Designating a Healthcare ProxyNCT07290478
Encouraging Older Adults and Adults With Serious Illness to Designate a Health Care Proxy
A study testing Mailer, Provider Request and Pre-commitment Prompt in people with Designating a Healthcare Proxy, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Designating a Healthcare Proxy
- What is being tested?
- Mailer, Provider Request and Pre-commitment Prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 13 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Primary care provider not assigned at time of randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Contra Costa Regional Medical Center
Martinez, California, 94553
About this study
Official title: A Randomized Trial to Encourage Older Adults and Adults With Serious Illness to Designate a Health Care Proxy
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.
- Conditions
- Designating a Healthcare Proxy
- Being tested
- Mailer, Provider Request, Pre-commitment Prompt
- Keywords
- healthcare proxy, advance care planning, end-of-life care, surrogate decision-maker, durable power of attorney, behavioral economics, pre-commitment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MailerBehavioural
Patient mailers will ask the patient to name a healthcare proxy at their next primary care visit.
Provider RequestBehavioural
Patient mailers will be sent from and signed by the patient's provider for their next scheduled primary care visit.
Pre-commitment PromptBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mailer; Behavioral: Provider Request; Behavioral: 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 Receives: Behavioral: Mailer; Behavioral: 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. Receives: Behavioral: Mailer; Behavioral: 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. Receives: Behavioral: Mailer |
| No Mailer Control | No intervention | Patients will not receive a mailer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with EHR-documented healthcare proxy
Documentation in the electronic health record of a healthcare proxy
Measured: From randomization through 30 days after the patient's scheduled index primary care visit date
Secondary outcomes (5)
Proportion of patients with legal advance care planning documentation
Documentation in the electronic health record of any legal advance care planning document, including an advance directive or power of attorney
Measured: From randomization through 30 days after the patient's scheduled index primary care visit date
Proportion of patients that attended scheduled visit
Patient attended the scheduled primary care visit
Measured: On the date of the patient's scheduled index primary care visit
Proportion of patients with EHR-documented healthcare proxy through 90 days
Documentation in the electronic health record of a healthcare proxy
Measured: 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
Documentation in the electronic health record of any legal advance care planning document, including an advance directive or power of attorney
Measured: 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
Patient attended a primary care visit
Measured: From randomization through 90 days after the patient's scheduled index primary care visit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jun 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Designating a Healthcare ProxyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 factorial + a no intervention control group
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Contra Costa Health
- Responsible party
- Principal investigator, Mireille Jacobson, University of Southern California
- Investigators
- Mireille Jacobson, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290478
- Sponsor's protocol ID
- UP-23-01203
- Other IDs
- P30AG024968
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD used for results publication may be shared upon request and with approval by the health system.
Publications
Cloughesy JN, Chang TY, Enguidanos S, Jacobson M. Study protocol for a factorial randomized trial of behavioral interventions to increase health care proxy documentation among older and seriously ill adults. medRxiv [Preprint]. 2026 Sep 7:2026.09.02.26362062. doi: 10.64898/2026.09.02.26362062.
PubMed 42818427
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Encourage Older Adults and Adults With Serious Illness to Designate a Health Care Proxy
- ClinicalTrials.gov ID
- NCT07290478
- Acronym / sponsor ID
- UP-23-01203
- Conditions
- Designating a Healthcare Proxy
- Keywords
- healthcare proxy, advance care planning, end-of-life care, surrogate decision-maker, durable power of attorney, behavioral economics, pre-commitment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Contra Costa Health
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 13 Sep 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 2 x 2 factorial + a no intervention control group
| Arm | Type | Receives |
|---|---|---|
| Provider Mailer with a Pre-commitment Prompt | Experimental | Behavioral: Mailer, Behavioral: Provider Request, Behavioral: Pre-commitment PromptPatients 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. |
| Health System Mailer with a Pre-commitment Prompt | Experimental | Behavioral: Mailer, Behavioral: Pre-commitment PromptPatients 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 |
| Provider Mailer without a Pre-commitment Prompt | Experimental | Behavioral: Mailer, Behavioral: Provider RequestPatients 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. |
| Health System Mailer without a Pre-commitment Prompt | Experimental | Behavioral: MailerPatients 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. |
| No Mailer Control | No intervention | –Patients will not receive a mailer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Primary care provider not assigned at time of randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MailerPatient mailers will ask the patient to name a healthcare proxy at their next primary care visit. | Behavioural | Health System Mailer with a Pre-commitment Prompt, Health System Mailer without a Pre-commitment Prompt, Provider Mailer with a Pre-commitment Prompt, Provider Mailer without a Pre-commitment Prompt |
| Provider RequestPatient mailers will be sent from and signed by the patient's provider for their next scheduled primary care visit. | Behavioural | Provider Mailer with a Pre-commitment Prompt, Provider Mailer without a Pre-commitment Prompt |
| Pre-commitment PromptPatient 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. | Behavioural | Health System Mailer with a Pre-commitment Prompt, Provider Mailer with a Pre-commitment Prompt |
Primary outcome
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
Documentation in the electronic health record of a healthcare proxy
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Derived from this study: PubMed 42818427Cloughesy JN, Chang TY, Enguidanos S, Jacobson M. Study protocol for a factorial randomized trial of behavioral interventions to increase health care proxy documentation among older and seriously ill adults. medRxiv [Preprint]. 2026 Sep 7:2026.09.02.26362062. doi: 10.64898/2026.09.02.26362062.
- Individual participant dataSharing planned: Yes. De-identified IPD used for results publication may be shared upon request and with approval by the health system.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mireille Jacobson, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailer, Provider Request and Pre-commitment Prompt in people with Designating a Healthcare Proxy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07290478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.