bluuebunny/crossref_metadata_2025 huggingface dataset:
585. A Cost-Effective Implementation Reducing The Number Of Urine Cultures In An Acute Care Community Hospital
Authors: Jain Rohit , Sahu Nitasa , Marsh Denise , Raines Shannon , Jones Kirk , Vunnam Ramarao , Bhatt Dhirisha , Golamari Reshma , Hussein Rezhan
Published: January 2021

Background

Asymptomatic bacteriuria is a common finding in hospitalized patients. This is defined as bacteriuria of ≥105 colony-forming units (cfu) per mL without any genitourinary signs or symptoms. Treatment for such leads to increased antimicrobial resistance and is especially common in the inpatient setting. One study showed a lack of appropriate clinical indication to order a urinalysis in more than half of the patients. In order to expedite a patient’s care, it is common to order a urinalysis and urine culture together and await the results. One study evaluated the impact of changing the order set in inpatients and yielded a 45% reduction in the urine cultures ordered and cost savings as high as $103,845. Reflex testing is used to facilitate effective and efficient patients care while remaining compliant with state and federal regulations in the ordering of lab test.

Methods

Starting October 25, 2019, the electronic medical record order set was changed so there were only 2 options from the previous 9 options. The modified options included a “Urine analysis with reflex culture” and “Urine analysis with microscopy.” The reflex was not encouraged to be used for those who were pregnant, neutropenic, or had any evidence of immunocompromise.

Results

Following the implementation of this initiative in October 2019, there was a decrease in overall urine culture cost. From Jan 2019 to September 2019, the cost ranged between $13428.96 to $15157.44/month in the Emergency Department. On the inpatient side, it ranged between $5141.12 to $6559.36/month. After revision of the new order set, the ED cost had dropped to as low as $5672.96/month and $3811.52/month for inpatients. This is a cost reduction of approximately $9484.48 and $2747.84 for the ED and inpatient, respectively.The total number of cultures also reduced from an average of 326/month in the ED to 193/month. The inpatient number of cultures dropped from an average of 130/month to 102/month.

Conclusion

Modifying the process of urine culture ordering has significantly cut down cost for both the hospital and patient. With clear education and modification of the electronic medical record, such interventions can dramatically improve the unnecessary testing for UTI’s.

Disclosures

All Authors: No reported disclosures
586. Classification of patients with sepsis according to immune cell characteristics: a bioinformatic analysis of two cohort studies
Authors: Zhang Shi
Published: January 2021

Background

Sepsis is well known to alter innate and adaptive immune responses for sustained periods after initiated by an invading pathogen. Identification the immune cell characteristics may shed light on the immune signature of patients with sepsis and further appropriate immune-modulatory therapy for distinct population. Therefore, we aimed to establish an immune model to classify sepsis into different immune endotypes via transcriptomics data analysis of previous published cohort studies.

Methods

Datasets from two observational cohort studies that included 585 consecutive sepsis patients admitted to two intensive care units were downloaded as training cohort and external validation cohort. We analyzed genome-wide blood gene expression profiles from these patients by machine learning and bioinformatics.

Results

The train cohort and the validation cohort had 479 and 106 patients respectively. Principal component analysis indicated that two immune sub-phenotypes for sepsis, designated immunoparalysis endotype and immunocompetent endotype could be distinguished clearly. In the train cohort, the worse prognosis was found in patients classified as immunoparalysis endotype and its hazard ratio is 2.32 (95% CI: 1.53 to 3.46 vs immunocompetent endotype). External validation furthermore demonstrates that present model could categorize sepsis into immunoparalysis and immunocompetent status precisely and efficiently. The percentage of 4 immune cells (Macrophages M0, Macrophages M2, B cells naïve, T cells CD4 naive) were found that associated with 28-day cumulative mortality significantly（P < 0.05）.

Conclusion

The present study developed a comprehensive tool to identify immunoparalysis endotype and immunocompetent status in sepsis be hospitalized and provides novel clues for further targeting of therapeutic approaches.

Disclosures

All Authors: No reported disclosures
592. A Pilot Program to Evaluate Home Telemedicine Visits in an OPAT Program
Authors: Sheridan Kathleen R , Wingfield Josh , Clouse Natalie
Published: January 2021

Background

Outpatient parenteral antimicrobial therapy (OPAT) is a well-established and effective way of delivering and monitoring patients requiring long-term IV antibiotics1-2. OPAT follow-up appointments are typically in-office appointments. There is limited to no data regarding readmission rates and outcomes of OPAT patients that had home audio-visual (AV) telemedicine (TM) follow-up appointments3.

Our OPAT Program began in December 2013 and serves a major academic Level 1 trauma center as well as several smaller community hospitals within our health system. The OPAT team is a multidisciplinary team consisting of ID Physicians, Nurse Practitioners, Pharmacist, Nurses and a Coordinator. Historically, we have evaluated patients in the office within 1-2 weeks of hospital discharge and just prior to antibiotic completion. However, there are several barriers to visit completion including lack of transportation, lack of perceived benefit of appointment by the patient, and other mobility issues. In July 2019, we began a pilot program of offering home AV TM visits.

Methods

We conducted a retrospective chart review of commercially insured OPAT patients discharged to home from UPMC Presbyterian from July 2019 to February 2020 that had home AV TM visits. We evaluated 30-day readmission rates and complication rates.

Results

13 OPAT patients had a telemedicine video visit.. Patient demographics are listed in Table 1. 8 patients were female. The average age of the patients was 54 (range 35-75). 10 of the 13 (77%) patients were treated for osteomyelitis or septic arthritis. 9 of the 13 (69%)patients received a beta-lactam. 4 patients were readmitted, 3 had an ER visit and 1 patient had a PICC line complication (rash). (Figure 1). Half of the readmissions were due to non-infectious causes (OB delivery & pacemaker placement). 2 patients were readmitted due to ongoing infection but only one of these patients had a home TM appointment before their readmission. The other patient’s visit occurred after their readmission. Reasons for ER visits were PICC malfunction, dysuria, and syncope.

Patient Demographics

Clinical Outcomes

Conclusion

Home Telemedicine video visits could be an alternative to in-office appointments for OPAT patients. More studies should be done to evaluate this visit modality.

Disclosures

All Authors: No reported disclosures
593. Additional medical expenditures attributable to pneumococcal disease in Japan
Authors: Fukuda Haruhisa
Published: January 2021

Background

Japan requires a reexamination of its current vaccination policies to reduce the prevalence of pneumococcal disease (PD). Although the decision-making process for vaccination programs must be informed by cost-effectiveness analyses, the lack of cost data from Japan precludes such investigations. This study was therefore performed to quantify the medical expenditures attributable to PD in Japan.

Methods

The study was conducted using surveillance data from the Japan Nosocomial Infections Surveillance (JANIS) program’s Clinical Laboratory Division and insurance claims data under the Diagnosis Procedure Combination (DPC) system. Data from April 2015 to September 2017 were obtained from 145 hospitals throughout Japan. As the analysis focused on community-acquired infections, the medical expenditures incurred during the PD hospitalization episodes directly represented the additional expenditures attributable to these infections. The descriptive statistics of the medical expenditures (mean, standard deviation, median, and interquartile range) incurred by the PD cases were calculated from the linked JANIS data and DPC data. In addition, these descriptive statistics were also generated according to the presence/absence of IPD and age groups.

Results

The study sample comprised 1,689 PD cases from 29 hospitals during the study period. Of these, 77 were IPD cases and 1,612 were non-IPD cases. The mean medical expenditures (standard deviation) for all PD cases, IPD cases, and non-IPD cases were estimated to be 1,016,801 yen (1,704,067 yen), 1,660,477 yen (2,078,667 yen), and 986,055 yen (1,678,705 yen), respectively. In addition, the medical expenditures associated with patients aged 60–64 years (1,646,739 yen) and 65 years or older (1,646,286 yen) were substantially higher than those of younger patients aged 5–59 years (1,424,105 yen).

Conclusion

These estimates have applications in cost-effectiveness analyses of PD preventive measures, which can subsequently inform and guide national vaccination policies.

Disclosures

Haruhisa Fukuda, n/a, Pfizer Japan Inc. (Scientific Research Study Investigator)
594. Characteristics of an At-Risk Patient Population Presenting to a Philadelphia Student-Run Free Clinic within 30 Days of Hospital Visit
Authors: Thomesen Kaitlyn , Lipow Matthew , Munoz Tess S , Schultz Sara K
Published: January 2021

Background

30-day readmission rates are the parameter that hospitals and insurance companies use to measure clinical quality of care and set reimbursement levels for care (McCormack, et al., 2013). The 2019 readmission rate for United States hospitals was 14.9%; however, reported readmission rates vary in accuracy due to exclusion of at-risk populations or patients who seek care outside the hospital network (America’s Health Rankings, 2020; Gupta, et al., 2018). As coordinators of a student-run urgent care clinic operating within a Philadelphia syringe exchange and harm-reduction social services organization, we serve an at-risk patient population that includes a large portion of individuals who are transiently housed, people who engage in sex work, and people who use drugs (PWUD). We sought to determine our at-risk population’s impact on current readmission rates and the ability of hospitalization to meet their unique medical needs.

Methods

We conducted a retrospective review of 607 electronic charts for patients who sought care at our student run clinic associated with a syringe exchange in Kensington, Philadelphia from January 2017 to January 2020, and identified patients who visited our clinic within 30 days of self-reported hospitalization. We identified time since hospitalization, purpose for hospitalization, and reason for clinic visit.

Results

Of 607 visits, 100 (16.5%) self-reported hospitalization within 30 days clinic presentation. Of these 100 clinic visits, 64% presented with the same chief complaint as their reason for hospitalization, and 21% presented with a complication related to their hospital visit. 33% of visits associated with previous hospitalization were from infections associated with IV drug use, including abscess, cellulitis, and osteomyelitis. On average, patients presented 7.5 days following hospital departure.

Conclusion

We identified a high incidence of clinic visits for medical needs associated with recent hospitalization, particularly injection-related infection, which suggests insufficient hospital care for this at-risk population. The number of readmissions for this population is underestimated due to their ability to seek medical care outside of the hospital network.

Disclosures

All Authors: No reported disclosures
605. Factors Underlying Antifungal Price Trends in the United States
Authors: Thomas Christine , Shae Whitney , Koestler Devin , DeFor Terese , Bahr Nathan , Alpern Jonathan
Published: January 2021

Background

Antifungal drugs are used to treat conditions ranging from topical dermatologic disease to life-threatening systemic infections. Given their widespread use, understanding factors that affect antifungal pricing will help clinical and policy-related decisions. The purpose of this study was to identify factors associated with price trends among antifungal drugs.

Methods

Antifungal drug products available in the United States were identified using the Food and Drug Administration (FDA) Orange Book database. Multiple characteristics related to how a drug may be priced were identified using a variety of sources, including the number of FDA indications (IBM Micromedex), quantity of professional guideline recommendations and use as prophylaxis (Infectious Diseases Society of America guidelines for treatment of fungal infections), and route of administration. Wholesale acquisition cost per unit was identified for each drug from the first date listed through 2019 using the Medi-Span and First Databank databases. Statistical analysis was performed using R (version 3.6.3). Price trajectories over time observed on 138 antifungal drugs were clustered into three groups by the shape of their trajectory using the R package KmlShape (Genolini 2016). Clusters were characterized by stable prices, moderate price increases, and extreme price increases over time. Relationships between cluster membership and drug characteristics were assessed using Fisher’s Exact Test and Likelihood Ratio Tests. All tests were conducted at the 5% level of significance.

Results

The majority (n=116) of antifungal drugs were characterized by moderate price increase and an additional n=6 exhibited extreme price increases over time. Few (n=16) were stable. Associations were identified between drug characteristics and extreme price increase cluster membership. These included a fewer number of FDA indications (p=0.0028) and atypical route of administration (p=0.0025). No association was identified between cluster membership and quantity of guideline recommendations, or use as prophylaxis.

Conclusion

Nearly 90% of antifungal drugs exhibited at least moderate price increases over time. Extreme price increases were associated with a fewer number of FDA indications and atypical route of administration.

Disclosures

All Authors: No reported disclosures
608. Impact of Implementing Pharmacist Review and Monitoring of Outpatient Parenteral Antimicrobial Therapy
Authors: Kirkpatrick Emily R , Hand Elizabeth O , Hughes Darrel W , Badwal Jasmin K , Traugott Kristi A
Published: January 2021

Background

Given current efforts to increase the safety of outpatient parenteral antimicrobial therapy (OPAT) programs nationwide, this project sought to determine whether pharmacist managed OPAT review and monitoring improves adherence to standard of care laboratory monitoring recommendations.

Methods

A single-center, retrospective review of patients > 18 years of age who received OPAT from University Health System was conducted. Patients who received OPAT between October 2018 and December 2018 served as the historical control group. After a pharmacist transitions of care program was implemented, patients who received OPAT between October 2019 and December 2019 were included in the intervention group. Patients were excluded if they received less than 7 days of OPAT, completed therapy prior to discharge, or died while inpatient. The primary endpoint was adherence to laboratory monitoring recommendations > 75% of the duration of planned OPAT. Only patients followed by the OPAT clinic were included in this analysis. Recommendations provided in the 2018 Infectious Diseases Society of America OPAT guidelines were used to define appropriate lab monitoring. Secondary endpoints included 30-day readmissions.

Results

A total of 409 patients were included in this study: 198 patients in the pre-implementation group and 211 patients in the post-implementation group. In patients with OPAT clinic follow-up, the post-implementation group was significantly more likely to receive monitoring adherent to standard of care laboratory monitoring recommendations > 75% of the duration of planned OPAT: 42/161 (26.1%) vs. 98/176 (55.7%), OR 3.6 (95% CI 2.2-5.6, p = 0.0001). There was no difference in 30-day readmission rates between groups in the overall population. Patients in the post-implementation group with OPAT clinic follow up had lower 30-day infectious disease-attributed readmissions: 18/161 (11.2%) vs. 14/176 (8.0%), p = 0.31.

Conclusion

Implementation of a transitions of care pharmacist significantly improved adherence to laboratory monitoring recommendations for patients receiving OPAT and numerically reduced 30-day infectious disease-attributed readmissions.

Disclosures

All Authors: No reported disclosures
610. Incidence of Acute Kidney Injury in Outpatient Parenteral Antimicrobial Therapy (OPAT) Patients Receiving Vancomycin
Authors: Hamad Yasir , Nickel Katelin B , Burnett Yvonne , Olsen Margaret A
Published: January 2021

Background

Vancomycin therapy is known to be associated with nephrotoxicity. Predictors of nephrotoxicity in outpatients are not well defined and have only been reported in relatively small studies. We examined the factors associated with incidence of nephrotoxicity during outpatient parenteral antimicrobial therapy (OPAT) using administrative data.

Methods

A large insurance claims database of privately insured patients (IBM-MarketScan) ages 18 - 64 from 2010 to 2016 was queried for patients discharged from the hospital on vancomycin OPAT. The primary endpoint was 42-day hospital readmission with acute kidney injury (AKI). A Chi-square test was used to examine associations with AKI. Factors with significant associations in univariate analysis were then incorporated into a multivariable logistic regression model.

Results

A total of 14,196 patients were included in the study, median age was 54 years and 53.8% were male. Hospital readmission with AKI occurred in 385 (2.7 %). Factors associated with AKI in univariate analysis included older age, living in a rural area, heart failure (CHF), chronic kidney disease (CKD), liver disease, diabetes, cancer, septicemia, MRSA infection, concomitant penicillin therapy, receiving therapy at home versus an infusion center, and infectious diseases consult during index hospitalization. In the multivariable model, septicemia, CHF, CKD, liver disease, and concomitant use of a penicillin family drug were independently associated with increased risk of acute kidney injury (Table).

Conclusion

Septicemia, use of penicillins and some comorbidities were associated with AKI in patients treated with vancomycin OPAT. Patients at high risk for vancomycin nephrotoxicity should be monitored closely and an alternative therapy should be considered.

Table

Disclosures

Margaret A. Olsen, PhD, MPH, Merck (Grant/Research Support)Pfizer (Consultant, Grant/Research Support)
611. Infectious Disease Management of Homeless and Non-Homeless Populations in United States Emergency Departments
Authors: Barnes Jessica , Segars Larry , Wasserman Jason , Karabon Patrick , Taylor Tracey A
Published: January 2021

Background

Studies have long documented the increased emergency department usage in the United States by homeless persons compared to their housed counterparts, as well as an increased overall prevalence of infectious diseases. However, there is a gap in knowledge on the treatment that homeless persons receive for these infectious diseases within United States emergency departments compared to their housed counterparts. This study seeks to understand this potential difference in treatment, including diagnostic services tested, procedures performed, and medications prescribed.

Methods

This study utilized a retrospective, cohort study design to analyze data from the 2007-2010 National Hospital Ambulatory Medical Care Survey (NHAMCS) database. Complex sample logistic regression analysis was used to compare variables, including diagnostic services, procedures, and medication classes prescribed between homeless and private residence individuals seeking emergency department treatment for infectious diseases. This provided an odds ratio to compare the two populations, which was then adjusted for confounding variables.

Results

Compared to private residence individuals, homeless persons were more likely (OR: 10.99, p< 0.05, CI: 1.08-111.40) to receive sutures or staples when presenting with an infectious disease in United States emergency departments. Compared to private residence persons, homeless individuals were less likely (OR: 0.29, p< 0.05, CI: 0.10-0.87) to be provided medications or immunizations when presenting with an infectious disease in United States emergency departments, and significant differences were detected in prescribing habits of multiple medication classes.

Conclusion

This study detected a significant difference in suturing/stapling and medication prescribing patterns for homeless persons with an infectious disease in United States emergency departments, compared to their housed counterparts. These results provide a platform for continual research.

Disclosures

All Authors: No reported disclosures
613. Lessons learned from a Rhode Island academic out-patient Lyme and tick-borne disease clinic
Authors: McCarthy Meghan L , Reece Rebecca , Vargas Sara E , Johnson Jennie , Adelson-Mitty Jennifer , Flanigan Timothy P
Published: January 2021

Background

Although the prevalence of tick-borne diseases (TBD) continues to increase, there remains significant confusion regarding treatment for Lyme and other TBDs. We conducted a chart review of all new patients that came to an academic center for Lyme and TBDs. We then initiated a quality improvement project for feedback from a small subset of patients with Post-treatment Lyme disease syndrome (PTLDS).

Methods

Charts of patients visiting the clinic between March and November 2018 were reviewed. Data abstracted from the electronic health record included demographics, laboratory and clinical data. A small subset of patients who reported a history of Lyme and at least 6 months of symptoms after antibiotic treatment were enrolled in a phone survey to evaluate their experience with treatment for PTLDS.

Results

Symptoms most commonly seen in 218 new patients included fatigue (66.5%), joint pain (58.2%), cognitive difficulty (32.1%), headache (27.9%) and sleep disturbance (27.5%). 87% had already received tick-borne disease directed antibiotic treatment. Over half (60.5%) of patients report having symptoms for more than 6 months. More than half of patients (54.8%) who had more than 6 months of Lyme-related symptoms had positive serological testing. Common themes identified in the 16 phone surveys of patients with PTLDS conducted so far included significant frustration related to the dismissive attitudes from medical professionals (n=9/16), and many sought alternative or complementary therapies (n=11/16). Six patients reported receiving very long-term antibiotic regimens from other Lyme specialists. Many patients expressed satisfaction with the visit and medical advice even in the absence of curative therapy (n=9/16), although a significant number continued to seek care elsewhere (n=6/16).

Conclusion

More than half of new patients reported symptoms lasting more than 6 months after targeted antibiotic therapy. Further research is needed to develop interventions for the common symptoms of fatigue, joint pain, cognitive difficulty and sleep disturbance. Treatments to improve sleep, diet, and physical activity and decrease inflammation among patients who suffer from PTLDS are needed.

Disclosures

All Authors: No reported disclosures
615. Overlooking those at Intermediate Risk? ASCVD Prevention Measures among People Living with HIV at an Urban Academic Medical Center
Authors: Liotta Mark , Cangialosi Peter , Ho Jeanne , Finkel Diana , Swaminathan Shobha , Keller Steven
Published: January 2021

Background

The American College of Cardiology (ACC) recognizes HIV as a risk factor for atherosclerotic cardiovascular disease (ASCVD). However, 2019 guidelines do not address people living with HIV (PLWH), aside from stating that their Risk Estimator Plus tool, which is used to calculate a 10-year risk for ASCVD and advise management, likely underestimates CVD risk in PLWH. This quality assessment project examines rates of ACC guideline adherence for ASCVD prevention for PLWH who have calculated risk scores in the low (< 7.5%), intermediate (> 7.5% & < 20%), and high-risk (> 20%) ranges. Patients analyzed are from an HIV registry of University Hospital Infectious Disease Outpatient clinic in Newark, NJ. The clinic’s 2451 total patients are 40% female, 63% non-Hispanic black, 23% Hispanic, and 64% > 45 years old.

Methods

This project was approved by the Rutgers IRB. Patients (40-79 years) with a clinic visit from 2/1/2019 to 1/31/2020 were reviewed. ASCVD risk scores were calculated using the Risk Estimator Plus for all patients when data was available. Guideline adherence rate was defined as following 2019 ACC guidelines for appropriate statin therapy, while considering medication interactions.

Results

Of the 1127 patients who met criteria, 744 ASCVD risk scores were calculated. Lipid values outside the calculator range (229) or no documented lipids (154) resulted in non-calculatable scores. Guideline adherence rate for the intermediate-risk group was significantly less than the high-risk and low-risk groups (P< 0.05): low-risk 92.8% (95% CI 90.0-95.1, n=346), intermediate-risk 35.2% (95% CI 29.7-41.1, n=270), and high-risk 52.3% (95% CI 43.8-60.8, n=128). Adherence rates within the intermediate-risk group for patients with hypertension (HTN) and smokers were significantly less than those with CVD (P< 0.05).

Table 1: Patients with Calculated ASCVD Risk Score > 20 for PLWH from 2/1/2019 – 1/31/2020

Table 2: Patients with Calculated ASCVD Risk Score > 7.5 & < 20 for PLWH from 2/1/2019 – 1/31/2020

Table 3: Patients with Calculated ASCVD Risk Score < 7.5 for PLWH from 2/1/2019 – 1/31/2020

Conclusion

Lower overall guideline adherence rates within the intermediate risk group, and particularly among those with a history of HTN and smoking, highlights the need for targeted care. Provider education on the calculation and application of ASCVD risk scores, as well as increased awareness of the risk-enhancing nature of HIV infection in coexistence with the traditional risk factors of CVD history, diabetes, HTN, and smoking are important steps to increase adherence rates.

Disclosures

All Authors: No reported disclosures
618. Post-discharge Care Coordination Telephone Call for Patients Enrolled in the UNC OPAT Program
Authors: Boerneke Renae A , Swartwood Michael J , Kinlaw Alan C , Holt Anita , Mavrogiorgos Nikolaos , Marx Ashley , Ciccone Emily J , Schranz Asher J , Bowman Mary C , Farel Claire E
Published: January 2021

Background

At hospital discharge, patients enter a transition period that carries risks for their health and access to care, particularly those receiving home infusion. In April 2019, to enhance care coordination at discharge, our OPAT program implemented a structured telephone outreach program.

Methods

Starting in April 2019, the UNC OPAT program rolled out a patient outreach intervention. Within approximately 3 days after discharge, a pharmacist or nurse coordinator called the patient or caregiver to discuss UNC’s OPAT program, review all medications and potential adverse effects, discuss home infusion and line care, schedule relevant follow-up appointments and transportation, and address patient/caregiver concerns. To evaluate dissemination and impact, we analyzed data from UNC OPAT patients from April 2019-May 2020. We abstracted EHR data for unplanned readmissions and adverse events (hepatotoxicity, nephrotoxicity, neutropenia, eosinophilia, thrombocytopenia, creatine kinase elevation, rash, Clostridioides difficile infection, line complications). We estimated risk differences (RD) to compare outcomes between contacted versus uncontacted patients. To provide context, we also assessed unplanned readmissions and adverse events in a historical control period from April 2018-March 2019, before implementation of the outreach program.

Results

After rollout of the outreach program, 374 patients completed their OPAT course and all were targeted for outreach. The success rate of contacting patients was 61%. Median age was similar between contacted and uncontacted patients (52 versus 55). Unplanned readmissions occurred less frequently for contacted patients (14% versus 21%; RD -7%; 95%CI -15%, 1%). Risk of adverse events was similar between contact groups (58% versus 54%; RD 4%; 95%CI -6%, 15%). In the historical control period (n=287, median age 56), unplanned readmission risk was 22% and adverse event risk was 63%.

Conclusion

Patients who completed the outreach phone call had lower risk of readmission compared to those who could not be reached. This intervention may be a simple, low-cost way to reduce readmissions for OPAT patients, but further study and a sustainable reimbursement structure are needed.

Disclosures

All Authors: No reported disclosures
625. Sustained Efforts Improve Adherence to Monitoring for Solid Tumor Patients Discharged on Outpatient Parenteral Antimicrobial Therapy (OPAT) at a Comprehensive Cancer Center
Authors: Robins Alison , McDaneld Patrick , Garnes Natalie J Dailey , Rowan Meagan , Bartek Jalen
Published: January 2021

Background

OPAT helps reduce hospital length of stay, but 1 in 4 patients is readmitted within 30 days of discharge. Follow up < 30 days after discharge and laboratory monitoring during therapy have been shown to reduce hospital readmissions. However, few OPAT studies have included patients with malignancies, who may not experience the same benefits due to increased risks for hospital admission and infection related to antineoplastic therapy. We started an OPAT program to increase laboratory monitoring and clinic follow up among patients with solid tumors, attempting to also decrease readmissions.

Methods

We obtained demographic data and baseline frequencies of laboratory monitoring, ID clinic follow up, 30-day OPAT-related readmissions, Emergency Center (EC) visits, and deaths by retrospective chart review. We conducted multiple interventions from June 2018-January 2020: clarifying physician recommendations for laboratory monitoring and follow up by using a standardized electronic medical record template, communicating recommendations to case management, and changing the lab ordering workflow. We compared frequencies after interventions to baseline by using Fisher’s exact test.

Results

Most commonly observed malignancies in our patient cohort included genitourinary, breast, gastrointestinal, gynecologic, and head and neck. The most commonly treated infections included abscess, bacteremia, and skin and soft tissue. The percentage of patients without recommended lab monitoring decreased from 32.3% to 15.3% (p=0.03). We observed trends toward improved ID clinic follow up (54.8% to 71.8%; p=0.12) and decreased 30-day OPAT-related readmissions from 16.7% to 8.6% (p = 0.17). We observed no difference in mortality or EC visits.

Conclusion

OPAT-treated infections in our solid tumor patient cohort differed from those reported commonly. Through continued interventions, we improved lab monitoring rates among solid tumor patients with trends toward improved ID clinic follow up and decreased readmission rates. Our findings suggest that despite competing reasons for hospital readmission, OPAT may still benefit this population.

Disclosures

All Authors: No reported disclosures
626. Tackling the HIV Epidemic in South Florida: Patient Insights on Approaches for HIV Counseling, Testing, and Access to Prevention or Treatment
Authors: Fallon Stephen J , Molnar Kimberly , Taneva Ekaterina S , Simone Laura , Carter Jeffrey , Sapir Tamar
Published: January 2021

Background

The South Florida Metropolitan Statistical Area has for several years recorded the highest HIV incidence in the nation, and prevalence in the top three of all counties. To address the alarming disparity in HIV impact, we developed a survey study to learn about the beliefs, attitudes, and perspectives of persons who accessed services at an HIV community-based organization in South Florida.

Methods

Surveys were administered in English and Spanish to 109 persons who visited a community-based HIV service provider (Latinos Salud) at any of its three South Florida sites in April 2019. The survey evaluated the participants’ perspectives on different avenues for HIV counseling, screening, and accessing HIV medications for prevention or treatment.

Results

The majority of survey participants were male (90%), homosexual/gay/queer (75%), and Hispanic/Latino (56%; Table 1). Participants’ self-reported their HIV status as negative (64%), positive (30%), or unknown (6%; Table 1). Of those not currently living with HIV, 77% reported having been tested within the past 6 months, and 81% reported recent engagement in high-risk activities (Table 1).

Most participants considered using social media to promote awareness of HIV and related services a good idea (Table 2). Large proportions of participants endorsed receiving HIV counseling through in-person conversations with clinicians (91%), staff at community-based organizations (83%), friends (83%), telehealth visits (69%), conversations with teachers (63%), or church members (56%; Table 2). Most participants endorsed a range of both clinical (e.g. local health clinic) and non-clinical (e.g. mobile van) locations as acceptable settings for HIV testing (Table 2). Large proportions of participants endorsed receiving medications to prevent or treat HIV immediately after testing (82%), by home delivery (78%), or through telehealth (60%; Table 2). Meaningful associations were found between certain patient demographics (race/ethnicity, testing history, or insurance status) and the participants’ perspectives on specific strategies (Table 3).

Table 1. Participant Characteristics

Table 2. Participants’ Views on Strategies for HIV Counseling, Testing, and Access to Medications

Table 3. Participants’ Views on Strategies for HIV Counseling, Testing, and Access to Medications Stratified by Patient Characteristics

Conclusion

These real-world findings can be used to inform clinic- and community-based interventions tailored to individual patient characteristics.

Disclosures

Tamar Sapir, PhD, Gilead Sciences, Inc. (Other Financial or Material Support, Independent medical education grant)
627. Tele-OPAT Outcomes at Two Community Hospitals
Authors: Sheridan Kathleen R , Abdel-Massih Rima , Gupta Nupur , Mellors John
Published: January 2021

Background

Outpatient parenteral antimicrobial therapy (OPAT) is well-established for the care of patients requiring IV antibiotics after hospital discharge but little is known about the effectiveness of OPAT delivered through telemedicine.1-3 We therefore investigated outcomes from telemedicine OPAT services (Tele-OPAT) at two community hospitals.

Methods

Data was collected from two community hospitals in the UPMC system for which both inpatient and outpatient telemedicine ID services (Tele-ID), including Tele-OPAT services, are provided. Tele-ID services at Site 1 (171 beds) began in January 2014 and at Site 2 (133 beds) in January 2018. All patients had inpatient Tele-ID consults via live audio-video (AV) visits or EHR review. After discharge, patients were managed by a Tele-OPAT team consisting of an ID pharmacist, RN and ID physician. Live AV Tele-OPAT outpatient follow-up visits were conducted with the assistance of a tele-presenter at 2 clinic sites.

Results

A total of 489 unique patients with 536 encounters were evaluated. Site 1 accounted for 284 patients, Site 2 had 252. Demographics are listed in Table 1. 47% of the patients were male with an average age of 65. 51% of the patients were diabetic. Half of the patients were discharged to home. Bacteremia (24.4%) and osteomyelitis (23.3%) were the most frequent diagnoses. Vancomycin was the most commonly used antibiotic (25.6%). Tele-ID Clinic follow up rates varied by year and site between 19 to 26.6% (Figure 1). The choice of follow-up was determined by the primary inpatient physician. 30 Day Readmission Rates were lower for patients that were seen by the Tele-OPAT service (combined rate of 7.4%) vs. no follow up (62%) vs. PCP follow up (22%) vs. follow up with another MD (12.8%) (Figure 2a). Most patients seen by Tele-OPAT were readmitted for reasons not related to their initial infection or their antibiotic course (Figure 2b).

Table 1. Patient Demographics

Figure 1. Clinic Follow Up Rates

Figure 2. Readmission Rates & Reasons for Readmission

Conclusion

Patients discharged on IV antibiotics who were managed via a Tele-OPAT service in an outpatient clinic had lower readmission rates than those who were seen by non-ID physicians or who had no outpatient follow-up. Tele-OPAT is an important option for patients residing in rural areas who are discharged on parenteral antibiotics.

Disclosures

Rima Abdel-Massih, MD, Infectious Disease Connect (Shareholder, Other Financial or Material Support, Chief Medical Officer) John Mellors, MD, Abound Bio (Shareholder)Accelevir Diagnostics (Consultant)Co-Crystal Pharmaceuticals (Shareholder)Gilead (Consultant, Grant/Research Support)Merck (Consultant)
633. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Efficacy in Participants with Pre-Existing Primary Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical Trials
Authors: D’Antoni Michelle L , Andreatta Kristen , Acosta Rima K , Chang Silvia , Martin Ross , White Kirsten L
Published: January 2021

Background

Pre-existing drug resistance can affect the efficacy of antiretroviral therapy. Studies in treatment-naïve and virologically suppressed participants have demonstrated safety and efficacy of B/F/TAF, including in patients with M184V/I mutations. In this pooled analysis, we investigated virologic outcomes after 48 weeks of B/F/TAF treatment in individuals with pre-existing integrase strand transfer inhibitor resistance (INSTI-R).

Methods

Although INSTI-R was prohibited per study entry criteria, pre-existing INSTI-R (T66A/I/K, E92G/Q, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, R263K) was evaluated in participants from studies 1489, 1490, 1844, 1878, 4030. INSTI-R was assessed by historical genotypes and/or retrospective deepType HIV assay (Seq-IT, Germany), GenoSure IN, GenoSure Archive (Monogram Biosciences). Virologic outcomes were defined by last on-treatment observation carried forward (LOCF) method.

Results

Pre-existing primary INSTI-R substitutions were detected in 20/1907 participants (1.0%) after enrolment. Of the 20, 75% were male, 30% white, and 85% had HIV-1 subtype B, baseline median CD4 counts of 594 (IQR 517, 700), and median age of 52 (43, 59) years. One participant was treatment-naïve with a baseline viral load of 30,000 copies/ml and had Q148H (+ G140S on plasma RNA genotype) and was sensitive to bictegravir (< 2.5-fold change). The other 19 participants were virologically suppressed and had E92G (n=3), Y143C (n=2), Y143H (n=4), S147G (n=2), N155S (n=1), Q148H (n=3), Q148K (n=1), Q148R (n=1), or R263K (n=2) INSTI-R mutations by DNA genotype. The treatment-naïve individual was suppressed by Week 4 and maintained viral loads of < 50 copies/mL through Week 48. All suppressed participants had HIV RNA < 50 copies/mL throughout Week 48. All study participants had virologic success by LOCF (< 50 copies/mL) at Week 48.

Conclusion

Participants with primary INSTI-R substitutions had or maintained virologic suppression through 48 weeks of B/F/TAF treatment. Consistent with the potent in vitro activity of bictegravir against many INSTI-R mutations, these virologic outcomes suggest that B/F/TAF may have potential as a treatment option for some patients with pre-existing INSTI-R, if confirmed by further studies.

Disclosures

Michelle L. D’Antoni, PhD, Gilead Sciences (Employee, Shareholder) Kristen Andreatta, MSc, Gilead Sciences (Employee, Shareholder) Rima K. Acosta, BS, Gilead Sciences, Inc. (Employee, Shareholder) Silvia Chang, Masters, Gilead Sciences (Employee, Shareholder) Ross Martin, PhD, Gilead Sciences (Employee, Shareholder) Kirsten L. White, PhD, Gilead Sciences, Inc. (Employee, Shareholder)
634. Chlorhexidine Oral Rinses to Alter the Oral and Sputum Microbiota in COPD (CLIMB): a Randomized, Double-blinded, Placebo-controlled, Parallel-group Pilot Study
Authors: Pragman Alexa , Fieberg Ann , Reilly Cavan , Wendt Chris
Published: January 2021

Background

Chronic obstructive pulmonary disease (COPD) is a progressive, inflammatory lung disease with few available disease-modifying therapies. Acute exacerbations of COPD (AECOPD) increase morbidity and mortality, and their occurrence coincides with sputum and oral microbiota dysbiosis. The oral microbiota also serves as the source of the lower airway microbiota. Chlorhexidine oral rinses are known to alter the oral microbiota. We hypothesized that subjects randomized to 8 weeks of chlorhexidine oral rinses (vs. placebo) will demonstrate decreased microbiota biomass compared to baseline and those on placebo.

Methods

We performed a randomized, double-blind, placebo-controlled, 8-week study of the effects of twice-daily chlorhexidine oral rinses on 44 subjects with COPD. Baseline and post-treatment data were obtained evaluating oral and sputum microbiota biomass and composition, systemic inflammation (CRP, fibrinogen, and WBC count), and respiratory symptoms (Breathlessness, Cough, and Sputum Scale [BCSS], St. George’s Respiratory Questionnaire [SGRQ], and AECOPD assessment). All analyses were prespecified.

Results

Forty of 44 participants completed the study. The primary analysis of the mean differences in oral and sputum microbiota biomass between treatment groups was not significant. Chlorhexidine use was associated with a decrease in oral and sputum microbiota alpha diversity compared with placebo (Shannon diversity index change [standard error]: -0.349 [0.091] and -0.622 [0.169] respectively; padj=0.001 for both). There was no significant change in CRP, fibrinogen, WBC count, or BCSS score between treatment groups over the study period. Chlorhexidine use was associated with a significant improvement in SGRQ score when compared to the placebo (mean change ± standard deviation: chlorhexidine -4.7 ± 8.0 vs. placebo 1.7 ± 8.9, p=0.011; minimal clinically important difference in SGRQ score -4). Few adverse events were reported.

Conclusion

Among those with COPD, use of twice-daily chlorhexidine oral rinses resulted in decreased oral and sputum microbiota alpha diversity and clinically significant improvement in COPD symptoms. Chlorhexidine use did not result in decreased oral or sputum microbiota biomass or decreased systemic inflammation.

Disclosures

All Authors: No reported disclosures
636. Immunogenicity, Safety and Tolerability of a Booster Dose of Clostridium difficile Vaccine and 4 Year Antibody Persistence
Authors: Remich Shon A , Kitchin Nicholas , Pride Michael W , Anderson Annaliesa S , Li Ping , Webber Chris
Published: January 2021

Background

Clostroidides difficile (C difficile) is a common cause of antibiotic-associated diarrhea. To date, there is no vaccine to prevent C. difficile infection (CDI). This extension of a phase 2 study explores the immunogenicity, safety, and tolerability of a 4th dose, and antibody persistence of a three-dose regimen of a toxoid-based C difficile vaccine in 300 healthy adults 65 to 85 years of age in the United States.

Methods

The first stage of this study was conducted from 16 July 2015 to 7 March 2017, in which subjects were enrolled and randomized to receive one of two antigen dose levels (100µg or 200µg total toxoid A and B) or placebo, administered in one of two three-dose regimens: Days 1, 8 & 30 or Months 0, 1 & 6. Immunogenicity testing was conducted on samples obtained at each of nine study visits through 12 months post dose 3. In this extension stage, subjects who had received vaccine in the first stage were re-randomized at 12 months post dose 3 to receive either a booster dose or placebo in a 1:1 ratio. Subjects were followed for immunogenicity three (3) years post booster (four years post dose #3)

Results

Peak antibody response to vaccination was observed between day 8 and 30 following booster administration. Both regimens demonstrated robust anamnestic responses with peak levels above the three-dose peak (stage 1). Toxin A geometric mean concentrations (GMCs) remained above pre-booster GMCs, 3 years post booster for both dose levels and regimens. Antibody persistence for both groups demonstrated stable antibody levels four years after the primary vaccination series among subjects who did not receive a booster dose. No Grade 4 reactogenicity was reported during the study. Pain was the most common local reaction. Adverse event rates per subject were similar between both regimens and placebo. There were no Serious Adverse Events (SAEs) considered related to the investigational product at any dose or regimen. The safety profile was consistent with what was seen in the first stage of the study.

Conclusion

A booster dose of Clostroidides difficile vaccine candidate is highly immunogenic, well tolerated and demonstrates an acceptable safety profile in both dose groups for the Day and the Month regimens. Antibody persistence remains stable from 12 months to 4-year post dose 3.

Disclosures

Nicholas Kitchin, MD, Pfizer, Inc (Employee) Michael W. Pride, PhD, Pfizer (Employee, Shareholder) Annaliesa S. Anderson, PhD, Pfizer (Employee, Shareholder) Chris Webber, MD, Pfizer Inc (Employee, Shareholder)