Using Systems Engineering and Implementation Science to Design an Implementation Package for Preoperative Comprehensive Geriatric Assessment Among Older Adults Having Major Abdominal Surgery: Protocol for a 3-Phase Study
Authors: Berian Julia R , Schwarze Margaret L , Werner Nicole E , Mahoney Jane E , Shah Manish N 
Published: July 2024

Background
Older Americans, a growing segment of the population, have an increasing need for surgical services, and they experience a disproportionate burden of postoperative complications compared to their younger counterparts. A preoperative comprehensive geriatric assessment (pCGA) is recommended to reduce risk and improve surgical care delivery for this population, which has been identified as vulnerable. The pCGA optimizes multiple chronic conditions and factors commonly overlooked in routine preoperative planning, including physical function, polypharmacy, nutrition, cognition, mental health, and social and environmental support. The 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 the pCGA, a paucity of strategic guidance for implementation limits its uptake to a few academic medical centers. By applying implementation science and human factors engineering methods, this study will provide the necessary evidence to optimize the implementation of the pCGA in a variety of health care settings.

Objective
The purpose of this paper is to describe the study protocol to design an adaptable, user-centered pCGA implementation package for use among older adults before major abdominal surgery.

Methods
This protocol uses systems engineering methods to develop, tailor, and pilot-test a user-centered pCGA implementation package, which can be adapted to community-based hospitals in preparation for a multisite implementation trial. The protocol is based upon the National Institutes of Health Stage Model for Behavioral Intervention Development 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 apply user-centered design methods, engaging health care providers, patients, and caregivers to co-design a pCGA implementation package. This package will be applicable to a diverse population of older patients undergoing major abdominal surgery at a large academic hospital and 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 anticipate that this study will take approximately 60 months (April 2023-March 2028).

Results
This study protocol will generate (1) a detailed process map of the pCGA; (2) an adaptable, user-centered pCGA implementation package ready for feasibility testing in a pilot trial; and (3) preliminary pilot data on the implementation and effectiveness of the package. We anticipate that these data will serve as the basis for future multisite hybrid implementation-effectiveness clinical trials of the pCGA in older adults undergoing major abdominal surgery.

Conclusions
The expected results of this study will contribute to improving perioperative care processes for older adults before major abdominal surgery.

International Registered Report Identifier (IRRID)
DERR1-10.2196/59428