Group Advanced Care Planning Pilot for Veterans

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT06646614
• Lead Sponsor: VA Palo Alto Health Care System

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 50 participants will be randomly assigned to either usual care (n=25) or usual care + group advanced care planning intervention (n=25). 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 1-hour 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 Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-17
• Study Start: 2025-07-15
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-28
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Goals of Care Documentation	Week 8 after patient enrollment	Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.

Secondary Outcome Measures

Name	Time	Method
Feeling Heard and Understood	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.
Change in patient activation using the Patient Activation Measure	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.
Change in patient satisfaction with decision using the Satisfaction with Decision Measure	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.
Palliative Care Use (Self-reported and Chart Review)	At Baseline, 8 weeks and 6 months after patient enrollment	Palliative care use will be analyzed for each patient at Week 8.
Hospice Care Use (Self-reported and Chart Review)	At Baseline, 8 weeks and 6 months after patient enrollment	Hospice care use will be analyzed for each patient at Week 8.
Hospitalization Visits (Self-reported and Chart Review)	At Baseline, 8 weeks 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 Week 8.

Trial Locations

Locations (1)

VA Palo Alto; 🇺🇸 Palo Alto, California, United States