Abstract
Objective
To determine if COVID-19 was associated with a change in patient refusals after Emergency Medical Services (EMS) administration of naloxone.
Methods
This is a retrospective cohort study in which the incidence of refusals after naloxone administration in a single EMS system was evaluated. The number of refusals after naloxone administration was compared across the before-pandemic interval (01/01/20 to 02/15/20) and the during-pandemic interval (03/16/20 to 04/30/20). For comparison the incidence of all other patient refusals before and during COVID-19 as well as the incidences of naloxone administration before and during COVID-19 were also reported.
Results
Prior to the widespread knowledge of the COVID-19 pandemic, 24 of 164 (14.6%) patients who received naloxone via EMS refused transport. During the pandemic, 55 of 153 (35.9%) patients who received naloxone via EMS refused transport. Subjects receiving naloxone during the COVID-19 pandemic were at greater risk of refusal of transport than those receiving naloxone prior to the pandemic (RR = 2.45; 95% CI 1.6-3.76). Among those who did not receive naloxone, 2067 of 6956 (29.7%) patients were not transported prior to the COVID-19 pandemic and 2483 of 6016 (41.3%) were not transported during the pandemic. Subjects who did not receive naloxone with EMS were at greater risk of refusal of transport during the COVID-19 pandemic than prior to it (RR = 1.39; 95% CI 1.32-1.46).
Conclusion
In this single EMS system, more than a two-fold increase in the rate of refusal after non-fatal opioid overdose was observed following the COVID-19 outbreak.
Introduction
Background
Opioid overdoses are one of the leading causes of accidental death in the United States (Citation1,Citation2). From 2007 to 2017, drug overdose deaths involving any opioid more than doubled (Citation3), and in 2016, opioids were in involved in 84% of all drug overdose deaths (Citation2). Patients whose overdoses are reversed with naloxone frequently refuse subsequent transport to an emergency department (Citation4). Although several studies have shown that this practice is relatively safe, with few fatal overdoses in the next several hours (Citation4–8), naloxone reversal by EMS is a poor prognostic factor for annual mortality; around ten percent of patients who receive a naloxone reversal by emergency medical service (EMS) providers die within the year (Citation9,Citation10).
On March 11 of 2020, the World Health Organization (WHO) declared SARS-CoV-2, the virus that causes COVID-19, a global pandemic. From mid-March to mid-April of 2020, emergency department volumes in the United States dropped by about 50%, in large part due to patient concerns around contracting COVID-19 (Citation11,Citation12). A poll conducted by the American College of Emergency Physicians found that 80% of adults surveyed were worried about contracting COVID-19 from another patient or visitor if they went to the emergency department, leading about 30% of participants to delay or avoid medical care (Citation13).
Importance
Similar to concerns of patients delaying care for other chronic and acute medical conditions, there is worry that patients with opioid use disorder, which carries a high mortality rate, will be afraid to accept medical treatment for fear of contracting the virus (Citation14). Many experts theorize that opioid overdose rates may increase during COVID-19 due to the closure of substance use clinics, potential of shelter in place orders to affect mental health and decrease rates of bystander naloxone administration, and shifting focus of the healthcare system on COVID-19 (Citation15–17). Thus, as there have been specific concerns around decreased access to care for patients with opioid use disorder during COVID-19, we wanted to focus on this unique population.
Goals of This Investigation
The primary aim of this investigation was to determine if the rates of refusal of transport after EMS naloxone administration increased when public fear around COVID-19 increased. We also sought to compare the rate of EMS refusal of transport for patients receiving naloxone to the rate of EMS refusal of transport of all other patients.
Methods
Study Design
This study was a retrospective cohort study in which we reviewed EMS records during two 46-day-long time-frames in 2020. Data was analyzed from before COVID-19 had known community spread within the United States (Jan 1-Feb 15), and after (March 16- April 30). Patient encounters from February 16 - March 15 were excluded, as these dates were considered part of a transition period between low and high community awareness of COVID-19.
Identifying exact dates at which a pandemic begins to affect the psychosocial behavior of a community is difficult. The first-known case of community spread within the United States wasn’t identified until February 26, 2020 (Citation18). On March 11th, the WHO declared the outbreak a pandemic and the state of Arizona declared a state of emergency related to COVID-19 (Citation19). On March 13th, the United States declared COVID-19 to be a national emergency (retroactively beginning on March 1st) (Citation20). Although Governor Ducey of Arizona did not issue a stay-at home order until March 31, we believe that public fear in our community increased before this official date. We chose our dates based on a sense of danger in the community, rather than purley on official declarations, although it is certainly challenging to pinpoint a specific date that could be interpreted as the beginning of public panic and behavior change due to COVID-19 (Citation21).
Governor Ducey’s stay at home order was extended to last until May 15 (Citation22). However, by late April, public behavior had again started to pivot related to COVID-19. In late April, protesters began to demonstrate at the Arizona capitol against the stay-at-home order (Citation23). Again, there was a shift in the sense of danger, and resulting behavior, in our community that occurred before official declarations. Thus, April 30th was chosen as the terminal date for the purposes of this study.
This project was reviewed by The University of Arizona Institutional Review Board and classified as a project exempt from human subjects review (2006748314).
Setting
The city of Tucson is the second largest in Arizona, with an estimated 2019 population of 548,073 people (Citation24). According to the 2010 census, 41.59% of the population identifies as Latinx and 69.72% as white (Citation25). Tucson resides in Pima County.
In Pima County, there were 286 deaths attributed to drug overdoses in 2018, with that number projected to rise to 337 in 2019 (Citation26). For the first three quarters of 2019, 90% of overdose deaths were considered to be accidental, opioids contributed to nearly 70% of those overdoses, and the majority occurred at home. 66% of those who died had one or more visits to an ED or hospital from January 2018 to the date of death.
Tucson Fire Department is the exclusive 9-1-1 provider for the city of Tucson, serving 548,073 residents. In 2019, total EMS call volume was 87,801. All medical encounters were documented using Zoll® electronic patient care report (ePCR) software (Zoll® Medical Corporation, Chelmsford, Massachusetts, version 6.5). At the time of this study, naloxone administration was limited to Advanced Life Support (ALS) providers, although Basic life support (BLS) providers could transport eligible patients.
According to Tucson Fire Department’s administrative guidelines (Appendix 1), all patients should receive transport to the emergency department after naloxone reversal. Patients may refuse transport to the emergency department if the paramedic deems that they have decision-making capacity. At the time of this study, there were no options for treat and refer or provider-led transport refusal decisions.
Selection of Participants and Outcomes
For the primary outcome, a SAP® Crystal Report (SAP Global Corporate Affairs, Walldorf, Germany) was used to query all the Tucson Fire Department (TFD) electronic patient care reports (ePCR) from 01/01/20-02/15/20 and 03/16/20 − 04/30/20. Those cases with a primary impression entered by the paramedics of “not a patient,” invalid assist, cardiac arrest (Dead on Arrival, Fetal Stillborn >22 weeks, Maternal/Post Delivery, Sudden Infant Death, and Cardiac Arrest) were excluded. Patients with a paramedic-entered outcome of Dead on Scene were additionally excluded. These subjects were then separated into two groups based upon whether naloxone was administered on scene.
Information obtained from the ePCR includes: incident number, date, dispatch time, at scene time, transport time, zip code, sex, date of birth, nature of call (how it was dispatched), intervention, provider primary impression, and outcome. Except for “intervention,” all of the above data points are mandatory in each patient care record and are enforced by closed call rules or are imported directly from computer aided dispatch records. These records were compared against other records during the same time period for all other calls (unrelated to suspected opioid overdose).
Outcomes
The primary outcome was the relative risk of patient refusal of transport after naloxone administration during the COVID-19 pandemic from 03/16/20 to 04/30/20, compared to the period before broad recognition of the pandemic from 01/01/20 to 02/15/20. For comparison the rate of all other patient refusals before and during COVID-19 as well as the incidences of naloxone administration before and during COVID-19 were also reported.
Data Analysis
We performed all analyses using Stata Statistical Software (version 16.1; StataCorp, College Station, Tx). Subject characteristics are reported with descriptive statistics presented as frequencies, medians, and interquartile ranges. We compared the incidence of patient refusal of transport across the time periods before and during the Covid-19 pandemic for both the Naloxone-receiving and non-Naloxone-receiving cohorts using relative risks (RRs) with 95% confidence intervals (CIs).
Results
Characteristics of the Study Subjects
As illustrated in , from Jan 1 to Feb 15, 2020, Tucson Fire Department had 8,806 patient encounters. 1686 patients were excluded per study protocol. Of the remaining 7120 encounters, 164 patients were administered naloxone and 6956 were not. From March 16 to April 30, 2020, Tucson Fire Department responded to 7980 patient encounters. 1811 patients were excluded per study protocol. Of the remaining 6169 encounters, 153 patients were administered naloxone and 6016 were not.
Figure 1. Identification of cases.
Limited demographic information was available for those patients who received naloxone. As illustrated in , of those patients who received naloxone, the median age was 36.4% and 37.8% were identified as female. Among those receiving naloxone, the most common primary impressions were given as overdose in 214 (67%), altered level of consciousness in 27 (8.5%), and unconscious in 26 (8.2%). Among those not receiving naloxone, the most common primary impressions were given as general illness in 3149 (24.3%), injury in 1683 (13%), and difficulty breathing in 1049 (8.1%) of subjects.
Table 1. Case demographics
Table 2. Results: comparing refusals before and during COVID-19
Main Results
Prior to the widespread knowledge of the COVID-19 pandemic, 24 of 164 (14.6%) patients who received naloxone via EMS were not transported. During the pandemic, 55 of 153 (35.9%) patients who received naloxone via EMS were not transported (). Subjects receiving naloxone during the COVID-19 pandemic were at greater risk of refusal of transport than those receiving naloxone prior to the pandemic (RR = 2.45; 95% CI 1.6-3.76).
Among those who did not receive naloxone, 2067 of 6956 (29.7%) patients were not transported prior to the COVID-19 pandemic and 2483 of 6016 (41.3%) were not transported during the pandemic. Subjects who did not receive naloxone with EMS were at greater risk of refusal of transport during the COVID-19 pandemic than prior to it (RR = 1.39; 95% CI 1.32-1.46).
Discussion
Since this is a retrospective cohort study, we cannot show causation, but we can show correlation: In Tucson, Arizona, EMS refusals after naloxone administration have more than doubled (RR = 2.45) during the advent of COVID-19.
It has been reported widely that both EMS and Emergency Department call volumes have decreased (Citation11, Citation27,Citation28). This same trend was observed in this study with an overall reduction in EMS call volume and an increase in EMS refusals. This may be due to patient fear of iatrogenic spread in the emergency department, but it may also be due to EMS provider practice changes. Perhaps paramedics were more inclined to encourage alternate modes of patient transport. It is not surprising that refusal rates for those patients receiving naloxone increased to a greater extent than did other similar medical complaints. Commonly, it is bystanders who call 9-1-1 for acute opioid overdoses, not the patients themselves, which is not observed for many EMS related calls.
Although we considered comparing rates of refusal among a similar patient population, it was difficult to find such a group. For example, patients with seizure and syncope may be similar to those with overdose in that a bystander may call 911 and the patient may refuse transport. However, it is unlikely that the annual mortality rate is as high for these conditions as it is for acute overdose. Furthermore, these are patients identified by their primary impression, not their intervention, and our cohort was identified by an intervention (naloxone administration).
From purely a study design perspective, it would make more sense to compare patients who received naloxone (an intervention) to those who received an intervention for hypoglycemia (dextrose, oral glucose, or oral glucagon), but in our system, we often encourage patients who have responded to hypoglycemia interventions to decline subsquent transport. That is not the case for our patients who receive naloxone. Thus, at baseline, the rates of refusal are higher in the patients who received an intervention for hypoglycemia than those who received naloxone. Furthermore, the sample size for patients receiving an intervention for hypoglycemia (n = 50) was too small during our cohort to show a significant difference in rates of refusal.
Figure 2. 2019 vs 2020 Jan 1-April 30 naloxone incidents with patient refusals, 7 day moving average.
However, we did compare our incidents of naloxone administration and rates of refusal to matching dates in 2019. There was no significant difference in rates of refusal between January 1 and February 15 in 2019 vs. 2020. However, from March 15th to April 30th, the rate of refusal was 15.9% in 2019 vs. 35.9% in 2020. shows a 7-day moving average of patients who received naloxone and then refused transport in 2019 vs. 2020. Seasonal variation does not seem to be the reason why rates of refusals increased in the spring in 2020.
It is concerning that rates of patient refusals after prehospital naloxone administration have increased. Although there have been concerns around the return of respiratory depression after naloxone wears off, causing a second, acute overdose that may be fatal if not observed in a medical setting, several studies have shown that patient refusal after naloxone distribution is relatively safe in the short-term and that there are few fatal overdoses in the next several hours.4-8 What is alarming is that naloxone reversal by EMS is a poor prognostic factor for annual mortality, with approximately ten percent of patients who receive a naloxone reversal by EMS dying within the subsequent year (Citation9,Citation10). If increasing numbers of patients refuse transport to the emergency department following nonfatal opioid overdose, more patients will potentially miss out on life-saving treatments and referrals (Citation29). While it is unclear in the literature that transport to an emergency department leads to improved outcomes for these patients, most such studies were performed before it was considered the standard of care for emergency departments to initiate medications for opioid use disorder (MOUD). Several of the ED’s in our system do offer buprenorphine and direct linkage to outpatient care.
Several EMS initiatives should be considered to address this gap in care. Potential "EMS friendly” interventions that could be implemented to address this problem include: opioid education and naloxone distribution (OEND), syringe exchange, referral to treatment, initiation of MOUD, transport to an alternate destination of a treatment facility, or direct engagement with telemedicine-directed MOUD.
The premise of an OEND program is that laypeople are given naloxone and instructed in overdose recognition and naloxone administration. Several agencies recommend expanding access to naloxone, including the US Department of Health and Human Services, the Surgeon General, the World Health Organization, the American Medical Association, the American Public Health Association, and the National Association of Boards of Pharmacy (Citation30–35). OEND programs have been shown to effectively train bystanders how to recognize an overdose and administer naloxone, reduce the number of fatal overdoses, and encourage recipients to reduce opioid use and enter treatment (Citation36–43). Several programs have been implemented in EMS systems across the country (Citation44–47).
Syringe exchange programs allow intravenous drug users to exchange their used syringes for new, clean ones with the aim of reducing the transmission of bloodborne illnesses. Although it is unclear whether or not they have achieved that aim (Citation48,Citation49), such programs have shown other benefits, such as reductions in both drug use and crime (Citation50–53). In North Carolina, Havelock Fire Rescue and Jones County EMS included a syringe exchange into their prehospital OEND protocol (Citation54).
Referral to outpatient addiction treatment for MOUD is another possible prehospital intervention. Retention in methadone and buprenorphine treatment is associated with substantial reductions in the risk for all cause and overdose mortality in people dependent on opioids (Citation55). It also is associated with decreased amounts of other risky behaviors such as illicit opioid use, intravenous use, sharing of injecting equipment, and exchange of sex for drugs or money (Citation56).
Unfortunately, referral alone rarely leads to retention in addiction treatment (Citation57). In D’Onofrio’s landmark study, patients were much more likely to still be receiving addiction treatment at 30 days if they were also given their first dose of buprenorphine while in the emergency department (Citation58,Citation59). In New Jersey, one EMS agency has started to administer buprenorphine to eligible patients (Citation60).
However, as most states do not currently include buprenorphine in their list of medications approved for paramedic administration, this is not yet a feasible option for most agencies. Furthermore, as a patient cannot take their first dose of buprenorphine until they are in opioid withdrawal, not all patients will be eligible to receive EMS-administered buprenorphine. Thus, patients not in active withdrawal may benefit from direct transport to an opioid treatment program (as an alternate destination) that can begin MOUD. In Philadelphia, a specific unit will respond to overdoses and offer to transport patients directly to rehabilitation or treatment facilities (Citation61).
However, during COVID-19, treatment facilities may be concerned about new patients arriving on their doorstep from an infection-control perspective. Luckily, regulation is now increasingly supportive of moving addiction treatment into the virtual arena. Until recently, federal law has required an in-person evaluation before MOUD with buprenorphine or methadone could be initiated for opioid use disorder (Citation62). However, in response to the declaration of a public health emergency around COVID-19, on March 19, 2020, the Substance Abuse and Mental Health Administration (SAMHSA) granted an exception to this rule for the prescription of buprenorphine, allowing a telephone visit to replace the mandatory physical exam for the duration of the national public health emergency (Citation62,Citation63). On March 31, 2020, the Drug Enforcement Agency issued similar recommendations (Citation63). With the advent of such increased flexibility around buprenorphine, EMS can play a greater role in linking patients to buprenorphine via telemedicine.
In this single center study, we identified a 2.45 times increase in refusal of EMS transport after patients received naloxone during the advent of COVID-19. This dramatic increase far exceeded that seen among all other prehospital patients during the same timeframe. Other EMS systems should determine if this problem also exists in their community and consider implementation of a comprehensive system to provide care for patients who refuse transport after receiving naloxone in the field.
Limitations
This study has several limitations. It is possible that some patients who received naloxone were missed because of missed ePCR documentation, either because naloxone was administered prior to EMS arrival and not documented, or it was administered by the EMS provider and not documented. This number is likely to be very small, and this potential for missing data is likely equivalent in both cohorts.
Second, due to the rapidly developing nature of the COVID-19 pandemic, it was necessary to study a narrow study period. It is unclear if the observed trends will continue as the pandemic continues.
Additionally, this study relied on EMS providers to correctly recognize, treat and document medical conditions. We were not able to perform any validation of outcomes. It is possible, although unlikely, that EMS provider practice changed due to the COVID-19 outbreak and this change affected the observed outcomes.
In addition, we are not able to control for all the other patient characteristics that might confound the association between time period and refusal. For example, we don’t have accurate data around race, insurance status, or employment characteristics in our EMS records.
Finally, although there are legitimate concerns around increasing overdose rates during COVID-19, this study was not designed to evaluate overdose rates before and during COVID-19. Naloxone administration is an insensitive marker for opioid overdose (Citation64), so the use of naloxone administration as a data point in our study should be interpreted as an imperfect proxy of overdose. Furthermore, outcome data were not obtained for patients treated by EMS for potential opioid overdose. It is possible that the risk of death related to opioid use disorder did not change as a result of the increased refusal and nontransport rate during the pandemic.
Meetings: This submission is an original work and has not previously been presented, published or submitted for publication.
Author Contributions: KP and AH had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. MJG drafted and submitted the manuscript, and all authors contributed substantially to its revision. MJG takes responsibility for the paper as a whole.
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