The ultimate aim of this project is to pilot test training modules to improve the informed consent process in U.S. hospitals.
Clinical informed consent is the process by which a patient is told about the risks and benefits of proposed treatments or procedures, as well as alternatives, and makes a decision based on that information. Informed consent may be jeopardized by incorrect clinician assumptions about patient comprehension, the manner in which consent is sought, and poor readability of consent forms (Paasche-Orlow et al., 2013). All too frequently, patients do not understand the risks, benefits, and alternatives of their treatments even after signing a consent form (Braddock et al., 1999; Sudore et al., 2006).
De-identified accreditation data analyzed as part of AHRQ's preliminary research for this data collection effort suggest that some hospitals are not following the basic ethical principles underlying informed consent. These data, as well as the guidance from the study's Expert and Stakeholder Panel, indicate that hospital administrators and clinicians could benefit from training on evidence-based practices to improve the informed consent process. These include, improving communication, using interpreters to meet the communication needs of patients with limited English proficiency, using high-quality decision aids to support the informed consent discussion, and using teach-back to verify patient understanding (Temple University Health System, 2009). Hospital system changes that can facilitate these practices include improving hospitals' informed consent policies and the infrastructure that supports the informed consent process (e.g., interpreter services, high-quality decision aids, easy-to-understand forms).
Building upon a previously published guide, a review of the literature, and the aforementioned analysis of de-identified accreditation data, AHRQ has developed two new Informed Consent training modules of approximately 1 hour each (one for hospital leaders, the other for health care professionals), to be offered through a Learning Management System. Health care professionals taking the training will be eligible for continuing education (CE) credit.
In the project's next phase, AHRQ will pilot test the training modules to assess:
⢠Facilitators and barriers of implementing the tools and recommended improvements in the training modules
⢠Effectiveness of the training modules in improving informed consent processes and relevant outputs and outcomes
Pilot test results will be used to improve the training modules and provide information to hospitals considering using the training modules to improve their informed consent processes. The pilot test will take place in four hospitals. Each participating hospital will be asked to:
⢠Deliver the leader training module to hospital leaders of their choosing
⢠Champion improvements in their informed consent policies and processes based on the information and tools in the leader training
⢠Deliver the health care professional training module to health care professionals in four units, including at least one surgical unit
⢠Implement improvement initiatives over a period of two to six months in participating units based on materials presented in the health care professional training
o In at least one unit: implementation will last at least three months and use at least one of the techniques presented in the training (e.g., use teach-back to confirm patient understanding, use high quality decision aids, overcome communication barriers)
⢠Conduct and cooperate with assessment activities.
o In at least one unit, use the Rapid Feedback Patient Survey.
o In at least one surgical unit, collect surgical cancellation and delay rates.
o Collect other metrics to assess the effectiveness of the informed consent training modules.
o Cooperate with project team in the data collection efforts described below.
US Code:
42 USC 299
Name of Law: Healthcare Research and Quality Act of 1999
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Attachment M - Secondary Data