- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03128060
Expanding Access to Home-Based Palliative Care
Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Background and Significance
Patients with serious illness from cancer, heart failure (HF), and chronic obstructive pulmonary disease (COPD) often receive poor quality of care, resulting in unmitigated pain and related symptoms, unmet psychosocial needs, and significant caregiver burden. Palliative care, a patient-centered approach that provides pain and symptom management and psychosocial and spiritual support, has strong evidence for improved outcomes for these seriously ill patients. Palliative care differs from hospice in that it is offered early in the illness course and in conjunction with other therapies intended to prolong life. Most palliative care programs are hospital-based; few offer care at home, where patients spend the most time and require the most support.
Study Aims
This study will test the effectiveness of integrating an evidence-based model of home-based palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill patients (and approximately 884 family caregivers) who receive primary care from 30-40 regional accountable care organizations (ACOs) in California to one of two study groups: HBPC or enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate, following the death of the patient.
The study's specific aims are:
- Specific Aim 1: Determine differences in improvement on measures of physical and psychological well-being between patients receiving HBPC and patients receiving enhanced usual care (EUC).
- Specific Aim 2: Determine differences in survival time between patients receiving HBPC and patients receiving EUC.
- Specific Aim 3: Determine differences in number of emergency department (ED) visits and hospital admissions between patients receiving HBPC and patients receiving EUC.
- Specific Aim 4: Determine differences in improvement on patient-provider communication between patients receiving HBPC and patients receiving EUC.
- Specific Aim 5: Determine differences in improvement on psychosocial outcomes between caregivers of patients receiving HBPC and caregivers of patients receiving EUC.
Study Description
Study Population. The study will enroll 1,155 patients and approximately 883 caregivers from primary care medical groups operating under ACO contracts with Blue Shield of California (Blue Shield), the study's insurance partner. About 75% of patients will be age 65 or older; about 55% will be female. About 45% of patients will be ethnic minority members, predominantly of Hispanic decent.
Comparators. The study will compare outcomes from two groups: patients who receive EUC (with usual care enhanced by: 1) provider training in palliative care; 2) case management for EUC patients; and 3) provider support through palliative care consultation) and patients who receive HBPC provided by an HBPC team. HBPC features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Outcomes. Primary outcomes are change in patient pain, symptoms, depression, and anxiety. These measures will be collected via patient self-report at baseline and at one- and two-months following enrollment. Change in survival, ED visits, and hospital episodes (including length of stay, when applicable) also are primary outcomes that will be collected from the electronic medical record (EMR). These data will be collected following patient death or at study's end. Secondary patient outcomes are peace, patient-physician communication, and hope.Secondary caregiver outcomes are change in caregiver depression, anxiety, burden, and patient-physician communication, with these assessments all collected at baseline and one- and two-months following enrollment. Caregiver's experience of patient death will be collected one month following patient death, when applicable.
Analytic Methods. Investigation of the main effect of HBPC and EUC on outcomes will be conducted at each follow-up and then on the longitudinal trend. Baseline outcome measures will be treated as covariates to control for potential baseline differences. Repeated measures analyses will be used to investigate the longitudinal effects of program conditions on outcome measures. Sub-analyses will examine outcome differences by patient age, diagnosis, and race.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90089
- USC Davis School of Gerontology
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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:
- 18 years of age or older;
- diagnosis of HF, COPD, or advanced cancer;
- one or more hospitalizations or ED visits in the previous year;
- an Australia-Modified Karnofsky Performance Scale score of 70% or less; and
- English- or Spanish-speaking.
Exclusion Criteria:
- is receiving hospice care;
- has end-stage renal disease; and/or
- lives in a nursing home.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Home-based Palliative Care
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
|
The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain).
This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs.
Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver.
Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs.
At a minimum, a core team member visits the patient at home once per week.
Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed.
As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
Outros nomes:
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Comparador Ativo: Enhanced Usual Care
Enhanced usual care refers to: 1) usual primary care provided by a primary care physician who has been offered special training in the core elements of palliative care; 2) case management services; and 3) provider support through palliative care consultation.
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Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management. These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Score on the Edmonton Symptom Assessment for patients
Prazo: At baseline and 1- and 2- months following baseline
|
This is a brief and reliable (Cronbach alpha: 0.85) self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms.
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At baseline and 1- and 2- months following baseline
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Change in Score on Hospital Anxiety and Depression Scale (HADS) for patients
Prazo: At baseline and 1- and 2- months following baseline
|
The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D).
|
At baseline and 1- and 2- months following baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in Score on the Patient Health Questionnaire-9 (PHQ-9) for patients
Prazo: At baseline and 1- and 2- months following baseline
|
This is a 9-item assessment to diagnose depression.
It is based on the nine DSM-IV criteria for depression
|
At baseline and 1- and 2- months following baseline
|
Change in rating of being at peace among patients
Prazo: At baseline and 1- and 2- months following baseline
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This is a 1-item probe that assesses an individual's feeling of being at peace.
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At baseline and 1- and 2- months following baseline
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Change in Score on Hearth Hope Index for patients
Prazo: At baseline and 1- and 2- months following baseline
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This 12-item scale is used to assess hope as it relates to a person's ability to cope with medical illness, loss, and related psychosocial stressors.
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At baseline and 1- and 2- months following baseline
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Change in Consultation Care Measure (CCM) for patients
Prazo: At baseline and 1- and 2- months following baseline
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This patient-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life.
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At baseline and 1- and 2- months following baseline
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Change in Score on Zarit Burden (ZBI) Interview among caregivers
Prazo: At baseline and 1- and 2-months following baseline
|
The Zarit Burden Interview (ZBI) is a 12-item instrument that has been used with caregivers for a wide range of patients, including those with chronic illnesses.
The instrument demonstrates good internal reliability, with a Cronbach's alpha of 0.93, and test-retest reliability of 0.89.
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At baseline and 1- and 2-months following baseline
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Caregiver's experience of death rating on Family Assessment of Treatment at End of Life (FATE-S), when applicable
Prazo: Whenever a patient death occurs during the 2-month study period
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We will use the Family Assessment of Treatment at End of Life (FATE) to measure caregiver's experience of death .
This survey is reliable and valid and is used by the Veteran's Administration across the country.
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Whenever a patient death occurs during the 2-month study period
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Change in Score on Hospital Anxiety and Depression Scale (HADS) for caregivers
Prazo: At baseline and 1- and 2- months following baseline
|
The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D).
|
At baseline and 1- and 2- months following baseline
|
Change in Consultation Care Measure (CCM) for caregivers
Prazo: At baseline and 1- and 2- months following baseline
|
This caregiver-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life.
|
At baseline and 1- and 2- months following baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan Enguidanos, Ph.D., USC Davis School of Gerontology
Publicações e links úteis
Publicações Gerais
- Enguidanos S, Rahman A, Lomeli S. A Tale of Two Trials: A Comparative Case Study of Successful versus Terminated Home-Based Palliative Care Trials. J Palliat Med. 2022 Dec;25(12):1767-1773. doi: 10.1089/jpm.2022.0065. Epub 2022 Jun 8.
- Enguidanos S, Rahman A. Early Termination of a Palliative Care Trial: Perspectives of Multiple Stakeholders on Barriers to Palliative Care and Research. J Palliat Med. 2022 Jan;25(1):54-59. doi: 10.1089/jpm.2021.0234. Epub 2021 Jun 30.
- Enguidanos S, Rahman A, Fields T, Mack W, Brumley R, Rabow M, Mert M. Expanding Access to Home-Based Palliative Care: A Randomized Controlled Trial Protocol. J Palliat Med. 2019 Sep;22(S1):58-65. doi: 10.1089/jpm.2019.0147.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PCORI-1234
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