Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Research Assistant Support.
- Who it may be relevant to
- Registry conditions: Shared Decision-Making, Quality of Life, Advanced Illness, Terminal Illness. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EMBRACE - Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care
Overview
The purpose of the EMBRACE Study is to evaluate whether a facilitated intervention improves shared decision-making (SDM) and patient activation among low-income and minority individuals more than usual care only. The ultimate goal is to enhance SDM and patient activation in care.
Detailed description
This study will assess if an intervention that is delivered by a Stanford trained Research Assistant (RA) will help people better engage in their care with their clinicians.
A total of n=138 patients will be recruited for this study using flyers that will be distributed to our community partner organizations. Approximately 69 patients will be randomized into each study group.
Participants will receive either usual care or will be assigned into the intervention (EMBRACE). Participants assigned to the intervention will receive education provided by a trained RA who will meet with participants by phone for 30 minutes once a month for 6 months to: 1) discuss the importance of shared decision-making, advance care planning, and goal concordant care, and 2) encourage to engage in SDM with their clinicians.
All participants in the study will receive 4 surveys: at baseline (at time of enrollment), 1, 3, and 6 months after study enrollment by telephone, mail, or through a secure REDCap online link delivered to participants.
Interventions
- Behavioral Research Assistant Support
For those in the experimental group, a Research Assistant will provide health education and support as described in the Intervention arm.
Primary outcome measures
- Patient activation using the "Patient Activation Measure" survey [Time frame: 3-months post-enrollment]
- Patient activation using the "Patient Activation Measure" survey [Time frame: 6-months post-enrollment]
Secondary outcome measures (8)
- Quality of shared decision-making using the "Shared Decision Making" questionnaire [Time frame: 3-months post-enrollment]
- Quality of shared decision-making using the "Shared Decision Making" questionnaire [Time frame: 6-months post-enrollment]
- Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey" [Time frame: 3-months post-enrollment]
- Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey" [Time frame: 6-months post-enrollment]
- Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood" [Time frame: 3-months post-enrollment]
- Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood" [Time frame: 6-months post-enrollment]
- Preference-Concordant Care using the "Preference Concordant Care" Survey [Time frame: 3-months post-enrollment]
- Preference-Concordant Care using the "Preference Concordant Care" Survey [Time frame: 6-months post-enrollment]
Eligibility criteria
Inclusion criteria
- Participants must be receiving clinical care by a primary care physician in the Monterey area
- Participants must be 18 years or older.
- Participants must speak either English or Spanish.
- Participants must be able to consent verbally in English or Spanish to all study procedures.
- Participants must self-identify as a racial/ethnic minorities OR identify as having low-income status
Exclusion criteria
\- Patients unable to respond to survey questions in either English or Spanish.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT07652359 · 80353