NCT07290478

Brief Summary

This study is a Stage III randomized trial to encourage patients in advance of a health care appointment to designate a healthcare proxy. Patients will be randomly assigned to receive a mailer containing information about designating a healthcare proxy, or to not receive any mailer. For patients assigned to receive a mailer, the mailer will differ by the presence or absence of a patient pre-commitment prompt, and contain a personalized provider request or a generic health system request. The work will evaluate the randomized trial and identify factors that predict intervention effectiveness.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50,000

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress13%
Jun 2026Sep 2027

First Submitted

Initial submission to the registry

December 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

December 12, 2025

Last Update Submit

June 11, 2026

Conditions

Keywords

healthcare proxyadvance care planningend-of-life caresurrogate decision-makerdurable power of attorneybehavioral economicspre-commitment

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with EHR-documented healthcare proxy

    Documentation in the electronic health record of a healthcare proxy

    Within 30 days of the patient's first scheduled primary care visit

Secondary Outcomes (5)

  • Proportion of patients with legal advance care planning documentation

    Within 30 days of the patient's first scheduled primary care visit

  • Proportion of patients that attended scheduled visit

    On the date of the patient's first scheduled primary care visit

  • Proportion of patients with EHR-documented healthcare proxy within 90 days

    Within 90 days of the patient's first scheduled primary care visit

  • Proportion of patients with legal advance care planning documentation within 90 days

    Within 90 days of the patient's first scheduled primary care visit

  • Proportion of patients with primary care visit within 90 days

    Within 90 days of the patient's first scheduled primary care visit

Study Arms (5)

Provider Mailer with a Pre-commitment Prompt

EXPERIMENTAL

Patients will receive a mailer containing a pre-commitment prompt to bring in a form listing their healthcare proxy to their next primary care visit. The mailer will be sent from and signed by their primary care provider.

Behavioral: MailerBehavioral: Provider RequestBehavioral: Pre-commitment Prompt

Health System Mailer with a Pre-commitment Prompt

EXPERIMENTAL

Patients will receive a mailer containing a pre-commitment prompt to bring in a form listing their healthcare proxy to their next primary care visit. The mailer will be sent from and signed by the health system

Behavioral: MailerBehavioral: Pre-commitment Prompt

Provider Mailer without a Pre-commitment Prompt

EXPERIMENTAL

Patients will receive a mailer, but it will not contain a pre-commitment prompt to bring in a form listing their healthcare proxy to their next primary care visit. The mailer will be sent from and signed by the patient's provider.

Behavioral: MailerBehavioral: Provider Request

Health System Mailer without a Pre-commitment Prompt

EXPERIMENTAL

Patients will receive a mailer, but it will not contain a pre-commitment prompt to bring in a form listing their healthcare proxy to their next primary care visit. The mailer will be sent from and signed by the health system.

Behavioral: Mailer

No Mailer Control

NO INTERVENTION

Patients will not receive a mailer.

Interventions

MailerBEHAVIORAL

Patient mailers will ask the patient to name a healthcare proxy at their next primary care visit.

Health System Mailer with a Pre-commitment PromptHealth System Mailer without a Pre-commitment PromptProvider Mailer with a Pre-commitment PromptProvider Mailer without a Pre-commitment Prompt

Patient mailers will be sent from and signed by the patient's provider for their next scheduled primary care visit.

Provider Mailer with a Pre-commitment PromptProvider Mailer without a Pre-commitment Prompt

Patient mailers will contain a box that asks the patient to bring a form with their choice for a healthcare proxy to their next primary care visit.

Health System Mailer with a Pre-commitment PromptProvider Mailer with a Pre-commitment Prompt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No EHR-documented healthcare proxy at enrollment
  • Age ≥ 55 years OR age ≥ 18 years and listed in the health system's cancer, CHF, or CKD registries

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contra Costa Regional Medical Center

Martinez, California, 94553, United States

Location

Study Officials

  • Mireille Jacobson, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Hospital staff, including clinicians, will not be alerted to the patient's assigned intervention. However, clinicians may learn of the patient's assigned intervention if the patient brings their mailer to the visit.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: 2 x 2 factorial + a no intervention control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 18, 2025

Study Start

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

De-identified IPD used for results publication may be shared upon request and with approval by the health system.

Shared Documents
SAP, ANALYTIC CODE
Time Frame
IPD will be available for one year after the study publication date.
Access Criteria
IPD access criteria will be governed by a data use agreement signed by both parties.

Locations