Significant improvement was achieved in obtaining written informed consent and providing patient education prior to the start of oral oncology drugs by implementing use of a standardized consent and education packet and conducting a staff in-service on the new process, according to a poster presentation at the 2016 ASCO Quality Care Symposium.1

Because oral oncology medications are self-administered, appropriate patient education directly impacts adherence to drug regimen. At this community-based medical oncology clinic, implied consent was obtained while providing patient education on side effects, and whether written informed consent was obtained was not documented. This was identified as a patient safety and risk management concern. 

A first step was to develop a new consent form that meets the American Society of Clinical Oncology/Oncology Nursing Society safety standards. Packets including the new consent form and patient education materials were placed in a central location and reminder checklists were placed in examination rooms to prompt clinicians on the new process. Finally, clinicians were in-serviced on the new process, including contacting the nurse to initiate the new prescription and begin patient education before the patient left clinic.

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Using the plan-do-study-act technique, the intervention was implemented over a 6-month period from April to October 2015. Data were collected on 101 consecutive patients initiated on oral oncology drugs.

Outcome measures included data on nurse obtained written informed consent and patient receipt of education handouts prior to starting oral oncology drug, as documented in patients’ charts. Data on clinician adherence to notifying the nurse prior to end of clinic visit were collected as a balance measure. 

Results at the end of the initial implementation period indicated obtaining written informed consent improved from 0% to 75%, and documenting patient education improved 37% to 80%.


1. Zatarain LA, Ashford J, Bivens D. Improving the quality of the consenting and education process for patients starting on oral oncology medications. J Clin Oncol. 2016;34(suppl7S):Abstract 82.