Randomized Evaluation of a Remote Management Program to Improve Guideline-Directed Medical Therapy: The DRIVE Trial.

BACKGROUND: Several SGLT2i (sodium-glucose transport protein 2 inhibitors) and GLP1-RA (glucagon-like peptide-1 receptor agonists) reduce cardiovascular events and improve kidney outcomes in patients with type 2 diabetes; however, utilization remains low despite guideline recommendations. METHODS: A randomized, remote implementation trial in the Mass General Brigham network enrolled patients with type 2 diabetes with increased cardiovascular or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP1-RA were randomly assigned to simultaneous virtual patient education with concurrent prescription of SGLT2i or GLP1-RA (ie, Simultaneous) or 2 months of virtual education followed by medication prescription (ie, Education-First) delivered by a multidisciplinary team driven by nonlicensed navigators and clinical pharmacists who prescribed SGLT2i or GLP1-RA using a standardized treatment algorithm. The primary outcome was the proportion of patients with prescriptions for either SGLT2i or GLP1-RA by 6 months. RESULTS: Between March 2021 and December 2022, 200 patients were randomized. The mean age was 66.5 years; 36.5% were female, and 22.0% were non-White. Overall, 30.0% had cardiovascular disease, 5.0% had cerebrovascular disease, and 1.5% had both. Mean estimated glomerular filtration rate was 77.9 mL/(min‧1.73 m2), and mean urine/albumin creatinine ratio was 88.6 mg/g. After 2 months, 69 of 200 (34.5%) patients received a new prescription for either SGLT2i or GLP1-RA: 53.4% of patients in the Simultaneous arm and 8.3% of patients in the Education-First arm (P<0.001). After 6 months, 128 of 200 (64.0%) received a new prescription: 69.8% of patients in the Simultaneous arm and 56.0% of patients in Education-First (P<0.001). Patient self-report of taking SGLT2i or GLP1-RA within 6 months of trial entry was similarly greater in the Simultaneous versus Education-First arm (69 of 116 [59.5%] versus 37 of 84 [44.0%]; P<0.001) Median time to first prescription was 24 (interquartile range [IQR], 13-50) versus 85 days (IQR, 65-106), respectively (P<0.001). CONCLUSIONS: In this randomized trial, a remote, team-based program identifies patients with type 2 diabetes and high cardiovascular or kidney risk, provides virtual education, prescribes SGLT2i or GLP1-RA, and improves guideline-directed medical therapy. These findings support greater utilization of virtual team-based approaches to optimize chronic disease management. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06046560.

Effect of a Rivaroxaban Patient Assistance Kit (R-PAK) for Patients Discharged With Rivaroxaban: A Randomized Controlled Trial.

Background: The combination of poor health literacy and a complex dosing regimen/transition for rivaroxaban in venous thromboembolism (VTE) treatment may increase the likelihood of negative clinical outcomes secondary to nonadherence. Objective: The aim was to determine if a Rivaroxaban Patient Assistance Kit (R-PAK) given at hospital discharge increases proper dose transition and overall patient adherence. Methods: This prospective, randomized, controlled trial was conducted at an 859-bed academic medical center. Patients were randomized into 2 groups. In the treatment group, patients received the R-PAK with counseling at discharge, whereas patients in the control group received discharge counseling alone. In addition, patients were contacted after 21 days of therapy to assess dose transition, adherence, satisfaction, and safety. The primary outcome was percentage of patients who properly transitioned to rivaroxaban once daily on day 22. Results: Twenty-five patients were enrolled; 12 received an R-PAK, whereas 13 comprised the control group. No difference in the baseline assessment of health literacy status was noted (P = 1.00). Proper transition to daily administration on day 22 was no different between the groups (P = .891). Adherence was reported in 99.8% of R-PAK patients and 97.65% of control patients (P = .074). Side effects were rarely reported. Conclusions: The use of an R-PAK for the treatment of VTE was not associated with an improvement in transition to daily administration; however, both groups had high rates of overall adherence. Pharmacist counseling/education was provided in both groups and is an important component to include in any patient discharge, especially for medications with dose transitions.

Conception of a Personalized Medication Adherence Discharge Kit for Rivaroxaban.

Purpose: Due to a lack of necessary monitoring with rivaroxaban, patients have fewer opportunities for education, adherence reinforcement, and follow-up. If rivaroxaban is taken incorrectly, patients are at increased risk for adverse events. The objective was to create personalized rivaroxaban patient adherence kits (R-PAKs) to enhance successful transition from 15 mg twice daily to 20 mg once daily on day 22 of venous thromboembolism (VTE) treatment. Summary: A review of rivaroxaban drug information and existing medication adherence tools was completed to increase understanding of ways to improve adherence. Clinical pharmacists identified several concerns the R-PAK should address, including patient understanding of correct dose, administration timing, serious adverse effects, and importance of compliance, along with loss to follow-up by a health care provider. In the pilot phase, 100 R-PAKs were created. Each kit includes an educational handout describing adverse effects, administration, and monitoring; a reminder card with dosing information, date to transition, and emergency contact information; and a personalized 28-day pill organizer containing customized dividers to correlate with the first 21 days of treatment. Color-coded stickers denote the first day of starting twice-daily therapy upon discharge and the day of transition to once-daily dosing. The items were distributed in tote bags at discharge along with pharmacist education. Conclusion: The R-PAKs are being used at a community teaching hospital for patients newly diagnosed with VTE who are discharged on rivaroxaban. The concept of a personalized medication box could be modified for any medication that requires high compliance or dose transitions.

Methods, rationale, and design for a remote pharmacist and navigator-driven disease management program to improve guideline-directed medical therapy in patients with type 2 diabetes at elevated cardiovascular and/or kidney risk.

AIM: Describe the rationale for and design of Diabetes Remote Intervention to improVe use of Evidence-based medications (DRIVE), a remote medication management program designed to initiate and titrate guideline-directed medical therapy (GDMT) in patients with type 2 diabetes (T2D) at elevated cardiovascular (CV) and/or kidney risk by leveraging non-physician providers. METHODS: An electronic health record based algorithm is used to identify patients with T2D and either established atherosclerotic CV disease (ASCVD), high risk for ASCVD, chronic kidney disease, and/or heart failure within our health system. Patients are invited to participate and randomly assigned to either simultaneous education and medication management, or a period of education prior to medication management. Patient navigators (trained, non-licensed staff) are the primary points of contact while a pharmacist or nurse practitioner reviews and authorizes each medication initiation and titration under an institution-approved collaborative drug therapy management protocol with supervision from a cardiologist and/or endocrinologist. Patient engagement is managed through software to support communication, automation, workflow, and standardization. CONCLUSION: We are testing a remote, navigator-driven, pharmacist-led, and physician-overseen management strategy to optimize GDMT for T2D as a population-level strategy to close the gap between guidelines and clinical practice for patients with T2D at elevated CV and/or kidney risk.

Association between dextrose-containing maintenance fluids and phosphorus supplementation during total parenteral nutrition initiation in adult patients who were hospitalized: A retrospective cohort study.

BACKGROUND: Use of dextrose-containing maintenance fluids prior to parenteral nutrition (PN) initiation is speculated to reduce the risk for refeeding syndrome. We aimed to assess if the use of dextrose vs nondextrose maintenance fluids before PN initiation changes electrolyte supplementation requirements and shifts during initiation. METHODS: This retrospective cohort study included patients who received nothing by mouth but received maintenance fluids ≥72 h before PN. The major end point was phosphorus supplementation over 48 h following nutrition initiation. Minor end point included other electrolyte supplementation, changes in electrolyte levels, time to discharge, and goal kilocalories per day. RESULTS: Fifty-three patients between August 1, 2019, and August 26, 2020, met criteria for analysis; 60% (n = 32) used a dextrose and 40% (n = 21) used a nondextrose maintenance fluid. Baseline characteristics were similar between fluid groups except for body mass index (25.1 dextrose vs 27.5 kg/m2 nondextrose), sex (43.8% female vs 52.4% male), and severe malnutrition (46.9% vs 28.6%), respectively. Phosphorus (52.5 vs 50 mmol; P = 0.33) and magnesium (24 vs 22 g; P = 0.63) supplementation 48 h following nutrition initiation were similar between groups; however, potassium supplementation was lower in the dextrose group (165.0 vs 208.7 mEq; P = 0.01). No difference was observed between groups for time to discharge following nutrition initiation or time to goal kilocalories per day. After controlling for patients who were malnourished between fluid groups using linear regression, phosphorus repletion differences remained nonsignificant. CONCLUSION: This study did not detect a difference in phosphorus supplementation between groups, even after controlling for patients who were malnourished.

Suspected donepezil toxicity: A case report.

Donepezil toxicity can present similarly to beta-blocker overdose and colitis. Symptoms include confusion, diaphoresis, and bradycardia. In patients with suspected medication-related toxicities, it is important to consider all possible causative agents in the active medication list.

Effect of a Pharmacist-Driven Medication Management Intervention Among Older Adults in an Inpatient Setting.

BACKGROUND: Older adults have a seven times greater risk than younger adults of being hospitalized due to an adverse drug event. OBJECTIVE: The objective of this study was to compare the number of potentially inappropriate medications (PIMs) on admission to the number of PIMs on discharge following pharmacist intervention. PATIENTS AND METHODS: This was a prospective, single-center pilot study performed at a tertiary medical center. Eighty-two adults aged 65 years or older on five or more medications who were admitted to the general medicine floor between December 2016 and May 2017 were included in the analysis. Pharmacists completed a review of prior admission medications and identified PIMs. Recommendations for PIMs were communicated to the medical team and documented in the patient's electronic medical record. PIMs were measured by the use of validated screening tools and an assessment of patient-specific parameters. RESULTS: Fifty-two percent of our patients were taking at least one PIM. The average number of PIMs on admission was found to be 0.84 ± 1.12. Pharmacist intervention resulted in a statistically significant reduction to an average of 0.56 ± 0.91 PIMs (P < 0.01). The mean time to complete the medication therapy management (MTM) process was 49.39 ± 16.2 min per patient. CONCLUSION: While pharmacist-driven MTM significantly reduced PIMs in our study, the implementation of this model in the inpatient setting faces several challenges.

Thrombolytic Therapy in Wake-Up Stroke Patients.

OBJECTIVE: The aim of the study is to review existing and ongoing trial data on wake-up stroke (WUS) patients for thrombolytic therapy. METHODS: A literature search was conducted in PubMed (conception-October 2016) using the terms wake-up stroke, acute ischemic stroke, wake-up thrombolysis, computed tomography imaging in wake-up stroke, and magnetic resonance imaging in wake-up stroke. Ongoing trials were found using the ClinicalTrials.gov website. RESULTS: The search yielded 61 articles in PubMed and 7 ongoing trials. After removing duplicate/irrelevant articles, 33 articles and relevant references were reviewed; of these, 6 articles and 3 ongoing trials were included. Two retrospective studies evaluating the characteristics between WUS and known-onset stroke were identified; the only significant difference between groups was the ability to receive treatment with tissue plasminogen activator (tPA). One study suggested that perfusion brain imaging may be useful to identify patients that may benefit from tPA. In addition, 3 studies have evaluated WUS treatment; all used different methods to identify potential patients. Two of 3 studies showed that treatment with tPA is associated with better outcomes when controlling for baseline National Institutes of Health Stroke Scale. No difference in safety outcomes was seen between groups for all 3 studies. CONCLUSIONS: Available data suggest promising strategies to identify WUS patients who may benefit from thrombolysis. Once on-going trials are complete, there may be sufficient information to redefine tPA eligibility for previously excluded patients.