Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06646614

Group Advanced Care Planning Pilot for Veterans

The proposed research aims to engage participants in group educational sessions to facilitate learning of topics related to advanced care planning and to determine whether this approach is more effective than usual care alone.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto

Palo Alto, California, 94305, United States

Location status: Recruiting

Location contact

Madhuri Agrawal, MS

CONTACT

[email protected]

650-304-7744

About this study

The purpose of this study is to compare usual care against a group advanced care planning intervention comprised of two sessions led by trained community health workers or health educators from VA Palo Alto. A total of 60 participants will be randomly assigned to either usual care (n=30) or usual care + group advanced care planning intervention (n=30). Those in usual care will be mailed some educational materials about advanced care planning that they may review independently. Those in the group advanced care planning arm will participate in two 60-90 minute educational sessions led by a community health worker/educator that will either be conducted in person on-site, by VA-approved video conference, or a hybrid model. Topics will include an introduction to advanced care planning, goals of care topics, advance directives, and physicians order of life sustaining treatment. Both usual care and the group advanced care planning arms will also participate in pre/post surveys and/or interviews.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients >18 years old with newly diagnosed cancer are eligible.
  • Patients must have the ability to understand and willingness to provide verbal consent
  • Participants must speak English

Exclusion criteria

  • Inability to consent to the study
  • Plans to move within the area and leave the VA system within 4 months

Treatment and study plan

Group Advance Care Planning Education

Behavioral

Those assigned to the group ACP arm will receive usual care and the intervention which consists of 2 virtual or in-person sessions for a total of 2 hours by a trained community health worker/health educator. Sessions will introduce advanced care planning, help veterans discuss their goals of care with their care teams and learn how to discuss with their families and oncologist, and filing an advanced directive. Participants will be surveyed and interviewed at baseline and again at 8 months post-enrollment.

Primary outcomes

  1. Goals of Care Documentation

    Time frame: Week 8 after patient enrollment

    Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.

Secondary outcomes

  1. Feeling Heard and Understood

    Time frame: Baseline and Week 8 after patient enrollment

    Each patient will receive a validated Heard and Understood assessment survey. 4-item National Quality Forum-endorsed survey assessing self-perceived quality of communication with clinical care team. Each question is scored with a range of 0 to 4, with analyses comparing the proportion of patients reporting a top score (4) for a given question. The measure's reliability and validity has been assessed in a large study of outpatients with serious illness. It will be collected by self-report and self-administered assessment for each patient at Baseline and Week 8.

  2. Change in patient activation using the Patient Activation Measure

    Time frame: Baseline and Week 8 after patient enrollment

    Each patient will receive a validated patient activation survey (PAM-13) to assess their activation. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. It will be collected for each patient by self-assessment at Baseline and Week 8.

  3. Change in patient satisfaction with decision using the Satisfaction with Decision Measure

    Time frame: Baseline and Week 8 after patient enrollment

    Each patient will receive a validated satisfaction with decision survey to assess their satisfaction with decision. It will be analyzed for each patient at Baseline and Week 8.

  4. Palliative Care Use (Self-reported and Chart Review)

    Time frame: At Baseline and 6 months after patient enrollment

    Palliative care use will be analyzed for each patient at month 6.

  5. Hospice Care Use (Self-reported and Chart Review)

    Time frame: At Baseline and 6 months after patient enrollment

    Hospice care use will be analyzed at month 6.

  6. Hospitalization Visits (Self-reported and Chart Review)

    Time frame: At Baseline and 6 months after patient enrollment

    Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at month 6.

Study contacts

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

Madhuri Agrawal

CONTACT

[email protected]

650-304-7744

Manali I Patel, MD MPH MS

CONTACT

[email protected]

6504935000

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Jul 20, 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.

Published trials that share one or more normalized conditions with this study.