I CAN DO Surgical ACP

Not Applicable

• Conditions: Surgical Advanced Care Planning
• Interventions: Behavioral: Letter, AD, PREPARE, reminders; Behavioral: Letter, AD, PREPARE, reminders, healthcare navigator; Behavioral: Letter, AD, PREPARE

• Registration Number: NCT06090552
• Lead Sponsor: University of California, San Francisco

Brief Summary

The goal of the Advanced Care Planning (ACP) study is to encourage patients aged 65 or older who are referred for elective surgery to have advanced care planning.

Detailed Description

ACP is also a critical way to support older adults in participating actively with clinicians in making real-time, complex medical decisions so that the medical care they receive is aligned with their goals. Our team has designed and tested a theory-based, interactive ACP patient-facing technology solution (PREPARE) based on the new ACP paradigm of preparing people for communication and medical decision-making. The study team hypothesizes that by including PREPARE into the electronic health record (EHR)-centric pre-surgery workflow for older adults and including automated reminders, the study team can empower patients and surgical teams to engage in ACP discussions.

Participants will be randomized to Arms: (1) Letter about ACP, PREPARE advanced directive (AD), PREPARE website; (2) Letter, advanced directive (AD), PREPARE plus reminder messages; (3) Letter, advanced directive (AD,) PREPARE plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome). All patients randomized to the intervention will be sent a patient-reported ACP engagement survey (secondary outcome).

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Status Verified: 2025-02
• Study Start: 2025-02-26
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Older Adults (age 65+) referred for surgical evaluation

Exclusion Criteria

1. ACP on file within 3 years prior to surgery (UCSF and UCI) and 5 years (UMN)
2. Was previously randomized into intervention for a prior surgery during the 18-month study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letter, AD, PREPARE, reminders	Letter, AD, PREPARE, reminders	Letter, AD, PREPARE plus reminder text/phone messages
Letter, AD, PREPARE, reminders, healthcare navigator	Letter, AD, PREPARE, reminders, healthcare navigator	Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (discussions and care-plans, primary outcome)
Letter, AD, PREPARE	Letter, AD, PREPARE	Letter about ACP, PREPARE advanced directive (AD), PREPARE website

Primary Outcome Measures

Name	Time	Method
Number of participants with clinically meaningful Advanced Care Planning	6 months	clinically meaningful ACP documentation (ACP-specific clinical notes, problem lists, Epic Smartforms or Smartphrases, advanced directives, Physician Orders for Life Sustaining Treatment, out of hospital do-not-resuscitate order, living wills, or CPT billing codes) available in the HCS EHR within 6 months of intervention.

Secondary Outcome Measures

Name	Time	Method
Patient Engagement Scores	6 months	Patient-centered outcomes will be derived from the validated 4-item ACP Engagement Survey.The survey will be administered after the surgical clinic visit and a follow up survey will be sent 6 months later.

Trial Locations

Locations (3)

University of California, Irvine; 🇺🇸 Irvine, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States