Algorithm-enabled Goals of Care Communication

Part of paid clinical trials in Palo Alto, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07690904
Status
Not Yet Recruiting

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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual Care — BEHAVIORAL
    Usual care or standard of care as per the clinical site in which participant is receiving cancer care.
  • Usual Care + A-EPAC — BEHAVIORAL
    Educational and support intervention for participants regarding goals of care discussions and engagement in these topics with a lay health worker.

Study Details

In 2017, the VA launched the Life-Sustaining Treatment Decisions Initiative (LSTDI), a national program to promote Goals of Care communication between clinicians and patients regarding goals and preferences for care. Despite clinician training and standardized Life Sustaining Treatment (LST) notes in the electronic health record (EHR), 60% of Veterans with cancer have not engaged in such communication with their oncology clinicians before death. Over the past 10 years, the team developed and tested: 1) a lay health worker-led intervention to improve these conversations and reduce unwanted, intensive end-of-life care, and 2) an algorithm-driven approach to identify patients in need of urgent conversations with their clinical teams. This randomized study will evaluate the effectiveness of an intervention combining these two approaches across 7 VA oncology sites. The outcomes include LST documentation, Veteran-reported anxiety and depression, and the identification of factors to inform broad scale of Veteran-centric interventions to improve GoC communication.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Usual Care
    Participants will receive usual cancer care for 12 months or until death whichever is first.
  • Experimental: Usual Care + A-EPAC
    Participants will be assigned to a lay health worker who will conduct education sessions over 30-45 minutes by phone initially followed by 15 minute conversations twice monthly for 6 months to discuss goals of care and how to engage in these discussions with their clinical teams. Participants will also receive usual cancer care for a total of 12 months or until death, whichever is first.

Primary Outcome Measure

Life Sustaining Treatment Documentation [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Madhuri Agrawal
[email protected]
650-304-7744
Manali I Patel, MD MSPH (PRINCIPAL_INVESTIGATOR)

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VA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CA

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