Using computerized chemotherapy ordering to improve performance and documentation of informed consent.

Abstract

299 Background: Informed consent is the foundation of patient-centered care. In the context of clinical trials involving chemotherapy, rigorous adherence to this principle is required. However, for the large majority of patients treated with chemotherapy outside of clinical trials, adherence to obtaining consent is suboptimal. In the past five Quality Oncology Practice Initiative (QOPI) audits, Northwestern University Hematology/Oncology performed worse than other academic cancer centers and the aggregated QOPI cohort. Methods: Informatics devised three steps to transform the process from memory dependent to electronically driven: 1. Insertion of “InformedConsentChemotherapy” generates text documentation of the required elements of informed consent: Cancer/Stage, Goals, Dose/Schedule, Side effects, Alternatives. 2. Required completion of the following pop-up attestation before electronic orders can be signed: “Informed consent (including the required elements) has been discussed and documented.” 3. Display of the completed attestation statement when the patient’s chemotherapy module is accessed. Results: One month after implementation an audit showed 100% display of the attestation statement and 98% concordance with actual informed consent documentation. Conclusions: This innovative informatics process change yielded major improvement in adherence to the fundamental patient-centered standard that chemotherapy informed consent be discussed and documented. Potential weaknesses in this informatics solution include completion of the attestation without documentation of informed consent and completion of the attestation without an actual consent discussion. The audit demonstrated that the first occurs rarely while the second is impossible to measure without continuous direct observation. Minimizing dependence on memory, the advantages of electronic chemotherapy ordering provide the capacity to make doing the right thing—documenting informed consent—the easy thing. [Table: see text]