Date of Award
2024
Document Type
Doctor of Nursing Practice (DNP)
Degree Name
Doctor of Nursing Practice (DNP)
Department
Nursing
Committee Chair
Darlene Showalter
Subject(s)
Informed consent (Medical law), Medical care--Decision making, Clinical trials
Abstract
Informed consent discussions are often one of the first steps in a medical treatment plan of care. Literature has shown effective communication and a standardized checklist, used as a guide by the consenter to ensure all mandated elements of informed consent are discussed, will help potential research participants make an informed decision. The purpose of this clinical project is to implement a standardized checklist that guides consenters during the informed consent process at a pediatric, hematology, and oncology hospital. The project focused only on therapeutic studies. The consenter performed two informed consent conversations without any prior education on the standardized checklist. The consenter was then educated on the standardized checklist and then performed two more informed consent discussions. The Process and Quality of Informed Consent Checklist was used to score the consenters on how well they discussed the informed consent content and their communication skills. Procedurally, a high score required the consenter to complete two additional informed consent discussions. A lower score required re-education on the standardized checklist. The consenter then performed the two final informed consent discussions. The Quality Informed Consent Collection Tool was used to assess research participant understanding and satisfaction after each consent. This allowed for the collection of pre- and post-intervention data. A spreadsheet and SPSS were used to apply descriptive statistics and non-parametric tests. The results showed improvements in the communication of the consenters from pre- to post-intervention and an increase in participant satisfaction and understanding from pre- to post-intervention. Some limitations were identified as the project was conducted only in therapeutic studies and with English-speaking participants. It also only looked at continued enrollment as yes or no and did not collect additional data pointing to rationales. To increase knowledge on this topic, more studies focused on informed consent and its impact should be designed to include non-therapeutic studies and languages other than English.
Recommended Citation
Shirley, Simone, "Practice change by implementing a standardized checklist during informed consent and improving effective communication, patient understanding and satisfaction, and continued enrollment" (2024). Doctor of Nursing Practice (DNP). 77.
https://louis.uah.edu/uah-dnp/77