Algorithm-enabled Goals of Care Communication

NCT07690904 | Not Yet Recruiting DMC

• 2 other identifiers: HSR6-015-24W1-I01-RD-0000421-01-A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

• Life Sustaining Treatment Documentation

  Proportion of participants in both study groups who have a life sustaining treatment document in the electronic health record.

  3 months

Secondary Outcomes (6)

• Patient-reported Anxiety and Depression

  3 months

• Advance Directive Documentation

  12 months

• Acute Care Use

  12 months

• Life Sustaining Treatment Documentation

  6 months

• Life Sustaining Treatment Documentation

  9 months

Other Outcomes (9)

• Family reported quality of end-of-life care

  12 months

• Heard and Understood

  3 months

• Proportion of patients with Intensive End of life Care

  12 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants will receive usual cancer care for 12 months or until death whichever is first.

Behavioral: Usual Care

Usual Care + A-EPAC

EXPERIMENTAL

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.

Behavioral: Usual Care; Behavioral: Usual Care + A-EPAC

Interventions

Usual Care BEHAVIORAL

Usual care or standard of care as per the clinical site in which participant is receiving cancer care.

Also known as: Standard of care, standard therapy

Usual Care; Usual Care + A-EPAC

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.

Also known as: Goals of Care Behavioral Intervention

Usual Care + A-EPAC

Eligibility Criteria

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

You may qualify if:

• Veteran patients with diagnosis of a solid malignancy with any cancer stage
• English or Spanish-speaking
• Can self-administer questionnaires in English or Spanish
• Valid telephone number
• Receiving oncology care at one of 7 sites
• Receiving systemic anti-cancer therapy, defined as oral, injection, or intravenous therapy
• chemotherapy
• hormone therapy
• targeted therapy
• or immunotherapy defined by the National Cancer Institute A to Z List of Cancer Drugs)
• CAN risk score ≥98th percentile (may be adjusted after examining site-level CAN performance)

You may not qualify if:

• No capacity to consent
• Actively receiving hospice care

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Manali I Patel, MD MSPH

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manali I Patel, MD MSPH

CONTACT

(650) 493-5000; Manali.Patel2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel randomization at the participant-level

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)