Randomized Evaluation of Default Access to Palliative Services (REDAPS)
10 de setembro de 2020 atualizado por: University of Pennsylvania
Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients.
The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system.
To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
The REDAPS trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of inpatient palliative consultative services (IPCS) and to test the incremental effectiveness and costs of a simple, scalable method to increase IPCS utilization among properly selected patients.
The REDAPS trial will also compare the effectiveness of different palliative care team structures and services and identify patient subgroups most likely to benefit from IPCS.
To achieve these goals, the investigators will conduct a clinical trial at 11 Ascension Health hospitals using the same electronic health record.
Participating hospitals first contribute a minimum of 4 months of data under the control paradigm (opt-in model), where physicians must identify patients who may benefit from palliative care consultation and actively order such services.
Then, using a stepped-wedge design, the hospitals are randomly assigned to begin the intervention in intervals spaced approximately 2.7 months apart.
During the intervention, patients meeting consensus criteria for eligibility for palliative care consultation are identified by the electronic health record, a consultation is ordered by default, physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
By the end of the trial, all hospitals will have utilized the intervention paradigm of palliative care consultation for at least 4 months.
The REDAPS trial will compare outcomes (clinical, economic, and process measures) before and after implementation within hospitals, as well as comparisons among hospitals at given time points.
Tipo de estudo
Intervencional
Inscrição (Real)
34239
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Connecticut
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Bridgeport, Connecticut, Estados Unidos, 06606
- St. Vincent's Medical Center
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Florida
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Jacksonville, Florida, Estados Unidos, 32204
- St. Vincent's Medical Center, Riverside
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Jacksonville, Florida, Estados Unidos, 32216
- St. Vincent's Medical Center, Southside
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Kansas
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Wichita, Kansas, Estados Unidos, 67214
- Via Christi Hospital, St. Francis
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Wichita, Kansas, Estados Unidos, 67218
- Via Christi Hospital, St. Joseph
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Michigan
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Kalamazoo, Michigan, Estados Unidos, 49048
- Borgess Medical Center
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New York
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Binghamton, New York, Estados Unidos, 13905
- Our Lady of Lourdes Memorial Hospital
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37205
- St. Thomas West Hospital
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Texas
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Austin, Texas, Estados Unidos, 78701
- University Medical Center Brackenridge
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Wisconsin
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Mequon, Wisconsin, Estados Unidos, 53097
- Columbia St. Mary's, Ozaukee
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Milwaukee, Wisconsin, Estados Unidos, 53211
- Columbia St. Mary's, North Lake
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age 65 years or older
- Current hospitalization of at least 3 calendar days (modified ITT)
Diagnosis of one or more of the following:
- End-stage renal disease (ESRD) on dialysis
- Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months
- Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months
Exclusion criteria:
1. Patients younger than 65 years old will not receive the intervention
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Default ordering of palliative consult
Hospitals randomized to the intervention arm will adopt a system whereby eligible patients are identified by the electronic health record, a consultation is ordered by default, and physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
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Sem intervenção: Usual care
There will be no trial-driven approach to care.
Inpatient palliative care consultative services will be actively requested by physicians as in usual care.
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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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Composite Measure: Length of Stay and In-Hospital Mortality
Prazo: Duration of hospital stay, an expected average of 8 days
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The primary outcome is a composite measure of in-hospital mortality and hospital length-of-stay that ranks deaths along the length-of-stay distribution.
Data is extracted from the electronic health record.
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Duration of hospital stay, an expected average of 8 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Goals of care assessment
Prazo: Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' goals of care within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Pain assessment
Prazo: Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' pain scores within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Dyspnea assessment
Prazo: Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' dyspnea within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Code status
Prazo: Duration of hospital stay, an expected average of 8 days
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Code status documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Mechanical ventilation
Prazo: Duration of hospital stay, an expected average of 8 days
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Documented orders for mechanical ventilation within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Cardiopulmonary resuscitation
Prazo: Duration of hospital stay, an expected average of 8 days
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Documented orders for cardiopulmonary resuscitation within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Inpatient dialysis
Prazo: Duration of hospital stay, an expected average of 8 days
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Documented orders for dialysis during inpatient stay within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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ICU admission
Prazo: Duration of hospital stay, an expected average of 8 days
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Transferal to an intensive care unit documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Hospital discharge status
Prazo: Duration of hospital stay, an expected average of 8 days
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Hospital discharge disposition code documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Discharge planning orders
Prazo: Duration of hospital stay, an expected average of 8 days
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Discharge orders for home care services documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Hospital readmission
Prazo: 30 days
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30-day hospital re-admissions documented within the Premier database
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30 days
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Direct cost per day
Prazo: Duration of hospital stay, an expected average of 8 days
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Direct cost per day documented within the Premier database
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Duration of hospital stay, an expected average of 8 days
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Direct cost per hospitalization
Prazo: Duration of hospital stay, an expected average of 8 days
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Direct cost per hospitalization documented within the Premier database
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Duration of hospital stay, an expected average of 8 days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Scott D Halpern, PhD,MD, University of Pennsylvania
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de março de 2016
Conclusão Primária (Real)
1 de novembro de 2018
Conclusão do estudo (Real)
1 de setembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de julho de 2015
Primeira postagem (Estimativa)
22 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de setembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de setembro de 2020
Última verificação
1 de setembro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 822134
- UH2AG050311 (Concessão/Contrato do NIH dos EUA)
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