Goals of Care Conversations Study
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05001009
- Status
- Enrolling By Invitation
Conditions
- Cancer
- Chronic Obstructive Pulmonary Disease
- Dementia
- End-stage Liver Disease
- End-stage Renal Disease
- Heart Failure
- Interstitial Lung Disease
- Seriously Ill Patients
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Clinician Implementation Strategy Stage 1: low intensity clinician training — BEHAVIORALA "booster" of the established LSTDI implementation strategy. Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study. Online training options and when and how to complete goals of care conversations and documentation will be highlighted.
- Clinician Implementation Strategy Stage 2: high intensity clinician training — BEHAVIORALThis includes two components: 1. Team facilitation to help the primary care team (advance practice provider, nurse, social worker) work together to create roles and responsibilities for accomplishing goals of care conversations with patients 2. A patient list "trigger" of patients potentially eligible for goals of care conversations (the patient study population) will be sent to the primary care clinicians.
- Low patient engagement — BEHAVIORALPatients will be sent information about goals of care conversations, including the PREPARE website.
- High patient engagement — BEHAVIORALPatients will be sent information about goals of care conversations, including the PREPARE website. Follow-up phone calls to discuss goals of care conversations and the PREPARE website will be made.
Study Details
The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.
Key Dates
- Start date
- Sep 13, 2022
- Status verified
- Dec 2024
- Primary completion
- Sep 30, 2024
- Completion
- Sep 30, 2025
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: No then high patient engagementFirst stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training.
- Active Comparator: No then low patient engagementFirst stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training.
- Active Comparator: Low then high patient engagementFirst stage: Low intensity patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training.
- Active Comparator: Low then low patient engagementFirst stage: Low patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training.
Primary Outcome Measure
Percent of patients with a goals of care conversation note documented in Stage 2 [ Time Frame: From the start of stage 2 to 9 months later ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | - |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | - |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | - |
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