Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care
Introduction Diabetes is one of the most common serious chronic health conditions in the USA. People living with diabetes face multiple barriers to optimal diabetes care, including gaps in access to medical care and self-management education, diabetes distress, and high burden of treatment. Community paramedics (CPs) are uniquely positioned to support multidisciplinary care for patients with diabetes by delivering focused diabetes self-management education and support and bridging the gaps between patients and the clinical and community resources they need to live well with their disease. Methods and analysis We will conduct a pragmatic single-arm prospective trial of a CP-led Diabetes Rescue, Engagement and Management (D-REM) programme that seeks to reduce diabetes distress. We will enrol 70 adults (≥18 years) with diabetes who have haemoglobin A1c (HbA1c)≥9.0%, experienced an emergency department (ED) visit or hospitalisation for any cause within the prior 6 months, and reside in areas with available CP support in Southeast Minnesota (Olmsted, Freeborn and Mower counties) and Northwest Wisconsin (Barron, Rusk and Dunn counties). Participants will be identified using Mayo Clinic electronic health records, contacted for consent and enrolled into the D-REM programme. Visit frequency will be individualised for each patient, but will be an average of four CP visits over the course of approximately 1 month. Outcomes will be change in diabetes distress (primary outcome), confidence in diabetes self-management, health-related quality of life, self-reported hypoglycaemia and hyperglycaemia, HbA1c, ED visits and hospitalisations. Outcomes will be assessed on enrolment, programme completion and 3 months after programme completion. Ethics and dissemination The study was approved by Mayo Clinic Institutional Review Board. Findings will be disseminated through peer-reviewed publications and presentations. If demonstrated to be successful, this model of care can be implemented across diverse settings and populations to support patients living with diabetes. Trial registration number NCT04385758 .
Stabilizing the pharmacy technician workforce as an imperative for the chief pharmacy officer
ABSTRACT Introduction Erectile dysfunction (ED) is a common consequence of Diabetes Mellitus (DM). The medical literature is inconclusive as to which DM related morbidities improve with better glycemic control. Surgical literature often associates infection outcomes with DM and with glycemic control. There is limited research on the relationship between Hemoglobin A1c and severity of vascular ED. Objective To evaluate the relationship between hemoglobin A1c (HbA1c) and severity of vascular ED in men with DM diagnosed with vascular ED by penile color duplex Doppler ultrasound (CDDU). Methods We retrospectively analyzed patients with a history of DM who underwent intracavernous injection followed by CDDU at our institution between 2005 and 2019. CDDU findings including peak systolic velocities (PSV), primary diagnosis after CDDU, and resistive indices (RIs) were recorded. Doppler diagnosis was based on post stimulation PSV and RI. Arterial Insufficiency (AI) was classified as PSV < 25 cm/s (severe), or (moderate) PSV 25-34.9 cm/s with RI ≥ 0.90. Corporal veno-occlusive disease (CVOD) was classified as PSV ≥ 35 cm/s with RI < 0.90. Mixed ED was classified as PSV 25-34.9 cm/s with RI < 0.90. HbA1c was recorded at time of assessment. Among our cohort of 1490 men who had CDDU, 520 had DM: 130 with CDDU diagnosis of ED, 270 with CDDU diagnosis of ED + Peyronie's disease (PD), 94 with PD alone and 26 with normal vascular erections on CDDU and no PD. The 130 patients with DM diagnosed with ED without presence of PD were included in our analysis. We used a Kruskal-Wallis rank sum test to evaluate the overall association between HgA1c and CDDU diagnosis (AI, CVOD, and mixed ED). Spearman rank correlation tests were used to explore the relationship of HbA1C with PSV and RI. Results Among the 130 men with DM + ED without PD, the median age was 61 y (range 20-79 y), 76 (58%) had hypertension, 37 (28%) had heart disease, median BMI was 30.7 kg/m2 (range 21.2-48.9 kg/m2), and median HgbA1C was 7.0 (range 5.0-11.0). PDE-5 inhibitor use was reported in 119/129 (92.2%) and among those who reported using it 108/119 (90.8%) reported PDE-5 inhibitor failure. CDDU diagnoses were 53 (40.8%) AI, 44 (33.8%) CVOD, and 33 (25.4%) mixed vascular (25%). The median (interquartile range) HbA1c was 7.0 (6.1-7.8) in men with AI, 7.1 (6.3-8.0) in men with CVOD, and 6.7 (6.1-7.0) in men with mixed ED. We did not find evidence of a relationship between HbA1c and severity of vascular ED (Kruskal-Wallis test P = 0.25). We also did not find evidence of a correlation of HbA1c with either post-stimulation PSV (Spearman rank correlation = 0.04, P=0.68) or RI (Spearman rank correlation = -0.03, P = 0.79). Conclusions Median HbA1c did not vary with the vascular diagnosis of men with DM + ED (AI vs. CVOD vs. Mixed Vascular). DM is a significant risk factor for ED and HbA1c is used to monitor and advise patients. We found no predictive relationship between HbA1c and type of vascular ED as defined by CDDU. Disclosure No
Analysis of Fixed and Variable Operating Room (OR) Time Point Efficiency in Partial Nephrectomies: Open Versus Robotic-assisted
Abstract Objective: To analyze operating room (OR) efficiency by evaluating fixed and variable OR times for open (OPN) and robotic-assisted partial nephrectomies (RAPN).Methods: We analyzed consecutive OPN and RAPN performed by one surgeon over a 24-month period. All patients were placed in the lateral decubitus position and secured with a beanbag regardless of approach. Fixed (nonprocedural) OR times were prospectively collected and defined as: in room to anesthesia release time (IRAT), anesthesia release to cut time (ARCT), and close to wheels out time (CTWO). Variable OR time was procedural cut to close time (CTCT). Comparison of fixed and variable OR time points between OPN and RAPN were performed using the Wilcoxon rank sum test. Results: 146 RAPN and 31 OPN were evaluated from 2019-2020. Median IRAT was similar for RAPN versus OPN [20 min (IQR: 16-25) vs. 20 min (IQR: 16-26), P=0.57]. Median ARCT was longer for RAPN than it was for OPN [40 min (IQR: 36-46) vs. 34 min (IQR: 30-39), P<0.001]. Median CTWO was similar for OPN (12 min, IQR: 9-14) and RAPN (11 min, IQR: 7-15) (P=0.89). Median CTCT was longer for RAPN (202 min, IQR: 170-236) compared to OPN (164 min, IQR: 154-184) (P<0.001).Conclusions: In a single surgeon partial nephrectomy series with the same patient positioning, utilization of robotic technology was associated with longer surgeon operating time as well as less efficient fixed OR times, specifically ARCT.
P07: RESULTS FROM THE CC-220-MM-001 DOSE-EXPANSION PHASE OF IBERDOMIDE PLUS DEXAMETHASONE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Introduction: The once-in-a-generation COVID-19 pandemic accelerated the pace at which virtual care (VC) was advanced to triage, evaluate, and care for patients. An early adopter of VC delivery, Mayo Clinic had provided video visits and other remote care options for more than 5 years, yet the need for VC during the pandemic surpassed our available capacity for telehealth care. Methods: To continue providing high-quality care while preventing exposure of patients and staff to high-risk environments, staff from Primary Care and Express Care (minor acute services) collaborated to expand the outpatient VC service to triage patients with acute or chronic symptoms and to address concerns that could be managed remotely. We aimed to maximize the treatment options available outside of high-cost settings and also aimed to accelerate development of longer-term solutions for improving care coordination and continuous population management. Results: Patient use of virtual visits showed an unprecedented increase after changes were implemented that expanded the existing virtual visit menu, facilitated patient self-triage and direct scheduling, streamlined physical connections for virtual appointments, and incorporated additional language (medical interpreter) support. The combination of patient convenience, ease of scheduling, and added safety for providers and patients, in conjunction with other telehealth options, resulted in a better overall patient experience. Conclusion: Any organization that is considering deploying a sustainable program of VC must put patient needs and safety at the center. Organizations should seize opportunities to agilely adjust and advance any emergency-response solutions to serve a longer-term purpose.
The Effects of Prolonged Water-Only Fasting and Refeeding on Markers of Cardiometabolic Risk
(1) Background: Cardiometabolic disease, including insulin resistance, hyperlipidemia, and hypertension, are major contributors to adverse health outcomes. Fasting has gained interest as a nonpharmacological therapeutic adjunct for these disorders. (2) Methods: We conducted a prospective, single-center study on the effects of prolonged water-only fasting followed by an exclusively whole-plant-food refeeding diet on accepted measures of cardiovascular risk and metabolic health. Participants were recruited from patients who had voluntarily elected to complete a water-only fast in order to improve their overall health according to an established protocol at an independent, residential medical center. Median fasting and refeed lengths were 17 and 8 days, respectively. The primary endpoint was to describe the mean glucose tolerance as indicated by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) scores at baseline, end-of-fast (EOF), and end-of-refeed (EOR) visits. Secondary endpoints were to describe the mean weight, body mass index (BMI), abdominal circumference (AC), systolic blood pressure (SBP), diastolic blood pressure (DBP), lipid panel, and high-sensitivity C-reactive protein (hsCRP) at the same time points. (3) Results: The study enrolled 48 overweight/obese non-diabetic participants, of which 26 completed the full study protocol. At the EOF visit, the median SBP, AC, low-density lipoprotein (LDL), and hsCRP were decreased and triglycerides (TG) and HOMA-IR scores were increased. Conclusion: Prolonged water-only fasting and whole-plant-food refeeding holds potential as a clinical therapy for cardiometabolic disease but increased TG and HOMA-IR values after refeeding necessitate further inquiry.
Diabetes Management for Community Paramedics: Development and Implementation of a Novel Curriculum