Group Advanced Care Planning Pilot for Veterans
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Palo Alto Health Care System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to consent to the study
Plans to move within the area and leave the VA system within 4 months
Trial design
Design model
Parallel
Treatments tested in this trial
Group Advance Care Planning Education
BehavioralThose 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Group Advance Care PlanningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Goals of Care Documentation
Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.
Time frame
Week 8 after patient enrollmentSecondary outcomes
1
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.
Time frame
Baseline and Week 8 after patient enrollment2
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.
Time frame
Baseline and Week 8 after patient enrollment3
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.
Time frame
Baseline and Week 8 after patient enrollment4
Palliative Care Use (Self-reported and Chart Review)
Palliative care use will be analyzed for each patient at Week 8.
Time frame
At Baseline, 8 weeks and 6 months after patient enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Palo Alto Health Care System
Lead sponsor
US Department of Veterans Affairs
Collaborator
Source ClinicalTrials.gov