key: cord-0982493-sagb5hex
authors: Rodriguez, Robert M.; Torres, Jesus R.; Chang, Anna Marie; Haggins, Adrianne N.; Eucker, Stephanie A.; O’Laughlin, Kelli N.; Anderson, Erik; Miller, Daniel G.; Wilkerson, R. Gentry; Caldwell, Martina; Lim, Stephen C.; Raja, Ali S.; Baumann, Brigitte M.; Graterol, Joseph; Eswaran, Vidya; Chinnock, Brian
title: The Rapid Evaluation of COVID-19 Vaccination in Emergency Departments for Underserved Patients Study
date: 2021-05-31
journal: Ann Emerg Med
DOI: 10.1016/j.annemergmed.2021.05.026
sha: 4c501762e8559cb077b1d869fa780e7ead8e836e
doc_id: 982493
cord_uid: sagb5hex

Objectives Emergency departments (EDs) often serve vulnerable populations who may lack primary care and have suffered disproportionate COVID-19 pandemic effects. Comparing patients having and lacking a regular source of medical care and other ED patient characteristics, we assessed COVID-19 vaccine hesitancy, reasons for not wanting the vaccine, perceived access to vaccine sites and willingness to get the vaccine as part of ED care. Methods Cross sectional survey conducted from 12/10/2020 to 3/7/21 at 15 safety net United States EDs. Primary outcomes were COVID-19 vaccine hesitancy, reasons for vaccine hesitancy, and sites (including EDs) for potential COVID-19 vaccine receipt. Results Of 2575 patients approached, 2301 (89.4%) participated. Of the 18.4% of respondents who lacked a regular source of medical care, 65% used the ED as their usual source of healthcare. The overall rate of vaccine hesitancy was 39%; the range among the 15 sites was 28 to 58%. Respondents who lacked a regular source of medical care were more commonly vaccine hesitant than those who had a regular source of medical care (47 vs 38%, 9% difference, 95% CI 4 – 14%). Other characteristics associated with greater vaccine hesitancy were younger age, female gender, African American race, Latinx ethnicity, and not having received an influenza vaccine in the past five years. Of the 61% COVID-19 vaccine acceptors, 21% stated that they lacked a primary doctor or clinic to receive it; the vast majority (95%) of these respondents would accept the COVID-19 vaccine as part of their care in the ED. Conclusions ED patients who lack a regular source of medical care are particularly hesitant to COVID-19 vaccination. Most COVID-19 vaccine acceptors would accept it as part of their care in the ED. EDs may have pivotal roles in COVID-19 vaccine messaging and delivery to highly vulnerable populations.

The greatest public health crisis of the past century, the SARS-CoV-2 (COVID- 19 ) pandemic has led to over 500,000 deaths in the United States (US) as of February 23, 2021. 1 While community lockdowns, social distancing, contact tracing and mask wearing have had varied success in stemming COVID-19 spread, adherence to these interventions has waned over time, and these measures are essentially bridges to the ultimate mitigation measurebroad population COVID-19 immunization. [2] [3] [4] [5] [6] The strength of immunization for pandemic mitigation is predicated on broad acceptance and administration of COVID-19 vaccines to a majority of the population. To achieve herd immunity from COVID-19 infection, experts have estimated that approximately 67-90% of the population must be immune (by either vaccination or natural infection). 7, 8 With approximately a third of the population saying that they will not accept it, COVID-19 vaccine hesitancy is a major barrier to reaching this target in the US. [9] [10] [11] [12] [13] [14] [15] [16] The major limitation of prior investigations of COVID-19 vaccine hesitancy is that they have been primarily conducted online or by telephone, sampling methods that often miss medically underserved or disadvantaged populations who may be at the greatest risk from COVID-19 infection. [17] [18] [19] They also may not reflect the attitudes of patients during true, in-person healthcare encounters, when they might actually receive a vaccine.

The emergency department (ED) has been commonly described by policymakers as "the safety net of the safety net". 20 With approximately 140 million visits in the US annually, EDs serve as the primary (and often only) health care access point for up to a fifth of the population that includes a number of vulnerable groups -immigrants, persons experiencing homelessness, the impoverished, and the uninsured, many of whom fall into high-risk categories for poor outcomes from COVID-19 infection. [21] [22] [23] [24] [25] [26] [27] [28] [29] [30] [31] Minorities, especially African Americans and Latinos who have suffered disproportionate morbidity and mortality during the pandemic, also receive high amounts of primary healthcare through EDs. [21] [22] [23] [24] [25] [26] [27] [28] J o u r n a l P r e -p r o o f

The overall premise underlying this research is that efforts toward vaccinationbased herd immunity, prevention of disease in high-risk, vulnerable groups, and equitable distribution of the COVID-19 vaccine must go where vulnerable individuals go for care and consider ED-based vaccine messaging and administration programsanalogous to other programs pioneered in the early 1990s in which EDs provide influenza and pneumococcal vaccines. [32] [33] [34] [35] [36] [37] In this in-person survey study of patients conducted in a real-world, healthcare safety net setting (patient visits to 15 EDs across the US), we assessed the need for such ED-based programs. Comparing patients having and lacking a regular source of medical care and delineating a group that uses the ED as their usual source of care, we assessed COVID-19 vaccine hesitancy, reasons for vaccine hesitancy, and willingness to get the COVID-19 vaccine as part of ED care. Boston, MA). The median annual visits to these EDs was 77,000 (range 45,000 to 120,000). We obtained institutional review board (IRB) approval to conduct this survey study by scripted verbal consent at all study sites. We followed the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines.

The lead investigator reviewed existing literature on vaccine hesitancy and consulted with experts in survey development at the University of California San Francisco (UCSF) to generate an initial survey template. Questions about vaccine hesitancy were adapted from previously published instruments. [9] [10] [11] [12] [13] [14] [15] [16] We reviewed this J o u r n a l P r e -p r o o f initial template with a focus group of eight community participants from the UCSF COVID-19 Patient Community Advisory Board (PCAB) to gain recommendations about survey questions' relevance, wording, cultural sensitivity, comprehension, and length;

we also sought input on overall study procedures in terms of survey location, timing, languages needed and delivery. Investigators on the research team reviewed and edited the template according to focus group recommendations, and we represented this second iteration to the PCAB for final review and editing. We pilot tested the final instrument on six ED patients at the core site and found excellent comprehension and response consistency (Survey Supplement).

Because of differing times to receive IRB approval, the sites began enrollment at different times from December 10, 2020 to January 21, 2021; each site targeted enrollment of 150 patients over a 5-week period. We enrolled adult patients (> 18 years of age) using convenience sampling according to the availability of study personnel (typically four-to six-hour time blocks), excluding patients with these characteristics: major trauma, transfer from another facility, incarceration, psychiatric hold, intoxication, altered mental status, critical illness, and temporary visit from another country.

Research personnel reviewed triage logs and ED electronic health record census boards to identify potentially eligible participants. At eleven sites all surveys were conducted in person; given constraints for in-person surveys during the pandemic, three sites utilized a second mechanism of calling into telephones in ED patient rooms to conduct the survey, and one site called patients immediately after ED discharge. After scripted verbal consent, research personnel read survey questions to participants directly from data collection forms and tablets in their preferred language. Before questions about COVID-19 vaccines, we presented this statement: It is likely that one or more vaccines for COVID-19 will be available in the spring or summer of next year.

While these vaccines cannot assure complete protection, they will decrease your and your family members' likelihood of becoming infected with COVID-19. These vaccines will likely be provided free of charge.

Vaccine hesitancy was defined as a "no" or "unsure" response to the question: Our primary outcomes were responses to key survey questions regarding acceptance versus non-acceptance (hesitancy) of the COVID-19 vaccine, reasons for vaccine hesitancy, sites for potential receipt of the COVID-19 vaccine, and acceptability of the COVID-19 vaccine as part of care in the ED.

We summarized patient characteristics as raw counts and frequency percent and aggregate key survey question responses as percentages with 95% confidence intervals (CIs), excluding non-responses to individual questions in proportion denominators. To assess differences in vaccine hesitancy between groups (have vs lack regular source of medical care, male vs female gender, African American vs White race, Latinx vs White/non-Latinx ethnicity, homeless vs housed and having received an influenza vaccine in the past five years vs not having received an influenza vaccine), we compared 95% CIs around differences in proportions. We used a two-sample Wilcoxon rank-sum test to test for differences in vaccine hesitancy for the non-normally distributed age characteristic. We further stratified vaccine hesitancy by the 15 sites, along with data regarding having a regular source of medical care and ED usual source of care for context. We stratified reasons for vaccine hesitancy according to whether respondents had a regular source of medical care.

In our a priori sample size calculation, we determined that we would need to enroll 2,144 patients to attain a 2% margin of error around point estimates of primary outcome questions and therefore sought 150 respondents at each of the 15 sites. We 

Of 2575 patients approached, 2301 (89.4%) participated: 339 (14.7%) had been previously diagnosed with COVID-19. Most respondents (81%) had primary care doctors or clinics. Of the 19% who lacked primary care, 65% used the ED as their usual source of healthcare and 26% went to an urgent care center or clinic. As compared to have primary care patients, no primary care patients were younger (median age 36 vs 52 years, p < 0.001), more often male (67% vs 47%, p < 0.001), more commonly Latinx (37% vs 21%, p < 0.001), more commonly homeless (10% vs 2%, p < 0.001), more commonly uninsured (38% vs 7%, p < 0.001), less commonly had English as their primary language (71% vs 83%, p < 0.001), and less commonly had received a flu vaccine in the past five years (46% vs 74%, p < 0.001).

The overall rate of vaccine hesitancy was 39% (95% CI 37 to 41%).

Respondents who lacked a regular source of medical care were more commonly vaccine hesitant than those who had a regular source of medical care (47 vs 38%; 9% difference, 95% CI 4 to 14%); likewise, the subgroup of ED usual source of care respondents was more vaccine hesitant than those who had a regular source of medical care (46% vs 38%; difference 8%, 95% CI 2 to 14%). Other characteristics associated with greater vaccine hesitancy were younger age (median 40 vs 52, p < 0.0001), (female gender (45% vs 33%; difference 12%, 95% CI 8 to 16%), African-American race (54% vs 30%; difference 24%, 95% CI 19 to 29%), Latinx ethnicity (39% vs 30%; difference 9%, 95% CI 4 to 14%), and not having a prior influenza vaccine in the past five years (58% vs 31%; difference 27%, 95% CI 23 to 32%). Homelessness and uninsured status were not associated with greater vaccine hesitancy. Fewer vaccine hesitant respondents reported that some or all of their family members would accept the J o u r n a l P r e -p r o o f COVID-19 vaccine if it was offered to them (29% vs 75%, 46% difference, 95% CI 42 to 50%). (Table 1) The lowest rate of vaccine hesitancy (28%) was at the UCSF Parnassus ED (San Francisco, CA), which also had the lowest rate of ED usual source of care patients. At the county hospital ED in the same city -Zuckerberg San Francisco General, the hesitancy rate was 40%. The highest vaccine hesitancy rate (58%) was at the Cooper University Hospital site (Camden, NJ). (Figure) 

The three primary reasons for vaccine hesitancy were similar in those with and without a source of regular medical care: concerns about side effects and safety (65%), need for more information (47%), have heard stories in the media or online (24%). The fourth most common reason in have primary care respondents was "don't believe the vaccine will work"; in lack primary care respondents the fourth most common reason was "not worried about getting COVID-19 infection". (Table 3 )

Of the 1392 (61%) respondents who stated they would accept the COVID-19 vaccine, 1100 (79%) had a primary clinic to get it. The vast majority of all vaccine acceptors (93%) and ED usual source of care patients (95%) reported that they would accept the COVID-19 vaccine as part of their care in the ED;

Our study is subject to the limitations inherent in survey-type research, most notably various elements of spectrum bias. All of the sites in this study were urban EDs affiliated with academic medical institutions; our findings may not apply to rural, nonacademic ED populations. We only surveyed people who actually came to the EDs -people who have the greatest distrust of healthcare and highest vaccine hesitancy may be less likely to come to an ED (or any health care facility) for care. We had numerous exclusions for this study, including critical illness, major trauma, and altered mental status that limit the applicability of our findings to the fully alert and less ill segment of J o u r n a l P r e -p r o o f the ED population. Nevertheless, most of these excluded patients would be unable to meaningfully participate in COVID-19 vaccine messaging programs; they would likewise be ineligible to receive COVID-19 vaccines in the ED. In other words, our sampling precisely reflects the population that would practically benefit from ED-based COVID-19 interventions.

Although we employed best-practice methods for survey development and standard questions to assess vaccine hesitancy, our instrument was not independently validated. Despite using neutral tones and reading questions directly off survey instruments, we may have induced a social desirability bias in subject responses, which would likely inflate rates of vaccine acceptance.

Conducted in a real-world, healthcare safety net setting, the REVVED UP study defines populations who are distinctly vulnerable to vaccine hesitancy and poor health care access for receipt of vaccinesthose who lack a regular source of medical care and whose primary health care access is through EDs. Nearly half of these groups were COVID-19 vaccine hesitant and over a fifth of those who would accept a COVID-19 vaccine reported that they do not have a clinic or doctor to readily get it. Notably, twothirds of lack regular source of medical care and ED usual source of care patients in our EDs are African American or Latinx, racial and ethnic groups that have had disproportionately high morbidity and mortality during the COVID-19 pandemic.

Supporting the notion that these populations have traditionally suffered other vaccinerelated health care disparities is our finding that less than half had received an influenza vaccine in the past 5 years.

Toward herd immunity and greater acceptance and delivery of the COVID-19 in vulnerable populations, our research highlights an ideal site for interventionsthe emergency department. Homelessness, poverty, language difficulties and other factors may render traditional internet, television, radio and social media-based vaccine hesitancy messaging platforms ineffective in these groups. Even in those who do have access to media, messages that are directed at socioeconomically dissimilar populations may not resonate or convince them to accept the COVID-19 vaccine. Side J o u r n a l P r e -p r o o f effects and misinformation were commonly reported concerns among vaccine hesitant responders in our study and approximately half stated that they wanted more information about the vaccines. Considering that nearly two thirds of lack regular source of medical care respondents stated that their usual care occurs in EDs, ED health care personnel may de facto become their primary care providers and consequently serve as their best trusted messengers to promote COVID-19 vaccine acceptance.

Similarly, the ED has great potential to overcome the other barrier to COVID-19 vaccination for these groupsperceived lack of a healthcare site for receipt of the vaccine. Because most sites in this study conducted their surveys when vaccines were available only to healthcare workers and nursing home residents, we did not ask questions about attempts to obtain the COVID-19 vaccine. Nevertheless, the vast majority of respondents who had received a flu vaccine got it at their primary care clinic and many vaccine acceptors reported not having a clinic to get the COVID-19 vaccine.

Furthermore, current internet-based signups and drive-through mass vaccination may not be feasible mechanisms for COVID-19 vaccination of many vulnerable populations who lack internet access and cars. [39] [40] [41] In addition to messaging about safety and efficacy of the vaccine, ED providers can inform patients where, when and how they can get the COVID-19 vaccine, perhaps assisting them to schedule appointments prior to discharge from the ED.

An even more ambitious role for the ED is as a site for actual COVID-19 vaccine administration, analogous to the current practice in many EDs of providing influenza vaccines to their patients as part of their ED care for other problems. Almost all vaccine acceptors, including 95% of ED Usual Source of Care patients, stated they would accept a COVID-19 vaccine as part of their ED care. Some EDs have already adopted the practice of using "end-of-the-day" leftover supplies of vaccines from their affiliated hospital vaccine sites. 42 In terms of practicality of broader ED-based immunization programs, single dose (Johnson and Johnson) vaccines would alleviate the problems of scheduling return visits for a second COVID-19 injection. 43 One shot ED-based COVID-19 vaccine delivery programs may be particularly useful for homeless persons, many of whom derive most of their healthcare and at times subsistence needs in EDs, as well as for others who do not have pre-established hospital connections. 31, 44, 45 Undocumented J o u r n a l P r e -p r o o f immigrants, many of whom fear discovery and deportation when providing personal information, 46 would also benefit from a limited, one-time interaction for COVID-19 vaccination in the ED. Although feasibility constraints and interference with critical ED workflow preclude converting EDs into mass vaccination sites for the general population, opportunistically vaccinating patients while they are already in EDs for other reasons could leverage ED's great visit volumes (139 million visits in 2017) 21 and lead to substantially greater COVID-19 vaccine delivery to vulnerable populations whose only health care occurs there. In a survey that our team conducted with the American College of Emergency Physicians, a majority of ED medical directors indicated support for such adjunctive ED-based COVID-19 immunization programs. 47 As compared to other online and telephone based investigations of the national landscape regarding vaccine hesitancy, our high response rate, in-person survey of all eligible ED patients has several notable advantages: First, it reduces the sampling bias inherent in the other methods, allowing for the potential inclusion of those who do not have internet access and those who do not respond to telephone surveys. Second, views expressed in true healthcare environments are likely to more accurately represent true healthcare decisions than those expressed over the phone or via anonymous internet survey. Finally, our site stratification provides granular information that may inform local efforts to address vaccine hesitancy at specific institutions.

Our findings are similar to other surveys with regards to the higher rates of vaccine hesitancy in African Americans and Latinos. [11] [12] [13] [14] This vaccine hesitancy gap threatens to further exacerbate the existing disproportionate effects of the COVID-19 pandemic on African Americans, Latinos and other vulnerable communities. [48] [49] [50] [51] [52] Despite having over twice the age-adjusted death rates of whites, African Americans and Latinos have had approximately half the vaccination rates. 53, 54 Of the 57 million people in the US who had received a COVID-19 vaccine as of March 6, 2021, only 7% were African American and 8.5% Latinx, as compared to 65.3% non-Hispanic Whites. 54 Given that they serve high proportions of African Americans and Latinos, EDs are uniquely positioned to address COVID-19 and other health care disparities. In terms of other characteristics, younger age, female gender and not having previously received J o u r n a l P r e -p r o o f influenza vaccines were powerful predictors of vaccine hesitancy, but homelessness and uninsured status were not.

The reasons for COVID-19 vaccine hesitancy found in our study mirror those reported in research regarding vaccines in the setting of other infectious disease outbreaks. 55, 56 In a survey conducted in Detroit during a Hepatitis A outbreak, 23% of homeless individuals reported hesitation in receiving Hepatitis A immunization, citing safety and efficacy concerns, as well as mistrust of the intentions of healthcare providers and vaccine manufacturers. 55 Among a predominantly Latinx population of homeless individuals in New York City, concerns regarding becoming ill secondary to the vaccine was the most common reason cited for not receiving the influenza vaccination during the 2018-2019 influenza season. 56 We have identified populations, those who lack a regular source of medical care and whose principal health care access occurs in EDs, that are particularly vulnerable to vaccine hesitancy and perceived limited access to sites for receipt of the COVID-19

vaccine. National programs for ED-based COVID-19 vaccine messaging and vaccine delivery should be considered for these highly vulnerable populations.

J o u r n a l P r e -p r o o f 

COVID-19 Cases, Deaths, and Trends in the U.S | CDC COVID Data Tracker

Mathematical assessment of the impact of nonpharmaceutical interventions on curtailing the 2019 novel Coronavirus

Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US. Health Aff (Millwood)

Change in Reported Adherence to Nonpharmaceutical Interventions During the COVID-19 Pandemic

World Health Organization. Pandemic Fatigue | Reinvigorating the public to prevent COVID-19

Clinical outcomes of a COVID-19 vaccine: implementation over efficacy

The Long Road Toward COVID-19 Herd Immunity: Vaccine Platform Technologies and Mass Immunization Strategies

COVID-19 herd immunity: where are we?

KFF COVID-19 Vaccine Monitor

The VACCINES Act, Deciphering Vaccine Hesitancy in the Time of COVID19

National Trends in the US Public's Likelihood of Getting a COVID-19 Vaccine

Acceptability of a COVID-19 vaccine among adults in the United States: how many people would get vaccinated? Vaccine

Black Americans face higher COVID-19 risks, are more hesitant to trust medical scientists, get vaccinated. Fact Tank, Pew Research Center

Attitudes toward a potential SARS-CoV-2 vaccine: a survey of U.S. adults

US Public Attitudes Toward COVID-19 Vaccine Mandates | Infectious Diseases | JAMA Network Open | JAMA Network. Accessed

Mandating COVID-19 Vaccines

Comparing in person and internet methods to recruit low-SES populations for tobacco control policy research

Use of web and in-person survey modes to gather data from young adults on sex and drug use: an evaluation of cost, time, and survey error based on a randomized mixed-mode design

Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups

Emergency care: then, now, and next. Health Aff (Millwood)

National Hospital Ambulatory Medical Care Survey: 2017 emergency department summary tables. National Center for Health Statistics

Trends in United States emergency department visits and associated charges from 2010 to 2016

Trends in Emergency Department Visits -HCUP Fast Stats

Does lack of a usual source of care or health insurance increase the likelihood of an emergency department visit? Results of a national population-based study

Data Finder -Health, United States -Products

The emergency department as usual source of medical care: estimates from the 1998 National Health Interview Survey

Medical Mistrust, and Segregation in Primary Care as Usual Source of Care: Findings from the Exploring Health Disparities in Integrated Communities Study

Trends and characteristics of US emergency department visits

Commentary: Embracing the Problem of Subsistence Needs in the Emergency Department

Adolescents who use the emergency department as their usual source of care

Emergency Department Use in a Cohort of Older Homeless Adults: Results from the HOPE HOME Study

Emergency department immunization of the elderly with pneumococcal and influenza vaccines

Influenza and pneumococcal vaccination in the ED: is it feasible?

Vaccination of ED patients at high risk for influenza

Demonstration of the feasibility of ED immunization against influenza and pneumococcus

An emergency department-based pneumococcal vaccination program could save money and lives

Understanding vaccine hesitancy around vaccines and vaccination from a global perspective: A systematic review of published literature

Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support

How to Get a COVID-19 Vaccine in Los Angeles Without a Car

How Inequity Gets Built into America's Vaccination System

In Mississippi, Black residents are desperate to get vaccinated

UNC Health turns to Twitter to make sure leftover COVID vaccine doses are used

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Janssen COVID-19 Vaccine -United States

Shelter and Safety Needs Motivating Homeless Persons' Visits to an Urban Emergency Department

Covid-19 Vaccine Is a Struggle for Those With No Hospital Connection

Fear of discovery among Latino immigrants presenting to the Emergency Department

ED Medical Directors Share COVID-19 Needs in Survey. Accessed

Association of Social and Demographic Factors With COVID-19 Incidence and Death Rates in the US

This Time Must Be Different: Disparities During the COVID-19 Pandemic

Disparities in Incidence of COVID-19 Among Underrepresented Racial/Ethnic Groups in Counties Identified as Hotspots During

COVID-19 and Racial/Ethnic Disparities

Color of Coronavirus: COVID-19 deaths analyzed by race and ethnicity. APM Research Lab. Accessed

Latest Data on COVID-19 Vaccinations Race/Ethnicity

Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States. Centers of Disease Control

Barriers, beliefs, and practices regarding hygiene and vaccination among the homeless during a hepatitis A outbreak in Detroit, MI. Heliyon

Identifying Associations Between Influenza Vaccination Status and Access, Beliefs, and Sociodemographic Factors Among the Uninsured Population in Suffolk County

Will accept vaccine (1381, 60%) Vaccine hesitant (900, 39%) Age in years, median (IQR) 48 J o u r n a l P r e -p r o o f J o u r n a l P r e -p r o o f e. Otro________________

It is likely that one or more vaccines for COVID-19 will be available in the spring or summer of next year. While these vaccines cannot assure complete protection, they will decrease your and your family members' likelihood of becoming infected with COVID-19. These vaccines will likely be provided free of charge.