Background: Informed consent is a process of communication between clinician and patient that results in the patient's decision about whether to undergo a specific intervention. However, patients often do not understand the risks, benefits, and alternatives, even after signing a consent form.
Methods: Mixed-methods pilot test of two Agency for Healthcare Research and Quality (AHRQ) informed consent training modules implemented in four hospitals. Methods included staff and patient surveys, interviews, site visits, and pre- and posttests of the modules.
Results: A low proportion of clinicians reported using teach-back (40.0%) or high-quality decision aids (55.0%). Patients reported limited use of best practices, including being asked to teach-back (58.4%), having other options described (54.9%), viewing decision aids (37.4%), and finding the form very easy to understand (66.8%). Content of the training modules aligned well with identified deficiencies. Barriers to completing the modules included staff turnover, competing demands, and lack of accountability. Facilitators included committed champions with available time, motivation, and release time for staff to take modules. Knowledge increased for leaders (p <0.05) and staff (p <0.001) who completed the training modules. Hospitals reported the effects of piloting the modules included fostering dialogue and identifying opportunities for improvements, identifying and rectifying policy ambiguity and noncompliance, reinforcing the use of interpreter services, and using modules' strategies and tools to improve informed consent.
Conclusion: Many opportunities exist for hospitals to improve their informed consent practices. AHRQ's two training modules, have face validity, addressed demonstrated deficiencies in hospitals' informed consent policies and processes, and stimulated improvement activity in motivated hospitals.
Copyright © 2018. Published by Elsevier Inc.