VA Palo Alto
Palo Alto, California, 94305, United States
Location status: Recruiting
NCT Number: NCT06646614
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Palo Alto, California, 94305, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: At Baseline and 6 months after patient enrollment
Palliative care use will be analyzed for each patient at month 6.
Time frame: At Baseline and 6 months after patient enrollment
Hospice care use will be analyzed at month 6.
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.
Contact information is provided by the study sponsor or research team.
Madhuri Agrawal
CONTACT
Manali I Patel, MD MPH MS
CONTACT
VA Palo Alto Health Care System
Fed
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.
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