New NIH-backed trial targets advance care planning for older surgical patients

Editor's Note

Fewer than one in ten older adults undergoing major elective surgery complete advance care planning (ACP), but a new multisite randomized trial aims to change that. According to a September 23 article published by BMJ Open, the study design for the I CAN DO Surgical ACP trial has been published, marking a milestone for this National Institutes of Health (NIH) Collaboratory initiative.

The trial, led by Elizabeth Wick and Rebecca Sudore of the University of California, San Francisco, and Genevieve Melton-Meaux of the University of Minnesota, will enroll 6,000 patients aged 65 and older across three sites. Its goal is to test a system-based approach that integrates ACP into presurgical workflows, using digital tools, patient navigators, and electronic health record (EHR) engagement.

As detailed in the article, participants will be randomized into one of three escalating intervention arms. The first arm provides patients with ACP information, advance directive materials, and access to the PREPARE online ACP program via mail and the patient portal. The second arm adds digital reminders through text or portal messages. The third arm layers in personalized outreach and support from a healthcare navigator.

The primary endpoint is completion of clinically meaningful ACP documentation within 6 months of the surgical clinic visit. This includes surrogate decision-maker designations, advance directives, and documented ACP discussions captured in the EHR. Secondary outcomes focus on patient engagement with ACP, measured using a validated survey 2 weeks after the surgical visit and again at 6 months.

The researchers noted while the PREPARE ACP program has been proven effective in general populations, its adoption in surgical contexts remains limited. Embedding ACP into preoperative workflows may create a critical opportunity for patients and surgical teams to align care decisions before major procedures. If effective, the approach could shift how perioperative teams address ACP, helping ensure that patient goals and values inform surgical care decisions well before the OR.

The trial is single-blinded, pragmatic in design, and conducted under NIH oversight, with approvals from Advarra and site-specific Institutional Review Boards. Patient and clinician advisory boards, along with a data safety monitoring board, are providing ongoing input. Findings will be disseminated broadly to academic and community stakeholders.