Center for Clinical Trials Innovation (CCTI)
An international research, training, and collaboration hub that will improve health through methodological advances in clinical trials.
Nudging Effective and Equitable Delivery of Specialty Palliative Care (NEEDS-PC) Trial
Funded by the National Institute of Aging
Study design: : Pragmatic, 3-arm cluster-randomized supplementation trial
Summary: This trial evaluates an automated, electronic health record (EHR)-based palliative care needs trigger at nine hospitals within MedStar Health, assessing its impact on approximately 18,000 seriously ill inpatients. Over 108 weeks, in a randomly assigned sequence, hospitals transition from usual care to implementing two automated PC needs-triggered alerts. The first alert nudges clinicians to place an order for a specialty PC. Hospitals later adopt the second alert, which notifies hospital clinicians of a default PC consult order with an opt-out option.
Learn more about the NEEDS-PC Trial at MedStar Health.
Principal Investigators
Katherine Courtright
Michael Harhay
Pediatric ARDS MAnagement (PARMA) Trial
Funded by the National Institute of Child Health and Human Development
Study design: Pragmatic Bayesian phase 2A trial
Summary: Lung-protective ventilation with lower tidal volumes and driving pressures (defined as plateau pressure minus positive end-expiratory pressure) is the backbone of ventilation strategies in adults, with variable adoption in pediatrics. However, pre-clinical and observational clinical data suggest that the tidal volume and driving pressure limits extrapolated from adults are too restrictive for children. Further, as pediatrics uses different ventilator modes, plateau pressures are rarely measured and ΔP (peak pressure minus positive end-expiratory pressure, a close approximate of driving pressure in pediatric modes) is substituted. Thus, the PARMA trial will compare high versus low ΔP ventilation in pediatric ARDS conducted at the Children’s Hospital of Philadelphia (CHOP).
Principal Investigators
Nadir Yehya
Michael Harhay
Markers of Nephrotoxicity During Treatment with Antibiotic Combinations (MONACO) Trial
Funded by the National Institute of Diabetes and Digestive and Kidney Diseases
Study design: Pragmatic, open-label, non-inferiority trial
Summary: Hospitalized patients with infection are commonly treated with the antibiotic vancomycin (VN) in combination with either piperacillin-tazobactam (PT) or cefepime (CP). Although these antibiotic regimens have similar effectiveness, recent observational evidence suggests they may differ in terms of risk for acute kidney injury (AKI). Interpretation of existing evidence is complicated by the limitations of creatinine, the standard biomarker used to monitor kidney function, which has poor sensitivity and specificity for drug induced AKI. To address this important knowledge gap, we are conducting the MONACO trial will examine the comparative risk of AKI between these standard-of-care antibiotic combinations using sensitive and specific markers of drug-induced AKI. We hypothesize that the regimen of VN in combination with PT (VN+PT) is noninferior to the regimen of VN in combination with CP (VN+CP) in terms of AKI risk.
Principal Investigator
Todd Minao