- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07926815
An Intervention to Improve the Experience of Patients in Intermediate and Long-term Care Units
Study on the Impact of an Intervention to Improve the Experience of Patients Admitted to Intermediate and Long-term Care Units
The goal of this clinical trial is to learn if an intervention that detects and addresses the problems perceived by patients during their hospital stay can improve trust in the hospital among older patients admitted to intermediate and long-term care units. The main questions it aims to answer are:
- Does the intervention increase patients' trust in the hospital, measured as their likelihood of recommending it?
- Does the intervention reduce formal complaints, improve patients' emotional well-being, and improve the job satisfaction of nursing staff? Researchers will compare patients admitted before the intervention was introduced with patients admitted one year after it was introduced to see if trust in the hospital improves.
Participants will:
- Complete, after one month of admission, the hospital's satisfaction questionnaire (which includes the trust question) and a short emotional well-being questionnaire, either themselves or through a relative or caregiver
- In the post-intervention period, be interviewed between days 10 and 15 of admission about the negative aspects of their stay; the results are discussed at multidisciplinary team meetings, where corrective actions are agreed Nursing staff and nursing assistants on the participating wards will complete a job satisfaction questionnaire before and after the intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a quasi-experimental before-and-after study. The primary outcome will be collected cross-sectionally from all eligible patients admitted at a given time before the intervention is implemented, and again from eligible patients admitted one year after implementation. Formal complaints will be collected retrospectively for the year before the intervention and for the intervention year. Patient questionnaires will be completed on paper without personal information and returned in a sealed envelope identified only by a participant code; the envelopes will be opened by independent research staff, and analysts will be blinded to the study period.
The primary analysis will compare the primary outcome between the pre- and post-intervention groups using a superiority approach, with parametric or non-parametric tests as appropriate and multivariable adjustment for potential confounders that differ between periods. Subgroup analyses by type of ward (conventional vs psychogeriatric) are planned. With 93 patients per group, the study has more than 80% power (two-sided alpha 0.05) to detect an increase in the proportion of patients with trust in the institution (score above 7) from 30% to 50%.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Noemí Casaponsa
- Número de teléfono: 43197 0034938960025
- Correo electrónico: recerca@csapg.cat
Ubicaciones de estudio
-
-
Barcelona
-
Vilanova i la Geltrú, Barcelona, España
- Reclutamiento
- Hospital Sant Antoni Abat-Consorci Sanitari Alt Penedès-Garraf
-
Contacto:
- Noemí Casaponsa
- Número de teléfono: 43197 0034938960025
- Correo electrónico: recerca@csapg.cat
-
Investigador principal:
- Helena Camell
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients admitted to intermediate and long-term care units
Descripción
Inclusion Criteria:
- Admitted to an intermediate or long-term care unit of Hospital Sant Antoni Abat
- Length of stay of at least 1 month
- Patient and/or caregiver able to take part in the study assessments
- Signed informed consent, given by the patient or by the patient's legal representative
Exclusion Criteria:
- Cognitive or affective disorder that limits the ability to answer the study questionnaires, with no reference person available to answer on the patient's behalf
- Participation in another study involving an experimental intervention during the period of this study and/or with a visit schedule incompatible with this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Pre-intervention
Patients admitted to intermediate and long-term care units before the intervention is implemented, receiving usual care |
|
|
Post-intervention
Patients admitted to the same units one year after the intervention is implemented |
Between days 10 and 15 of admission, patients (or their relatives or caregivers) are interviewed following a structured script about the negative aspects they perceive in their hospital stay, including quality of care, comfort, medical information, and assistance with daily activities. Responses are classified using the Net Promoter Score framework. The results are presented at the periodic multidisciplinary team meetings, where a personalized action plan is agreed, documented in the clinical record with assigned responsibilities and deadlines, and reassessed at approximately 30 days. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Trust in the institution
Periodo de tiempo: After 1 month of admission, in the pre-intervention group and in the post-intervention group
|
Score on the question "If needed, would you recommend Hospital Sant Antoni Abat?" from the hospital's inpatient satisfaction questionnaire, rated from 0 (would never recommend) to 10 (would actively recommend). Higher scores indicate greater trust. A score above 7 is considered to indicate trust in the institution. |
After 1 month of admission, in the pre-intervention group and in the post-intervention group
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSAPG-83
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Marco de tiempo para compartir IPD
After publication of main results of the study
Criterios de acceso compartido de IPD
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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.
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. .