Impact and Experiences of Using Decisions Aids in Outpatient Mental Health.
DAN-SHARE. Impact and Experiences of Using Decisions Aids in Hospital Outpatient Mental Health Settings. A Mixed Methods Study on Shared Decision-making Practice in the Danish Mental Healthcare
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Shared decision-making (SDM) is a collaborative model for treatment decision-making and is widely regarded as a cornerstone of patient-centered care. In SDM, patients and healthcare professionals jointly review available treatment options and identify the solution that best aligns with the patient's preferences and values. Decision aids that are designed to support SDM by presenting treatment options and helping patients formulate and communicate their preferences, are often a central component of SDM. However, little is known about how healthcare professionals and patients understand and experience the use of decision aids in their clinical encounters. In particular, there is a lack of knowledge on the use of decision aids within mental healthcare.
This study aims to evaluate the impact of the Decision Helper™, when used in mental healthcare. The Decision Helper™ is developed as part of the broad implementation of SDM across all hospitals in the Region of Southern Denmark, but is not yet investigated within mental healthcare.
In the study, patients are randomized to either an intervention group or an active control group. In the intervention group, treatment consultations are conducted using the Decision Helper™, whereas in the control group, consultations follow SDM practices without the use of the decision aid. Additionally, the study seeks to explore patients' and mental healthcare professionals' understanding of, and experiences with, using the Decision Helper™ as part of the SDM practice.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lisa Korsbek, Associate Professor, PhD
- Número de teléfono: 45 21254258
- Correo electrónico: lisa.korsbek.christensen@rsyd.dk
Copia de seguridad de contactos de estudio
- Nombre: Regina Christiansen, Assistant Professor, PhD
- Correo electrónico: reginachristiansen@health.sdu.dk
Ubicaciones de estudio
-
-
-
Odense, Dinamarca, 5450
- Reclutamiento
- Odense University Hospital
-
Contacto:
- Christensen
- Número de teléfono: 45 21254258
- Correo electrónico: lisa.korsbek.christensen@rsyd.dk
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- In treatment for a mental health disorder in one of the participating settings of the study
Exclusion Criteria:
- Unable to understand Danish language
- Unable to provide verbal and written informed consent
- Diagnosed with cognitive impairment or dementia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: SDM practice by using Decision Helper
|
Patients assigned to the intervention group will be exposed to the Decision Helper™ during consultations in which treatment decisions or related issues are addressed.
The Decision Helper™ used in these consultations follows a five-step process based on the core principles of shared decision-making: (1) framing the situation and explaining the purpose of the consultation; (2) clarifying the patient's preferred level of information; (3) exploring what matters most to the patient in the decision-making process; (4) presenting the available treatment options, including their advantages and disadvantages; and (5) asking whether the patient is ready to make a decision regarding their preferred treatment option.
Patients assigned to the control group will not be exposed to the Decision Helper™ during treatment consultations in which decisions are made.
However, because all healthcare professionals in the participating settings have received training in shared decision-making, the control group constitutes an active control condition, as patients will still be exposed to the general principles of SDM during decision-making consultations.
|
|
Comparador activo: SDM without Decision Helper
|
Patients assigned to the intervention group will be exposed to the Decision Helper™ during consultations in which treatment decisions or related issues are addressed.
The Decision Helper™ used in these consultations follows a five-step process based on the core principles of shared decision-making: (1) framing the situation and explaining the purpose of the consultation; (2) clarifying the patient's preferred level of information; (3) exploring what matters most to the patient in the decision-making process; (4) presenting the available treatment options, including their advantages and disadvantages; and (5) asking whether the patient is ready to make a decision regarding their preferred treatment option.
Patients assigned to the control group will not be exposed to the Decision Helper™ during treatment consultations in which decisions are made.
However, because all healthcare professionals in the participating settings have received training in shared decision-making, the control group constitutes an active control condition, as patients will still be exposed to the general principles of SDM during decision-making consultations.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient involvement in decision-making
Periodo de tiempo: Throughout study completion, an average of 3 months.
|
Observed level of patient involvement in decision making according to the OPTION 12 scale. OPTION 12 measures the level of patient involvement in decision-making by assessing recordings of treatment consultations on a 5-point Likert scale (0 to 4). Raw score rangs from 0 to 48 and is converted to a score ranging from 0 to 100. Higher scores indicate a higher level of patient involvement. |
Throughout study completion, an average of 3 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-perceived level of involvement in decision-making
Periodo de tiempo: Patient-assessed within two weeks after the treatment consultation.
|
Patient-reported perceived involvement in decision-making, measured using the 9-item Shared Decision Making Questionnaire (SDM-Q-9).
The SDM-Q-9 assesses the extent to which patients perceive themselves as being involved in decision-making.
Patients rate their level of agreement with each of the 9 statements on a 6-point Likert scale.
Raw scores range from 0 to 45 and are converted to a standardized score ranging from 0 to 100.
|
Patient-assessed within two weeks after the treatment consultation.
|
|
Clinician-perceived level of involving the patient
Periodo de tiempo: Clinician-assessed within two weeks after the treatment consultation.
|
Clinician-reported perceived level of patient involvement in decision-making, measured using the clinician version of the 9-item Shared Decision Making Questionnaire (SDM-Q-Doc).
The SDM-Q-Doc assesses the extent to which clinicians perceive that they involve patients in the decision-making process.
Clinicians evaluate each of the 9 items on a 6-point Likert scale.
Raw scores range from 0 to 45 and are converted to scores ranging from 0 to 100.
Higher scores indicate greater clinician-perceived involvement of patients in decision-making.
|
Clinician-assessed within two weeks after the treatment consultation.
|
|
Personal recovery
Periodo de tiempo: Patient-assessed within two weeks after the treatment consultation.
|
Patient-reported measure of personal recovery, assessed using the Brief INSPIRE-O. The Brief INSPIRE-O is a 5-item self-rated measure of recovery, i.e., a patient-reported outcome measure (PROM), that assesses personal recovery from the patient's perspective. Each of the five statements is rated by the patient on a 5-point Likert scale ranging from 0 to 4. Item scores are summed and multiplied by 5 to generate a total score ranging from 0 to 100. Higher scores indicate higher levels of patient-perceived personal recovery. |
Patient-assessed within two weeks after the treatment consultation.
|
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
- DAN-SHARE
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .