Role of clinical nurse educators (CNEs) in levodopa-carbidopa intestinal gel (LCIG) clinical studies in Parkinson’s disease (PD) (P6.379)

OBJECTIVE: To describe a unique support network provided by clinical nurse educators (CNEs) to study sites in the levodopa-carbidopa intestinal gel (LCIG/carbidopa-levodopa enteral suspension [CLES]) development program for patients with advanced Parkinson’s disease (PD). BACKGROUND: LCIG is delivered via a percutaneous gastrojejunostomy tube (PEG-J) to provide PD patients with more stable levodopa levels. Execution of clinical trials requiring PEG-J placement for this novel drug delivery system necessitated a unique multidisciplinary model. METHODS: CNEs with intensive LCIG system training were assigned to study sites to provide technical support for healthcare professionals (HCPs). RESULTS: CNEs were present for 391/425 (92[percnt]) of the PEG-J placements and LCIG dose titrations, but not directly involved in patient care. CNEs developed training materials, provided hands-on device training, supported gastroenterologists in real-time during PEG-J placement, and provided broad knowledge of titration options to HCPs performing LCIG titrations. CNEs were the first point of contact for new sites with regard to PEG-J procedures and LCIG titration. They collaborated with the sponsor to develop a “dry-run” model for site initiation, and liaised critically between members of the multidisciplinary team. CONCLUSIONS: Implementation of the CNE model provided benefits to clinicians and clinical research sites, ultimately improving the patient experience. Involvement of CNEs optimized and streamlined site initiation, study/product monitoring, issue resolution, and communication within a multidisciplinary care model. This approach could be considered for future studies of complex drug delivery systems that require a multidisciplinary team to optimize patient care. Study Supported by: AbbVie Inc. Disclosure: Dr. Olson holds stock and/or stock options in AbbVie. Dr. Greene has received personal compensation for activities with Quintiles. Dr. Espay has received personal compensation for activities with AbbVie as a study coordinator and advisory board member. Dr. Wagner has received personal compensation for activities with AbbVie. Dr. Krai Chatamra holds stock and/or stock options in AbbVie, which sponsored research in which Dr. Catamra was involved as an investigator. Dr. Benesh holds stock and/or stock options in AbbVie, which sponsored research in which Dr. Benesh was involved as an investigator. Dr. Slevin has received research support from Abbott Laboratories, BioTie, and Teva. Dr. Espay has received personal compensation as a consultant/scientific advisory board member for Abbvie, Chelsea Therapeutics, TEVA, Impax, Merz, Pfizer, Acadia, Cynapsus, Solstice Neurosciences, Lundbeck, and USWorldMeds; and honoraria from Abbvie, UCB,