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Enrolling by invitation NCT07290478

Encouraging Older Adults and Adults With Serious Illness to Designate a Health Care Proxy

No phase Interventional Designating a Healthcare Proxy

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: Mailer, Provider Request, Pre-commitment Prompt.
Who it may be relevant to
Registry conditions: Designating a Healthcare Proxy. Basic parameters: from 18 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

A Randomized Trial to Encourage Older Adults and Adults With Serious Illness to Designate a Health Care Proxy

Overview

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.

Interventions

  • Behavioral Mailer
    Patient mailers will ask the patient to name a healthcare proxy at their next primary care visit.
  • Behavioral Provider Request
    Patient mailers will be sent from and signed by the patient's provider for their next scheduled primary care visit.
  • Behavioral 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.

Primary outcome measures

  • Proportion of patients with EHR-documented healthcare proxy [Time frame: From randomization through 30 days after the patient's scheduled index primary care visit date]
Secondary outcome measures (5)
  • Proportion of patients with legal advance care planning documentation [Time frame: From randomization through 30 days after the patient's scheduled index primary care visit date]
  • Proportion of patients that attended scheduled visit [Time frame: On the date of the patient's scheduled index primary care visit]
  • Proportion of patients with EHR-documented healthcare proxy through 90 days [Time frame: From randomization through 90 days after the patient's scheduled index primary care visit date]
  • Proportion of patients with legal advance care planning documentation through 90 days [Time frame: From randomization through 90 days after the patient's scheduled index primary care visit date]
  • Proportion of patients with primary care visit through 90 days [Time frame: From randomization through 90 days after the patient's scheduled index primary care visit date]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Primary care provider not assigned at time of randomization.

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
Factorial
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Contra Costa Regional Medical Center — Martinez

Identifiers

NCT: NCT07290478 · UP-23-01203 · P30AG024968

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗