Dataset Information

Clinician Perspectives on Monoclonal Antibody Treatment for High-Risk Outpatients with COVID-19: Implications for Implementation and Equitable Access.

ABSTRACT:

Background

There is an urgent need to identify and address factors influencing uptake and equitable access to monoclonal antibody (mAb) treatment for high-risk outpatients with COVID-19.

Objective

To assess clinician knowledge, beliefs, and experiences regarding obtaining mAb treatment for eligible patients.

Design and participants

Survey of clinicians (N = 374) practicing in the state of Colorado who care for patients with COVID-19 in primary care, emergency medicine, and other clinical settings.

Main measure(s)

Diffusion of innovation theory concepts including knowledge, perceived strength of evidence, barriers, and experience with, ease of use, preparedness, and feasibility, appropriateness, and acceptability of mAb referral systems and processes.

Key results

Most respondents indicated little to no knowledge about mAb therapies for COVID-19 (67%, 74%, 77%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). About half reported little to no familiarity with eligibility criteria (50.9%) and did not know the strength of evidence (31%, 43%, 52%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). Lack of knowledge or confidence in treatment was a top barrier to mAbs use; other barriers included complicated referral processes, patients not eligible when seen, and out-of-pocket costs concerns. Respondents rated four mAb referral steps as generally acceptable, appropriate, and feasible to complete in their primary outpatient clinical setting. Only 24% indicated their clinical setting was very prepared to facilitate referrals, 40% had ever referred a patient for mAbs, and 43% intended to refer a patient in the next month.

Conclusions

Clinician education on strength of evidence and eligibility criteria for mAbs is needed. However, education alone is not sufficient. Given the urgent need to rapidly scale up access to treatment and reduce hospitalizations and death from COVID-19, more efficient, equitable systems and processes for referral and delivery of care, such as those coordinated by health systems, public health departments, or disaster management services, are warranted.

SUBMITTER: Kwan BM

PROVIDER: S-EPMC9255528 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:The ongoing novel coronavirus (COVID-19) pandemic has highlighted the need for individuals to have easy access to healthcare facilities for treatment as well as vaccinations. The surge in COVID-19 hospitalizations during 2020 also underscored the fact that accessibility to nearby hospitals for testing, treatment and vaccination sites is crucial for patients with fever or respiratory symptoms. Although necessary, quantifying healthcare access is challenging as it depends on a complex interaction between underlying socioeconomic and physical factors. In this case study, we deployed a Multi Criteria Decision Analysis (MCDA) approach to uncover the barriers and their effect on healthcare access. Using a least cost path (LCP) analysis we quantified the costs associated with healthcare access from each census block group in the Los Angeles metropolitan area (LA Metro) to the nearest hospital. Social vulnerability reported by the Centers for Disease Control and Prevention (CDC), the daily number of COVID-19 cases from the Los Angeles open data portal and built environment characteristics (slope of the street, car ownership, population density distribution, walkability, traffic collision density, and speed limit) were used to quantify overall accessibility index for the entire study area. Our results showed that the census block groups with a social vulnerability index above 0.75 (high vulnerability) had low accessibility owing to the higher cost of access to nearby hospitals. These areas were also coincident with the hotspots for COVID-19 cases and deaths which highlighted the inequitable exposure of socially disadvantaged populations to COVID-19 infections and how the pandemic impacts were exacerbated by the synergistic effect of socioeconomic status and built environment characteristics of the locations where the disadvantaged populations resided. The framework proposed herein could be adapted to geo-target testing/vaccination sites and improve accessibility to healthcare facilities in general and more specifically among the socially vulnerable populations residing in urban areas to reduce their overall health risks during future pandemic outbreaks.

Project description:BackgroundRecent data suggest that complications and death from coronavirus disease 2019 (Covid-19) may be related to high viral loads.MethodsIn this ongoing, double-blind, phase 1-3 trial involving nonhospitalized patients with Covid-19, we investigated two fully human, neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, used in a combined cocktail (REGN-COV2) to reduce the risk of the emergence of treatment-resistant mutant virus. Patients were randomly assigned (1:1:1) to receive placebo, 2.4 g of REGN-COV2, or 8.0 g of REGN-COV2 and were prospectively characterized at baseline for endogenous immune response against SARS-CoV-2 (serum antibody-positive or serum antibody-negative). Key end points included the time-weighted average change in viral load from baseline (day 1) through day 7 and the percentage of patients with at least one Covid-19-related medically attended visit through day 29. Safety was assessed in all patients.ResultsData from 275 patients are reported. The least-squares mean difference (combined REGN-COV2 dose groups vs. placebo group) in the time-weighted average change in viral load from day 1 through day 7 was -0.56 log10 copies per milliliter (95% confidence interval [CI], -1.02 to -0.11) among patients who were serum antibody-negative at baseline and -0.41 log10 copies per milliliter (95% CI, -0.71 to -0.10) in the overall trial population. In the overall trial population, 6% of the patients in the placebo group and 3% of the patients in the combined REGN-COV2 dose groups reported at least one medically attended visit; among patients who were serum antibody-negative at baseline, the corresponding percentages were 15% and 6% (difference, -9 percentage points; 95% CI, -29 to 11). The percentages of patients with hypersensitivity reactions, infusion-related reactions, and other adverse events were similar in the combined REGN-COV2 dose groups and the placebo group.ConclusionsIn this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group. (Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services; ClinicalTrials.gov number, NCT04425629.).

Project description:BackgroundIn the phase 1-2 portion of an adaptive trial, REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, reduced the viral load and number of medical visits in patients with coronavirus disease 2019 (Covid-19). REGEN-COV has activity in vitro against current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern.MethodsIn the phase 3 portion of an adaptive trial, we randomly assigned outpatients with Covid-19 and risk factors for severe disease to receive various doses of intravenous REGEN-COV or placebo. Patients were followed through day 29. A prespecified hierarchical analysis was used to assess the end points of hospitalization or death and the time to resolution of symptoms. Safety was also evaluated.ResultsCovid-19-related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%; P<0.001); these outcomes occurred in 7 of 736 patients in the REGEN-COV 1200-mg group (1.0%) and in 24 of 748 patients in the placebo group who underwent randomization concurrently (3.2%) (relative risk reduction, 70.4%; P = 0.002). The median time to resolution of symptoms was 4 days shorter with each REGEN-COV dose than with placebo (10 days vs. 14 days; P<0.001 for both comparisons). REGEN-COV was efficacious across various subgroups, including patients who were SARS-CoV-2 serum antibody-positive at baseline. Both REGEN-COV doses reduced viral load faster than placebo; the least-squares mean difference in viral load from baseline through day 7 was -0.71 log10 copies per milliliter (95% confidence interval [CI], -0.90 to -0.53) in the 1200-mg group and -0.86 log10 copies per milliliter (95% CI, -1.00 to -0.72) in the 2400-mg group. Serious adverse events occurred more frequently in the placebo group (4.0%) than in the 1200-mg group (1.1%) and the 2400-mg group (1.3%); infusion-related reactions of grade 2 or higher occurred in less than 0.3% of the patients in all groups.ConclusionsREGEN-COV reduced the risk of Covid-19-related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo. (Funded by Regeneron Pharmaceuticals and others; ClinicalTrials.gov number, NCT04425629.).

Project description:BackgroundWhile South Africa spends approximately 7.4% of GDP on healthcare, only 43% of these funds are spent in the public system, which is tasked with the provision of care to the majority of the population including a large proportion of those in need of antiretroviral treatment (ART). South Africa is currently debating the introduction of a National Health Insurance (NHI) system. Because such a universal health system could mean increased public healthcare funding and improved access to human resources, it could improve the sustainability of ART provision. This paper considers the minimum resources that would be required to achieve the proposed universal health system and contrasts these with the costs of scaled up access to ART between 2010 and 2020.MethodsThe costs of ART and universal coverage (UC) are assessed through multiplying unit costs, utilization and estimates of the population in need during each year of the planning cycle. Costs are from the provider's perspective reflected in real 2007 prices.ResultsThe annual costs of providing ART increase from US$1 billion in 2010 to US$3.6 billion in 2020. If increases in funding to public healthcare only keep pace with projected real GDP growth, then close to 30% of these resources would be required for ART by 2020. However, an increase in the public healthcare resource envelope from 3.2% to 5%-6% of GDP would be sufficient to finance both ART and other services under a universal system (if based on a largely public sector model) and the annual costs of ART would not exceed 15% of the universal health system budget.ConclusionsResponding to the HIV-epidemic is one of the many challenges currently facing South Africa. Whether this response becomes a "resource for democracy" or whether it undermines social cohesiveness within poor communities and between rich and poor communities will be partially determined by the steps that are taken during the next ten years. While the introduction of a universal system will be complex, it could generate a health system responsive to the needs of all South Africans.

Project description:ImportanceUS residents report broad access to firearms, which are the most common means of suicide death in the US. Standardized firearm access questions during routine health care encounters are uncommon despite potential benefits for suicide prevention.ObjectiveTo explore patient and clinician experiences with a standard question about firearm access on a self-administered mental health questionnaire routinely used prior to primary care and mental health specialty encounters.Design, setting, and participantsQualitative semistructured interviews were conducted from November 18, 2019, to October 8, 2020, at Kaiser Permanente Washington, a large integrated care delivery system and insurance provider. Electronic health record data identified adult patients with a documented mental health diagnosis who had received a standard question about firearm access ("Do you have access to guns? yes/no") within the prior 2 weeks. A stratified sampling distribution selected 30% who answered "yes," 30% who answered "no," and 40% who left the question blank. Two groups of clinicians responsible for safety planning with patients at risk of suicide were also sampled: (1) licensed clinical social workers (LICSWs) in primary and urgent care settings and (2) consulting nurses (RNs).Main outcomes and measuresParticipants completed semistructured telephone interviews, which were recorded and transcribed. Directive (deductive) and conventional (inductive) content analyses were used to apply knowledge from prior research and describe new information. Thematic analysis was used to organize key content, and triangulation was used to describe the intersections between patient and clinician perspectives.ResultsThirty-six patients were interviewed (of 76 sampled; mean [SD] age, 47.3 [17.9] years; 19 [53%] were male; 27 [75%] were White; 3 [8%] were Black; and 1 [3%] was Latinx or Hispanic. Sixteen participants had reported firearm access and 15 had reported thoughts of self-harm on the questionnaire used for sampling. Thirty clinicians were interviewed (of 51 sampled) (mean [SD] age, 44.3 [12.1] years; 24 [80%] were female; 18 [60%] were White; 5 [17%] were Asian or Pacific Islander; and 4 [13%] were Latinx or Hispanic) including 25 LICSWs and 5 RNs. Key organizing themes included perceived value of standardized questions about firearm access, challenges of asking and answering, and considerations for practice improvement. Clinician interview themes largely converged and/or complemented patient interviews.Conclusions and relevanceIn this qualitative study using semistructured interviews with patients and clinicians, a standardized question about firearm access was found to encourage dialogue about firearm access. Respondents underscored the importance of nonjudgmental acknowledgment of patients' reasons for firearm access as key to patient-centered practice improvement.