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Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care (EMBRACE)

10. juni 2026 opdateret af: Manali Indravadan Patel, Stanford University

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

138

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Usual Care
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.
Eksperimentel: EMBRACE plus usual care
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.
Adfærdsmæssigt: Research Assistant Support
For those in the experimental group, a Research Assistant will provide health education and support as described in the Intervention arm.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patientaktivering ved hjælp af undersøgelsen "Patientaktiveringsmål".
Tidsramme: 3 måneder efter tilmelding
Hver patient vil modtage en valideret patientaktiveringsundersøgelse ved hjælp af "Patient Activation Measure" ved tilmelding og 3 måneder efter tilmelding til undersøgelsen. Dette er et valideret mål fra Insignia Health. Svarene er: meget uenig, uenig, enig, meget enig med højere aktivering korreleret med svar på enig og meget enig. Hvert punkt er bedømt på en 4-trins skala (1 er meget uenig til 4 meget enig, med yderligere "ikke relevant" mulighed). Højere score indikerer større patientaktivering. For PAM-10 er minimumscore 0 (hvis alt ikke er relevant) og maksimum er 40. Rå scoringer konverteres til aktiveringsniveauer i henhold til scoringsretningslinjerne af Insignia Health for: niveau 1 uengageret og overvældet, niveau 2 at blive bevidst, men stadig kæmper, niveau 3 at tage handling og få kontrol, niveau 4 at opretholde "adfærd og skub videre". Resultaterne for hver gruppe vil blive beregnet i gennemsnit 3 måneder efter studieindskrivning.
3 måneder efter tilmelding
Patientaktivering ved hjælp af undersøgelsen "Patientaktiveringsmål".
Tidsramme: 6 måneder efter tilmelding
Hver patient vil modtage en valideret patientaktiveringsundersøgelse ved hjælp af "Patient Activation Measure" ved tilmelding og 6 måneder efter tilmelding til undersøgelse. Dette er et valideret mål fra Insignia Health. Svarene er: meget uenig, uenig, enig, meget enig med højere aktivering korreleret med svar på enig og meget enig. Hvert punkt er bedømt på en 4-trins skala (1 er meget uenig til 4 meget enig, med yderligere "ikke relevant" mulighed). Højere score indikerer større patientaktivering. For PAM-10 er minimumscore 0 (hvis alt ikke er relevant) og maksimum er 40. Rå scoringer konverteres til aktiveringsniveauer i henhold til scoringsretningslinjerne af Insignia Health for: niveau 1 uengageret og overvældet, niveau 2 at blive bevidst, men stadig kæmper, niveau 3 at tage handling og få kontrol, niveau 4 at opretholde "adfærd og skub videre". Gennemsnitsresultaterne for hver gruppe vil blive beregnet til 6 måneder efter tilmelding til studiet.
6 måneder efter tilmelding

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of shared decision-making using the "Shared Decision Making" questionnaire
Tidsramme: 3-months post-enrollment
The SDM-Q-9, a questionnaire assessing patient involvement in shared decision-making (SDM), is scored by summing the responses to its nine items, each on a 6-point Likert scale (0 completely disagree to 5 completely agree). The raw scores range from 0 to 45, with higher scores indicating greater perceived SDM. We will measure the change in shared-decision making at baseline to 3 months.
3-months post-enrollment
Quality of shared decision-making using the "Shared Decision Making" questionnaire
Tidsramme: 6-months post-enrollment
The SDM-Q-9, a questionnaire assessing patient involvement in shared decision-making (SDM), is scored by summing the responses to its nine items, each on a 6-point Likert scale (0 completely disagree to 5 completely agree). The raw scores range from 0 to 45, with higher scores indicating greater perceived SDM. We will measure the change in shared-decision making at baseline to 6 months.
6-months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Tidsramme: 3-months post-enrollment
Each patient will the validated "Functional Assessment of Cancer Therapy - General Survey (FACT-G)," which is a 27-item survey with response options including: not at all, a little bit, somewhat, quite a bit, or very much. Five items also allow for a response of 'prefer not to answer.' Scoring for the FACT-G will be done in accordance with the FACT-G Scoring Guidelines (Version 4), available here: https://www.facit.org/measures-scoring-downloads/fact-g-scoring-downloads. In summary, scoring is for four subscales included within the survey, including (1) Physical Well-Being (score range: 0-28), (2) Social Family Well-Being (score range: 0-28), (3) Emotional Well-Being (score range: 0-24), and (4) Functional Well-Being (score range: 0-28). A total score is created from the sum of the subscale scores and has a minimum of zero and maximum of 108, where a higher score indicates greater quality of life. We will measure the change in quality of life at baseline to 3 months.
3-months post-enrollment
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Tidsramme: 6-months post-enrollment
Each patient will the validated "Functional Assessment of Cancer Therapy - General Survey (FACT-G)," which is a 27-item survey with response options including: not at all, a little bit, somewhat, quite a bit, or very much. Five items also allow for a response of 'prefer not to answer.' Scoring for the FACT-G will be done in accordance with the FACT-G Scoring Guidelines (Version 4), available here: https://www.facit.org/measures-scoring-downloads/fact-g-scoring-downloads. In summary, scoring is for four subscales included within the survey, including (1) Physical Well-Being (score range: 0-28), (2) Social Family Well-Being (score range: 0-28), (3) Emotional Well-Being (score range: 0-24), and (4) Functional Well-Being (score range: 0-28). A total score is created from the sum of the subscale scores and has a minimum of zero and maximum of 108, where a higher score indicates greater quality of life. We will measure the change in quality of life at baseline to 6 months.
6-months post-enrollment
Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"
Tidsramme: 3-months post-enrollment
The "Feeling Heard and Understood" Survey is a self-report instrument designed to assess participants' subjective experiences of being listened to and understood in clinical care settings. The survey consists of Likert-scale items that capture the quality and emotional impact of these experiences. Participants rate statements on a 5-point scale ranging from "Strongly Disagree" to "Strongly Agree." Composite scores are calculated by averaging item responses, with higher scores indicating a greater perceived sense of being heard and understood. We will measure the change in feeling heard and understood at baseline to 3 months.
3-months post-enrollment
Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"
Tidsramme: 6-months post-enrollment
The "Feeling Heard and Understood" Survey is a self-report instrument designed to assess participants' subjective experiences of being listened to and understood in clinical care settings. The survey consists of Likert-scale items that capture the quality and emotional impact of these experiences. Participants rate statements on a 5-point scale ranging from "Strongly Disagree" to "Strongly Agree." Composite scores are calculated by averaging item responses, with higher scores indicating a greater perceived sense of being heard and understood. We will measure the change in feeling heard and understood at baseline to 6 months.
6-months post-enrollment
Preference-Concordant Care using the "Preference Concordant Care" Survey
Tidsramme: 3-months post-enrollment
The Preference Concordant Care survey is a patient-reported instrument designed to assess the extent to which healthcare delivery aligns with a patient's individual preferences, values, and goals of care. The tool utilized Likert-style questions to evaluate six key domains: understanding of preferences, alignment of care, communication, provider advocacy, outcome satisfaction, and responsiveness to changes in patient values over time. Higher scores across domains indicate stronger alignment of care with the patient's stated preferences. We will measure the change in preference-concordant care at baseline to 3 months.
3-months post-enrollment
Preference-Concordant Care using the "Preference Concordant Care" Survey
Tidsramme: 6-months post-enrollment
The Preference Concordant Care survey is a patient-reported instrument designed to assess the extent to which healthcare delivery aligns with a patient's individual preferences, values, and goals of care. The tool utilized Likert-style questions to evaluate six key domains: understanding of preferences, alignment of care, communication, provider advocacy, outcome satisfaction, and responsiveness to changes in patient values over time. Higher scores across domains indicate stronger alignment of care with the patient's stated preferences. We will measure the change in preference-concordant care at baseline to 6 months.
6-months post-enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stanford University

Samarbejdspartnere

Gilead Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. juli 2029

Studieafslutning (Anslået)

1. januar 2030

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 80353

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Study data will not be shared with researchers outside of this project.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Livskvalitet

Kliniske forsøg med Research Assistant Support

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Placeringer

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