Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

Abundant data suggest that if elderly and ill patients are fully informed of the risks, benefits and alternatives of invasive, life-prolonging critical care (including but not limited to cardiopulmonary resuscitation and mechanical ventilation) they will opt out of receiving these current defaults. In patients admitted to acute care hospitals, we hypothesize that patients randomized to an intervention that explains the risks, benefits and alternatives of critical care will enhance autonomy and prevent invasive unwanted therapies of patients who opt out and that the frequency of critical care, mechanical ventilation, CPR, length of stay and hospital cost will be greater in patients randomized to routine (control group) care.

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

The primary technology that will be tested is informed consent.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Adults, aged>60 years, hospitalized for acute illness.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Prospective informed consent is appropriate for all patients, but we will concentrate this study on elders.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Benefits include:

1. Respect of autonomy.
2. Preventing administration of invasive therapies that the patient would not want if fully informed of their risks, benefits and alternatives.
3. #2 saves the patient and his family preventable suffering.
4. Saves scarce resources for patients who want them and are most likely to benefit.
5. Saves healthcare dollars from being spent on therapies patients don't want.

Describe any health-related risks, side effects, or harms that you are concerned about.

There are no known harms of informed consent.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cancer
• Dementia, including Alzheimer's disease
• Infectious diseases, including HIV/AIDS
• Pulmonary disease/asthma

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

A disproportionate amount of healthcare spending is provided in the last year of each patient's life, and critical care is often provided with overall poor outcomes, whether a patient has actively requested it or not. Since billions of dollars are spent on critical care in this country, there is the simultaneous opportunity to practice care that is more ethical (i.e. respects patients' autonomy), effective (i.e. provides an opportunity for physicians to explain risk, benefits and alternatives to high-risk populations who are not as likely to benefit from invasive critical care), and economic (i.e. allows patients to opt out, thereby obviating costs of default critical care that is currently the standard in the U.S.).

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

I have just completed editing a monograph for Seminars in Pulmonary and Critical Care which reviews the intersection of outcomes (i.e. increasing realization of poor outcomes associated with critical care), ethics and economics. The natural conclusion was that before more active rationing should be introduced to the U.S. healthcare system, greater care should be taken to ensure that only patients who want critical care receive it.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

The Patient Self-Determination Act was intended to have the effect that this "intervention" would have, i.e. to expand autonomy of end-of-life decision-making. Unfortunately, the law as currently implemented failed to have the intended effect, whereas this intervention - if proven effective - would serve the public by simply asking for their informed consent before subjecting them to a trial of invasive, potentially death-prolonging therapies.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Multi-center study

Describe the timeframe in which an answer to your question is needed.

1 year

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Minority groups are particularly suspicious of healthcare processes - they are less likely to craft advance directives and more likely to request invasive therapies. While this intervention does not address the genesis of those differences, it does provide patients with information that will allow them to make an informed choice.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

Multi-center study

Are you making a suggestion as an individual or on behalf of an organization?

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