I CAN DO Surgical ACP

NCT ID: NCT06090552

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2028-08-31

Brief Summary

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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

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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).

Conditions

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Surgical Advanced Care Planning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1:1 simple randomized block design stratified by enrollment site
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Letter, AD, PREPARE

Letter about ACP, PREPARE advanced directive (AD), PREPARE website

Group Type OTHER

Letter

Intervention Type BEHAVIORAL

Letter about ACP

AD

Intervention Type BEHAVIORAL

PREPARE advanced directive (AD)

PREPARE website

Intervention Type BEHAVIORAL

PREPARE website

Letter, AD, PREPARE, reminders

Letter, AD, PREPARE plus reminder messages

Group Type OTHER

Letter

Intervention Type BEHAVIORAL

Letter about ACP

AD

Intervention Type BEHAVIORAL

PREPARE advanced directive (AD)

PREPARE website

Intervention Type BEHAVIORAL

PREPARE website

reminders

Intervention Type BEHAVIORAL

reminders to complete the advance directive

Letter, AD, PREPARE, reminders, healthcare navigator

Letter, AD, PREPARE website plus reminders plus a healthcare navigator on ACP documentation (clinically meaningful ACP, primary outcome)

Group Type OTHER

Letter

Intervention Type BEHAVIORAL

Letter about ACP

AD

Intervention Type BEHAVIORAL

PREPARE advanced directive (AD)

PREPARE website

Intervention Type BEHAVIORAL

PREPARE website

reminders

Intervention Type BEHAVIORAL

reminders to complete the advance directive

healthcare navigator

Intervention Type BEHAVIORAL

healthcare navigators provide assistance to complete the advance directive

Interventions

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Letter

Letter about ACP

Intervention Type BEHAVIORAL

AD

PREPARE advanced directive (AD)

Intervention Type BEHAVIORAL

PREPARE website

PREPARE website

Intervention Type BEHAVIORAL

reminders

reminders to complete the advance directive

Intervention Type BEHAVIORAL

healthcare navigator

healthcare navigators provide assistance to complete the advance directive

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Fairview University Medical Center

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Wick, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, Irvine

Irvine, California, United States

Site Status RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth Wick, MD

Role: CONTACT

415-353-2357

Irina Gorodetskaya

Role: CONTACT

415-514-7430

Facility Contacts

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Jeein Kim

Role: primary

949-697-9706

Neika Saville

Role: backup

Irina Gorodetskaya

Role: primary

415-514-7430

Sandra P Oreper

Role: backup

Erin Linden, MPH

Role: primary

References

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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 Sep 23;15(9):e108850. doi: 10.1136/bmjopen-2025-108850.

Reference Type DERIVED
PMID: 40987739 (View on PubMed)

Other Identifiers

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1UG3AG081663-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P0562156

Identifier Type: -

Identifier Source: org_study_id

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