By Stacey Kusterbeck
Informed consent is rooted in the ethical principles of patient autonomy and shared decision-making. Suboptimal consenting practices can jeopardize patient autonomy. “This can lead to coercion or undue influence in the decision-making process,” warns Neena Jube-Desai, MD, MBA, neonatologist at the University of Maryland Children’s Hospital’s neonatal intensive care unit (NICU). Jube-Desai is also an assistant professor of pediatrics at the University of Maryland School of Medicine.
This can prevent patients and families from making informed decisions aligned with their values and preferences. “The patients and families we care for are highly vulnerable given their medical circumstance, emotional distress, level of health literacy, socioeconomic status, and cultural differences,” says Jube-Desai. There also is a power imbalance between healthcare providers and patients or families. “Healthcare providers must be mindful of this when obtaining informed consent and should take steps to avoid taking advantage of this vulnerability,” Jube-Desai urges.
Failing to ethically obtain informed consent could result in significant long-term consequences. Patients may suffer physical, psychological, and financial impacts. “This leaves patients and families unprepared for the challenges they may face post-ICU,” says Jube-Desai. Additionally, failure to effectively communicate with families can lead to a breakdown in the patient-provider relationship. Poor informed consent practices also can result in long-lasting mistrust in the healthcare system.
However, clinicians face multiple obstacles to ethically obtaining informed consent. For clinicians, barriers include lack of awareness of consenting expectations and needs, time constraints, language and cultural barriers, limited health literacy, the highly technical and complex nature of medical information, limited availability of a proxy to consent, extensive medical care needs, and the patient’s lack of decision-making capacity. “Creating an adequate infrastructure and system that intentionally address these obstacles is essential to promoting appropriate consenting practices,” says Jube-Desai.
Obtaining informed consent early in the intensive care unit (ICU) course can help foster important conversations regarding a patient’s medical status, values, and preferences. “This ensures that we, as healthcare providers, are building trust with the families, promoting shared decision-making, and preserving autonomy. Unfortunately, there is limited literature, especially in the neonatal population, on the quality and/or presence of informed consent documentation,” says Jube-Desai.
Over a 37-month time frame, Jube-Desai and colleagues used a multi-faceted approach to improve informed consent practices at University of Maryland Children’s Hospital.1 “We discovered that utilizing a clinical decision support alert to address barriers led to sustained improvement in bundled consent documentation compliance,” reports Jube-Desai. The new consent documentation process increased compliance from 0% to 50% in the NICU.
“It was important that we share our success so that other intensive care units could similarly benefit from utilizing a clinical decision support intervention to improve obtaining and documenting informed consent,” says Jube-Desai.
Ethicists can play a significant role in these ways, suggests Jube-Desai:
• by facilitating effective communication between healthcare providers and families;
• by promoting a culture of shared decision-making;
• by developing policies and guidelines related to informed consent;
• by providing education and training to healthcare professionals involved in obtaining informed consent;
• by offering consultations to address complex ethical dilemmas related to decision-making;
• by performing ongoing quality assurance to assess the effectiveness of current informed consent practices, and to identify areas for improvement.
“Ethicists can emphasize the importance of maintaining a positive and trusting relationship with patients and families by upholding the core medical ethical principle of patient autonomy,” asserts Jube-Desai.
- Sangillo E, Jube-Desai N, El-Metwally D, Driscoll CH. Impact of a clinical decision support alert on informed consent documentation in the neonatal intensive care unit. Pediatr Qual Saf 2024;9:e713.
