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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manali I Patel, MD MPH MS | Contact | 6504935000 | manalip@stanford.edu | |
| Madhuri Agrawal | Contact | 650-304-7744 | madhuri.agrawal@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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The statistician analyzing the data will be masked from the experimental treatment and the control as will all research staff who are abstracting or collecting outcomes data.
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| 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 |