Challenge. Clinical Question and Practice Setting:
You are a clinical pharmacist working for an anticoagulation service that supports an academic hospital and two community hospitals. As part of a team, you support initial dosing for inpatients starting warfarin anticoagulation. Your service also provides outpatient follow up including INR monitoring, dose modifications, and consulting when needed.
Two years ago, your service incorporated pharmacogenomic testing prior to the initiation of warfarin at the academic hospital. New patients are genotyped with a test that determines genotypes for CYP2C9 and VKORC1 with rapid (2 hour) turnaround, then Initial warfarin dosing is determined using the results and guidance from the Clinical Pharmacogenetics Implementation Consortium (CPIC) and the FDA labeling. With the exception of the initial dosing based on pharmacogenomics, standard-of-care is equivalent across all three hospitals your service supports. All patients receive the same follow up care for dose adjustments, INR monitoring, etc.
The service director is enthusiastic about the support the pharmacogenomic testing provides and wants to expand it to the two community hospitals. This expansion would require additional staffing and training, and there is significant pushback from those hospitals’ administration. They point out that not all private insurers reimburse the genetic test, which might lead to increased costs. It is also noted that there are significant population differences at the three medical centers, where approximately 90% of patients at the academic hospital are of Caucasian ancestry while both community hospitals are in much more diverse areas.
The director turns to you for help in determining the next steps. She wants to answer the following questions for the hospital administration:
- Is there currently a difference in outcomes at the academic medical center vs. the community hospitals?
- Is the genetic testing model that is incorporated at the academic medical center appropriate for the community hospitals?
There is a board of directors meeting in two months where she wants to present findings relevant to these questions, so she expects you to provide an appropriately structured, cited, and data-driven response to these questions.
Assignment Instructions
For this Active Learning Assignment, using a Microsoft Word document you will create an Objective statement, create Primary and Secondary Aims and develop a Methods section. This document will be uploaded in CANVAS.
- The heading “Objective” – Followed by ONE sentence stating the objective of your study
- The heading “Aims” – Followed by your primary aim (single statement) and secondary aim(s) (single statement for each).
- The heading “Methods” – Followed by the subheadings in the order shown below, with a paragraph for each subheading. Please note the Methods section should be written as narrative and not in bulleted format. Refer to the writing style and format used by some of the studies you retrieved in your background section.
Study Design: Describe the design being used by your study.
Study Population: Clearly describe the population to be studied, with inclusion and exclusion criteria.
Materials: Clearly state supplies and equipment required. If no materials are required, state that in your proposal.
Study Endpoints, Data Collection and Analysis: Describe the study endpoints to be measured, data collection process and how your data will be analyzed.
Study Protocol: This should have enough detail to allow an outside reader to understand the steps you will follow from subject recruitment through data analysis. Outline the steps you will take to identify and randomize patients, the study timeline, etc. Be sure to include how your primary and secondary endpoints will be measured. There may be some repetition from above sections, but that’s ok.