Preparing older adults for major abdominal surgery with preoperative comprehensive geriatric assessments: a three-phase research protocol using systems engineering and implementation science (Preprint)

BACKGROUND Older Americans are a growing segment of the population with an increasing need for surgical services, and they suffer a disproportionate burden of postoperative complications compared to their younger counterparts. Preoperative comprehensive geriatric assessment (pCGA) is recommended to reduce risk and improve surgical care delivery for this vulnerable population. The pCGA optimizes multiple chronic conditions and factors commonly overlooked in routine preoperative planning, including physical function, polypharmacy, nutrition, cognition, mental health, and social/environmental support; pCGA has been shown to decrease postoperative morbidity, mortality and length of stay in a variety of surgical specialties. Although national guidelines recommend the use of pCGA, a paucity of strategic guidance for implementation limits its uptake to a few academic centers. By applying human factors engineering methods, this study will provide the necessary evidence to optimize the implementation of the pCGA in a variety of healthcare settings. OBJECTIVE The purpose of this paper is to describe the study protocol to design an adaptable, user-centered implementation package for the pCGA for use among older adults before major abdominal surgery. METHODS This protocol uses systems-based engineering methods to develop, tailor and pilot test a user-centered implementation package for the pCGA – one that can be adapted to community-based hospitals in preparation for a multi-site implementation trial. The protocol is based upon the National Institutes of Health Stage Model and aligns with the goal to develop behavioral interventions with an eye to real-world implementation. In phase 1, we will use observation and interviews to map the pCGA process and identify system-based barriers and facilitators to its use among older adults undergoing major abdominal surgery. In phase 2, we will employ user-centered design methods, engaging healthcare providers, patients and caregivers to co-design an implementation package for the pCGA. The implementation package will be applicable to a diverse population of older patients undergoing major abdominal surgery at (2a) a large academic hospital and (2b) an affiliate community site. In phase 3, we will pilot test and refine the pCGA implementation package in preparation for a future randomized controlled implementation-effectiveness trial. We anticipated this study will take approximately 60 months in total, beginning in April 2023 and ending in March 2028. RESULTS This study protocol will generate (1) a detailed process map of the pCGA, (2) an adaptable, user-centered implementation package for the pCGA ready for feasibility testing in a pilot trial, and (3) preliminary pilot data on implementation and effectiveness of the implementation package. We anticipate that these data will serve as the basis for future multi-site hybrid implementation-effectiveness clinical trials of the pCGA in older adults undergoing major abdominal surgery. CONCLUSIONS The expected results of this study will improve perioperative care processes for older adults before major abdominal surgery. CLINICALTRIAL NCT06184919 (Phase 1 & 2 – Observational phases) and NCT06184724 (Phase 3 – Pilot trial)