Research Assistant Support for Enhanced Care
(EMBRACE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether extra support from a research assistant can help people make better healthcare decisions. It aims to improve communication between low-income and minority individuals and their doctors, increasing their involvement in care. For six months, participants will receive phone calls to discuss healthcare decision-making. Researchers will compare those receiving extra support to those receiving regular care. Ideal candidates are individuals in the Monterey area who identify as racial/ethnic minorities or have low income or public health insurance and already see a primary care doctor. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance healthcare communication and decision-making for underserved communities.
What prior data suggests that Research Assistant Support is safe for enhancing shared decision-making and patient activation?
Research has shown that shared decision-making, where healthcare providers and patients collaborate on choices, is generally safe and well-accepted. Studies on tools that help people understand their healthcare options have demonstrated that these tools make patients feel more informed without causing negative effects.
Other research indicates that shared decision-making can boost patient satisfaction and health outcomes without causing harm. These findings suggest that using a Research Assistant to aid in shared decision-making in healthcare is likely safe for participants.12345Why are researchers excited about this trial?
Researchers are excited about the Research Assistant Support trial because it introduces a unique method to enhance patient care through guided education and shared decision-making. Unlike the usual care where patients primarily rely on their own initiative, this approach involves a trained research assistant who provides monthly phone sessions. These sessions focus on empowering patients to actively engage in their healthcare decisions, potentially leading to better outcomes and a more personalized care experience.
What evidence suggests that Research Assistant Support is effective for improving shared decision-making and patient activation?
Research has shown that providing patients with more support in making healthcare decisions can be beneficial. In this trial, participants in the "EMBRACE plus usual care" arm will receive education from a trained Research Assistant to discuss shared decision-making (SDM) and encourage engagement with their clinicians. One study found that patients with this extra support had 5.3% lower medical costs than those with regular support. This approach strengthens the bond between patients and doctors, potentially leading to better health outcomes. It also boosts patients' confidence in their healthcare choices. Evidence suggests that SDM improves communication and helps patients make informed decisions. Overall, enhancing SDM is linked to a better quality of life and higher patient satisfaction.46789
Who Is on the Research Team?
Manali I Patel, MD, MPH, MS
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for adults (18+) in the Monterey area who speak English or Spanish, are under primary care, and identify as racial/ethnic minorities or have low income. Participants must be able to give verbal consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
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 discuss shared decision-making and encourage engagement with clinicians.
Usual Care
Participants in the control group will receive usual care from their regular provider and care team with no change in their care plans.
Follow-up
Participants are monitored for changes in shared decision-making, patient activation, and quality of life from baseline to 6 months.
What Are the Treatments Tested in This Trial?
Interventions
- Research Assistant Support
Trial Overview
The study tests if having support from a research assistant helps patients make healthcare decisions and feel more involved in their care compared to usual care without extra support.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
Enhanced Support For Shared Decision Making Reduced ...
We found that patients who received enhanced support had 5.3 percent lower overall medical costs than patients who received the usual level of support.
Shared decision-making as a method of care - PMC - NIH
Doing SDM can deepen the relationship between patient and clinician and this relationship can offer resilience to adverse patient outcomes. In ...
3.
nam.edu
nam.edu/perspectives/shared-decision-making-strategies-for-best-care-patient-decision-aids/Shared Decision-Making Strategies for Best Care: Patient ...
Position statements, practice guidelines, decision support tools, conference sessions, and continuing education are some of the methods used by these societies ...
Interventions to support patient decision making about ...
This review suggests that the types of interventions we identified may be useful to support better communication, informed decision making and consent. Among ...
5.
digital.ahrq.gov
digital.ahrq.gov/2020-year-review/research-summary/strengthening-patient-engagement-improve-care-and-shared-decision-making-emerging-researchStrengthening Patient Engagement to Improve Care and ...
PRO-informed, shared decision making (SDM) tool that estimates the probability of a successful clinical outcome regarding operative versus non-operative ...
Interventions for increasing the use of shared decision making ...
The aim of this review was to find out if activities to increase shared decision making by healthcare professionals are effective or not. Examples of these ...
Strategy 6I: Shared Decisionmaking
Shared decisionmaking is a model of patient-centered care that enables and encourages people to play a role in the medical decisions that affect their health.
Impact of shared decision making on healthcare in recent ...
This scoping review accentuates effects of shared decision making interventions on more distal and distant outcomes related to the healthcare ...
Using shared clinical decision support to reduce adverse ...
To examine the role of shared clinical decision support (SCDS) in reducing adverse drug events and enhancing patient safety outcomes. Shared Clinical Decision ...
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