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1.
mBio ; 15(5): e0040024, 2024 May 08.
Article in English | MEDLINE | ID: mdl-38602414

ABSTRACT

Although severe coronavirus disease 2019 (COVID-19) and hospitalization associated with COVID-19 are generally preventable among healthy vaccine recipients, patients with immunosuppression have poor immunogenic responses to COVID-19 vaccines and remain at high risk of infection with SARS-CoV-2 and hospitalization. In addition, monoclonal antibody therapy is limited by the emergence of novel SARS-CoV-2 variants that have serially escaped neutralization. In this context, there is interest in understanding the clinical benefit associated with COVID-19 convalescent plasma collected from persons who have been both naturally infected with SARS-CoV-2 and vaccinated against SARS-CoV-2 ("vax-plasma"). Thus, we report the clinical outcome of 386 immunocompromised outpatients who were diagnosed with COVID-19 and who received contemporary COVID-19-specific therapeutics (standard-of-care group) and a subgroup who also received concomitant treatment with very high titer COVID-19 convalescent plasma (vax-plasma group) with a specific focus on hospitalization rates. The overall hospitalization rate was 2.2% (5 of 225 patients) in the vax-plasma group and 6.2% (10 of 161 patients) in the standard-of-care group, which corresponded to a relative risk reduction of 65% (P = 0.046). Evidence of efficacy in nonvaccinated patients cannot be inferred from these data because 94% (361 of 386 patients) of patients were vaccinated. In vaccinated patients with immunosuppression and COVID-19, the addition of vax-plasma or very high titer COVID-19 convalescent plasma to COVID-19-specific therapies reduced the risk of disease progression leading to hospitalization.IMPORTANCEAs SARS-CoV-2 evolves, new variants of concern (VOCs) have emerged that evade available anti-spike monoclonal antibodies, particularly among immunosuppressed patients. However, high-titer COVID-19 convalescent plasma continues to be effective against VOCs because of its broad-spectrum immunomodulatory properties. Thus, we report clinical outcomes of 386 immunocompromised outpatients who were treated with COVID-19-specific therapeutics and a subgroup also treated with vaccine-boosted convalescent plasma. We found that the administration of vaccine-boosted convalescent plasma was associated with a significantly decreased incidence of hospitalization among immunocompromised COVID-19 outpatients. Our data add to the contemporary data providing evidence to support the clinical utility of high-titer convalescent plasma as antibody replacement therapy in immunocompromised patients.


Subject(s)
COVID-19 Serotherapy , COVID-19 Vaccines , COVID-19 , Hospitalization , Immunization, Passive , Immunocompromised Host , SARS-CoV-2 , Humans , COVID-19/immunology , COVID-19/therapy , COVID-19/prevention & control , Immunization, Passive/methods , Female , Male , Middle Aged , SARS-CoV-2/immunology , COVID-19 Vaccines/immunology , COVID-19 Vaccines/administration & dosage , Aged , Hospitalization/statistics & numerical data , Adult , Antibodies, Viral/blood , Antibodies, Viral/immunology , Immunosuppression Therapy , Outpatients , Treatment Outcome
2.
Sci Rep ; 14(1): 5430, 2024 03 05.
Article in English | MEDLINE | ID: mdl-38443438

ABSTRACT

Studies conducted prior to SARS-CoV-2 Omicron demonstrated that sotrovimab and remdesivir reduced hospitalization among high-risk outpatients with mild to moderate COVID-19. However, their effectiveness has not been directly compared. This study examined all high-risk outpatients with mild to moderate COVID-19 who received either remdesivir or sotrovimab at Mayo Clinic during the Omicron BA.1 surge from January to March 2022. COVID-19-related hospitalization or death within 28 days were compared between the two treatment groups. Among 3257 patients, 2158 received sotrovimab and 1099 received remdesivir. Patients treated with sotrovimab were younger and had lower comorbidity but were more likely to be immunocompromised than remdesivir-treated patients. The majority (89%) had received at least one dose of COVID-19 vaccine. COVID-19-related hospitalization (1.5% and 1.0% in remdesivir and sotrovimab, respectively, p = .15) and mortality within 28 days (0.4% in both groups, p = .82) were similarly low. A propensity score weighted analysis demonstrated no significant difference in the outcomes between the two groups. We demonstrated favorable outcomes that were not significantly different between patients treated with remdesivir or sotrovimab.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , COVID-19 , Outpatients , Humans , COVID-19 Vaccines , SARS-CoV-2 , COVID-19 Drug Treatment
3.
J Telemed Telecare ; 29(4): 298-303, 2023 May.
Article in English | MEDLINE | ID: mdl-33461397

ABSTRACT

INTRODUCTION: Telehealth service provision has accelerated during the Coronavirus disease 2019 (COVID-19) pandemic. As the pandemic continues, clinical practices have discovered ways to resume operations. Opportunities exist to understand patient preferences for telehealth clinical services and to tailor offerings to different demographic groups. METHODS: We conducted a survey of patients receiving telehealth services through our outpatient practice to understand the types of healthcare services for which patients report preferences for telehealth. RESULTS: We received 551 survey responses (response rate = 20.8%; 551/2650). More than half of patients indicated being 'very likely' to use telehealth services to refill medication(s) (67.3%), prepare for an upcoming visit (66.1%), review test results (60.3%), or receive education (54.2%). Males had lower odds of preferring telehealth services for reviewing test results (odds ratio (OR) = 0.57; 95% confidence interval (CI): 0.34-0.94) or mental health issues (OR = 0.54; 95% CI: 0.38-0.77). Respondents who received a video visit were significantly more likely than those who received a telephone visit to report preferences for using telehealth for education, care plan discussions, long-term health issues, and mental health. DISCUSSION: Patient preferences for telehealth services vary by services provided and respondent demographics. Experience with telehealth increases the likelihood for future use of these services.


Subject(s)
COVID-19 , Telemedicine , Male , Humans , Patient Preference , COVID-19/epidemiology , Mental Health , Odds Ratio
4.
Clin Infect Dis ; 76(3): e537-e539, 2023 02 08.
Article in English | MEDLINE | ID: mdl-35698452

ABSTRACT

In a cohort of 483 high-risk patients treated with nirmatrelvir/ritonavir for COVID-19, 2 patients (0.4%) required hospitalization by day 30. Four patients (0.8%) experienced rebound of symptoms, which were generally mild, at a median of 9 days after treatment, and all resolved without additional COVID-19-directed therapy.


Subject(s)
COVID-19 , Ritonavir , Humans , Ritonavir/therapeutic use , COVID-19 Drug Treatment
5.
Open Forum Infect Dis ; 9(10): ofac411, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36213724

ABSTRACT

Background: Antispike monoclonal antibodies are recommended for early treatment of high-risk persons with mild to moderate coronavirus disease 2019 (COVID-19). However, clinical outcomes of their use during the severe acute respiratory syndrome coronavirus 2 Omicron wave are limited. Methods: This is a descriptive retrospective study of high-risk adult patients who received treatment with sotrovimab (January 1-March 20, 2022) or bebtelovimab (March 21-April 30, 2022). The primary outcome was the proportion of patients who progressed to severe outcome within 30 days after receiving antispike-neutralizing monoclonal antibody infusion. Results: A total of 3872 high-risk patients (median age, 62.7 years; 41.1% male) with mild to moderate COVID-19 received sotrovimab (n = 2182) or bebtelovimab (n = 1690). Among sotrovimab-treated patients, the most common comorbidities were an immunosuppressed condition (46.7%), hypertension (38.2%), and diabetes (21.2%). The rates of severe outcome, intensive care unit (ICU) admission, and mortality were 2.2%, 1.0%, and 0.4%, respectively, after sotrovimab infusion. Among bebtelovimab-treated patients, the most common comorbidities were hypertension (42.7%), diabetes (17.1%), and an immunosuppressed condition (17.0%). The rates of severe disease, ICU admission, and mortality were 1.3%, 0.5%, and 0.2%, respectively, after bebtelovimab infusion. Older age, immunosuppressed status, and several comorbidities were associated with severe disease progression, while COVID-19 vaccination was associated with lower risk. No anaphylaxis was reported during monoclonal antibody infusion. Conclusions: This real-world analysis of a large cohort of high-risk patients demonstrates low rates of severe disease after treatment with sotrovimab during the era dominated by Omicron B.1.1.529 and after treatment with bebtelovimab during the era dominated by BA.2 and Omicron subvariants.

6.
Mayo Clin Proc ; 97(9): 1641-1648, 2022 09.
Article in English | MEDLINE | ID: mdl-36058578

ABSTRACT

OBJECTIVE: To describe and compare the clinical outcomes of bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab treatment of mild to moderate coronavirus disease 2019 (COVID-19) during the severe acute respiratory coronavirus 2 (SARS-CoV-2) B.1.617.2 Delta surge. METHODS: This is a retrospective study of high-risk patients who received bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab for mild to moderate COVID-19 between August 1, 2021, and December 1, 2021. Rates of severe disease, hospitalization, intensive care unit admission, and death were assessed. RESULTS: Among 10,775 high-risk patients who received bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab for mild to moderate COVID-19 during the Delta surge, 287 patients (2.7%) developed severe disease that led to hospitalization, oxygen supplementation, or death within 30 days after treatment. The rates of severe disease were low among patients treated with bamlanivimab-etesevimab (1.2%), casirivimab-imdevimab (2.9%), and sotrovimab (1.6%; P<.01). The higher rate of severe outcomes among patients treated with casirivimab-imdevimab may be related to a significantly lower COVID-19 vaccination rate in that cohort. Intensive care unit admission was comparable among patients treated bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab (1.0%, 1.0%, and 0.4%, respectively). CONCLUSION: This real-world study of a large cohort of high-risk patients shows low rates of severe disease, hospitalization, intensive care unit admission, and mortality after treatment with bamlanivimab-etesevimab, casirivimab-imdevimab, and sotrovimab for mild to moderate COVID-19 during the SARS-CoV-2 Delta surge.


Subject(s)
COVID-19 Drug Treatment , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , COVID-19 Vaccines , Humans , Retrospective Studies , SARS-CoV-2
7.
J Infect Dis ; 226(10): 1683-1687, 2022 11 11.
Article in English | MEDLINE | ID: mdl-36124696

ABSTRACT

The effectiveness of bebtelovimab in real-world settings has not been assessed. In this retrospective cohort study of 3607 high-risk patients, bebtelovimab was used more commonly than nirmatrelvir-ritonavir for treatment of coronavirus disease 2019 (COVID-19) among older patients, immunosuppressed patients, and those with multiple comorbid conditions. Despite its use in patients with multiple comorbid conditions, the rate of progression to severe disease after bebtelovimab (1.4% [95% confidence interval, 1.2%-1.7%]) was not significantly different from that for nirmatrelvir-ritonavir treatment (1.2% [.8%-1.5%]). Our findings support the emergency use authorization of bebtelovimab for treatment of COVID-19 during the Omicron epoch dominated by BA.2 and subvariants.


Subject(s)
COVID-19 Drug Treatment , SARS-CoV-2 , Humans , Ritonavir/therapeutic use , Retrospective Studies
8.
Mayo Clin Proc ; 97(2): 327-332, 2022 02.
Article in English | MEDLINE | ID: mdl-35120695

ABSTRACT

Anti-spike monoclonal antibodies have proven invaluable in preventing severe outcomes from COVID-19, including hospitalization and death. The rise of the SARS-CoV-2 delta variant begs the question of whether monoclonal antibodies maintain similar efficacy now as they had when the alpha and beta variants predominated, when they were first assessed and approved. We used a retrospective cohort to compare rates of severe outcomes in an epoch in which alpha and beta were predominant compared with delta. A total of 5356 patients were infused during the alpha/beta variant-predominant (n=4874) and delta variant-predominant (n=482) era. Overall, odds of severe infection were 3.0% of patients in the alpha/beta-predominant era compared with 4.9% in the delta-predominant cohort. The unadjusted odds ratio (OR) was higher for severe disease in the delta era (OR, 1.67; 95% CI, 0.96 to 2.89), particularly when adjusted for Charlson Comorbidity Index (adjusted OR, 2.04; 95% CI, 1.30 to 3.08). The higher odds of severe infection could be due to a more virulent delta variant, although the possibility of decreased anti-spike monoclonal antibody effectiveness in the clinical setting cannot be excluded. Research into the most effective strategies for using and improving anti-spike monoclonals for the treatment of emerging variants is warranted.


Subject(s)
Antibodies, Monoclonal/therapeutic use , COVID-19 Drug Treatment , Immunologic Factors/therapeutic use , SARS-CoV-2/immunology , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Patient Acuity , Retrospective Studies , United States/epidemiology
9.
J Infect Dis ; 225(4): 598-602, 2022 02 15.
Article in English | MEDLINE | ID: mdl-34791298

ABSTRACT

BACKGROUND: Breakthrough coronavirus disease 2019 (COVID-19) may occur in fully vaccinated persons. METHODS: We assessed the clinical outcomes of breakthrough COVID-19 in fully vaccinated individuals. RESULTS: In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID- 19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly associated with the number of medical comorbidities. Antispike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (odds ratio, 0.227; 95% confidence interval, 0.128-0.403; P < .001). The number needed to treat (NNT) to prevent 1 hospitalization was 225 among the lowest risk patient group compared with NNT of 4 among those with highest numbers of medical comorbidity. CONCLUSIONS: Monoclonal antibody treatment is associated with reduced hospitalization in vaccinated high-risk persons with mild to moderate COVID-19.


Subject(s)
Antibodies, Monoclonal , COVID-19 , Vaccination , Antibodies, Monoclonal/therapeutic use , COVID-19/therapy , COVID-19 Vaccines , Comorbidity , Female , Humans , Male , Middle Aged , Risk Factors
10.
J Prim Care Community Health ; 12: 21501327211056796, 2021.
Article in English | MEDLINE | ID: mdl-34872410

ABSTRACT

OBJECTIVE: The purpose of this report is to describe the elements of a Covid-19 Care Clinic (CCC), patient demographics, and outcomes. METHODS: Descriptive statistics were used to describe demographics, clinical characteristics, and outcomes. This report is based on 4934 unique patients seen in the CCC who provided research authorization within a 10-month period of time (April 1, 2020-January 31, 2021). The CCC infection control processes consisted of a rooming process that mitigated SARS-COV-2 transmission, preparing examination rooms, using PPE by staff, in room lab drawing, and escorting services to minimize the time in clinic. RESULTS: Of the 4934 unique patients seen (age range newborn-102 years), 76.8% were tested for COVID-19. Of those tested, 11.8% were positive for SARS-CoV-2. Ninety-two percent of the patients with the reason for the visit documented had COVID-19 type symptoms. Cough, shortness of breath, and chest pain were the most common presenting symptom in those with COVID-19. At the time of the visit in the CCC, 5.8% of the patients were actively contagious. Thirty days after being seen in the CCC, 9.1% of the patients were seen in the emergency department (ED) and 0.2% died. During the 10-month period there were no known occupationally related COVID-19 infections. CONCLUSION: The COVID-19 Care Clinic provided face-to-face access for all ages with COVID-19 type symptoms. A minority of patients had COVID-19 who were seen in the clinic. The clinic provided an additional venue of care outside of the ED. The infectious control measures employed were highly effective in protecting the staff. Lessons learned allow for decentralization of COVID-19 symptom care to the primary care practices employing the infection control measures.


Subject(s)
COVID-19 , Aged, 80 and over , Ambulatory Care Facilities , Emergency Service, Hospital , Hospitals , Humans , Infant, Newborn , SARS-CoV-2
11.
EClinicalMedicine ; 40: 101102, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34485873

ABSTRACT

BACKGROUND: Real-world clinical data to support the use of casirivimab-imdevimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. This study aimed to assess the outcomes of casirivimab-imdevimab treatment of mild to moderate COVID-19. METHODS: A retrospective cohort of 696 patients who received casirivimab-imdevimab between December 4, 2020 and April 9, 2021 was compared to a propensity-matched control of 696 untreated patients with mild to moderate COVID-19 at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin. Primary outcome was rate of hospitalization at days 14, 21 and 28 after infusion. FINDINGS: The median age of the antibody-treated cohort was 63 years (interquartile range, 52-71); 45·5% were ≥65 years old; 51.4% were female. High-risk characteristics were hypertension (52.4%), body mass index ≥35 (31.0%), diabetes mellitus (24.6%), chronic lung disease (22.1%), chronic renal disease (11.4%), congestive heart failure (6.6%), and compromised immune function (6.7%). Compared to the propensity-matched untreated control, patients who received casirivimab-imdevimab had significantly lower all-cause hospitalization rates at day 14 (1.3% vs 3.3%; Absolute Difference: 2.0%; 95% confidence interval (CI): 0.5-3.7%), day 21 (1.3% vs 4.2%; Absolute Difference: 2.9%; 95% CI: 1.2-4.7%), and day 28 (1.6% vs 4.8%; Absolute Difference: 3.2%; 95% CI: 1.4-5.1%). Rates of intensive care unit admission and mortality at days 14, 21 and 28 were similarly low for antibody-treated and untreated groups. INTERPRETATION: Among high-risk patients with mild to moderate COVID-19, casirivimab-imdevimab treatment was associated with a significantly lower rate of hospitalization. FUNDING: Mayo Clinic.

12.
J Clin Invest ; 131(19)2021 10 01.
Article in English | MEDLINE | ID: mdl-34411003

ABSTRACT

BACKGROUNDClinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) are needed.METHODS2335 Patients who received single-dose bamlanivimab infusion between November 12, 2020, and February 17, 2021, were compared with a propensity-matched control of 2335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21, and 28.RESULTSThe median age of the population was 63 years; 47.3% of the bamlanivimab-treated cohort were 65 years or more; 49.3% were female and 50.7% were male. High-risk characteristics included hypertension (54.2%), BMI greater than or equal to 35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs. 3.5%; risk ratio [RR], 0.41), 21 (1.9% vs. 3.9%; RR, 0.49), and 28 (2.5% vs. 3.9%; RR, 0.63). Secondary exploratory outcomes included lower intensive care unit (ICU) admission rates at days 14 (0.14% vs. 1%; RR, 0.14), 21 (0.25% vs.1%; RR, 0.25), and 28 (0.56% vs.1.1%; RR. 0.51) and lower all-cause mortality at days 14 (0% vs. 0.33%), 21 (0.05% vs. 0.4%; RR,0.13), and 28 (0.11% vs. 0.44%; RR, 0.26). Adverse events were uncommon with bamlanivimab, occurring in 19 of 2355 patients, and were most commonly fever (n = 6), nausea (n = 5), and lightheadedness (n = 3).CONCLUSIONSAmong high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization, ICU admission, and mortality compared with usual care.FUNDINGMayo Clinic.


Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , COVID-19 Drug Treatment , COVID-19 , Hospitalization , SARS-CoV-2/metabolism , Administration, Intravenous , Adult , Aged , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19/metabolism , COVID-19/mortality , Disease-Free Survival , Female , Humans , Intensive Care Units , Male , Middle Aged , Risk Factors , Survival Rate
13.
J Infect Dis ; 224(8): 1278-1286, 2021 10 28.
Article in English | MEDLINE | ID: mdl-34279629

ABSTRACT

BACKGROUND: Bamlanivimab and casirivimab-imdevimab are authorized for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in high-risk patients. We compared the outcomes of patients who received these therapies to identify factors associated with hospitalization and other clinical outcomes. METHODS: Adult patients who received monoclonal antibody from 19 November 2020 to 11 February 2021 were selected and divided into those who received bamlanivimab (n = 2747) and casirivimab-imdevimab (n = 849). The 28-day all-cause and COVID-19-related hospitalizations were compared between the groups. RESULTS: The population included 3596 patients; the median age was 62 years, and 50% were female. All had ≥1 medical comorbidity; 55% had multiple comorbidities. All-cause and COVID-19-related hospitalization rates at 28 days were 3.98% and 2.56%, respectively. After adjusting for medical comorbidities, there was no significant difference in all-cause and COVID-19-related hospitalization rates between bamlanivimab and casirivimab-imdevimab (adjusted hazard ratios [95% confidence interval], 1.4 [.9-2.2] and 1.6 [.8-2.7], respectively). Chronic kidney, respiratory and cardiovascular diseases, and immunocompromised status were associated with higher likelihood of hospitalization. CONCLUSIONS: This observational study on the use of bamlanivimab and casirivimab-imdevimab in high-risk patients showed similarly low rates of hospitalization. The number and type of medical comorbidities are associated with hospitalizations after monoclonal antibody treatment.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19 Drug Treatment , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/epidemiology , Drug Combinations , Female , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Multimorbidity , Retrospective Studies , Risk Factors , SARS-CoV-2/isolation & purification , Severity of Illness Index , Treatment Outcome , Young Adult
14.
medRxiv ; 2021 May 25.
Article in English | MEDLINE | ID: mdl-34075387

ABSTRACT

BACKGROUND: Clinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. METHODS: 2,335 patients who received single-dose bamlanivimab infusion between November 12, 2020 to February 17, 2021 were compared with a propensity-matched control of 2,335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21 and 28. RESULTS: The median age of the population was 63; 47.3% of the bamlanivimab-treated cohort were ≥65 years; 49.3% were female. High-risk characteristics included hypertension (54.2%), body mass index ≥35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs 3.5%; Odds Ratio [OR], 0.38), 21 (1.9% vs 3.9%; OR, 0.46), and 28 (2.5% vs 3.9%; OR, 0.61). Secondary exploratory outcomes included lower intensive care unit admission rates at days 14 (0.14% vs 1%; OR, 0.12), 21 (0.25% vs 1%; OR: 0.24) and 28 (0.56% vs 1.1%; OR: 0.52), and lower all-cause mortality at days 14 (0% vs 0.33%), 21 (0.05% vs 0.4%; OR,0.08) and 28 (0.11% vs 0.44%; OR, 0.01). Adverse events were uncommon with bamlanivimab, occurring in 19/2355, most commonly fever (n=6), nausea (n=5), and lightheadedness (n=3). CONCLUSIONS: Among high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization compared with usual care. FUNDING: Mayo Clinic.

15.
J Am Geriatr Soc ; 69(4): 868-873, 2021 04.
Article in English | MEDLINE | ID: mdl-33619724

ABSTRACT

BACKGROUND: Residents of nursing homes and long-term care facilities are at increased risk for severe coronavirus disease-19 (COVID-19) but may not be able to access monoclonal antibody therapies offered at outpatient infusion centers due to frailty and logistical issues. We describe a mobile monoclonal antibody infusion program for patients with COVID-19 in skilled nursing facilities and provide descriptive data on its outcomes. DESIGN: Retrospective cohort study. SETTING: Collaboration between Mayo Clinic and skilled nursing facilities in Southeast Minnesota was developed to administer anti-spike monoclonal antibodies under the FDA Emergency Use Authorization. PARTICIPANTS: Seventy five residents of skilled nursing facilities at high risk of COVID-19 complications. EXPOSURE: Emergency use treatment with bamlanivimab and casirivimab-imdevimab. MEASUREMENTS: Hospitalization and medically attended visits. RESULTS: The mobile infusion unit, staffed by Mayo Clinic Infusion Therapy registered nurses and supported by the skilled nursing facility staff, infused anti-spike monoclonal antibodies to 45 of 75 patients (average age, 77.8 years) in December 2020. The infusions occurred at an average of 4.3 days after COVID-19 diagnosis. Fourteen days after infusion, there were no deaths, two emergency department visits, and three hospitalizations, for a combined event rate of 11.1%. There was one reported adverse event. CONCLUSION: The implementation of a mobile infusion unit embedded in a collaborative process resulted in rapid infusion of monoclonal antibodies to high-risk COVID-19 patients in skilled nursing facilities, who would otherwise be unable to access the novel therapies. The therapies were well tolerated and appear beneficial. Further study is warranted to explore the scalability and efficacy of this program.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19 Drug Treatment , Mobile Health Units , Skilled Nursing Facilities , Aged , Drug Combinations , Female , Humans , Male , Minnesota , Patients/statistics & numerical data , Referral and Consultation , Retrospective Studies
16.
JMIR Med Inform ; 8(7): e16521, 2020 Jul 08.
Article in English | MEDLINE | ID: mdl-32673238

ABSTRACT

BACKGROUND: Patient portal registration and the use of secure messaging are increasing. However, little is known about how the work of responding to and initiating patient messages is distributed among care team members and how these messages may affect work after hours. OBJECTIVE: This study aimed to examine the growth of secure messages and determine how the work of provider responses to patient-initiated secure messages and provider-initiated secure messages is distributed across care teams and across work and after-work hours. METHODS: We collected secure messages sent from providers from January 1, 2013, to March 15, 2018, at Mayo Clinic, Rochester, Minnesota, both in response to patient secure messages and provider-initiated secure messages. We examined counts of messages over time, how the work of responding to messages and initiating messages was distributed among health care workers, messages sent per provider, messages per unique patient, and when the work was completed (proportion of messages sent after standard work hours). RESULTS: Portal registration for patients having clinic visits increased from 33% to 62%, and increasingly more patients and providers were engaged in messaging. Provider message responses to individual patients increased significantly in both primary care and specialty practices. Message responses per specialty physician provider increased from 15 responses per provider per year to 53 responses per provider per year from 2013 to 2018, resulting in a 253% increase. Primary care physician message responses increased from 153 per provider per year to 322 from 2013 to 2018, resulting in a 110% increase. Physicians, nurse practitioners, physician assistants, and registered nurses, all contributed to the substantial increases in the number of messages sent. CONCLUSIONS: Provider-sent secure messages at a large health care institution have increased substantially since implementation of secure messaging between patients and providers. The effort of responding to and initiating messages to patients was distributed across multiple provider categories. The percentage of message responses occurring after hours showed little substantial change over time compared with the overall increase in message volume.

17.
J Am Med Inform Assoc ; 27(6): 867-876, 2020 06 01.
Article in English | MEDLINE | ID: mdl-32357370

ABSTRACT

OBJECTIVE: Financial impacts associated with a switch to a different electronic health record (EHR) have been documented. Less attention has been focused on the patient response to an EHR switch. The Mayo Clinic was involved in an EHR switch that occurred at 6 different locations and with 4 different "go-live" dates. We sought to understand the relationship between patient satisfaction and the transition to a new EHR. MATERIALS AND METHODS: We used patient satisfaction data collected by Press Ganey from July 2016 through December 2019. Our patient satisfaction measure was the percent of patients responding "very good" (top box) to survey questions. Twenty-four survey questions were summarized by Press Ganey into 6 patient satisfaction domains. Piecewise linear regression was used to model patient satisfaction before and after the EHR switch dates. RESULTS: Significant drops in patient satisfaction were associated with the EHR switch. Patient satisfaction with access (ease of getting clinic on phone, ease of scheduling appointments, etc.) was most affected (range of 6 sites absolute decline: -3.4% to -8.8%; all significant at 99% confidence interval). Satisfaction with providers was least affected (range of 6 sites absolute decline: -0.5% to -2.8%; 4 of 6 sites significant at 99% confidence interval). After 9-15 months, patient satisfaction with access climbed back to pre-EHR switch levels. CONCLUSIONS: Patient satisfaction in several patient experience domains dropped significantly and stayed lower than pre-"go-live" for several months after a switch in EHR. Satisfaction with providers declined less than satisfaction with access.


Subject(s)
Electronic Health Records , Patient Satisfaction/statistics & numerical data , Ambulatory Care Facilities/organization & administration , Attitude to Health , Humans , Linear Models , Patient Access to Records , Surveys and Questionnaires , United States
18.
Health Serv Res Manag Epidemiol ; 6: 2333392819885284, 2019.
Article in English | MEDLINE | ID: mdl-31803794

ABSTRACT

BACKGROUND: Patient satisfaction surveys ask patients specific questions about provider behavior such as whether they were satisfied with the provider's instructions about medications or time spent with the patient. It's unclear how responses to these surveys can help providers focus on specific behaviors to improve. METHODS: In a primary care setting, we analyzed Press Ganey patient experience survey responses. We examined the 10 questions dealing with satisfaction specific to the care provider experience. We used the "Top Box" counts (counts of most favorable responses) and Top Box% (percentage of most favorable response) for categorical and continuous measures of patient satisfaction. RESULTS: For 12 consecutive months, 652 providers of 1014 accumulated at least 300 total responses from patients for the 10 provider-related questions. Only 8 of the 652 providers had significant differences (P < .05) in Top Box% for the 10 questions. Correlation of responses between the questions were between 0.86 and 0.96. Analysis of variance showed that 87% of the total variation in the Top Box% of the 10 questions was between providers and only 13% within providers. Factor analysis found no independent factors within the 10 questions (ie, a one factor model was sufficient; P < .0001). CONCLUSION: Patient survey questions appear to ask about specific provider behaviors that contribute to patient experience. However, the responses to 10 different questions are highly correlated and may not give providers or management enough statistically significant information to focus patient experience improvement efforts for individual providers.

19.
J Prim Care Community Health ; 10: 2150132719870879, 2019.
Article in English | MEDLINE | ID: mdl-31496342

ABSTRACT

Objective: Much has been written about the patients' perspective concerning weight management in health care. The purpose of this survey study was to assess perspectives of primary care providers (PCPs) and nurses toward patient weight management and identify possible areas of growth. Patients and Methods: We emailed a weight management-focused survey to 674 eligible participants (437 [64.8%] nurses and 237 [35.2%] PCPs) located in 5 outpatient primary care clinics. The survey focused on opportunities, practices, knowledge, confidence, attitudes, and beliefs. A total of 219 surveys were returned (137 [62.6%] from nurses and 82 [34.4%] from PCPs). Results: Among 219 responders, 85.8% were female and 93.6% were white non-Hispanic. In this study, PCPs and nurses believed obesity to be a major health problem. While PCPs felt more equipped than nurses to address weight management (P < .001) and reported receiving more training than nurses (50.0% vs 17.6%, respectively), both felt the need for more training on obesity (73.8% and 79.4%, respectively). Although, PCPs also spent more patient contact time providing weight management services versus nurses (P < .001), the opportunity/practices score was lower for PCPs than nurses (-0.35 ± 0.44 vs -0.17 ± 0.41, P < .001) with PCPs more likely to say they lacked the time to discuss weight and they worried it would cause a poor patient-PCP relationship. The knowledge/confidence score also differed significantly between the groups, with nurses feeling less equipped to deal with weight management issues than PCPs (-0.42 ± 0.43 vs -0.03 ± 0.55, P < .001). Neither group seemed very confident, with those in the PCP group only answering with an average score of neutral. Conclusion: By asking nurses and PCP general questions about experiences, attitudes, knowledge, and opinions concerning weight management in clinical care, this survey has identified areas for growth in obesity management. Both PCPs and nurses would benefit from additional educational training on weight management.


Subject(s)
Attitude of Health Personnel , Health Promotion/methods , Nurses/statistics & numerical data , Obesity/therapy , Physicians, Primary Care/statistics & numerical data , Primary Health Care/methods , Adult , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Midwestern United States , Surveys and Questionnaires/statistics & numerical data
20.
SAGE Open Med ; 6: 2050312118800209, 2018.
Article in English | MEDLINE | ID: mdl-30245819

ABSTRACT

BACKGROUND: There are numerous recommendations from expert sources that help guide primary care providers in cancer screening, infectious disease screening, metabolic screening, monitoring of drug levels, and chronic disease management. Little is known about the potential effort needed for a healthcare system to address these recommendations, or the patient effort needed to complete the recommendations. METHODS: For 73 recommended population healthcare items, we examined each of 28,742 patients in a primary care internal medicine practice to determine whether they were up-to-date on recommended screening, immunizations, counseling, and chronic disease management goals. We used a rule-based software tool that queries the medical record for diagnoses, dates, laboratory values, pathology reports, and other information used in creating the individualized recommendations. We counted the number of uncompleted recommendations by age groups and examined the healthcare staff needed to address the recommendations and the potential patient effort needed to complete the recommendations. RESULTS: For the 28,742 patients, there were 127,273 uncompleted recommendations identified for population health management (mean recommendations per patient 4.36, standard deviation of 2.65, range of 0-17 recommendations per patient). The age group with the most incomplete recommendations was age of 50-65 years with 5.5 recommendations per patient. The 18-35 years age group had the fewest incomplete recommendations with 2.6 per patient. Across all age groups, initiation of these recommendations required high-level input (physician, nurse practitioner, or physician's assistant) in 28%. To completely adhere to recommended services, a 1000-patient cross-section cohort would require a total of 464 procedures and 1956 lab tests. CONCLUSION: Providers and patients face a daunting number of tasks necessary to meet guideline-generated recommendations. We will need new approaches to address the burgeoning numbers of uncompleted recommendations.

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