- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02072941
Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94110
- San Francisco General Hospital and Trauma Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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New Advance Care Planning Documentation in the Medical Record at 15 Months
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Self-reported Engagement in Advance Care Planning Behaviors
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dean Schillinger, MD, University of California, San Francisco
- Investigador principal: Rebecca Sudore, MD, University of California, San Francisco
- Investigador principal: Deborah E Barnes, PhD, University of California, San Francisco
- Investigador principal: John Boscardin, PhD, University of California, San Francisco
- Investigador principal: Janet Shim, PhD, University of California, San Francisco
Publicações e links úteis
Publicações Gerais
- 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.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P0061026
- R-1306-01500 (Número de outro subsídio/financiamento: Patient-Centered Outcomes Research)
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