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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Group Advance Care Planning Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manali I Patel, MD MPH MS; Phone Number: 6504935000; Email: manalip@stanford.edu
• Study Contact Backup: Name: Madhuri Agrawal; Phone Number: 650-304-7744; Email: madhuri.agrawal@va.gov

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • VA Palo Alto
      • Contact: Madhuri Agrawal, MS; Phone Number: 650-304-7744; Email: madhuri.agrawal@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Inability to consent to the study
2. Plans to move within the area and leave the VA system within 4 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Advance Care Planning; The participant will engage in 2 hours of educational sessions regarding advance care planning and goals of care. They will be interviewed which is expected to last 20-30 min and surveys will last 15-20 min. The total involvement will be no more than 3 hours and 40 min over 8 weeks.	Behavioral: Group Advance Care Planning Education; 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.
No Intervention: Usual Care; The patient will continue to receive as normal and usual care. The participant will also receive educational materials in writing regarding advance care planning mailed to their preferred mailing address. The participants will complete surveys and interviews at baseline at again at 8 weeks post enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goals of Care Documentation	Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.	Week 8 after patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeling Heard and Understood	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.	Baseline and Week 8 after patient enrollment
Change in patient activation using the Patient Activation Measure	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.	Baseline and Week 8 after patient enrollment
Change in patient satisfaction with decision using the Satisfaction with Decision Measure	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.	Baseline and Week 8 after patient enrollment
Palliative Care Use (Self-reported and Chart Review)	Palliative care use will be analyzed for each patient at Week 8.	At Baseline, 8 weeks and 6 months after patient enrollment
Hospice Care Use (Self-reported and Chart Review)	Hospice care use will be analyzed for each patient at Week 8.	At Baseline, 8 weeks and 6 months after patient enrollment
Hospitalization Visits (Self-reported and Chart Review)	Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at Week 8.	At Baseline, 8 weeks and 6 months after patient enrollment

Collaborators and Investigators

• Sponsor: VA Palo Alto Health Care System
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 67728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No