Algorithm-enabled Goals of Care Communication (A-EPAC)

July 27, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1207
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Principal Investigator:
          • Manali I Patel, MD MSPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care
Participants will receive usual cancer care for 12 months or until death whichever is first.
Behavioral: Usual Care
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
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.
Behavioral: Usual Care
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
Behavioral: Usual Care + A-EPAC
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
12 months
Acute Care Use
Time Frame: 12 months
Any hospitalization or emergency room admission within 12-months of follow-up.
12 months
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.
6 months
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.
9 months
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.
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 months
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 months
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)
12 months
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)
6 months
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 months
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).
6 months
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)
6 months
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)
6 months
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manali I Patel, MD MSPH, VA Palo Alto Health Care System, Palo Alto, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSR6-015-24W
  • 1-I01-RD-0000421-01-A1 (Other Grant/Funding Number: VA HSR&D eRA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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