Balancing Efficient Procedure Consent With the Rule of Law

Abstract

Creating hospital policies to promote a standardized, efficient, safe, and effective consent process for invasive procedures in critically ill patients is a new activity with limited peer-reviewed literature. Our patients are a vulnerable population with wellrecognized alterations of mental status due to stress illnesses of varied etiologies, necessary sedation, and delirium. Our practice environment is a dynamic continuum in which the performance of ‘‘standard of care’’ procedures are performed from emergency life sustaining to elective circumstances at all hours of the day. Stuke provide both a large national survey of variable practices from academic critical care fellowship directors in high volume teaching hospitals and a voluntary prospective open cohort hospital policy and its implementation strategy with preliminary outcomes. Although only 14% of respondent fellowship directors were using a universal consent document, the majority (78%) were interested in further development and acceptance of such a consent policy and procedure in the care of their patients. However, this represented only 37% of the 189 adult pulmonary and surgical critical care medicine fellowships identified in the United States. Prior to approval of the multiple procedure consent policy by the institutional review board, hospital general counsel, and hospital corporation at Parkland Hospital, ‘‘it was not the routine practice of the surgical intensive care unit (ICU) personnel to obtain consent for any invasive procedure except tracheostomy and percutaneous gastrostomy.’’ This reality and the variable and low rates of consent in the larger cross-sectional survey document a compelling public need for improved hospital and professional performance in an era of ‘‘production pressure’’ and busy and at times overextended physician house staff, advanced nurse practitioners (ANPs), and physician assistants (PAs). While this new policy approach and the results of this small reported trial are encouraging, caution is required in appreciating the limitations of the report for other institutions undertaking this approach. Parkland Hospital has set a very high bar of performance, given that critical care units are staffed by faculty members in both medicine and surgery who attend in the ICU free of other professional duties often encompassed in primary faculty departmental clinical appointments (eg, operating room surgical staffing, clinics, emergency department medical, and trauma call). Furthermore, the authors state that all ICU procedures performed by resident trainees are supervised by ICU attending faculty. Thus, the consent process undertaken by resident physicians would come under the direct purview of attending physicians and be consistent with both medical practice and professional judgment, and the legal requirements for informed consent, should complications from the procedures arise or subsequent medical negligence actions undertaken against the professionals and/or the hospital. Davis et al studied multiple consent acquisition in 145 patients for 1 month. The cohort size of Parkland Hospital is 328 patients/surrogates who consented to the use of the multiple consent form. For widespread adoption of this approach, all hospitals undertaking such methods should consider aggregating their experience into a national registry so that the process could be rapidly standardized and its performance evaluated. An efficient health care system for the entire country could rapidly create such a database with the assistance of the American Hospital Association and the critical care organized societies. The demographics obtained in the cross-sectional survey underscore the significant influence of corporation counsels and conservative posture for legal liability on the part of hospital boards. To effect such a system change as suggested by Stuke will require an open process as was developed at the Parkland Hospital. It is significant that a public hospital with closed ICU operations and a diverse source of both insured and uninsured patients was able to achieve a 90% voluntary consent rate. Strikingly, the patients or surrogates who chose against multiple procedure consent were among the uninsured, a group historically mistrustful of hospitals and professionals when no prior fiduciary trust relationship existed. How this