PROJECT SUMMARY/ABSTRACT This is an application for a K23 award for Dr. Brett Einerson, a Maternal-Fetal Medicine (MFM) physician at the University of Utah. Dr. Einerson is a promising young investigator in placenta accreta spectrum (PAS) research. His long-term career goal is to become an independent investigator and national leader of PAS studies that evaluate treatments for PAS, including in situ conservative management (CM). This K23 award will provide Dr. Einerson with the protected time and mentored support to accomplish the following career goals: 1] develop expertise in clinical trial design and management; 2] acquire proficiency in interview study design and qualitative assessment; 3] obtain advanced skills in health economic evaluation; and 4] develop and strengthen research leadership and management skills. To achieve these goals, Dr. Einerson assembled a mentoring team comprising a primary mentor, Dr. Robert Silver, a MFM physician and international leader in PAS research, and two co-mentors: Dr. Erin Rothwell, a NIH-funded scientist and expert in shared decision-making, qualitative research, and research ethics, and Dr. Richard Nelson, a federally-funded health economist. Dr. Einerson also has four advisors with expertise in clinical trials, CM, and multicenter research leadership. PAS is an extremely morbid and increasingly common pregnancy condition that often results in massive obstetric hemorrhage. The standard treatment in the US is hysterectomy, but this treatment is complex, morbid, and costly. A promising alternative for PAS treatment is CM, a strategy in which the placenta is left in the uterus. Unfortunately, there are insufficient data available to compare outcomes of these two treatments because past studies are limited by non-randomized study designs, minimal inclusion of patient values in making treatment decisions, and nominal consideration of economic barriers to care. A large clinical trial comparing PAS treatments is needed. Dr. Einerson's research will provide essential data to prepare for a randomized clinical trial and will provide the evidence base for enhanced shared decision-making regarding treatments for PAS. He will (Aim 1) evaluate the feasibility of randomizing patients to CM for PAS; (Aim 2) identify the information needs, outcome priorities, and shared decision-making preferences for PAS; and (Aim 3) quantify the cost of PAS treatments. In Aim 1, Dr. Einerson will design and implement a pilot trial of PAS patients randomized to CM or hysterectomy to evaluate feasibility of a larger trial. In Aim 2, Dr. Einerson will conduct interviews with patients, clinicians, and partners to assess the information needs and values of those who are part of making treatment decisions for PAS. In Aim 3, Dr. Einerson will compare the cost of PAS treatments using advanced economic analytics. The expected outcome will lay the groundwork for a large clinical trial of CM versus hysterectomy for PAS and help to establish the data necessary for shared decision-making and value-based care in PAS. Completing these goals and aims will prepare Dr. Einerson for a successful transition into an independent clinical trialist.

PROJECT NARRATIVE Conservative in situ management is a promising alternative treatment to hysterectomy for patients with placenta accreta spectrum and may be safer and preferable for some patients. The proposed research will evaluate the feasibility of a future randomized clinical trial comparing these treatments and provide novel data to inform shared decision-making and cost-effective care for patients with this deadly pregnancy disorder.