may be insufficient HCQ dosing. The dose in the Minnesota PrEP study at 400 mg weekly or twice weekly is lower than the dose in the HERO-HCQ study, which is 600 mg orally twice daily on day 1, followed by 400 mg daily for an additional 29 days.

HERO Research leadership are encouraged by the results from this study and are committed to finishing the HERO-HCQ study to return aggregate results to study participants, study sites, and the broader research community.

“Results from this study should not deter our efforts in HERO-HCQ but instead fuel our determination to complete enrollment and conduct a definitive study,” said Susanna Naggie, Vice Dean of Clinical Research at Duke University School of Medicine and Principal Investigator for the HERO-HCQ. “We are confident that the HERO-HCQ trial results will further contribute to the scientific community by definitively addressing the role of daily dosed HCQ for the prevention of clinical COVID-19 in people who work in health care.”

Learn more about this study and sign up to join the HERO Registry to be linked to opportunities to participate in HERO-HCQ and other clinical trials and study opportunities.

Researching HERO Community Priorities: Please Vote!

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The HERO program doesn’t just want to ask about healthcare worker experiences and opinions about COVID-19. We also want to listen and act.

HERO community members have identified three research questions about COVID-19 that are of the most interest to them through their participation in regular surveys.

  1. Dietary zinc supplement to prevent COVID-19 infection
  2. Mindfulness to reduce stress & improve well being
  3. Disinfection practices to reduce household transmission

We have emailed all HERO members to vote for which one of these ideas we should pursue for our next study. After the votes are in and the top question is selected, we will be designing and executing a rapid-cycle research project open to all HERO members. If you are not a HERO member yet, please sign up now so that you can help choose and participate in the next HERO study. We will also be polling our followers on Twitter as well.

This study is one of many opportunities for HERO community members to help fight COVID-19 and protect themselves and their communities through research:

  • The HERO-HCQ study is continuing to enroll participants throughout the country so that we can answer whether or not hydroxychloroquine is effective in preventing infection. While there has been a lot of confusion around this topic, this question has not yet been answered for primary prevention and the HERO study is continuing to find an answer. 
  • HERO members have expressed interest and willingness to participate in vaccine studies and several opportunities are currently being explored.
  • In addition to these opportunities, we have kicked off “hot topics” polling with the HERO community. HERO members will be asked each month about topics that are affecting their lives in real time. We hope the answers to these questions will help members feel less alone and help the media and public better understand their challenges. Stay tuned for our first hot topic – how changes to schools this year have affected healthcare workers with school aged children.