Cancer
Conditions
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). Usual care includes written, mailed educational materials about advanced care planning that patients may review independently. Those in the group advanced care planning arm will receive usual care along with the written materials and will participate in two 60-90 minute educational sessions led by a community health worker that will either be conducted in person on-site or 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.
Interventions
BEHAVIORALGroup 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 60-90 minute sessions 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 2 months post-enrollment.
Sponsors
VA Palo Alto Health Care System
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goals of Care Documentation | Month 2 after patient enrollment | Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeling Heard and Understood | Baseline and Month 2 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 Month 2 after patient enrollment | Each patient will receive a validated patient activation survey (PAM-10) 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 Month 2 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 and Month 6 after patient enrollment | Palliative care use will be analyzed for each patient at month 6. |
| Hospice Care Use (Self-reported and Chart Review) | At Baseline and Month 6 after patient enrollment | Hospice care use will be analyzed at month 6. |
| Hospitalization Visits (Self-reported and Chart Review) | At Baseline and Month 6 after patient enrollment | Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at month 6. |
Countries
United States
Outcome results
None listed