• Goal of Treatment as Part of the Chemotherapy Consent Process

      Boord, Christina E.; Connolly, Mary Ellen (2021-05)
      Problem: Patients consenting for chemotherapy require a clear understanding of the goal of treatment to make an informed treatment decision reflective of their own goals and values. Identified barriers to patient understanding include lack of information on the consent form and the use of ambiguous language by providers. Both the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) recommend goal of treatment as part of the consent process. Purpose: The purpose of this quality improvement project was to develop and implement a new chemotherapy consent form that includes goal of treatment; to improve documentation compliance and to evaluate patients’ understanding of their treatment goal. Methods: A multidisciplinary committee at the project site decided to include three goals of treatment: curative, palliative, and palliative/life-extending as part of the consent form. Goal definitions using plain language were included to ensure consistency across providers in how these terms were defined during consent conversations. Patient surveys were developed to evaluate perceived satisfaction with the information provided during the consent conversation as well as the patient’s own perceived goal of treatment. Results: Between August 31, 2020 and December 11, 2020, 155 patients were consented for chemotherapy with 54% of patients completing the patient survey. Goal of treatment documentation compliance increased from 8% to 99% with adoption of the new consent form. Goal concordance, defined as a patient’s ability to correctly identify their goal of treatment compared to the physician’s documented goal of treatment, increased from 42% to 61%; an increase of 43%. However, a chi-square test of independence revealed no significant association between the rate of agreement and consent form used (X2 (1, N = 84) = 2.72, p = .10). Conclusions: Goals of treatment are a vital part of consent conversations. Including goal of treatment as part of the consent form creates opportunity for meaningful, in-depth goals of care conversations which can help patients make treatment decisions reflective of their own goals and values. Although improvement in goal concordance did not reach statistical significance, a 43% improvement in concordance with the new consent form cannot be overlooked.
    • Leveraging Technology Solutions to Automate Informed Consent in a Clinical Research Hospital

      Sawyerr, Claribel L.; Van de Castle, Barbara (2021-05)
      Problem: Paper informed consent (PIC) forms are associated with incomplete and or inaccurate information such as missing signatures and incorrect patient identification. The Food and Drug Administration’s Bioresearch Monitoring Program audit for the 2019 fiscal year lists failure to obtain informed consent (IC) requirements as one of the most common violations (2%) by clinical investigators in clinical trials. In a selected practice site, approximately 440 (2%) out of 25,000 PICs were returned by the medical records department to clinicians in 2019 due to incomplete and or inaccurate information. This resulted in significant delays in the start of clinical trials, incurring additional time and effort for participants and clinicians to correct and or re-consent. Purpose: The purpose of this quality improvement project was to implement electronic informed consent (EIC) for research participants in the adult oncology, infectious disease, and digestive diseases outpatient clinics in a clinical research hospital. Methods: Pre and post implementation surveys were administered to clinicians (n = 43) to obtain baseline perceptions, and compare preferences and satisfaction with using PIC versus EIC. The clinicians were trained on using EIC for signatures, then EIC was implemented and tracked for eight specific protocol studies. Results: The average confirmed IC available in the electronic health record (EHR) within one day of signing by clinicians for all three clinics increased from 52.5% (pre) to 61.3% (post). EIC use increased by 20%, and returned consents decreased from an average of 2.2% to 0.6%. Clinician preference to use EIC over PIC increased from 44.8% to 57.1%, Fisher’s Exact Test = 0.5256, 2-sided, p > .05. Conclusions: Replacing PIC with EIC was preferred by clinicians, improved documentation of consent, and decreased the time for consent availability in the EHR. The implications for practice are that automating informed consent is associated with improved consenting processes and supports remote workflows.