I CAN DO Surgical ACP

August 4, 2025 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

6000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Carmichael
        • Principal Investigator:
          • Lisa Gibbs
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Rebecca Sudore, MD
        • Principal Investigator:
          • Elizabeth Wick, MD
        • Contact:
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Genevieve Melton-Meaux
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Letter, AD, PREPARE
Letter about ACP, PREPARE advanced directive (AD), PREPARE website
Behavioral: Letter
Letter about ACP
Behavioral: AD
PREPARE advanced directive (AD)
Behavioral: PREPARE website
PREPARE website
Other: Letter, AD, PREPARE, reminders
Letter, AD, PREPARE plus reminder messages
Behavioral: Letter
Letter about ACP
Behavioral: AD
PREPARE advanced directive (AD)
Behavioral: PREPARE website
PREPARE website
Behavioral: reminders
reminders to complete the advance directive
Other: Letter, AD, PREPARE, reminders, healthcare navigator
Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)
Behavioral: Letter
Letter about ACP
Behavioral: AD
PREPARE advanced directive (AD)
Behavioral: PREPARE website
PREPARE website
Behavioral: reminders
reminders to complete the advance directive
Behavioral: healthcare navigator
healthcare navigators provide assistance to complete the advance directive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinically meaningful Advanced Care Planning
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Engagement Scores
Time Frame: 6 months
Patient-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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Aging (NIA)
University of Minnesota
University of California, Irvine
Fairview University Medical Center

Investigators

  • Principal Investigator: Elizabeth Wick, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • P0562156
  • 1UG3AG081663-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data sets are available at request at the conclusion of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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