Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
22 avril 2019 mis à jour par: University of California, San Francisco
Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making
In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:
Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.
Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:
2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and
2b. Direct observation.
2c. Improve self-efficacy and satisfaction with medical decision making.
2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.
Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions.
It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors.
The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion.
The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.
Type d'étude
Interventionnel
Inscription (Réel)
445
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94110
- San Francisco General Hospital and Trauma Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
55 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Spanish-speaking adults ≥ 55 years of age
- ≥ 2 chronic illnesses determined by ICD-9 codes
- ≥ 2 visits with an outpatient primary care clinician at San Francisco General hospital in the past year
- ≥ 2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year
Exclusion Criteria:
- Deaf, blind, demented or psychotic as determined by ICD-9 codes
- Too mentally or physically ill to participate as determined by their clinicians
- Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity)
- Self-reported poor vision and inability to see the words on a newspaper
- Lack of a telephone (for follow-up)
- Traveling or moving out of the area for ≥3 months during the study follow-up period.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: PREPARE intervention
The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD).
Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions.
During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning).
To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD.
One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.
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At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning (ACP), self-efficacy with ACP, and activation in and satisfaction with decision making.
Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.
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Aucune intervention: Control
The control arm will review an easy-to-read AD.
Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired.
One to three days before a primary care visit, controls will receive a reminder to come to their appointment.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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New Advance Care Planning Documentation in the Medical Record at 15 Months
Délai: 15 months after study enrollment
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The primary outcome is documentation of advance care planning wishes in the medical record.
ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).
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15 months after study enrollment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Self-reported Engagement in Advance Care Planning Behaviors
Délai: 12 months
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Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey.
This questionnaire includes both Behavior Change Process and ACP Action measures.
Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions.
The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement.
Action measures include ACP actions such as identifying a surrogate decision-maker, identifying values and goals for medical care, choosing the level of leeway in surrogate decision-making, discussing one's wishes with clinicians and surrogates, and documenting one's wishes in an advance directive.
Action measures use "yes" or "no" response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions.
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12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Dean Schillinger, MD, University of California, San Francisco
- Chercheur principal: Rebecca Sudore, MD, University of California, San Francisco
- Chercheur principal: Deborah E Barnes, PhD, University of California, San Francisco
- Chercheur principal: John Boscardin, PhD, University of California, San Francisco
- Chercheur principal: Janet Shim, PhD, University of California, San Francisco
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Freytag J, Street RL Jr, Barnes DE, Shi Y, Volow AM, Shim JK, Alexander SC, Sudore RL. Empowering Older Adults to Discuss Advance Care Planning During Clinical Visits: The PREPARE Randomized Trial. J Am Geriatr Soc. 2020 Jun;68(6):1210-1217. doi: 10.1111/jgs.16405. Epub 2020 Mar 10.
- Sudore RL, Schillinger D, Katen MT, Shi Y, Boscardin WJ, Osua S, Barnes DE. Engaging Diverse English- and Spanish-Speaking Older Adults in Advance Care Planning: The PREPARE Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1616-1625. doi: 10.1001/jamainternmed.2018.4657.
- Sudore RL, Barnes DE, Le GM, Ramos R, Osua SJ, Richardson SA, Boscardin J, Schillinger D. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open. 2016 Jul 11;6(7):e011705. doi: 10.1136/bmjopen-2016-011705.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2014
Achèvement primaire (Réel)
1 mars 2017
Achèvement de l'étude (Réel)
1 mars 2017
Dates d'inscription aux études
Première soumission
24 février 2014
Première soumission répondant aux critères de contrôle qualité
26 février 2014
Première publication (Estimation)
27 février 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juillet 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 avril 2019
Dernière vérification
1 avril 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P0061026
- R-1306-01500 (Autre subvention/numéro de financement: Patient-Centered Outcomes Research)
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