Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care (EMBRACE)
26. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
138
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Manali I Patel, MD, MPH, MS
- Telefonnummer: (650) 736-2768
- E-post: manalip@stanford.edu
Studiesteder
-
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California
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Palo Alto, California, Forente stater, 94304
- Rekruttering
- Stanford University
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Ta kontakt med:
- Manali I. Patel, MD, MPH, MS
- E-post: manalip@stanford.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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 OR have public health insurance
Exclusion Criteria:
- Patients unable to respond to survey questions in either English or Spanish.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: 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.
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Eksperimentell: 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.
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For those in the experimental group, a Research Assistant will provide health education and support as described in the Intervention arm.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pasientaktivering ved hjelp av undersøkelsen «Pasientaktiveringstiltak».
Tidsramme: 3 måneder etter innmelding
|
Hver pasient vil motta en validert pasientaktiveringsundersøkelse ved å bruke «Pasientaktiveringsmålet» ved påmelding og 3 måneder etter studieregistrering.
Dette er et validert tiltak fra Insignia Health.
Svarene er: helt uenig, uenig, enig, enig med høyere aktivering korrelert med svar på enig og enig.
Hvert element er vurdert på en 4-punkts skala (1 helt uenig til 4 helt enig, med ekstra "ikke relevant"-alternativ).
Høyere skårer indikerer større pasientaktivering.
For PAM-10 er minimum poengsum 0 (hvis alt ikke er aktuelt) og maksimum er 40.
Rå poengsum konverteres til aktiveringsnivåer i henhold til retningslinjene for poengsum fra Insignia Health for: nivå 1 Frakoblet og overveldet, nivå 2 Å bli bevisst, men fortsatt sliter, nivå 3 Ta handling og få kontroll, nivå 4 Opprettholde "atferd og presse videre.
Poengsummene for hver gruppe vil være gjennomsnittlig 3 måneder etter studieoppmelding.
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3 måneder etter innmelding
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Pasientaktivering ved hjelp av undersøkelsen «Pasientaktiveringstiltak».
Tidsramme: 6 måneder etter påmelding
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Hver pasient vil motta en validert pasientaktiveringsundersøkelse ved bruk av «Pasientaktiveringsmålet» ved påmelding og 6 måneder etter studieregistrering.
Dette er et validert tiltak fra Insignia Health.
Svarene er: helt uenig, uenig, enig, enig med høyere aktivering korrelert med svar på enig og enig.
Hvert element er vurdert på en 4-punkts skala (1 helt uenig til 4 helt enig, med ekstra "ikke relevant"-alternativ).
Høyere skårer indikerer større pasientaktivering.
For PAM-10 er minimum poengsum 0 (hvis alt ikke er aktuelt) og maksimum er 40.
Rå poengsum konverteres til aktiveringsnivåer i henhold til retningslinjene for poengsum fra Insignia Health for: nivå 1 Frakoblet og overveldet, nivå 2 Å bli bevisst, men fortsatt sliter, nivå 3 Ta handling og få kontroll, nivå 4 Opprettholde "atferd og presse videre.
Poengsummen for hver gruppe vil bli beregnet i snitt 6 måneder etter studieregistrering.
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6 måneder etter påmelding
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of shared decision-making using the "Shared Decision Making" questionnaire
Tidsramme: 3-months post-enrollment
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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.
The change in shared-decision making from baseline to 3 months will be measured.
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3-months post-enrollment
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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.
The change in shared-decision making at baseline to 6 months will be measured.
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6-months post-enrollment
|
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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.
The change in quality of life at baseline to 3 months will be measured.
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3-months post-enrollment
|
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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.
The change in quality of life at baseline to 6 months will be measured.
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6-months post-enrollment
|
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Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"
Tidsramme: 3-months post-enrollment
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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.
The change in feeling heard and understood at baseline to 3 months will be measured.
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3-months post-enrollment
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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.
The change in feeling heard and understood at baseline to 6 months will be measured.
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6-months post-enrollment
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Preference-Concordant Care using the "Preference Concordant Care" Survey
Tidsramme: 3-months post-enrollment
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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.
The change in preference-concordant care at baseline to 3 months will be measured.
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3-months post-enrollment
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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.
The change in preference-concordant care at baseline to 6 months will be measured.
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6-months post-enrollment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Manali I Patel, MD, MPH, MS, Stanford University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. august 2026
Primær fullføring (Antatt)
14. juli 2029
Studiet fullført (Antatt)
14. januar 2030
Datoer for studieregistrering
Først innsendt
10. juni 2026
Først innsendt som oppfylte QC-kriteriene
10. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 80353
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Study data will not be shared with researchers outside of this project.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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