An Emergency Department-To-Home Intervention to Improve Quality of Life and Reduce Hospital Use
3 de enero de 2019 actualizado por: University of Florida
The purpose of this study is to determine if assigning older, chronically ill patients a healthcare coach after they leave the Emergency Department (ED) improves their quality of life and reduces the need for hospital-based care.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Investigators will review the ED electronic medical record in real-time to determine ED patients' study eligibility. Older, chronically ill ED patients who are eligible and agree to participate in the study will be randomly assigned to a healthcare coach and Care Transition Intervention or usual, post-ED care.
At the time of enrollment, all subjects will be asked to provide informed consent for study investigators to request Medicare Claims to determine how many ED visits, hospital admissions and doctor office visits the subject had at least 30 days after the index ED visit. All research participants will be asked basic personal information such as age, race, sex, employment and marital status. All subjects will be asked to complete a baseline survey about their quality of life.
If the subject is assigned to the Care Transition Intervention, the healthcare coach will visit the subject at home within 3 days of the ED visit. The coach will talk with the subject about following up with a regular, personal doctor and symptoms that indicate a worsening health condition. The coach will help the subject understand their medicines and help the subject make a personal health record (PHR). The coach will tell the subject about the Area Agency on Aging. If the subject receives usual care, they but will be given the usual discharge instructions from the ED nurse and doctor. If the subject receives the Care Transition Intervention, the coach will also call the subject at least 3 times after the ED visit and review the same items listed above.
All enrolled subjects will be asked to complete a phone survey within 31-60 days of the ED visit. This survey will again ask subjects about their quality of life.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1101
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32608
- UF Health
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Jacksonville, Florida, Estados Unidos, 32209
- UF Health
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 60 years of age or older
- Medicare beneficiaries
- Community dwelling
- Reside within defined geographical area (to enable home visits)
- Have a working telephone
- Have at least one of the following conditions documented in their electronic medical record: congestive heart failure, chronic obstructive pulmonary disease, coronary artery disease, diabetes, stroke, pneumonia, medical and surgical back conditions (predominantly spinal stenosis), hip fracture, peripheral vascular disease, cardiac arrhythmias, deep venous thrombosis, pulmonary embolism, peptic ulcer disease or hemorrhage
Exclusion Criteria:
- Current diagnosis of psychosis
- Cancer
- Dialysis
- History of organ transplantation
- Dementia without a live-in caregiver, or
- In hospice care
- Reside outside the defined geographical area
- Reside in a skilled nursing or assisted living facility
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ED-to-home care transition intervention
The ED-to-home care transition intervention is a coaching intervention.
It is a 4-week program that uses an Area Agency on Aging healthcare coach to conduct a home visit and at least 3 follow-up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers.
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The Area Agency on Aging coach's role is to build self-management capabilities for the patient and their caregiver.
During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit.
2: Knowledge of Red Flag Symptoms.
3: Medication Reconciliation.
4: The Personal Health Record (PHR).
The coach assists patients use the PHR to document and maintain vital information and to communicate with providers.
Otros nombres:
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Experimental: Usual Care
Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.
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Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Physical Function Between Baseline and 60 Days Post-ED Visit
Periodo de tiempo: Baseline up to 60 days after index ED Visit
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PROMIS Physical Function instruments measure self-reported capability.
Each of 7-items in the physical function instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Physical Function Instrument used is 7 and the maximum score is 35.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For positively-worded concepts like Physical Function, a T-score of 60 is one SD better than average.
A Physical Function T-score of 40 is one SD worse than average.
Change in Physical Function is the difference between baseline and 60 day T-score.
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Baseline up to 60 days after index ED Visit
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Change in Anxiety Between Baseline and 60 Days Post-ED Visit
Periodo de tiempo: Baseline up to 60 days after index ED Visit
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PROMIS Anxiety instruments measure self-reported fear, anxious misery, and hyperarousal.
Each of 8-items in the Anxiety Instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Anxiety Instrument used is 8 and the maximum score is 40.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average and an Anxiety T-score of 40 is one SD better than average.
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Baseline up to 60 days after index ED Visit
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Change in Informational Support Between Baseline and 60 Days Post-ED Visit
Periodo de tiempo: Baseline up to 60 days after index ED Visit
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PROMIS Informational Support instruments measure perceived availability of helpful information or advice.
Each of 5-items in the Informational Support Instrument used in this study has five response items ranging in value from one to five.
Thus, the minimum score for the Informational Support Instrument used is 5 and the maximum score is 25.
The raw score is translated to a T-score using PROMIS conversion tables.
The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10.
A higher PROMIS T-score represents more of the concept being measured.
For positively-worded concepts like Informational Support, a T-score of 60 is one SD better than average and a T-score of 40 is one SD worse than average.
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Baseline up to 60 days after index ED Visit
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Number of Participants With Outpatient Visit Claims
Periodo de tiempo: Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for an outpatient visit in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Number of Participants With ED Visit Claims
Periodo de tiempo: Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for an ED visit in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Number of Participants With In-patient Admission Claims
Periodo de tiempo: Within 30 days after index ED visit
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This outcome was determined by assessing the number of participants who had one or more Medicare claims for a hospitalization in the 30 days after the index ED visit.
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Within 30 days after index ED visit
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Donna L Carden, MD, MPH, University of Florida
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de mayo de 2014
Finalización primaria (Actual)
30 de noviembre de 2015
Finalización del estudio (Actual)
10 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
4 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
4 de marzo de 2014
Publicado por primera vez (Estimar)
6 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
3 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB201400005
- PCORI-1306-01451 (Otro número de subvención/financiamiento: PCORI)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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