Study protocol for a factorial randomized trial of behavioral interventions to increase health care proxy documentation among older and seriously ill adults
- 1University of Southern California
Abstract
IntroductionHealth care proxies serve as surrogate decision-makers for patients with limited decisional capacity, yet only one in three U.S. adults have designated one. This trial will evaluate low-cost, scalable behavioral interventions embedded in previsit mailed outreach to increase health care proxy documentation.
Methods and analysisIn this 2 x 2 + 1 factorial superiority trial, approximately 20,000 patients with an upcoming in-person primary care visit at a Northern California health system will be randomized over a 12-month period into one of four intervention mailers encouraging designation of a health care proxy, or to no mailer under usual care. Eligible patients will have no documentation of a health care proxy in the electronic health record (EHR) and will be aged 55 years or older, or 18 years or older with cancer, congestive heart failure, or chronic kidney disease. The four mailers differ by the presence or absence of a pre-commitment prompt, and whether the mailer is sent from the patients primary care provider or the health system. The primary outcome is EHR-documentation of a health care proxy by 30 days after the index scheduled visit date.
Secondary outcomes include proxy documentation through 90 days, legal advance care planning documentation through 30 and 90 days, and visit attendance. We will use logistic regression to estimate the intention-to-treat effect of receiving any intervention mailer versus no mailer, a pre-commitment mailer versus a mailer without pre-commitment, and a provider-signed versus health system-signed mailer.
Ethics and disseminationThe University of Southern California Institutional Review Board approved the protocol and granted a waiver of informed consent for this minimal-risk trial. Results will be posted on ClinicalTrials.gov within one year of the primary completion date.
Trial RegistrationThe trial was prospectively registered on December 12, 2025 at ClinicalTrials.gov (NCT07290478).
Strengths and limitations of this studyO_LIThis individually randomized 2 x 2 + 1 factorial trial evaluates two low-cost behavioral strategies embedded within mailed outreach to increase health care proxy documentation. C_LIO_LIUse of routinely collected electronic health record data and a waiver of informed consent reduce consent-related selection bias, permit enrollment of the entire eligible population, and limit missing outcome data due to loss to follow-up. C_LIO_LIThe primary outcome is health care proxy documentation in the electronic health record; however, the trial does not assess patient-proxy communication, proxy preparedness, goal-concordant care, or other downstream clinical outcomes. C_LIO_LIThe trial is conducted within a large, primarily Medicaid-serving integrated health system in Northern California. Results of this trial may not be generalizable to other populations, health care systems, and jurisdictions with different health care proxy designation requirements. C_LI
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BibTeX
@misc{cloughesy2026study,
title = {{Study protocol for a factorial randomized trial of behavioral interventions to increase health care proxy documentation among older and seriously ill adults}},
author = {J. N. Cloughesy and T. Y. Chang and S. Enguidanos and M. Jacobson},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.02.26362062},
url = {https://www.medrxiv.org/content/10.64898/2026.09.02.26362062v1},
note = {CC BY-NC},
}
RIS
TY - UNPB
TI - Study protocol for a factorial randomized trial of behavioral interventions to increase health care proxy documentation among older and seriously ill adults
AU - J. N. Cloughesy
AU - T. Y. Chang
AU - S. Enguidanos
AU - M. Jacobson
PY - 2026
DA - 2026/09/02
PB - medRxiv
DO - 10.64898/2026.09.02.26362062
UR - https://www.medrxiv.org/content/10.64898/2026.09.02.26362062v1
AB - IntroductionHealth care proxies serve as surrogate decision-makers for patients with limited decisional capacity, yet only one in three U.S. adults have designated one. This trial will evaluate low-cost, scalable behavioral interventions embedded in previsit mailed outreach to increase health care proxy documentation. Methods and analysisIn this 2 x 2 + 1 factorial superiority trial, approximately 20,000 patients with an upcoming in-person primary care visit at a Northern California health system will be randomized over a 12-month period into one of four intervention mailers encouraging designation of a health care proxy, or to no mailer under usual care. Eligible patients will have no documentation of a health care proxy in the electronic health record (EHR) and will be aged 55 years or older, or 18 years or older with cancer, congestive heart failure, or chronic kidney disease. The four mailers differ by the presence or absence of a pre-commitment prompt, and whether the mailer is sent from the patients primary care provider or the health system. The primary outcome is EHR-documentation of a health care proxy by 30 days after the index scheduled visit date. Secondary outcomes include proxy documentation through 90 days, legal advance care planning documentation through 30 and 90 days, and visit attendance. We will use logistic regression to estimate the intention-to-treat effect of receiving any intervention mailer versus no mailer, a pre-commitment mailer versus a mailer without pre-commitment, and a provider-signed versus health system-signed mailer. Ethics and disseminationThe University of Southern California Institutional Review Board approved the protocol and granted a waiver of informed consent for this minimal-risk trial. Results will be posted on ClinicalTrials.gov within one year of the primary completion date. Trial RegistrationThe trial was prospectively registered on December 12, 2025 at ClinicalTrials.gov (NCT07290478). Strengths and limitations of this studyO_LIThis individually randomized 2 x 2 + 1 factorial trial evaluates two low-cost behavioral strategies embedded within mailed outreach to increase health care proxy documentation. C_LIO_LIUse of routinely collected electronic health record data and a waiver of informed consent reduce consent-related selection bias, permit enrollment of the entire eligible population, and limit missing outcome data due to loss to follow-up. C_LIO_LIThe primary outcome is health care proxy documentation in the electronic health record; however, the trial does not assess patient-proxy communication, proxy preparedness, goal-concordant care, or other downstream clinical outcomes. C_LIO_LIThe trial is conducted within a large, primarily Medicaid-serving integrated health system in Northern California. Results of this trial may not be generalizable to other populations, health care systems, and jurisdictions with different health care proxy designation requirements. C_LI
ER -