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Recruiting NCT06090552

I CAN DO Surgical ACP

No phase Interventional Surgical Advanced Care Planning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Letter, AD, PREPARE website, reminders.
Who it may be relevant to
Registry conditions: Surgical Advanced Care Planning. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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

Primary outcome measures

  • Number of participants with clinically meaningful Advanced Care Planning [Time frame: 6 months]
Secondary outcome measures (1)
  • Patient Engagement Scores [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • University of California, Irvine — Irvine
  • University of California, San Francisco — San Francisco
  • University of Minnesota — Minneapolis

Publications

  • Welton L, Colley A, Sudore RL, Melton GB, Botsford C, Oreper S, O'Brien SE, Koopmeiners JS, Gibbs L, Carmichael JC, Wick EC. I CAN DO Surgical ACP (Improving Completion, Accuracy and Dissemination of Surgical Advanced Care Planning): a protocol for a multisite, single-blinded, pragmatic randomised controlled trial to improve ACP completion in older adults in the presurgical setting. BMJ Open. 2025 PMID 40987739

Identifiers

NCT: NCT06090552 · P0562156 · 1UG3AG081663-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗