NCT06090552

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Feb 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Feb 2025Aug 2028

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

October 13, 2023

Last Update Submit

August 4, 2025

Conditions

Surgical Advanced Care Planning

Outcome Measures

Primary Outcomes (1)

  • Number of participants with clinically meaningful Advanced Care Planning

    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 Outcomes (1)

  • Patient Engagement Scores

    6 months

Study Arms (3)

Letter, AD, PREPARE

OTHER

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

Behavioral: LetterBehavioral: ADBehavioral: PREPARE website

Letter, AD, PREPARE, reminders

OTHER

Letter, AD, PREPARE plus reminder messages

Behavioral: LetterBehavioral: ADBehavioral: PREPARE websiteBehavioral: reminders

Letter, AD, PREPARE, reminders, healthcare navigator

OTHER

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

Behavioral: LetterBehavioral: ADBehavioral: PREPARE websiteBehavioral: remindersBehavioral: healthcare navigator

Interventions

LetterBEHAVIORAL

Letter about ACP

Letter, AD, PREPARELetter, AD, PREPARE, remindersLetter, AD, PREPARE, reminders, healthcare navigator
ADBEHAVIORAL

PREPARE advanced directive (AD)

Letter, AD, PREPARELetter, AD, PREPARE, remindersLetter, AD, PREPARE, reminders, healthcare navigator
PREPARE websiteBEHAVIORAL

PREPARE website

Letter, AD, PREPARELetter, AD, PREPARE, remindersLetter, AD, PREPARE, reminders, healthcare navigator
remindersBEHAVIORAL

reminders to complete the advance directive

Letter, AD, PREPARE, remindersLetter, AD, PREPARE, reminders, healthcare navigator
healthcare navigatorBEHAVIORAL

healthcare navigators provide assistance to complete the advance directive

Letter, AD, PREPARE, reminders, healthcare navigator

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40987739DERIVED

MeSH Terms

Interventions

College Fraternities and Sororities

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Elizabeth Wick, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Wick, MD

CONTACT

415-353-2357Elizabeth.wick@ucsf.edu

Irina Gorodetskaya

CONTACT

415-514-7430Irina.Gorodetskaya@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 1:1:1 simple randomized block design stratified by enrollment site
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

February 26, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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

Locations

US(3)