Abstract NS4: Effectiveness in Using a Staff Nurse Coach for Clinical Trial Implementation: A Winning Strategy
Background: Ischemic stroke is a leading cause of significant life-long disability in the United States. Current treatment options are limited, especially for patients with large stroke and brain edema. The GAMES Pilot Study (Glyburide Advantage in Malignant Edema and Stroke Pilot) was a multicenter Phase IIa trial designed to test the feasibility of enrolling, evaluating and treating with RP-1127 (glyburide for injection). This trial depended on the expertise of the Neuroscience ICU nursing staff to comply with extensive study trial interventions which included: hourly measurements of glucose, daily acquisition of MRIs, and titration of study drug. The goal of this performance improvement project was to evaluate the effectiveness of having a staff nurse function as a unit based clinical trial coach to facilitate clinical trial implementation.
Methods: Effectiveness of using a staff nurse as a clinical trial coach was determined by assessing the ability to safely enroll 10 study patients with completion of study interventions. The coach was a senior RN and was taught the fundamentals of good clinical practices. The following interventions were developed and implemented by the GAMES coach: 1) facilitated 5 meetings with study staff, ICU management, radiology, and “bed control” to identify barriers for secured admission to Neuroscience ICU and transporting daily to MRI, 2) provided >10 staff nurse inservices, 3) designed study documents, 4) developed resource educational materials about study drug and interventions, and 5) provided expert support to colleagues during enrollment.
Results: The GAMES Pilot Study enrolled 10 patients. The GAMES coach facilitated inservices to > 85% of the neuroscience ICU staff. 100% of study participants were admitted to the Neuroscience ICU. Staff nurses were 100% compliant in obtaining and documenting glucose measurements. Compliance with obtaining MRIs was 100%.
Conclusion: Using a staff nurse as a clinical trial coach allowed early identification and removal of barriers for study enrollment. The GAMES Pilot Study coach was instrumental in garnering enthusiasm and support for implementation of a stroke trial. As a result of this study, acute stroke trials will always have a study coach identified.
- © 2012 by American Heart Association, Inc.