BACKGROUND: Consent to treatment is a critical part of ethical medical practice that values patient autonomy. Chemotherapy and other systemic therapies pose additional challenges with complex discussions on risks, benefits and patient preferences. Documentation of the consent process and outcome is an important quality and medicolegal requirement.
AIMS: To improve the proportion of new patients with documented consent for systemic therapy at the Sunshine Coast University Hospital Oncology Department over a 12-month period.
METHODS: A multidisciplinary team of quality improvement officers, physicians, nurses, pharmacists and administration staff investigated the root causes for low rates of documented consent. Quality improvement methodology including process flow charts, cause-and-effect analyses and Pareto charts were constructed to identify the key modifiable factors. After an initial run-in period (Apr to Jul 2017), Plan-Do-Study-Act (PDSA) interventions were implemented (August 2017 to July 2018) involving physician and nurse education, improved access to forms and modifications in clinic processes. Evidence of consent in the electronic medical record was documented via continuous tally sheets. The Chi-squared statistic was used to compare the difference in proportions of patients with consent in pre- versus post-intervention cohorts.
RESULTS: There were 546 eligible new patients in the study period. The post-intervention group were more likely to have documented consent than the pre-intervention group (χ2 = 15.45, p<0.001). In the pre-intervention group, only 54.2% had documented consent, compared to 73.1% in the post-intervention group, an improvement of 18.9% (95% CI 9.0% to 28.8%). Modifying clinic processes had the most impact with the most recent monthly consent rates now at 100%.
CONCLUSIONS: Rates of documented consent can be increased by systematic quality improvement methodology. Involvement of key stakeholders in the multidisciplinary team is critical for success. Ongoing efforts to monitor and continually improve the consent process are important for patient autonomy as well as ethical and medicolegal obligations.