- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02981563
Time Together: A Multi-site Nursing Intervention Project Using a Single System Experimental Design (TT)
The aim of this project is to test and evaluate a nursing intervention, Time Together (TT), created to enable quality interactions between patients and staff in psychiatric inpatient care. The research questions are:
Does TT influence the quality of interactions between staff and patients? Does TT influence patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of perceived stress and levels of stress of conscience? Does TT influence the prevalence of coercive measures, mean length of hospital stay and the use of PRN medication?
In parallel, a process evaluation will be conducted, answering questions such as:
How do staff and patients describe their experiences of the intervention and how do contextual factors influence the effects of the intervention? What are the relationship between the outcome variables and the degree of compliance with the intended intervention? What problems are there with recruitment and dropouts?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
BACKGROUND:
Despite the long known significance of the nurse-patient relationship, research in psychiatric inpatient care still reports on unfulfilled expectations of, and difficulties in interactions and relationships between patients and staff. As one solution to the contemporary circumstances, interventions that creates structures that allow quality interactions between patients and staff are needed.
INTERVENTION TT is an intervention, developed from the intervention Protected Engagement Time. The structure of TT is that staff, for a fixed time during the day, dedicates their time to exclusively engage with the patients. Other duties of more administrative nature, visits and meetings are organized to be performed at other times during the day. This structure will be tested at three psychiatric inpatient care wards in the north of Sweden.
DESIGN AND METHODS An experimental single system design (A-B-Follow-up) will be used. As TT will be introduced as a routine ward activity during the B phase, all patients and staff on the participating wards will be participating in TT. However, participating in the evaluation will be voluntary. Data will be collected through questionnaires once every seventh weekday during 5 weeks for the A phase, and 12 weeks during B phase.
In parallel, a process evaluation will be conducted using semi structured interviews and participating observations.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria for patients:
- 18 years or older
- Admitted to the wards during either A phase, B phase and/or follow-up
- Experience of at least one TT session is required to participate in the B phase
Exclusion criteria for patients:
- Does not master the Swedish language well enough to complete questionnaires and participate in interviews.
Inclusion criteria for staff:
- Regularly employed at the ward during A and B phase and/or follow-up.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Time Together
Time Together as described under "Interventions"
|
For a fixed time during the day, staff dedicates their time to exclusively engage with the patients.
Different activities will be offered to both patients and staff, such as playing board games, taking a walk, or having individual conversations.
Other duties of more administrative nature, visits and meetings will be performed at other times during the day.
Through this, opportunities for interaction are both created and protected.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of interactions [patients]
Periodo de tiempo: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
|
Perceived stress [staff]
Periodo de tiempo: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
PSS consists of 10 items answered on a 5-point Likert scale
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Global quality of interactions [patients, staff]
Periodo de tiempo: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
A 100 mm Visual Analogue Scale expressing the most positive and the most negative rating will be anchored at each end
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
|
Anxiety and depressive symptoms [patients]
Periodo de tiempo: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
The Hospital Anxiety and Depression Scale (HAD) will be used to measure anxiety and depressive symptoms.
All items are scored on a 4-point scale.
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
|
Stress of Conscience [staff]
Periodo de tiempo: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
The Stress of Conscience Questionnaire (SCQ) will be used to measure the frequencies of stressful situations and the degree to which these lead to stress of conscience among staff.
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
|
Quality of care [staff]
Periodo de tiempo: Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
The Quality in Psychiatric Care- Inpatient Staff (QPC-IPS) questionnaire will be used to measure quality of care.
|
Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)
|
|
Number of PRN medications given
Periodo de tiempo: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Data will be retrieved from ward registers.
|
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
|
Length of hospital stay
Periodo de tiempo: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Data will be retrieved from ward registers.
|
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
|
Use of coercion and violent situations
Periodo de tiempo: Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Data will be retrieved from ward registers.
|
Changes during baseline and intervention period (measured weekly for a total of 16 weeks)
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 350000210
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