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I CAN DO Surgical ACP

I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06090552
Enrollment
6000
Registered
2023-10-19
Start date
2025-02-26
Completion date
2028-08-31
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Advanced Care Planning

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 EHR-centric pre-surgery workflow for older adults and including automated patient reminders, easy-to-read materials, and, in Arm 3, directed support from a healthcare navigator (HCN), they can empower patients and surgical teams to engage in ACP discussions. They also hypothesize that ACP documentation will increase more with increasing resource intensity (i.e., Arm 3 more than Arm 2 more than Arm 1). 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).

Interventions

BEHAVIORALLetter

Letter about ACP

BEHAVIORALAD

PREPARE advanced directive (AD)

BEHAVIORALPREPARE website

PREPARE website

BEHAVIORALreminders

reminders to complete the advance directive

BEHAVIORALhealthcare navigator

healthcare navigators provide assistance to complete the advance directive

Sponsors

University of California, Irvine
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Fairview University Medical Center
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Intervention model description

1:1:1 simple randomized block design stratified by enrollment site

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with clinically meaningful Advanced Care Planning6 monthsclinically 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

MeasureTime frameDescription
Patient Engagement Scores6 monthsPatient-centered outcomes will be derived from the validated 4-item ACP Engagement Survey.The survey will be administered 2 weeks after the pre-surgical clinic visit and a follow up survey will be sent 6 months later.

Countries

United States

Contacts

Primary ContactElizabeth Wick, MD
Elizabeth.wick@ucsf.edu415-353-2357
Backup ContactIrina Gorodetskaya
Irina.Gorodetskaya@ucsf.edu415-514-7430

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026