8 ways to improve the informed consent process

,

Applied Evidence

8 ways to improve the informed consent process

J Fam Pract. 2010 July;59(7):373-377a

By

Preethy D. Kaibara, MD, Esq.

These practical suggestions can strengthen your rapport with patients and help ensure your professional counsel is complete and documented.

PDF Download

References

1. American Medical Association (AMA). Health and Ethics Policies of the AMA House of Delegates (Policy H-140.989 and H-160.998). Available at: http://www.ama-assn.org/ad-com/polfind/Hlth-Ethics.pdf. Accessed June 16, 1010.

2. Frosch DL, Kaplan RM. Shared decision making in clinical medicine: past research and future directions. Am J Prev Med. 1999;17:285-294.

3. For example, The Patient Self-Determination Act 42 U.S.C.§§1395cc(a) et seq., as amended (2003).

4. National Quality Forum. Implementing a National Voluntary Consensus Standard for Informed Consent: A Users Guide for Healthcare Professionals. Washington, DC: National Quality Forum; 2005:13, 15, 27.

5. Salgo v Stanford University Board of Trustees, 154 Cal. App. 2d 560, 317 P. 2d 170 (1957).

6. Cruzan v Director, Missouri Department of Health, 497 U.S. 261 (1990).

7. Berg JW, Appelbaum PS, Lidz CW, et al. Informed Consent Legal Theory and Clinical Practice. 2nd ed. New York, NY: Oxford University Press; 2001:46-55.

8. 61 Am Jur 2d Physicians and Surgeons §151-152 pp 274-275.

9. Levinson W, Roter DL, Mullooly JP, et al. Physician-patient communication: the relationship with malpractice claims among primary care physicians and surgeons. JAMA. 1997;277:553-559.

10. Rozovsky FA. Consent to Treatment: A Practical Guide. 4th ed. Frederick, Md: Aspen Publishers; 2007:8-11.

11. Martin v Hacker, 83 NY 2d 1, N.E. 2d 1308 (1993).

12. Moore v The Regents of the University of California, 793 P.2d 479 (Cal 1990).

13. Moore v Preventative Medicine Group Inc., 178 Cal. App 3d 728, 223 Cal Rptr. 859 (Cal Ct. App. 1986).

14. Truman v Thomas, 27 Cal. 3d 285, 611 P. 2d 902, 165 Cal. Rptr. 308 (1980).

15. Prooth v Walsh, 432 N.Y.S. 2d 663 (Sup Ct. 1980).

16. Landro L. Consent forms that patients can understand. The Wall Street Journal. February 8, 2008. Available at: http://online.wsj.com/article/SB120224055435844931.html. Accessed February 10, 2008.

17. Safeer RS, Keenan ES. Health literacy: the gap between physicians and patients. Am Fam Phys. 2005;72:463-468.

PRACTICE RECOMMENDATION

• Let patients know that informed consent is an interactive process leading to mutual agreement, rather than a formality and forced choice. C

• Present all treatment options even if a patient’s insurance does not cover them all. C

• Discuss the advantages, disadvantages, and limitations of the tests you are ordering or recommending—particularly nonroutine lab work. C

Strength of recommendation (SOR)

A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

Once viewed as simply a legal preamble to treatment, informed consent today encompasses much more. An essential part of the ethical practice of medicine,¹ it is also an opportunity to strengthen the doctor-patient relationship. Effective informed consent embodies the shift in primary care medicine to guide rather than dictate an individual’s health care decisions, often termed shared decision making.² Furthermore, informed consent is increasingly relevant in today’s evolving legislative expectations³ and health care initiatives.⁴ For risk management, the physician has more direct control over the process of informed consent than most other areas pertaining to medical negligence. Thus, incorporating improvements to the process of informed consent is time well invested.

In this article I will discuss the components of informed consent and recommend practical steps to its effective delivery for mentally competent adult patients.

What informed consent requires

In the office setting, obtain informed consent before you start treatments or procedures, prescribe medications, or order most diagnostic tests. Informed consent requires that the patient understands the following:

the material risks and benefits of a proposed treatment
the reasonable alternative treatments
the consequences of no treatment.

Physicians are not expected to disclose every risk to a patient. However, both common risks and uncommon but serious risks are considered material.⁵ In the extreme, a mentally competent patient may refuse lifesaving therapy if she or he understands the risk of doing so.⁶

The legal criteria that determine whether a physician satisfied the standard of care for informed consent vary from state to state. Some states test the physician’s conduct against what a “reasonable physician” should have disclosed. Other states apply what a “reasonable patient” would want to know, and some apply a combination of both. As such, legal cases provide little direction to physicians on how to decide what is material.⁷

Patients generally take 1 of 2 approaches when pursuing action against a physician that is related to informed consent.⁸

The first, and most common, cause of action is negligence. This occurs when a patient claims that the physician’s disclosures in the consent process were inadequate. The patient is then required to prove the elements of negligence: breach of standard of care, causation, and damages.

The second potential cause of action is battery, which is an unlawful touching. Proving battery is simpler because there are fewer elements to the claim. If a procedure or examination took place without the patient’s consent or was beyond the scope of the consent given, a battery action is possible, whether or not the outcome of a treatment was beneficial to the patient.

Now, on to the steps that can help improve the informed consent process.

1. Work on your rapport

The importance of good rapport between the patient and physician cannot be overemphasized. The level of rapport is a better predictor of the risk of litigation than the actual content of any particular discussion.⁹

FAST TRACK

Your level of rapport with a patient better predicts risk of litigation than does the content of any particular discussion.

A few tips to improve rapport. If you approach informed consent merely as a legal technicality, the tone you take in the discussion may reflect that attitude. Instead, enter into a consent discussion in such a manner that the patient understands it is an interactive process leading to mutual agreement rather than a formality. Should an adverse outcome occur, a patient who recalls feeling pressured may claim that not all the key information was presented. Don’t be dogmatic in making recommendations; scientific evidence and medical opinion can change with time. Hormone replacement therapy and cyclooxygenase-2 inhibitors are current examples that demonstrate the importance of allowing the patient to make a decision about therapy.

Effective communication reduces the likelihood of litigation.⁷ One model of more effective communication is the “teach back” approach,⁴ in which you identify the principal messages of the discussion and ask the patient to paraphrase them. This approach emphasizes the use of simple, clear language in layman’s terms, relying on your ability to explain rather than the patient’s ability to comprehend. Questions such as “Do you have any questions?” or “Do you understand?” are less effective than saying “I want to be sure we have the same understanding” or asking “Can you tell me in your own words?”⁴ (See “Putting informed consent principles into practice” by going to jfponline.com and scrolling to the end of this article.)

8 ways to improve the informed consent process

References

Pages

Next Article: