USF, Tampa General Hospital join nationwide COVID treatment study

From Bay News 9. January 28, 2022.

The University of South Florida and Tampa General Hospital have joined onto a nationwide study to look at existing medications as possible treatments for COVID-19 infections. 

According to the ACTIV-6 study’s website, the Duke Clinical Research Institute coordinating the study along with Vanderbilt University Medical Center.

To be eligible for the study, an individual must be at least 30 years old, have tested positive for COVID-19 within the past 10 days and have at least two symptoms, including fatigue, difficulty breathing, fever, couch, and nausea, among others. 

ACTIV-6 is a nationwide double-blind study that is expected to eventually have nearly 15,000 participants. People can participate from any part of the United States via the study’s website or by calling 833-385-1880.

Medications currently being studies include fluvoxamine, a selective serotonin reuptake inhibitor; fluticasone, an inhaled steroid; and ivermectin, which is used to treat parasitic infections.

USF’s Dr. Jason Wilson said participants will not have to leave their homes to be a part of the study.

“If you decide to take part in our study, our team reaches out to you, we have a conversation and get you medicine delivered the next day to your house in the mail,” he said. “So, really all the encounters will happen by phone and by mail, and you’ll always have that research team available to answer your questions.”

OUTPATIENT TREATMENT OPTIONS FOR COVID-19. UPDATED JANUARY 28, 2022

  • ACTIV-6 Study
  • Paxlovid
  • MolnupiravirF
  • luvoxamine
  • Sotrovimab
  • Remdesvir
  • Epic Orders
  • Epic SmartPhrase
  • DOH Medication/Treatment Locator
  • Other supportive care treatment options

ACTIV-6 Outpatient Study for Repurposed Medications

  • Enroll at ACTIV6STUDY.ORG
  • The purpose of the ACTIV-6 research study is to test medications that are already approved for other diseases to see if they can help people with mild to moderate COVID-19 feel better faster and stay out of the hospital. ACTIV-6 is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program.
  • Patients are able to self-enroll in ACTIV-6 at activ6study.org
  • Patients that enroll in ACTIV-6 can still receive other outpatient therapies including Mabs, remdesvir, Paxlovid, and MolnupiravirACTIV-6 includes arms for fluvoaxmine, fluticasone, ivermectin, placebo
  • adults, Covid+ last 10 days, do not have to come in, do not have to have been seen at TGH/USF
  • There is a .ACTIV6 smart phrase with text from an IRB approved recruitment flier under the Epic User Name Wilson, Jason [18448]. That can be included in the AVS for the patient and used for reference

Nirmatrelvir+Ritonavir [Paxlovid]

  • Paxlovid can be found in Epic but requires you to search the database. Below are some screenshots for locating Paxlovid.
  • You can add it to your favorites when you order the medicine the first time.
  • You should then be able to find it easier the next time

Paxlovid CrCl > 60 ml/min

Paxlovid CrCl 31-60 ml/min

  • You can select the pharmacy during the ePrescribe process by clicking on the current pharmacy name (this example has TGH Outpatient Pharmacy).
  • TGH Outpatient Pharmacy does not have Paxlovid.
  • Only retail pharmacies have been supplied medication.

To find a pharmacy with Paxlovid, use this website:
HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)

Information about Nirmatrelvir+Ritonavir [Paxlovid]

  • nirmatrelvir is a protease inhibitor that inhibits mPRO and stops viral replication EPIC-HR Trial (n=2,246).
  • 28 day hospitalization in Paxlovid arm 0.8% (n=8), 6.3% in placebo arm (n=66). Relative Risk Reduction = 88%, Absolute Risk Reduction = 5.5%, Number Needed to Treat to prevent 1 hospitalization on Paxlovid = 18
  • All cause 28 day mortality Paxlovid arm 0%, placebo arm 1.1% (n=12). RRR = 100%, ARR = 1.1%
  • Number needed to Treat to prevent 1 death on Paxlovid = 91
  • The EUA for Paxlovid can be found at this link
  • EUA allows for outpatient treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg)
  • no for PrEP or PEPstart within 5 days of symptom onset
  • RX: Take 3 pills in the morning (2 X 150mg nirmatrelvir, 1 X 100mg ritonavir) and 3 Pills in the evening (2 X 150mg nirmatrelvir, 1 X 100mg ritonavir)
  • 30 total pills dispensed in a dose pack for CrCl > 60 ml/min
  • If CrCl 31- 60 ml/min, there is decreased dosing (take 1 nirmatrelvir 150mg tablet in morning and night instead of 2) -> 20 total pills in CrCl 31-60
  • Avoid in patients with CrCl < 30 ml/min and hepatic impairment with Child-Pugh C
  • May want to avoid in patients with HIV
  • Caution if patient on drugs that reliant on CYP3A4 metabolism, especially if patient has decreased CrCl.Caution if on: statins, NOACs, warfarin, calcium channel blockers, anti-arrhythmics, HCV Direct Acting Antivirals, sofosbuvir, alfuzosin, pethidine, piroxicam, propoxyphene, ranolazine, amiodarone, dronderone, flecainide, propafenone, quinidine, cholchicine, lurasidone, pimozide, clozapine, dihydroergotamine, ergotamine, methylergonvine, sildafinil, triazolam, midazolam, apalutamide, carbamezapine, phenobarbital, phenytoin, rifampin, St. John’s Wort, bupropion, trazodone, voriconazole, isavuconazonium, itraconazole, ketoconazole, rifampin, clarithomycin, erythromycin, amlodipine, diltiazem, felodipine, nicardipine, nifedpine, digoxin, salmetrolsome
  • suggest avoiding concomitant use of Paxlovid and Systemic Corticosteroids
  • No available data in pregnant women or those that are breastfeeding
  • Not authorized in those younger than 12 years of age
  • no cost to patient, $530 cost to US Government

Molnupiravir

Molnupiravir can be found in Epic

Information about Molnupiravir [Lagevrio]

  • nucleoside analog that leads to viral lethal mutagenesis
  • MOVe-OUT Trial (n=1,433), 709 received molnupiravir, 699 patients received placebo.
  • 29 day combined hospitalization or death for molnupiravir group was 6.8% and 9.7% in placebo arm. RRR = 30%, ARR = 2.9%.
  • Number needed to treat to prevent 1 hospitalization or death on molnupiravir = 35
  • 29 day mortality in molnupiravir arm was 0.1% and 1.3% in placebo arm. RRR = 92%, ARR = 1.2%
  • Number needed to treat to prevent 1 death on molnupiravir = 83
  • EUA for molnupiravir can be found here
  • must be 18 years oldstart within 5 days of symptom onsetRx: 800mg BID X 5 days (40 pills)200mg pills, 4 pills each dose (comes in a 40 pill bottle)
  • Do NOT take if pregnant (embryo toxicity); bone/cartilage toxicity (no peds)
  • No known drug interactions
  • no cost to patient, $712 cost to US Government

To find a pharmacy with Molnupiravir, use this website (as of 1/28/22, Port Charlotte is closest location):
HHS/DOH COVID TREATMENT LOCATOR (Monoclonals, Paxlovid, Other)

Fluvoxamine

  • Non-pregnant, adult patients can potentially receive Fluvoxamine as part of ACTIV-6. However, if patient does not want to join research study or definitively wants/needs Fluvoxamine, this is reasonable given clinical data to prescribe.
  • The data for use of Fluvoxamine is found on the USF Emergency Medicine Blog
  • Clinical trial dosing was 100mg PO BID X 10 days (this is moderately large dose and can be associated with nausea; consider giving ondansteron RX with Fluvoxamine RX
  • Possible drug interactions (from the prescribing information which can be found at this link) with BZD, clozapine, methadone, mexiltine, antipsychotics, ramelton, theophyline, warfarin, NOACs, carbamazepine, sumatriptan, TCAs, tacrine, tryptophan, diltiazem, propranolol, metoprolol

Sotrivimab and Remdesvir

  • There is limited effectiveness of Eli-Lilly and Regeneron monoclonal antibody infusions for Omicron based on lab based studies.
  • Sotrovimab does have effectiveness against Omicron but there is very limited availability of the medication and requires high risk/immunocompromised conditions to access.
  • remdesvir is also available as outpatient but also requires high risk features and 3 days of return encounters.
  • Sotrovimab and remdesvir can be given in the GEDI at TGH to very high risk patients.
  • Patients and community providers can complete the referral form themselves.
  • TGH emergency medicine providers/TGH providers can utilize the AMB REFERRAL TO COVID 19 FOLLOW UP.
  • GEDI LINK: The patient and community provider link to GEDI Infusion for Sotrovimab and Remdesvir is here and can be completed by patient or provider
  • Sotrovimab and remdesvir referrals to GEDI from TGH/USF System can be made using the AMB Referral to Covid-19 Follow Up Patients must be high risk for sotrovimab or remdesvir infusion.

Epic Smart Phrase For All Outpatient Treatments and Risk Score for Mabs/Infusions



Other Outpatient Covid Treatment Options(USF Medicine, NIH, Collected Guidelines)

Non-Pregnant Patients

  • Vitamin D 5,000 units daily
  • encourage hydration
  • recommend prone positioning at home every 1 hour every 4 hours

Pregnant Patients

  • Can still be offered Vitamin D
  • Can be offered inhaled budesonide
  • Should not be prescribed fluvoxamine, molnupiravir, or paxlovid and are not eligible for ACTIV-6
  • Should not be advised to prone at home

Head over to the FCEP EM Pulse Winter/Spring 2022 Issue to see our new feature article!

Notes From the Field: Reducing Harm Among Injection Drug Users During and After the Emergency Department Visit

by Heather Henderson, MA, CAS, Asa Oxner, MD, Bernice McCoy, PhD, MPH, Jason Wilson, MD, MA and FACEP | Jan 25, 2022

Website now updated to add the USF EM Social Emergency Medicine Section!

Check this link to learn more about how we are addressing social determinants of health, healthcare disparities, health outcome inequities, and structural competency in the construction of patient centered pathways!

USF EM focuses on the assemblage of new care pathways through direct engagement and involvement of social scientists. We place social scientists (anthropologist) into the clinical space. This work has been best exemplified by our efforts to conduct non-targeted HIV and HCV screening and linkage to care, as well as the construction and implementation of an opioid use disorder bridge program utilizing buprenorphine, and the operation of a prehospital/out of hospital space syringe exchange program that moves us closer to a regional coordinated harm reduction system.

Our USF EM SEM team also have worked to vaccinate refugees, explore vaccine hesitancy in the ED, and investigate healthcare disparities and inequity in female health, including differential rates of endometrial cancer and potential opportunities for ED screening/intervention.

Read more about these efforts at our site!

Our USF EM SEM Section works to meet the goals outlined by the ACEP Social Emergency Medicine Vision Statement and follows the vision outlined by readings and projects conducted through the SAEM Social Emergency Medicine and Population Health Section

Academic Medicine Publication – Patient Shadowing

Jason Wilson, Roberta Baer and Seiichi Villalona are pleased to announce publication of our article in Academic Medicine which highlights the success we have had implementing a premed patient shadowing program that builds in a patient experience perspective into the preclinical years at the University of South Florida. The article is available for free at the Academic Medicine website. 

Patient shadowing early in training allows a shift in the clinical gaze that pays off in the long game in the development of future physicians


The article is available for free at this link

The article is available for free at this link
The PubMed citation is available here and the PMID is 31335819

NEJM Case Studies in Social Medicine Series

  1. Case Studies in Social Medicine — Attending to Structural Forces in Clinical Practice. Stonington Et al., November 2018
  2. The Power and Limits of Classification — A 32-Year-Old Man with Abdominal Pain. Stoumsa et al., May 2019
    1. ARITCLE
    2. PODCAST
  3. The structural violence of Hyperincarceration — A 44 year old man with back pain. Karandinos and Bourgois January 2019
  4. Structural Racism — A 60 yo black woman with breast cancer. Pallok et al., April 2019
  5. Structural Differential – A 32 year old man with persistent wrist pain. Seymour et al. May 2019
  6. Structural Iatrogenesis – A 43 year old man with “opioid misuse”. February 2019
  7. Misrecognition and Critical Consciousness — An 18-Month-Old Boy with Pneumonia and Chronic Malnutrition

Anthropology &
Special Patient Populations in the Emergency Department

Presented at the Society for Applied Anthropology
(TH-160) THURSDAY 5:30-7:20, April 6, 2018

CHAIR: WILSON, Jason (TGH, USF)

Opening Remarks

A gap exists between patient and provider expectations during healthcare encounters in the United States. Those gaps are especially prevalent in acute clinical settings such as the emergency department where physicians have a defined agenda to rule out life threatening disease within a small amount of time usually with a patient they do not know from previous visits. Sometimes the underlying reason for the ER visit is emergent and sometime it is not, sometimes the underlying reason is medical and sometimes it is not.

 

Arthur Klieinman framed the patient-physician gap over 30 years ago as a difference in explanatory models of disease and illness. Medical anthropologists have focused on the tension between biomedical and lay person models of health. However, the patient experience, as measured by healthcare surveys of satisfaction, has not improved significantly and may be even worse in a setting of overcrowded department, confusing healthcare insurance issues, and disjointed attempts at continuity.

Attempts to measure the existing gap between an ideal patient experience and the current state were formalized by Irwin Press in the 1980s with the now ubiquitous utilization of the Press-Ganey Survey. However, just because a phenomenon is measured does not mean that the problem is resolved.

 

Hospitals spend millions to improve the patient experience, or at least to improve scores on patient satisfaction surveys. Those scores are now tied to reimbursement and the proportion of reimbursement related to those scores will only increase for providers and facilities moving forward.

What do hospitals get for all of this spending on patient satisfaction? Essentially everyone achieves mediocrity. The spread around the mean of these scores is incredibly tight. Moving from 83% to 85% might move you from the 50th percentile to the 90th percentile. The first large spend on patient experience by healthcare facilities is to ensure 50th percentile – drop below that and you risk a loss of federal reimbursement. The goal, however, is to ultimately move above average since that is where the rewards for higher patient satisfactions scores exist. Thus, hospitals spend incredible amounts of money to improve a few percentage points but, as the score gets higher the ability to increase the score by another percent also becomes exponentially more expensive.

tampaerdoc.com/ant4930

Four years ago, a medical anthropologist and an emergency medicine physician decided to approach this issue together by repositioning the role of medical anthropology education in the premedical school curriculum as well as to position medical anthropologists as the obvious human resource for a healthcare organization patient experience department. As an ER doc who also went through the same training as our current students are just embarking upon, it was important to me to provide access to shadowing and research opportunities but with enhanced student engagement.

The papers you will hear this afternoon arose from this ongoing work. In the spring of 2015, we designed and co-taught our first iteration of an undergraduate course for pre-medical students, ANT4970 Patient-Physician Interaction. Now on our third rendition, each semester students first spend time shadowing patients and developing a patientcentric lens early in medical training. Student also learn the importance of utilizing mixed-method approaches such as participant observation, semi-structured interviews and quantitative analysis of data, to address questions focused on improving the overall patient experience. This course has had a tremendous impact on undergraduate students who often cite the class as a life changing experience.

Many of those students are now in medical school and Roberta Baer, Seiichi Villalona and I are following them and examining the sustainability of their early patientcentric training as they move through their training. Many students stay with us to complete undergraduate honors theses and we have now expanded our work in the ED to also include anthropology graduate students conducting dissertation research. This approach allows us to position graduate students as experts in patient experience within our institution and also to provide early, sustainable, training in patientcentric care that will, hopefully, be sustained as these trainees become physicians. Ideally, the course can be scaled up to other institutions, positioning med anthro training as a crtical aspect of improving patient experience.

The ability to move a patient satisfaction score from the 50th percentile to the 90th percentile is expensive and difficult. Mainstream medical approaches focus on reinforcing techniques that improve the perception of time spent with the provider during an acute clinical encounter as well as enhanced customer service approaches adopted from customer service friendly business, such as luxury hotel chains and well known amusement parks.

However, the premise of the work you will hear today suggests that those experience improvements may only be possible if specific special populations are better understood and addressed in the ED. The variation in patient visits and patient satisfaction scores is not described in the current Press-Ganey database and might not be well captured in quantitative analysis of large datasets. That is why these papers are critical to advancing our understanding of the patient experience in the ED.

First, you will hear from Seiichi Villalona. Seiichi is a graduate student receiving an MA this semester and moving on to the Robert Wood Johnson Medical School in New Jersey this fall. Seiichi’s work focused on the relationship between placement of patients in less-optimal areas of the ED, such as hallways, and how those circumstances effect the overall experience. Seiichi’s thesis work is on the use of medical interpreters which he conducted with both one of our ED residents as well as another presented today, Mery Yanez Yuncosa who completed her undergraduate honors thesis examining Spanish patients who receive variable translation services in the ED.

We will also here from another undergraduate student, Killian Kelly, who is planning to eventually move on to graduate school in anthropology and worked with us to develop a patientcentric generated expectations leaflet. In addition, we will hear from Carlos Osorno Cruz who completed his undergraduate degree in anthropology and stayed on in the Emergency Department to continue his work as a research assistant, focusing on ways to improve the care of patients with sickle cell disease patients in the ED. We will also hear from a PhD Student, Heather Henderson, who has recently completed her master degree work on the stigma of opioid addiction. Heather’s work focuses on the medicalization of opioid abuse and how we can work to decrease the marginalization of this population in the ED.

Each presenter will take up to 15 minutes and we will hold questions to the end. After the last presentation, Roberta Baer, the co-designer of this course and these efforts will join us and we will conduct a 15-20 minute discussion and Q&A.

VILLALONA, Seiichi (USF) and WILSON, Jason (TGH, USF) Patient Experience and Patient Satisfaction: Anthropologically Examining the Impact of Hallway Placement on Perceptions of Care

 

 

 

 

 

 

 

 

 

 

 

 

 

“I was in the hallway the entire time that I was being treated. I do understand that the ER was very busy and I am appreciative that I was seen and treated but I felt invisible most of the time that I was being treated even though I was visible to everyone that walked past. I did not even have a screen up around me and at one point the screen beside my gurney was taken to use for someone else. I do not think I would have minded so much if I would have been asked if I wanted it to be used for me first.” -58 year old female

“Nurses were sitting in station talking about personal matters. I was left in the hallway feeling uncomfortable with other visitors passing by and not being informed of anything.” -57 year old female

 

 

 

 

 

 

 

 

YANEZ, Mery and VILLALONA, Seiichi (USF), WILSON, Jason (TGH, USF)

Satisfactorily Unaware and the Perception Paradox: Experiences of Spanish-Speaking Patients in the Emergency Department

 

HENDERSON, Heather (USF) and WILSON, Jason (TGH, USF) Evolving Epidemiology: Perceptions of Stigma and Access to Care in Acute Opioid Crisis

 

 

 

 

 

 

 

 

 

 

OSORNO CRUZ, Carlos (TGH) and WILSON, Jason (TGH, USF) Understanding the Sickle-Cell Patient Experience and New Approaches to Pain Management

 

  • Patients have unmet expectations
  • lack of high quality evidence based approaches to management
  • the subjective nature of VOC-related pain and the likelihood of opioid dependence.
  • During a 3 year period from Nov 1, 2014 Oct 31, 2017, there were 2,742 SCD encounters related to pain crisis
  • 280 unique patients.
  • On average, there are 2.17  SCD encounters daily

  • a genetic, chronic blood disorder
  • effects 100,000 people in the United States
  • causes multiple medical problems including anemia, immune-dysfunction, stroke
  • frequent episodes of acute pain (sickling crises or vaso-occlusive crises (VOC))
  • 1 out of every 365 Black or African-American births
  • 1 out of every 16,300 Hispanic-American births
  • About 1 in 13 Black or African-American babies is born with sickle cell trait

What have we done to improve patient care?

  • worked to create an environment of clear expectations for providers and patients with SCD that present to the ED
  • developed a patient controlled analgesia strategy to help meet expectations for pain management during ED visits
  • currently working with a newly formed national ED SCD quality group to achieve a best practice approach
  • Patients and healthcare providers perspectives on current care at TGH ED were collected through interviews while in the ED and infusion clinics.

  • Unique patient visits decreased from 2.17 encounters per day to 1.33 encounters per day
  • Each patient that encountered our ED during the study period also visited less often, decreasing their visit rate by 38%
  • the admission rate declined from 69% in 2015 to 59% in 2017
  • ED LOS did not increase more than the entire ED LOS increased during the same time period for all patients (18%)
  • During the period reviewed, the rate of patients that left without being seen and against medical advice decreased by 33%
  • The hospital LOS for admitted patients with SCD VOC did not change significantly during this period
  • patients that received a PCA had a longer time period until pain medication administration (30 min w/o & 47 min w/)
  • The overall rate of PCA use increased from 8% to 65% during this period.

 

 

 

 

 

 

Patient Perspectives

“Having the PCA makes our treatment the same”

“We know our bodies better than they do”

“Call my doctor immediately not 3 hours later when you realize nothing is working”

“We aren’t taken serious”

Healthcare provider Perspectives

“they’re just drug seeking”

“they’re taking advantage of us”

“if we give them what they want they won’t stop coming”.

  • results support utilization of a PCA in patients with SCD VOC and suggest a potentially positive impact on patient flow
  • continued buy in from both healthcare providers and SCD patients is critical to ensure best practice
  • During triage patients like to be asked “what works for you?” followed with a loading dose through a NIPP order
  • Patients preferred to be discharged rather than admitted into “prison” matching the ED goal.

Unresolved Issues

  • RN’s not ordering pain meds with NIPP
  • PCA is not being used by all physicians
  • Healthcare providers misunderstanding sickle cell patients
  • Time to PCA set-up

Future Directions

1.Use NIPP approved for SCD Pain Crisis Including Pain Medication (essentially 0% use previous to 2018)

2.Decrease Door to Drug Time. Goal of 30 minutes to pain med (NIPP Utilization while awaiting PCA)

3.Increase PCA use (don’t expect 100% given NIPP use may decrease need for further IV meds)

4.Decrease SCD Pt Admission rate to overall ED admission rate (40%)

5.Decrease ED LOS D/C SCD Pts to 80% of pts D/C in 240 minutes

6.Decrease ED LOS Admit SCD Pts to 80% of pts in 420 minutes

Upcoming Interventions

1.Continue work with hospital VP on educational Video – multi-specialty collaboration for RNs to increase NIPP medication order utilization and acknowledgment of SCD patients

2.TGH Infusion Center and TGH Output Med  working with ED to facilitate pathways

 

KELLY, Kilian and BAER, Roberta (USF), WILSON, Jason (TGH, USF) The Patient Perspective: Applying Medical Anthropology to the Patient Experience in the Emergency Department


 

 

 

 

 

 

 

 

 

Implementing a program like this leaflet would allow patients to enter the ED with a better understanding of what is going on around them.

Closing Remarks From Session Chair Jason W. Wilson, MD, MA, FACEP

Discussion and Q&A Led by Course Co-Designer Roberta Baer, PhD


Non Medication Approaches to Pain Management – but need focus on acute and sub-acute pain

 

Non-medication approaches to pain management are critical contributions to clinical science. This JAMA interview lays out how 11 trials will be funded based on preliminary data showing possible benefit. While this interview and these trials are important, the focus, like most pain management related research is on chronic pain. Our work (foam rollers, movement, and TENS units) is beginning to focus on pain in the ED – a population most researchers have traditionally shied away from when testing non-medication analgesic approaches.