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Clinical Trials/NCT06646614
NCT06646614
Recruiting
N/A

Group Advanced Care Planning Pilot for Veterans

VA Palo Alto Health Care System1 site in 1 country50 target enrollmentJuly 15, 2025

Overview

Phase
N/A
Intervention
Usual Care
Conditions
Cancer
Sponsor
VA Palo Alto Health Care System
Enrollment
50
Locations
1
Primary Endpoint
Goals of Care Documentation
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2025
End Date
December 1, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manali I. Patel

Staff Physician

VA Palo Alto Health Care System

Eligibility Criteria

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

Arms & Interventions

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.

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.

Intervention: Group Advance Care Planning Education

Outcomes

Primary Outcomes

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

  • Feeling Heard and Understood(Baseline and Week 8 after patient enrollment)
  • Change in patient activation using the Patient Activation Measure(Baseline and Week 8 after patient enrollment)
  • Change in patient satisfaction with decision using the Satisfaction with Decision Measure(Baseline and Week 8 after patient enrollment)
  • Palliative Care Use (Self-reported and Chart Review)(At Baseline, 8 weeks and 6 months after patient enrollment)
  • Hospice Care Use (Self-reported and Chart Review)(At Baseline, 8 weeks and 6 months after patient enrollment)
  • Hospitalization Visits (Self-reported and Chart Review)(At Baseline, 8 weeks and 6 months after patient enrollment)

Study Sites (1)

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