On a busy day in your practice with back-to-back patients it can be easy to skip over some of the formalities of treating patients, like consent forms and patient education.
This can not only land you in legal hot water but may also hold you back from achieving improved health outcomes that come with patients who are active, fully informed participants in their healthcare management plans.
The starting point is understanding “informed consent” and how to implement it effectively in your practice.
What constitutes informed consent?
As defined by the HPCSA, informed consent means “patients must be given sufficient information in a way that they understand, to enable them to exercise their right to make informed decisions about their care”.
This patient’s rights flow from the Bill of Rights as enshrined in the South African Constitution, the National Health Act, the Health Professions Act and the HPCSA Ethical Rules and Guidelines. (The Health Professional Council of South Africa. (2008). Guidelines for good practice in the Healthcare Professions: Seeking patients’ informed consent - the ethical considerations. Booklet. 9)
As per Section 4.1, page 5 of Booklet 9, the South African courts have held that legally for a proper informed consent the patient must have:
1. Knowledge of the nature or extent of the harm or risk;
2. Appreciated and understood the nature of the harm or risk;
3. Consented to the harm or assumed the risk; and
4. The consent must have been comprehensive, (i.e. extended to the entire transaction, inclusive of its consequences)
What should your practice include in the informed consent process?
In order for the patient’s consent to be valid, they must be considered competent to make the decision and their consent must be voluntary. To facilitate voluntariness and strengthen the patient-doctor relationship, consent records must to be coupled with a robust conversation between the healthcare practitioner and the patient.
The HPCSA’s guidelines for the informed consent discussion are detailed in Section 6, page 6 of Booklet 9 and include such elements as:
Their patient’s health status except in circumstances where there is substantial evidence that the disclosure of the patient’s health status would be contrary to the best interests of the patient;
The nature of the decision/procedure
Reasonable alternatives to the proposed intervention
The relevant risks, benefits, and uncertainties related to each option
Assessment of patient understanding
The patient’s acceptance of, or right to refuse, health services and an explanation of the implications, risks and obligations of such refusal.
Section 13.4 of the guidelines further sets out that healthcare practitioners must use the patient's case notes or the consent formto detail the key elements of the discussion with the patient, including the nature of information provided, specific requests by the patient, and details of the scope of the consent given.
Lastly, to further support the process, “essential”, “understandable” and “actionable” patient education materials are required.
Are your patient materials written in plain, easy language? Are the key messages in your materials clear to all patients? Can they easily identify what actions they can take based on the information provided? This isn’t easy given the varying levels of patient health literacy.
In brief
Patient education is necessary for informed consent and it equips patients to take an active role in their care management. Doctors should take the time to educate their patients and make sure they understand how to help themselves.
Although providing education and soliciting questions require an initial time commitment, these efforts ultimately save time and lead to better health outcomes.