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Effect of Pharmacist Provided Drug Information Services After Hospital Discharge

4 de junio de 2019 actualizado por: Tim Emil Vejborg, Region Hovedstadens Apotek

Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.

Objective:

The aim of this study is to evaluate if offering drug counseling from a hospital pharmacy increases patient satisfaction and sense of security regarding drug treatment after hospital discharge.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Method and design:

This study was estimated to include 250 participants in a clinical randomized controlled trial. The participants were included from the Acute Medical Ward and the Department of Respiratory Medicine at Bispebjerg Hospital when discharged. The participants were randomized to one of two groups with unequal sizes: the control (50 participants) or intervention group (200 participants). This study used blocked randomization with block sizes of 5/10/15/20/25. The control group received the normal care following the Danish standard procedure. Participants in the intervention group also received the normal care but was also offered the possibility to contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Data for the primary outcome measures was collected 14 days after discharge through structured phone interviews. An interview guide with a semi-structured questionnaire and already validated questions were developed, pre-tested and optimized. The participants were asked to answer open-ended questions, closed-ended question and rate statements or questions on a five-point scale.

The participants in the control group were asked to answer 13 items (seven questions or statements on a five-point scale, four closed-ended questions and two open-ended questions).

The participants in the intervention group who did not make any queries were asked the same questions as the participants in the control group and additionally three closed-ended questions. A total of 16 items.

The participants in the intervention group who made queries were asked the same questions as the participants in the intervention group who did not make any queries and additionally five questions on a five-point scale, four closed-ended and one open-ended question. A total of 27 items.

The effect of the drug counseling regarding patient safety was evaluated by a pharmaceutical assessment in which it was assessed whether the drug counseling had potentially prevented a drug-related problem.

Quantitative data from the phone interviews will be analyzed in Microsoft excel with descriptive statistics and simple parametric statistics. An analysis will determine whether there is a difference in the primary outcome measures.

Tipo de estudio

Intervencionista

Inscripción (Actual)

250

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

    • København NV
      • Copenhagen, København NV, Dinamarca, 2400
        • Capital Regions Hospital Pharmacy

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients discharged from the acute medical ward and department of respiratory medicine at Bispebjerg Hospital.
  • Patients discharged to own home.
  • Can speak the danish language.
  • ≥18 years old.
  • Can be contacted by phone.

Exclusion Criteria:

  • Cognitive and communicative problems (e.g. dementia, aphasia, suicidal) or other barriers that unable the participant to use the intervention service.
  • Patient does not answer phone within five attempts on five different days, when trying to conduct patient interview.
  • Cognitive and communicative problems that unable the participant to answer questions in the patient interview.
  • Deceased or readmitted before patient interview.

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control group
Participants in the control group received the normal care following the Danish standard procedure.
Comparador activo: Intervention group
Participants in the intervention group received the normal care following the Danish stadard procedure. Additionally the participants was also offered the possibility to contact a hospital pharmacy department by phone or mail for drug counseling.
Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sense of security regarding drug treatment and satisfaction with drug counseling.
Periodo de tiempo: 2-4 weeks after discharge.
The questionnaire comprised closed-ended questions, open-ended questions and questions or statements where the respondents were asked to rate the questions or statements on a five-point scale. The scale used is a attitude measurement scale that assess attitudes by presenting respondents with sentences that state beliefs about the particular attitude being measured. The respondents then decide to what extent he or she agrees with the statement. The responses are divided numerically into a series of ordered responses. Ratings: 1 = not at all, 2 = to a small extent, 3 = to some extent, 4 = to a great extent, 5 = to a very great extent.
2-4 weeks after discharge.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of medications by admission.
Periodo de tiempo: Within one week after discharge.
Number of medications will be read in admission report.
Within one week after discharge.
Number of medications by discharge.
Periodo de tiempo: Within one week after discharge.
Number of medications will be read in discharge report..
Within one week after discharge.
Number of patients that received medication review by pharmacist during admission.
Periodo de tiempo: Within one week after discharge.
The patient's journal will be searched for a medication review.
Within one week after discharge.
Number of patients that received help with medication at home after discharge.
Periodo de tiempo: Within one week after discharge.
The patient's journal will be searched for information regarding help with medication at home.
Within one week after discharge.
Number of enquiries.
Periodo de tiempo: Directly after the patient received drug counseling.
Patient enquiries will be classified to one of the predefined categories: adverse effects, choice of therapy, dosage and administration, interactions, product information, storage and handling, indication or other.
Directly after the patient received drug counseling.
Number of potentially prevented drug-related problems.
Periodo de tiempo: Directly after the patient received drug counseling.
The pharmacist that performed the drug counseling assessed whether the drug counseling had potentially prevented a drug-related problem.
Directly after the patient received drug counseling.
Cause of hospitalization.
Periodo de tiempo: Within one week after discharge.
The patient's journal will be searched for cause of hospitalization.
Within one week after discharge.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Tim E Vejborg, M.Sc.Pharm, Region Hovedstadens Apotek

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)

12 de julio de 2018

Finalización primaria (Actual)

3 de junio de 2019

Finalización del estudio (Actual)

3 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

22 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

1 de febrero de 2019

Publicado por primera vez (Actual)

4 de febrero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2019

Última verificación

1 de junio de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • H-18003889

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

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. .

Ensayos clínicos sobre Drug counseling

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