Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care (EMBRACE)
26 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
138
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Manali I Patel, MD, MPH, MS
- Telefonnummer: (650) 736-2768
- E-post: manalip@stanford.edu
Studieorter
-
-
California
-
Palo Alto, California, Förenta staterna, 94304
- Rekrytering
- Stanford University
-
Kontakt:
- Manali I. Patel, MD, MPH, MS
- E-post: manalip@stanford.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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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Experimentell: 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.
|
For those in the experimental group, a Research Assistant will provide health education and support as described in the Intervention arm.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patientaktivering med hjälp av undersökningen "Patientaktiveringsåtgärd".
Tidsram: 3 månader efter anmälan
|
Varje patient kommer att få en validerad patientaktiveringsenkät med hjälp av "Patient Activation Measure" vid inskrivningen och 3 månader efter studieregistreringen.
Detta är en validerad åtgärd från Insignia Health.
Svaren är: håller inte med starkt, håller inte med, håller med, instämmer starkt med högre aktivering korrelerade med svaren håller med och instämmer starkt.
Varje punkt är betygsatt på en 4-gradig skala (1 håller helt med till 4 håller helt med, med ytterligare "ej tillämpligt"-alternativ).
Högre poäng indikerar större patientaktivering.
För PAM-10 är minsta poäng 0 (om allt inte är tillämpligt) och maximalt 40.
Råpoäng omvandlas till aktiveringsnivåer enligt riktlinjerna för poäng av Insignia Health för: nivå 1 Oengagerad och överväldigad, nivå 2 Att bli medveten men fortfarande kämpa, nivå 3 Att vidta åtgärder och få kontroll, nivå 4 Att upprätthålla "beteenden och driva vidare.
Poängen för varje grupp beräknas i genomsnitt 3 månader efter studieregistreringen.
|
3 månader efter anmälan
|
|
Patientaktivering med hjälp av undersökningen "Patientaktiveringsåtgärd".
Tidsram: 6 månader efter anmälan
|
Varje patient kommer att få en validerad patientaktiveringsenkät med hjälp av "Patient Activation Measure" vid inskrivningen och 6 månader efter studieregistreringen.
Detta är en validerad åtgärd från Insignia Health.
Svaren är: håller inte med starkt, håller inte med, håller med, instämmer starkt med högre aktivering korrelerade med svaren håller med och instämmer starkt.
Varje punkt är betygsatt på en 4-gradig skala (1 håller helt med till 4 håller helt med, med ytterligare "ej tillämpligt"-alternativ).
Högre poäng indikerar större patientaktivering.
För PAM-10 är minsta poäng 0 (om allt inte är tillämpligt) och maximalt 40.
Råpoäng omvandlas till aktiveringsnivåer enligt riktlinjerna för poäng av Insignia Health för: nivå 1 Oengagerad och överväldigad, nivå 2 Att bli medveten men fortfarande kämpa, nivå 3 Att vidta åtgärder och få kontroll, nivå 4 Att upprätthålla "beteenden och driva vidare.
Poängen för varje grupp beräknas i genomsnitt 6 månader efter studieregistreringen.
|
6 månader efter anmälan
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of shared decision-making using the "Shared Decision Making" questionnaire
Tidsram: 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.
The change in shared-decision making from baseline to 3 months will be measured.
|
3-months post-enrollment
|
|
Quality of shared decision-making using the "Shared Decision Making" questionnaire
Tidsram: 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.
|
6-months post-enrollment
|
|
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Tidsram: 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.
|
3-months post-enrollment
|
|
Patient Quality of Life Using the "Functional Assessment of Cancer Therapy - General Survey"
Tidsram: 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.
|
6-months post-enrollment
|
|
Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"
Tidsram: 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.
The change in feeling heard and understood at baseline to 3 months will be measured.
|
3-months post-enrollment
|
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Feeling Heart and Understood Using the "Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood"
Tidsram: 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.
|
6-months post-enrollment
|
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Preference-Concordant Care using the "Preference Concordant Care" Survey
Tidsram: 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.
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
Tidsram: 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.
|
6-months post-enrollment
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Manali I Patel, MD, MPH, MS, Stanford University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 augusti 2026
Primärt slutförande (Beräknad)
14 juli 2029
Avslutad studie (Beräknad)
14 januari 2030
Studieregistreringsdatum
Först inskickad
10 juni 2026
Först inskickad som uppfyllde QC-kriterierna
10 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 80353
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Study data will not be shared with researchers outside of this project.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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