An Initiative to Assess Patient Capacity for Clinical Informed Consent

Background:

Clinicians at comprehensive MS treatment centers are performing an increasing number of high-risk diagnostic and treatment procedures with our patients. Disease-modifying and symptomatic therapies are associated with rare but potentially severe complications. These procedures require more scrutiny by clinicians on the patient informed consent process. It is important for center staff to be aware of and follow procedures that ensure patients provide valid informed consent for these interventions. Participating in this informed consent process is an important component of ethical practice, mandated by The Joint Commission (TJC), and  legally required in some states.

Objectives: The prevalence of cognitive symptoms in the MS population is well documented and complicates the informed consent process. As part of the informed consent process it is important for clinicians to conduct ongoing assessment of a patient's capacity to consent to interventions and determine who else should represent the patient is determined incapacitated.

Methods: Members of the Mellen Center’s Quality Committee collaborated with staff from the Cleveland Clinic’s Department of Bioethics and Quality and Patient Safety Institute to develop guidance for our staff to use. The guidance document includes three components. The first is an outline of the process by to assess a patient’s capacity. The second is an outline of who else should be involed in the informed consent process (i.e., surrogate decision-makers) if the patient is determined incapacitated. The third is a recommendation that clinicians caring for patients and families with MS have an opportunity to participate in advanced planning.

Results: Mellen Center staff have endorsed and regularly use this guidance in the course of care. They also routinely provide patients with written materials early in their disease course. Materials include information about Healthcare Power of Attorney, Living Wills, Do Not Resuscitate Orders and Donor Registry enrollment.

Conclusions: Feedback from Mellen staff indicate that the guidance has been useful in clinical decision-making and that patients have been receptive to information provided in the written materials.