- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01221532
Support From Hospital to Home for Elders: A Randomized Controlled Study (SHHE)
The investigators will randomize 700 non-psychiatric, non-obstetric, non-surgical patients aged 55 years and older at San Francisco General Hospital (SFGH) to usual care (ten days of prescription medication, discharge summary sent to primary care provider (PCP), and outpatient appt made for patient, and patient's nurse reviews discharge plan,) or usual care plus a peridischarge intervention (a visit with specialized in-hospital discharge nurse, development of personalized discharge plan, two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge and availability of additional calls back from NP/PA, upon patient request, to help answer questions and assist patient's transition to outpatient care, and communication with primary care/subspecialty providers). The usual care and usual care plus intervention groups will be assessed for differences in mortality and rates of rehospitalization and emergency department use 30, 90 and 180 days following discharge from the hospital.
The discharge process from the hospital to home is frequently marked by poor quality and high risk of adverse events and readmissions. It has been hypothesized that better coordinated care, personalized patient education, and follow-up calls to identify potential sources of adverse events, such as medical complications and medication errors can reduce rehospitalization and emergency room visits following discharge from the hospital. Although these interventions have been shown to reduce combined hospital readmissions and emergency department visits in English-speaking patients, none has focused on elderly patients in a diverse urban public hospital setting that includes non-English-speakers, who might benefit more than other populations from enhanced services during and after discharge from the hospital. Further, these labor-intensive interventions are costly to implement, and it is unknown whether opportunity cost of providing additional services in a limited-resource environment such as San Francisco General Hospital (SFGH) outweighs the unknown clinical benefits.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94110
- San Francisco General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients age 55 and older
- admitted to the general medicine, family medicine, cardiology, and neurology services at San Francisco General Hospital,
- able to communicate in either English, Spanish, Mandarin or Cantonese,
- attending physicians agree to the patient's participation.
- Patients must be able to demonstrate an understanding of the study's goals through a set of teach back questions included in the consent process.
Exclusion Criteria:
- transferred from an outside hospital;
- admitted for a planned hospitalization (e.g. chemotherapy, a planned surgery)
- requiring hospice, nursing home, rehab or other institutional settings (i.e. expected by the physician team to be discharged to skilled nursing facilities) - those unable to independently consent (i.e. severely cognitively impaired, delirious, deaf, or involuntarily hospitalized because of severe mental illness)
- unable to understand English, Spanish or Cantonese (as reported by medical teams or unable to complete the consent teach-back process)
- less than age 55
- aphasic
- otherwise excluded by the medical team
- participated in the pilot project of this intervention.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Cuidado usual
|
|
Experimental: SHHE Peridischarge intervention
Patients receive the Support from Hospital to Home (SHHE) Peridischarge Intervention plus usual care
|
Support from Hospital to Home (SHHE) Peridischarge Intervention patients will receive Usual care plus
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Combined Emergency Department Visits and Inpatient Readmissions
Periodo de tiempo: 30 days after discharge from hospital
|
30 days after discharge from hospital
|
Combined Emergency Department Visits and Inpatient Readmissions
Periodo de tiempo: 90 days after discharge from hospital
|
90 days after discharge from hospital
|
Combined Emergency Department Visits and Inpatient Readmissions
Periodo de tiempo: 180 days after discharge from hospital
|
180 days after discharge from hospital
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jeffrey M Critchfield, MD, University of California, San Francisco
- Investigador principal: Sue Currin, RN, San Francisco General Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Chan B, Goldman LE, Sarkar U, Guzman D, Critchfield J, Saha S, Kushel M. High perceived social support and hospital readmissions in an older multi-ethnic, limited English proficiency, safety-net population. BMC Health Serv Res. 2019 May 24;19(1):334. doi: 10.1186/s12913-019-4162-6.
- Chan B, Goldman LE, Sarkar U, Schneidermann M, Kessell E, Guzman D, Critchfield J, Kushel M. The Effect of a Care Transition Intervention on the Patient Experience of Older Multi-Lingual Adults in the Safety Net: Results of a Randomized Controlled Trial. J Gen Intern Med. 2015 Dec;30(12):1788-94. doi: 10.1007/s11606-015-3362-y.
- Goldman LE, Sarkar U, Kessell E, Guzman D, Schneidermann M, Pierluissi E, Walter B, Vittinghoff E, Critchfield J, Kushel M. Support from hospital to home for elders: a randomized trial. Ann Intern Med. 2014 Oct 7;161(7):472-81. doi: 10.7326/M14-0094.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SHHE2010
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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