Question: Abstraction for Clinical Trial (STK)
Patient assigned an ICD-9-CM Principal Diagnosis Code 433.10, and enrolled in a research study for "Gore Embolic Filter in Carotid Stenting". Can "Yes" be abstracted for Clinical Trial (STK), if the patient was admitted for this procedure?
Answer:
To select 'Yes' for Clinical Trial (STK), two things are needed. There must be a signed consent form for the research study present in the medical record, AND documentation on the signed consent form that the patient was enrolled in a clinical trial in which patients with stroke are being studied. Patients may be either newly enrolled in a clinical trial during the hospital stay, or enrolled in a clinical trial prior to arrival and continued active participation in that clinical trial during the hospital stay.
Question Details
Focus area(s): Chart Abstracted Measure Specifications – Clinical, Related Manual - Data Quality Manual
Related documents: STK, Clinical Trial (STK)
File: