ABSTRACT
Background: Cancer clinical trial enrollment rates are low, with Black individuals especially underrepresented. We tested Partnering Around Cancer Clinical Trials (PACCT), a multi-level intervention designed to improve patient-physician communication and increase trial invitations among Black and White men with prostate cancer. This study reports only on PACCT Phase 1, the patient-focused intervention, because data collection for PACCT Phase 2, the physician-focused intervention, was halted by the COVID-19 pandemic. Method(s): Black and White men with prostate cancer and their physicians were invited to participate. Patients were tracked <two years for trial eligibility, with eligible patients randomized to usual care or intervention. Intervention patients received a brochure that included text promoting patient-physician partnerships and a trials-focused Question Prompt List to encourage them to participate actively in clinic visits, such as by asking questions or stating concerns. Patient-physician visits with eligible patients were video-recorded. After the visits, communication (i.e., patient active participation and physician patient-centered communication) was assessed via patient self-report and observer ratings of video-recordings. Medical chart ions determined trial invitations. Univariable logistic mixed-effects models nesting patients within physicians tested intervention effects by race on communication and trial invitation. Result(s): Among 199 participants (91 Black;108 White), 22% (n = 44;20 Black, 24 White) became eligible for a trial and received the intervention (n = 19) or usual care (n = 25). Regarding communication, Black intervention patients reported participating more actively than those in usual care (difference = 0.41, 95% CI -0.27-1.08), while White intervention patients reported participating less actively than those in usual care (difference = -0.34, 95% CI -0.72-0.05). No differences in observer ratings of active participation or self-report or observer ratings of physician communication were found. Regarding trial invitations, findings were nonsignificant, but showed more intervention patients (74%) than usual care patients (60%) received invitations (logOR = 1.97, 95% CI -0.30 to 4.24), with Black intervention patients having higher odds of receiving invitations (80%) than White intervention patients (67%) (logOR = 3.84, 95% CI -0.92 to 8.59 vs. logOR = -0.14, 95% CI -4.61 to 4.50). Conclusion(s): Few patients (22%, n = 44) were eligible for a trial during PACCT Phase 1. Despite this small sample, the PACCT intervention showed promise in increasing the level of active participation among Black patients and in increasing clinical trial invitations for Black and White patients. Future research should test this intervention in a larger sample and in combination with the physician-focused intervention.
ABSTRACT
Background/Case Studies: Ongoing labor shortages occurring during the SARS-Co-V-2 pandemic caused the blood center to re-evaluate current nurse staffing schedules and clinical offerings in the therapeutic apheresis department in order to maintain high quality apheresis delivery to hospitals and improve work-life balance for the apheresis nursing team. A major area of concern was the amount of on-call coverage the apheresis nursing staff experienced. Study Design/Methods: An internal working group (WG) of medical, nursing, administrative, and financial subject matter experts was assembled to evaluate the current model of 24-h, 7-day-week apheresis coverage with nurses regularly scheduled to cover day shift hours and take on-call for after hours and weekends. The WG reviewed hospital apheresis contracts, nurse on-call schedules, types of apheresis procedures, number of after-hours procedures, and geography of service requests for the prior 12 months. Alternative models for nursing staffing that would reduce on-call for the nurses were considered, including full nursing coverage for 3 out of 3 shifts, flexible 3- and 4-day work weeks, and limiting apheresis services to business hours only. Results/Findings: It was determined that covering 3 out of 3 shifts with full nursing staff in order to eliminate oncall would require hiring 8 additional nurses (representing a 25% increase in staff) at a cost of $650K annually. Flexible shifts of 3- and 4-day work weeks added scheduling complexity without resolving the on-call issue sufficiently. Analysis of the types of procedures performed after hours revealed that over 70% were non-emergencies. Limiting hours of apheresis services to 8A-5P M-F with after-hours available only for emergencies approved by the ordering clinician and blood center medical director offered a costneutral approach that mitigated on-call for the nurses and relieved current nursing staffing shortages. Conclusion(s): Chronic and significant labor shortages emerging from the pandemic necessitated changes to the way blood center apheresis services were offered to our hospitals. In-depth analysis of current offerings and types of procedures performed after business hours resulted in the development of an alternative, cost-neutral model for maintaining apheresis service levels and improving work-life balance for the apheresis nursing staff.
ABSTRACT
Background: Cancer clinical trial enrollment rates are low, with Black individuals especially underrepresented. We tested Partnering Around Cancer Clinical Trials (PACCT), a multi-level intervention designed to improve patient-physician communication and increase trial invitations among Black and White men with prostate cancer. This study reports only on PACCT Phase 1, the patient-focused intervention, because data collection for PACCT Phase 2, the physician-focused intervention, was halted by the COVID-19 pandemic. Methods: Black and White men with prostate cancer and their physicians were invited to participate. Patients were tracked <two years for trial eligibility, with eligible patients randomized to usual care or intervention. Intervention patients received a brochure that included text promoting patient-physician partnerships and a trial-focused Question Prompt List to encourage them to participate actively in clinic visits, such as by asking questions or stating concerns. Patient-physician visits with eligible patients were video-recorded. After the visits, communication (i.e., patient active participation and physician patient-centered communication) was assessed via patient self-report and observer ratings of video-recordings. Medical chart ions determined trial invitations. Univariable logistic mixed-effects models nesting patients within physicians tested intervention effects by race on communication and trial invitation. Results: Among 199 participants (91 Black;108 White), 22% (n = 44;20 Black, 24 White) became eligible for a trial and received the intervention (n = 19) or usual care (n = 25). Regarding communication, Black intervention patients reported participating more actively than those in usual care (difference = 0.41, 95% CI -0.27-1.08), while White intervention patients reported participating less actively than those in usual care (difference = -0.34, 95% CI -0.72-0.05). No differences in observer ratings of active participation or self-report or observer ratings of physician communication were found. Regarding trial invitations, findings were nonsignificant, but showed more intervention patients (74%) than usual care patients (60%) received invitations (logOR = 1.97, 95% CI -0.30 to 4.24), with Black intervention patients having higher odds of receiving invitations (80%) than White intervention patients (67%) (logOR = 3.84, 95% CI -0.92 to 8.59 vs. logOR = -0.14, 95% CI -4.61 to 4.50). Conclusions: Few patients (22%, n = 44) became eligible for a trial during PACCT Phase 1. Despite this small sample, the PACCT intervention showed promise in increasing active participation among Black patients and in increasing clinical trial invitations for both Black and White patients. Future research should test this intervention in a larger sample and in combination with the physician-focused intervention.
ABSTRACT
BackgroundTRIM is an evaluation of the triage models used by emergency ambulance services caring for patients with suspected COVID-19 during the pandemic’s first wave in 2020. We aimed to understand experiences and concerns of staff about implementation of triage protocols.MethodResearch paramedics interviewed stakeholders from four ambulance services (call handlers, clinical advisors, paramedics, managers) and ED clinical staff from receiving hospitals. Interviews (n=23) were conducted remotely using MS Teams, recorded, and transcribed in full. Analysis generated themes from implicit and explicit ideas within participants’ accounts (Braun and Clarke 2021), conducted by researchers and PPI partners working together.ResultsWe identified the following themes:Constantly changing guidelines – at some points, updated several times a day.The ambulance service as part of the wider healthcare system - changes elsewhere in the system left ambulance services as the default.Peaks and troughs of demand - fluctuating greatly over time, and varying across the staff groups.A stretched system - resources were overextended by staff sickness and isolation, longer job times, and increased handover delays at ED.Emotional load of responding to the pandemic - including call centre staff. Doing the best they can in the face of uncertainty - a rapidly evolving situation unlike any which ambulance services had faced before.ConclusionImplementing triage protocols in response to the COVID-19 pandemic was complex and had to be actively managed by a range of frontline staff, dealing with external pressures and a heavy emotional load.Conflict of interestNone.FundingUKRI-DHSC Covid-19 Rapid Response Funding.
ABSTRACT
Introduction During the coronavirus disease 2019 (COVID-19) pandemic, curbside international normalized ratio (INR) checks were implemented to monitor patients on warfarin therapy. Because of the lack of available data, clinical outcomes and patient satisfaction were assessed to determine if the implementation of curbside visits could be considered as an alternative to the standard of care. Objectives The objectives were to assess clinical outcomes, safety, and patient satisfaction in a patient cohort whose anticoagulation was managed inside the clinic in 2019 compared with the same patients managed in the curbside setting in 2020. Methods In this retrospective study, INR time in therapeutic range (TTR) was used as a marker for clinical appropriateness of anticoagulation therapy. Data were also prospectively collected in the form of patient satisfaction surveys. Adverse events and hospitalizations were assessed to ensure patient safety was not omitted. Results The median TTR in 2019 was significantly higher than in 2020, 95.7% (interquartile range [IQR] 33.3%) vs 84.3% (IQR 45.2%) (z = -3.99, P < .001). Clinically, the mean TTR remained higher in 2019 than in 2020 (81.3% vs 74.7%). Less patients experienced bleeding events in 2020, and there was an average of 1 less visit per patient in 2020 compared with 2019. Surveys indicated that more patients would like their visits to occur inside the clinic if there were no concerns for a pandemic. Conclusion Anticoagulation management assessed by TTR was significantly lower in the 2020 time frame compared with 2019;however, the average TTR in both time frames was above the clinically accepted threshold of adequate anticoagulation control. Patients demonstrated favor toward in-person visits unless there were concerns for a pandemic. If needed, curbside visits could be considered in the future at this site;however, more studies would need to be done to assess the impact of curbside visits at other institutions.
ABSTRACT
Background. During the COVID-19 pandemic, researchers continue to search for effective treatments. There have been mixed data on the safety and effectiveness of hydroxychloroquine (HCQ). Risk assessment is essential to identify patients who might be at high risk for complications from treatment. Objectives. The purpose of this study was to evaluate patients with confirmed or suspected COVID-19 treated with HCQ for risk of QT-interval prolongation and drug-induced sudden cardiac death (DI-SCD). Methods. A total of 100 patients admitted to the intensive or progressive care units at Ascension St. Vincent Hospital in Indianapolis, Indiana, between March 2020 and April 2020 with confirmed or suspected COVID-19 who were treated with HCQ were identified. Risk stratification was performed using the Ackerman algorithm. Serial electrocardiography (ECG) monitoring and 24-hour cardiac monitoring were completed. Results. According to the Ackerman algorithm, 80 (85.1%) of the 94 patients with ECG data were at low risk for corrected QT (QTc) interval prolongation (green category), 12 (12.8%) were intermediate risk (yellow category), and 2 (2.1%) were high risk (red category). Change in QTc interval greater than 60 milliseconds from initial to 48 hours was noted in 15 patients (16.0%). No events of DI-SCD were reported in patients in the green or yellow categories. DI-SCD was confirmed in 1 patient in the red category, with a QTc-interval prolongation greater than 60 milliseconds. Conclusions. Although treatment with this regimen remains controversial, the risk of DI-SCD is low in patients who have been risk-stratified to be at low or intermediate risk based on the Ackerman algorithm. © 2021 Cliggott Publishing Co.. All rights reserved.