- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03279627
Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission
Association of Glycemic Control With Comprehension of Discharge Instructions for Diabetes Therapy and Hospital Readmission
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Diabetes is a major contributor to hospital readmissions and health care expenditures. Previous studies have attempted to identify risk factors for readmission among patients with diabetes. However, no studies have looked at some potentially important factors including duration of diabetes, HbA1c, glycemic excursions preceding hospital discharge, and patient comprehension of discharge instructions provided for home diabetes management. In this study, we propose to examine patient understanding of instructions for insulin therapy provided at the time of hospital discharge as a potential risk factor for readmission during the following 30- and 90-day time periods. In addition, we will examine the contribution of glycemic excursions obtained in the 48-hour period prior to discharge on patient understanding of insulin therapy and risk for readmission.
Purpose: The purpose of this study is to identify and explore the existing components of discharge planning provided to patients with insulin treated diabetes in the inpatient setting and to examine the contribution of glycemic excursions as well as comprehension of discharge instructions among patients with diabetes, in predicting hospital readmissions.
Methods: This will be a prospective non-blinded observational study enrolling non-critically ill, non-pregnant, hospitalized patients aged 18-90 years of age with insulin treated diabetes and no evidence of baseline cognitive. The participants will be recruited from August 2017 to December 2018 from the Inpatient Endocrine and Diabetes Consult Services and from daily reports of patients experiencing BG< 70 mg/dL and >300 mg/dL. Eligible participants will be called within 24-48 hours following hospital discharge at which time they will be asked to complete a Diabetes Management Questionnaire to determine their comprehension of the recommendations provided for home-insulin and other diabetes therapies. This questionnaire will include questions about the types of insulin being used, the doses administered, and times given. Patient interviews will be conducted again via a telephone follow up at approximately 30- and 90-days following discharge with specific questions on home blood glucose control and ER or hospital visits and/or readmissions. The Clinical and Translational Science Institute at the University of Pittsburgh will be consulted for statistical analysis.
Study significance:
This study has the potential to identify modifiable factors that can potentially contribute to the observed frequency of hospital readmissions among patients with insulin treated diabetes. This study could also advocate for discharge protocols and close follow up of patients with insulin-treated diabetes following discharge to ensure appropriate understanding of discharge instructions for insulin therapy and home diabetes management.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Non-pregnant, non-critically ill, hospitalized patients aged 18-90 years with insulin treated diabetes in the hospital
Exclusion Criteria:
- Patients admitted with primary diagnosis of hypoglycemia, DKA; or Hyperglycemic Hyperosmolar Syndrome; patients receiving intravenous narcotic medications; patients discharged to skilled nursing facilities; patients with cognitive impairment defined as dementia or delirium documented in the Electronic Medical Record (EMR); patients with limited life expectancy as determined by "Do Not Resuscitate" Status, or documentation of receiving palliative care or terminal diagnoses with expected survival of less than 1 year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Otro
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Hypoglycemia
This group will be those who experience a BG < 70 mg/dl in the 24-48 hour time period preceding hospital discharge.
Study procedures are identical for each group.
All participants in this group will be asked to complete the Diabetes Management Questionnaire.
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Patients will be asked questions regarding their understanding of instructions for home diabetes management within 48 hours of hospital discharge.
At 1 and 3 months, participants will be contacted to obtain information regarding ER visits or hospital readmissions.
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Hyperglycemia
This group will be those who experience a BG > 250 mg/dl in the 24-48 hour time period preceding hospital discharge.
Study procedures are identical for each group.
All participants in this group will be asked to complete the Diabetes Management Questionnaire.
|
Patients will be asked questions regarding their understanding of instructions for home diabetes management within 48 hours of hospital discharge.
At 1 and 3 months, participants will be contacted to obtain information regarding ER visits or hospital readmissions.
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Glycemic control
This group will be those who maintain BG of 70 to 250 mg /dl in the 24-48 hour time period preceding hospital discharge.
Study procedures are identical for each group, but study outcomes including comprehension of discharge instructions and 1 and 3 month readmissions will be analyzed according to group category.All participants in this group will be asked to complete the Diabetes Management Questionnaire.
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Patients will be asked questions regarding their understanding of instructions for home diabetes management within 48 hours of hospital discharge.
At 1 and 3 months, participants will be contacted to obtain information regarding ER visits or hospital readmissions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient understanding of discharge instructions for home diabetes therapy according to presence or absence of hypoglycemia (defined as BG < 70 mg/dl), hyperglycemia (defined as BG > 250 mg/dl), or BG 70-250 mg/dl at time of hospital discharge
Periodo de tiempo: within 48 hours of hospital discharge
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Participants will be asked to complete a questionnaire regarding their home diabetes medications including timing, adjusting, and medication names.
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within 48 hours of hospital discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Association between patient understanding of home diabetes therapy and frequency of ER visits and hospital readmissions at 30- and 90-day following the index hospitalization
Periodo de tiempo: 1 and 3 months following index hospitalization
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Questionnaire for ER visits and Hospital Readmission
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1 and 3 months following index hospitalization
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mary T Korytkowski, MD, Univesity of Pittsburgh
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PRO17050222
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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