Form
Approved
OMB No. 0935-XXXX
Exp. Date XX/XX/20XX
Choose the best answer for each of the following questions.
True or
false: A signed consent form protects the hospital against lawsuits
alleging lack of informed consent.
True
Incorrect. If the patient signs the form without understanding the treatment and its risks, the hospital can still be held liable. What protects the hospital is the informed consent PROCESS, not the form. During the informed consent process, the proposed treatment is explained to a patient including its benefits, harms, and risks. When the patient understands the nature of the treatment and its possible benefits and harms, and accepts the risks, he or she is less likely to file a lawsuit alleging lack of informed consent and such lawsuits are less likely to be successful.
False
Correct. What protects the hospital is the informed consent PROCESS, not the form. During the informed consent process, the proposed treatment is explained to a patient including its benefits, harms, and risks. When the patient understands the nature of the treatment and its possible benefits and harms, and accepts the risks, he or she is less likely to file a lawsuit alleging lack of informed consent and such lawsuits are less likely to be successful.
Hospitals should…
Make high quality decision aids available to clinicians. It will ensure that clinicians know how to structure conversations about choices.
Correct. Decision aids not only help clinicians structure conversations about choices with patients, but they also improve patients’ knowledge of what their options are, result in more accurate expectations of possible benefits and harms of different options, help patients feel more informed and clearer about what matters most to them, help patients weigh the options based on their values, increase patient participation and communication, make it more likely that patients reach decisions consistent with their goals and values, and equip patients to cope better with treatment outcomes or adverse events.
Create their own decision aids. It will ensure that the decision aids are high quality.
Incorrect. While hospitals can create their own decision aids, this is an ambitious undertaking. High quality decision aids can be obtained from free and commercial databases. Decision aids not only help clinicians structure conversations about choices with patients, they also improve patients’ knowledge of what their options are, result in more accurate expectations of possible benefits and harms of different options, help patients feel more informed and clearer about what matters most to them, help patients weigh the options based on their values, increase patient participation and communication, make it more likely that patients reach decisions consistent with their goals and values, and equip patients to cope better with treatment outcomes or adverse events.
Promote the use of high quality decision aids instead of talking with patients. It will ensure that patients are getting standardized information about benefits, harms, and risks.
Incorrect. Decision aids are designed to be part of the informed consent discussion and should never be considered a substitute for it. Decision aids not only help clinicians structure conversations about choices with patients, they also improve patients’ knowledge of what their options are, result in more accurate expectations of possible benefits and harms of different options, help patients feel more informed and clearer about what matters most to them, help patients weigh the options based on their values, increase patient participation and communication, make it more likely that patients reach decisions consistent with their goals and values, and equip patients to cope better with treatment outcomes or adverse events.
A 25-year
old white woman presented alone to the ER, vomiting and fainting. By
the time the ER doctor saw her, she was unconscious and the ER
doctor thought she might have life-threatening meningitis. Was the
doctor right to immediately perform a lumbar puncture on her without
her consent or the consent of a surrogate decision maker in order to
provide a potentially life-saving treatment?
Yes
Correct. Since the patient had lost consciousness and there was no time to find a surrogate decision-maker, the doctor was justified to perform the lumbar puncture. If the patient had been conscious or if a surrogate decision maker had been available, the doctor would have had to obtain informed consent.
No
Incorrect. Since the patient had lost consciousness and there was no time to find a surrogate decision-maker, the doctor was justified to perform the lumbar puncture. If the patient had been conscious or if a surrogate decision maker had been available, the doctor would have had to obtain informed consent.
True or false: Informed
consent is legally binding while informed choice is not.
True
Incorrect. Informed choice fully meets all the legal obligations of informed consent. The term “Informed choice” makes it clear that patients get information about the benefits, harms, and risks of all of their options, including what happens if they have no treatment, and the clinician helps them to make decisions based on their goals and values.
False
Correct. Informed choice fully meets all the legal obligations of informed consent. The term “Informed choice” makes it clear that patients get information about the benefits, harms, and risks of all of their options, including what happens if they have no treatment, and the clinician helps them to make a decision based on their goals and values.
According to The Joint Commission, which of the following is a common problem with hospital informed consent policies?
Hospital informed consent policies don’t require a signed informed consent form when one is needed.
Incorrect. Explicit consent doesn’t always require a patient’s signature. For many procedures and treatments, oral consent can be sufficient. Hospital policies should address how oral informed consent should be documented. Queries to The Joint Commission from clinicians in the field, however, suggest that many clinicians need more detailed guidance from their hospital policies on informed consent.
Hospital informed consent policy is not detailed enough for clinicians to implement.
Correct. Queries to The Joint Commission from clinicians in the field suggest that many clinicians need more detailed guidance from their hospital policies on informed consent.
Hospital informed consent policy does not address whether or not minors must consent to treatment.
Incorrect. While your informed consent policy can establish a right for minors to consent if they are emancipated minors, mature minors, or minors seeking certain types of health services such as substance abuse counseling and reproductive health services, failure to do so is not a commonly cited problem by The Joint Commission. Queries to The Joint Commission from clinicians in the field, however, suggest that many clinicians need more detailed guidance from their hospital policies on informed consent.
True or False: A hospital with primarily English-speaking clinicians can meet its informed consent obligations toward Spanish-speaking patients by providing Spanish-language informed consent forms.
True
Incorrect – translated forms can be helpful for patients with limited English proficiency, but informed consent is a communication process, not a signature on a form. Therefore, the hospital should also provide qualified interpreters or use certified bilingual staff for informed consent discussions.
False
Correct – translated forms can be helpful for patients with limited English proficiency, but informed consent is a communication process, not a signature on a form. Therefore, the hospital should also provide qualified interpreters or use certified bilingual staff for informed consent discussions.
Which of the following is the most commonly expressed frustration by hospital staff about informed consent?
Confusion about who should be responsible for each part of the informed consent process.
Correct. The Joint Commission’s Standards Interpretation Group receives many questions each year from hospital staff expressing confusion about who should be responsible for what in the informed consent process. Mapping out workflows can help to clarify who is responsible for which aspects of the informed consent process.
Concern about the burden that informed consent paperwork places on clinicians.
Incorrect. While the paperwork involved does place a burden on clinicians, inquiries to The Joint Commission’s Standards Interpretation Group suggest that hospital staff were most concerned about who should be responsible for what in the informed consent process. Mapping out workflows can help to clarify who is responsible for which aspects of the informed consent process.
Which of the following is an important early step in creating organizational change?
Assembling people who are likely to oppose the change initiative so you can allay their concerns
Incorrect. While at some point you will want to reach out to those who oppose the initiative so you can allay their concerns, assembling opponents at the early stages is not advisable. You’ll want to begin by reaching out to other leaders who will be most receptive. Similarly, it is not advisable to start by trying to change your hospital’s culture since change in culture is slow. People need to see that the new processes and ideas work better, before the culture can change. “Creating and communicating a Change Vision” is the correct answer. Vision plays a key role in producing useful change. A sound vision statement helps people to picture a worthwhile future that they can help to achieve, and helps to direct, align, and inspire actions on the part of large numbers of people. To bring the vision to life, senior leaders must communicate often with everyone in the hospital about the vision.
Creating and communicating a Change Vision
Correct. Vision plays a key role in producing useful change. A sound vision statement helps people to picture a worthwhile future that they can help to achieve, and helps to direct, align, and inspire actions on the part of large numbers of people. To bring the vision to life, senior leaders must communicate often with everyone in the hospital about the vision. While at some point you will want to reach out to those who oppose the initiative so you can allay their concerns, assembling opponents at the early stages is not advisable. You’ll want to begin by reaching out to other leaders who will be most receptive. Similarly, it is not advisable to start by trying to change your hospital’s culture since change in culture is slow. People need to see that the new processes and ideas work better, before the culture can change.
Aligning organizational culture to be receptive to the change.
Incorrect. It is not advisable to start by trying to change your hospital’s culture since change in culture is slow. People need to see that the new processes and ideas work better, before the culture can change. Similarly, assembling opponents at the early stages is not advisable. While at some point you will want to reach out to those who oppose the initiative so you can allay their concerns, you’ll want to begin by reaching out to other leaders who will be most receptive. “Creating and communicating a Change Vision” is the correct answer. Vision plays a key role in producing useful change. A sound vision statement helps people to picture a worthwhile future that they can help to achieve, and helps to direct, align, and inspire actions on the part of large numbers of people. To bring the vision to life, senior leaders must communicate often with everyone in the hospital about the vision.
When creating a sense of urgency to improve informed consent it’s most important to…
Produce and disseminate a new informed consent policy quickly.
Incorrect. While it is important to produce a clear and complete informed consent policy, the writing of that policy should not be hurried and happens after a sense of urgency has been established. To establish a sense of urgency to improve informed consent, gather data to demonstrate that there is a problem that needs to be addressed. Data can include HCAHPS scores on patient understanding and surgery cancelation rates, patient safety event incidents (including near misses and failure to use interpreter services), and exposure to liability.
Target one strategy to improve informed consent to focus efforts.
Incorrect. Hospitals may choose to sequence implementation of strategies to focus on one at a time, but this does not create a sense of urgency. To establish a sense of urgency to improve informed consent, gather data to demonstrate that there is a problem that needs to be addressed. Data can include HCAHPS scores on patient understanding and surgery cancelation rates, patient safety event incidents (including near misses and failure to use interpreter services), and exposure to liability.
Use hospital data to make the case.
Correct. To establish a sense of urgency to improve informed consent, gather data to demonstrate that there is a problem that needs to be addressed. Data can include HCAHPS scores on patient understanding and surgery cancelation rates, patient safety event incidents (including near misses and failure to use interpreter services), and exposure to liability.
The best way to ensure that patients understand informed consent forms is to:
Use health literacy principles, such as plain language, informative headings, and clear layout.
Incorrect. Using health literacy principles has a number of advantages, such as improving the forms’ readability and giving clinicians jargon-free language they can use in their discussion. You won’t know, however, whether patients are able to understand your hospitals’ forms unless you test them with a diverse sample of patients.
Obtain free forms or purchase commercial databases of forms.
Incorrect. Purchased informed consent forms may or may not be understandable to your patient population. You won’t know whether patients are able to understand your hospitals’ forms unless you test them with a diverse sample of patients. Using health literacy principles has a number of advantages, such as improving the forms’ readability and giving clinicians jargon-free language they can use in their discussion, but isn’t the best way to ensure patients understand forms. The best way to ensure that patients are able to understand your hospitals’ informed consent forms is to test them with a diverse sample of patients.
Test forms with a diverse sample of patients.
Correct. The best way to ensure that patients are able to understand your hospitals’ informed consent forms is to test them with a diverse sample of patients. Purchased informed consent forms may or may not be understandable to your patient population. Using health literacy principles has a number of advantages, such as improving the forms’ readability and giving clinicians jargon-free language they can use in their discussion, but isn’t the best way to ensure patients understand forms.
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Sarah J. Shoemaker |
File Modified | 0000-00-00 |
File Created | 2021-01-26 |