The Pharmacist Discharge Care (PHARM-DC) study: A multicenter RCT of pharmacist-directed transitional care to reduce post-hospitalization utilization.

BACKGROUND: Older adults commonly face challenges in understanding, obtaining, administering, and monitoring medication regimens after hospitalization. These difficulties can lead to avoidable morbidity, mortality, and hospital readmissions. Pharmacist-led peri-discharge interventions can reduce adverse drug events, but few large randomized trials have examined their effectiveness in reducing readmissions. Demonstrating reductions in 30-day readmissions can make a financial case for implementing pharmacist-led programs across hospitals. METHODS/DESIGN: The PHARMacist Discharge Care, or the PHARM-DC intervention, includes medication reconciliation at admission and discharge, medication review, increased communication with caregivers, providers, and retail pharmacies, and patient education and counseling during and after discharge. The intervention is being implemented in two large hospitals: Cedars-Sinai Medical Center and the Brigham and Women's Hospital. To evaluate the intervention, we are using a pragmatic, randomized clinical trial design with randomization at the patient level. The primary outcome is utilization within 30 days of hospital discharge, including unforeseen emergency department visits, observation stays, and readmissions. Randomizing 9776 patients will achieve 80% power to detect an absolute reduction of 2.5% from an estimated baseline rate of 27.5%. Qualitative analysis will use interviews with key stakeholders to study barriers to and facilitators of implementing PHARM-DC. A cost-effectiveness analysis using a time-and-motion study to estimate time spent on the intervention will highlight the potential cost savings per readmission. DISCUSSION: If this trial demonstrates a business case for the PHARM-DC intervention, with few barriers to implementation, hospitals may be much more likely to adopt pharmacist-led peri-discharge medication management programs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04071951.

Thrombosis in suspected heparin-induced thrombocytopenia occurs more often with high antibody levels.

OBJECTIVE: The study objective was to determine whether higher antiplatelet factor 4 (PF4)/heparin antibody levels using an enzyme-linked immunosorbent assay are associated with more frequent thrombotic events in patients with clinically suspected heparin-induced thrombocytopenia. Heparin-induced thrombocytopenia is an immune-mediated adverse drug reaction. An enzyme-linked immunosorbent assay detects anti-PF4/heparin antibodies to support a suspected clinical diagnosis of heparin-induced thrombocytopenia. The utility of quantitative enzyme-linked immunosorbent assay results is uncertain. METHODS: Our single-centered study evaluated quantitative anti-PF4/heparin antibody levels using an enzyme-linked immunosorbent assay in consecutive hospitalized patients with a clinical suspicion of heparin-induced thrombocytopenia and positive anti-PF4/heparin antibody levels between July 2003 and December 2006. RESULTS: Overall, anti-PF4/heparin antibody values were available for 318 patients with clinically suspected heparin-induced thrombocytopenia. The median level was 0.85 optical density units (range 0.31-4.0). The overall rate of arterial or venous thrombosis was 23.3%. A 1-unit increase in anti-PF4/heparin antibody level was associated with an approximate doubling in the odds of thrombosis by 30 days (odds ratio, 1.9; 95% confidence interval, 1.5-2.6; P=.0001). The proportion of patients with pulmonary embolism increased with higher anti-PF4/heparin antibody levels. CONCLUSION: Higher levels of anti-PF4/heparin antibody are associated with increased thrombosis risk among patients with clinically suspected heparin-induced thrombocytopenia and might have clinical utility for prediction of true heparin-induced thrombocytopenia and the development of thrombosis.