UC Health Care Planning Study

NCT04012749 | Completed DMC

• 2 other identifiers: 18-001612PLC-1609-36291
• Study Type: interventional
• Target: 8,707
• Locations: 1 country
• Sites: 3

Brief Summary

Using a cluster randomized design at the clinic level, this project will implement and test three real-world, scalable advance care planning interventions among primary care clinics across three University of California health systems. Seriously ill patients identified using data from the electronic health record will receive (1) an advance directive with targeted messaging, (2) intervention 1 plus prompting to engage with the Prepare For Your Care website, or (3) intervention 2 plus engagement from a clinic-based facilitator. A Research cohort of patients will provide complete surveys at baseline, 12 and 24 months. The main outcomes are advance directive completion among the population cohort and goal concordant care among the Research cohort at 12 months.

Conditions

Advance Care Planning; Advance Directives; Advanced Cancer

Keywords

serious illness; POLST; population health; primary care

Outcome Measures

Primary Outcomes (2)

• Advance directive completion, 12 months

  Proportion of patients that have advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) at 12 months (or death) compared to baseline. Baseline date defined as the clinic intervention start date. Intention to treat analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

  12 months or death

• Research cohort: Goal concordant care, cross-sectional survey, 12 months

  Goal concordant care measured by patient/caregiver reports of receipt of preference concordant care based on questions from SUPPORT (Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical Care Inconsistent with Patients' Treatment Goals: Association with 1-Year Medicare Resource Use and Survival. J Am Geriatr Soc. 2002;50(3):496-500. doi:10.1046/j.1532-5415.2002.50116.)

  12 months or death

Secondary Outcomes (7)

• New advance directive completion, 12 months

  12 months or death

• Research cohort: Report of end of life care

  24 months

• Advance directive completion, 24 months

  24 months or death

• New advance directive completion, 24 months

  24 months or death

• Research cohort: Goal concordant care, cross-sectional survey, 24 months

  24 months or death

Other Outcomes (3)

• Healthcare utilization among decedents

  24 months

• Research cohort: advance care planning process, 12 months

  12 months

• Research cohort: advance care planning process, 24 months

  24 months

Study Arms (3)

Advance directive

ACTIVE COMPARATOR

Messaging and advance directive distribution. All arms receive physician advance care planning education at the clinic level.

Behavioral: Advance directive

Advance directive and Prepare

ACTIVE COMPARATOR

Messaging and advance directive distribution plus introduction to the Prepare For Your Care website. All arms receive physician advance care planning education at the clinic level.

Behavioral: Advance directive; Behavioral: Prepare

Advance directive, Prepare and Facilitator

ACTIVE COMPARATOR

Messaging and advance directive distribution, introduction to the Prepare For Your Care website, plus patient engagement from a trained facilitator who also can interact with the primary care physician. All arms receive physician advance care planning education at the clinic level.

Behavioral: Advance directive; Behavioral: Prepare; Behavioral: Facilitator

Interventions

Advance directive BEHAVIORAL

Patient receives a health system-specific advance directive along with a message crafted with input from a broad group of stakeholders at the clinical sites and external advisors. Messaging introduces advance care planning, the purpose of the advance directive and contains instructions for completing it and turning it in, as well as a prompt to discuss the document with the patient's primary care physician.

Advance directive; Advance directive and Prepare; Advance directive, Prepare and Facilitator

Prepare BEHAVIORAL

Patient invited to use the Prepare For Your Care website (www.prepareforyourcare.org) that will introduce and facilitate advance care planning and guide completion of an advance directive.

Advance directive and Prepare; Advance directive, Prepare and Facilitator

Facilitator BEHAVIORAL

Facilitator engages patient to activate advance care planning and to carry out navigation and facilitation aspects of advance care planning. Facilitator can tee up advance care planning activities with the primary care physician.

Advance directive, Prepare and Facilitator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 2 visits to a primary care clinic in the health system in the past 12 months
• Serious illness according to an algorithm using electronic health record data including patients with: advanced cancer, advanced heart failure, advanced chronic obstructive pulmonary disease, decompensated liver disease, end stage renal disease, amyotrophic lateral sclerosis, or was a vulnerable elder with a serious illness

You may not qualify if:

• Research cohort: Derived from the population cohort plus:
• Speak English or Spanish
• Provide informed consent
• Too cognitively impaired to provide informed consent
• Primary care physician identifies that survey may be harmful

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, San Francisco: collaborator
• University of California, Irvine: collaborator

Study Sites (3)

University of California, Irvine

Irvine, California, 92868, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

University of California at San Francisco

San Francisco, California, 94121, United States

Location

Related Publications (3)

• Walling AM, Sudore RL, Bell D, Tseng CH, Ritchie C, Hays RD, Gibbs L, Rahimi M, Sanz J, Wenger NS. Population-Based Pragmatic Trial of Advance Care Planning in Primary Care in the University of California Health System. J Palliat Med. 2019 Sep;22(S1):72-81. doi: 10.1089/jpm.2019.0142.

  PMID: 31486723 BACKGROUND

• Walling AM, Sudore RL, Gibbs L, Rahimi M, Hays RD, Tseng CH, Patel K, Santos K, Sanz Vidorreta FJ, Chau AJ, Antonio Lopez JC, Anand J, Marshall GR, DePaolis-Dickey A, Buen KI, Bell DS, Ritchie CS, Gonzalez V, Wenger NS. Interventions to Improve Advance Care Planning Documentation in the Electronic Health Record : A Cluster Randomized Trial. Ann Intern Med. 2026 Jan;179(1):42-50. doi: 10.7326/ANNALS-25-02111. Epub 2025 Nov 25.

  PMID: 41285010 DERIVED

• Hays RD, Walling AM, Sudore RL, Chau A, Wenger NS. Support for Use of Consumer Assessment of Healthcare Providers and Systems Communication Items Among Seriously Ill Patients. J Palliat Med. 2023 Sep;26(9):1234-1239. doi: 10.1089/jpm.2022.0572. Epub 2023 Apr 20.

  PMID: 37093298 DERIVED

MeSH Terms

Interventions

Advance Directives

Intervention Hierarchy (Ancestors)

Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Advance Care Planning; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Neil S Wenger, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician blinded to study arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster randomized trial at the primary care clinic level

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: July 9, 2019
• Study Start: October 25, 2019
• Primary Completion: June 30, 2022
• Study Completion: September 15, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)