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Recruiting

NCT Number: NCT06090552

I CAN DO Surgical ACP

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine, Irvine, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Letter

Behavioral

Letter about ACP

AD

Behavioral

PREPARE advanced directive (AD)

PREPARE website

Behavioral

PREPARE website

Reminders

Behavioral

reminders to complete the advance directive

healthcare navigator

Behavioral

healthcare navigators provide assistance to complete the advance directive

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Wick, MD

CONTACT

[email protected]

415-353-2357

Irina Gorodetskaya

CONTACT

[email protected]

415-514-7430

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 19, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.