Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care

NCT07652359 | Not Yet Recruiting

• 1 other identifier: 80353
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Shared Decision-Making; Quality of Life; Advanced Illness; Terminal Illness

Keywords

Goals of care; Advanced care planning

Outcome Measures

Primary Outcomes (2)

• Patient activation using the "Patient Activation Measure" survey

  Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at enrollment and 3 months after study enrollment. 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. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 40. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining "Behaviors and Pushing Further. Scores for each group will be averaged at 3 months after study enrollment.

  3-months post-enrollment

• Patient activation using the "Patient Activation Measure" survey

  Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at enrollment and 6 months after study enrollment. 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. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 40. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining "Behaviors and Pushing Further. Scores for each group will be averaged at 6 months after study enrollment.

  6-months post-enrollment

Secondary Outcomes (8)

• Quality of shared decision-making using the "Shared Decision Making" questionnaire

  3-months post-enrollment

• Quality of shared decision-making using the "Shared Decision Making" questionnaire

  6-months post-enrollment

• Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"

  3-months post-enrollment

• Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"

  6-months post-enrollment

• Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"

  3-months post-enrollment

Study Arms (2)

Usual Care

NO INTERVENTION

This arm is the control group. They will receive usual care from their regular provider and care team with no change in their care plans as a result of the intervention. Outcomes will be assessed at each of the following times: baseline, 3-months, and 6-months post-enrollment.

EMBRACE plus usual care

EXPERIMENTAL

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 shared decision-making and 2) encourage to engage in SDM with their clinicians. Outcomes will be assessed at each of the following times: baseline, 3-months, and 6-months.

Behavioral: Research Assistant Support

Interventions

Research Assistant Support BEHAVIORAL

For those in the experimental group, a Research Assistant will provide health education and support as described in the Intervention arm.

EMBRACE plus usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Patients unable to respond to survey questions in either English or Spanish.

Sponsors & Collaborators

• Stanford University: lead
• Gilead Sciences: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share