Improving institutional processes to reduce patient harm using evidence-based standards

Comprehensive treatment of life-threatening pregnancy complications sometimes includes pregnancy termination as one part of the evidence-based standard-of-care. Clinicians and healthcare institutions may have to alter treatment standards to comply with state law. Ambiguous definitions of “medical emergencies” which may be exempt from legal restrictions creates substantial uncertainty. Providers and hospital systems may question which clinical scenarios allow provision of care in compliance with state law. Additionally, the prospect of criminal liability may inhibit health systems from communicating with each other about interpretations of state law and care protocols developed in response to those interpretations. Rapid changes to the standard-of-care developed without the usual processes of evidence synthesis and open discussion may endanger patients, and must balance competing priorities for clinicians such as patient wellbeing versus avoidance of criminal legal liability. These changes to care standards in response to state reproductive health policy changes contribute to projected increases severe maternal morbidity and pregnancy-related mortality. Health care institutions urgently need data on optimal processes to develop alternative treatment standards that minimize harm to patients. The overall objective of this application is to develop recommendations that improve institutional processes for adapting evidence-based standards that adhere to state laws. In this proposal, we will combine qualitative data from a multistate group of clinician experts on processes they have used and problems they encountered (Aim 1) with quantitative data from a discrete-choice experiment on tradeoffs between patient safety and legal security for providers (Aim 2). We will then use a Delphi process including clinician experts, hospital policy makers and feedback from a patient collaborator group to develop consensus-based recommendations (Aim 3). Recommendations will focus on how institutions can translate state laws into alternative treatment standards using a harm-reducing, evidence-based and patient-centered process. We will be studying policy changes related to reproductive health which create uncertainty affecting the care and the health of pregnant and postpartum women, and women of reproductive age. Best-practices for rapid development and adaptation of alternative care standards will have applications to other potential scenarios, such as disasters and pandemics. Project Number: 1R01HD117843-01 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Jonas Swartz | Institution: DUKE UNIVERSITY, DURHAM, NC | Award Amount: $689,676 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZRG1 HSS-Q (90)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01HD11784301