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NCT Number: NCT07690904

Algorithm-enabled Goals of Care Communication

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location contact

Madhuri Agrawal

CONTACT

[email protected]

650-304-7744

Manali I Patel, MD MSPH

PRINCIPAL_INVESTIGATOR

About this study

The investigators developed the Engagement of Patients with Advanced Cancer (EPAC) intervention - a 6-month telephone-based intervention in which trained lay health workers (LHWs) educate and empower Veterans with cancer to engage in goals of care conversations with their oncology clinical teams. To facilitate scale, the investigator propose Algorithm-Enabled EPAC (A-EPAC), which uses the VA Care Assessment Needs (CAN) score to automatically identify patients with cancer who could benefit from EPAC. This intent-to-treat randomized trial is conducted in collaboration with the NTO and the National VA Oncology Programs (NOP). The investigators will randomize 200 Veterans with cancer receiving care across 7 VA facilities to either the A-EPAC intervention (algorithm-based identification and referral to EPAC for 6-months) or usual cancer care alone (cancer care provided by oncology teams at the local site). Participants will be followed for 12-months post enrollment. The primary outcome is Life Sustaining Treatment documentation at 3 months post-enrollment. Secondary outcomes are patient anxiety and depression at 3 months measured by PROMIS® short forms. Exploratory outcomes include intensive end-of-life care, advance directive documentation, and acute care use. Using a quant-qual framework, the investigators will conduct validated surveys with 40 Veterans with cancer and Veteran and clinician interviews at 6 months to identify factors associated with feasibility, adoption, acceptability, and A-EPAC fidelity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • No capacity to consent
  • Actively receiving hospice care

Treatment and study plan

Usual Care

Behavioral

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

Other names: Standard of care, standard therapy

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.

Other names: Goals of Care Behavioral Intervention

Primary outcomes

  1. Life Sustaining Treatment Documentation

    Time frame: 3 months

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

Secondary outcomes

  1. Patient-reported Anxiety and Depression

    Time frame: 3 months

    Change in mean score using the validated PROMIS Short Form v1.0 of Anxiety 4a and Depression 4a between time of enrollment and 3 months post-enrollment. Each scale consists of 4 items rated on a 5-point Likert scale. Higher scores indicate greater symptom severity. That is - higher score represents a worse outcome.

  2. Advance Directive Documentation

    Time frame: 12 months

    Proportion of participants with any advance directive documentation in the electronic health record between baseline and 12 months follow-up.

  3. Acute Care Use

    Time frame: 12 months

    Any hospitalization or emergency room admission within 12-months of follow-up.

  4. Life Sustaining Treatment Documentation

    Time frame: 6 months

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

  5. Life Sustaining Treatment Documentation

    Time frame: 9 months

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

  6. Life Sustaining Treatment Documentation

    Time frame: 12 months

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

Other outcomes

  1. Family reported quality of end-of-life care

    Time frame: 12 months

    For participants who die during the study period, the VA Veterans Experience Center will administer the Bereaved Family Survey which solicits bereaved family evaluations of care in the last 30 days of life. One component of this survey is the National Quality Forum-endorsed measure called the BFS Performance Measure (BFS-PM), a single item evaluation of the overall quality of EOL care. This measure is measured a 5-point Likert scale, which investigators will dichotomize as "excellent" vs all other categories. This measure will be reported out descriptively.

  2. Heard and Understood

    Time frame: 3 months

    Descriptive measure using the National Quality Forum 4-item survey which assesses perceptions of quality of communication with the clinical team.

  3. Proportion of patients with Intensive End of life Care

    Time frame: 12 months

    Number of participants who die within 12-months of follow-up who had any

    • hospital or Intensive Care Unit admission <30 days before death,
    • receipt of any systemic therapy <14 days before death (defined as both oral and intravenous chemotherapy and immunotherapy),
    • hospice referral <3 days before death. (abstracted from electronic health record)

  4. Acceptability

    Time frame: 6 months

    Investigators will measure patient-reported acceptability using the 12-item validated Acceptability of Intervention Measure (AIM) (Veterans or designated caregivers)

  5. Beliefs about GoC communication

    Time frame: 6 months

    Beliefs related to GoC communication (e.g., self-efficacy and readiness) will be measured using the 15-item validated Advance Care Planning Engagement survey (Veterans or designated caregivers), which has been validated in diverse populations of outpatients with advanced cancer. Beliefs related to GoC communication will be assessed using the 28-item validated End-of-Life Care Questionnaire (EOL-Q) (clinicians, LHW)

  6. Patient-Centered Care 1

    Time frame: 6 months

    Patient-clinician communication will be measured among patients using validated communication items from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) (Veterans or designated caregivers).

  7. Patient-Centered Care 2

    Time frame: 6 months

    Patient engagement will be measured using a 4-item measure of shared decision making (SDM Process-4) (Veterans or designated caregivers)

  8. Organizational Climate:

    Time frame: 6 months

    Investigators will administer the 18-item validated Implementation Climate Scale to capture degree to which the clinic supports use of GoC communication (clinicians, LHW)

  9. Pragmatic Context Assessment Tool (pCAT)

    Time frame: 6 months

    Investigators will administer a 14-item tool to assess barriers and facilitators to A-EPAC within the CFIR framework (Veterans or designated caregivers, clinician, LHW)

Study contacts

Contact information is provided by the study sponsor or research team.

Manali I Patel, MD MSPH

CONTACT

[email protected]

(650) 493-5000

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Algorithm-Enabled Engagement of Patients With Advanced Cancer (A-EPAC) to Improve Goals of Care Communication Among Veterans With Advanced Stages of Cancer

Acronym: A-EPAC

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 8, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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