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- Ensaio Clínico NCT03046771
Transport PLUS Intervention
Randomized Controlled Trial Evaluating Efficacy of EMS Providers Performing Discharge Comprehension and Home Fall Hazard Assessments
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The moment of transition between the hospital and the home is susceptible to lapses in quality and loss of key information regarding a patient's care. An increasing amount of attention is being given to improving the transition of care by targeting factors that contribute to return Emergency Department (ED) visits and readmissions. Following a hospitalization, as many as 40% of patients over age 60 will experience a fall in the subsequent six months and 76% of older adult patients are uncertain about their follow-up care plan. Patients transported home by ambulance following an ED visit were found to have a significantly higher rate of return ED visits at 30 days then overall rates for older adult ED patients (27.8% vs. 11.5%).
In response to these challenges, the researcher's study group developed and piloted an innovative care model known as "Transport PLUS" in which specially trained emergency medical technicians (EMTs) who are already transporting an older adult (65+ years in age) patient home from the ED add to their service two simple interventions - a home fall hazard assessment (FHA) and a discharge comprehension assessment (DCA). Both interventions are facilitated and measured using a checklist developed through a systematic review of the literature and existing tools, and later refined through EMT and patient focus groups.
This study will test the hypothesis that 'Transport PLUS,' a low cost, easily generalizable intervention, can improve transitions of care and improve patient safety following hospitalization as measured by decreased rates of falls and reduced rates of return to the hospital.
The researchers will conduct a pilot cluster randomized controlled trial comparing the Transport PLUS intervention to standard care in a population of older adult patients being discharged from the hospital. The researchers will randomize EMS providers to either perform Transport PLUS (the intervention) or to provide routine transport. It is estimated that approximately 400 patients over age 65 will be transported home from the study hospital by participating providers during the study enrollment period. Patient participants will receive Transport PLUS (n=200) or routine care (n=200) as determined by the transporting provider. Primary outcomes will be the rate of falls in the 3 months following hospitalization and 3-day and 30-day return ED visits (with or without a hospitalization). Process measures will include removal of fall hazards at 3 months and compliance with discharge instructions. Extending beyond the grant period, the researchers intend to follow the cohort for up to 1 year.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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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:
Emergency Medical Technicians (EMTs) are eligible to participate in study if
- employed by Hunter EMS
- over the age of 18 years, and
- certified as an EMT in New York State.
Patient participants are eligible if
- over the age of 65 years
- being discharged from the study hospital, and
- being transported directly to home.
Exclusion Criteria:
- EMTs who expect to leave the job in less than 1 year
- EMTs who have been previously trained in Transport PLUS.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Transport PLUS group
EMTs randomized to the Transport Plus group will view a 60-minute training video and then complete a 60-minute simulation training exercise on how to conduct the home fall hazard assessment (FHA) and the discharge comprehension assessment (DCA) and how to complete the FHA and DCA checklists.
The FHA involves performing a visual assessment of the home environment and noting certain fall hazards.
The DCA involves engaging the patient or caregiver in a conversation to assess their level of understanding of the elements of the discharge instructions.
The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence
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The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence.
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Sem intervenção: Routine Care
Providers randomized to routine care will not be trained on the FHA or DCA or the completion of the checklists.
All EMTs in both groups (Transport Plus and standard education), will be asked to answer some demographic questions and will be trained to collect responses to 3questions commonly used to assess a patient's risk of falling and to collect best contact information for phone follow up from patients or their caregivers and to obtain permission for a follow-up phone call from research personnel.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Rate of falls
Prazo: up to 3 months
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Rate of falls following transport home by ambulance
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up to 3 months
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Rate of return ED visits
Prazo: 30 days
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Rate of return ED visits following transport home by ambulance
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30 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Rate of falls
Prazo: up to 12 months
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up to 12 months
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Rate of return ED visits
Prazo: 3 days
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Numbers of patients with ED visits within 3 days of participation in study intervention or control arm.
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3 days
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Readmission
Prazo: up to 90 days
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Numbers of patients with readmissions after study intervention
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up to 90 days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kevin G Munjal, MD,MPH,MSCR, Icahn School of Medicine at Mount Sinai
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 (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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GCO 14-1842
- 1R03AG050917-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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