- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01133587
Patient Guided Psychiatric Admissions
Patient Guided Psychiatric Admissions (Self-referral to Inpatient Beds)
To meet the requirement for increased patient involvement, several Community Mental Health Centres (CMHC) have initiated a service called "patient-guided admissions". The investigators will compare a group with "patient guided admission/self-referral to inpatient beds" with a group having treatment as usual.
It is expected that patients in the intervention group will experience more increased feeling of coping (patient activation) after 4 months and 12 months as a result of participating in "patient-guided admissions" than patients getting treatment as usual. In addition the total number of inpatient days either in the CMHC, psychiatric hospital or community rehabilitation centre is expected to be clearly lower in the intervention group than in the 'treatment-as-usual' group during one year after intake. Also the number of involuntary admissions either as inpatient or outpatient will be significant lower in the intervention group than the 'treatment-as-usual' group.The number of admissions in CMHC and psychiatric hospital, as well as the number of outpatient consultations in primary care, CMHC and psychiatric hospitals, will be lower in the intervention group than in the 'treatment-as-usual' group. Patients in the intervention group will experience improved mental health, increased feeling of coping (patient activation) and increased experience of recovery after 4 months and 12 months as a result of participating in "patient-guided admissions".
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants will be patients with psychosis or bipolar disorders. Patients in the intervention group will have a contract on "self-referral to inpatient beds" for one year. They can call the CMHC directly and ask for a bed for until 5 nights.
The patients in the 'treatment-as-usual' group will follow common procedures by either contacting their general practitioner, emergency department or duty doctor, and they will be offered a "self-referral to inpatient bed" contract after a year if they satisfy the inclusion criteria.
Regardless of the participation in the intervention group, the patients can also be ordinary admitted during the project period by a doctor via regular procedures in both hospital and CMHC if there is a need for this. All admissions will appear in the register data.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Trondheim, Noruega, 7440
- St.Olavs hospital, Psykisk helsevern, Nidaros DPS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- schizophrenia or bipolar disorder
- long term care
- established relationship with the ward
Exclusion Criteria:
- extensive substance use problems
- self-destructive behavior
- not able to consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: admissions contract
contract regarding "patient-guided admissions"
|
contract regarding "patient-guided admissions" starting immediately
|
|
Comparador activo: wait list control
1 year on waiting list
|
Patient-guided admissions contract regarding "patient-guided admissions" starting a year after.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient activation/coping
Periodo de tiempo: 4 months
|
Patient Activation Measure (PAM 13)
|
4 months
|
|
Patient activation/coping
Periodo de tiempo: 12 months
|
Patient Activation Measure (PAM 13)
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of admissions
Periodo de tiempo: 12 months
|
Number of admissions in CMHC, psychiatric hospital of community rehabilitation centre
|
12 months
|
|
Total number of inpatient days
Periodo de tiempo: 12 months
|
Total number of inpatient days in CMHC, psychiatric hospital or community rehabilitation centre
|
12 months
|
|
Number of outpatient consultations
Periodo de tiempo: 12 months
|
Number of outpatient consultations in primary care, in CMHC and psychiatric hospital
|
12 months
|
|
Number of involuntary admissions
Periodo de tiempo: 12 months
|
Number of involuntary admissions either as inpatient or outpatient
|
12 months
|
|
Symptoms/functioning and recovery
Periodo de tiempo: 4 months
|
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
|
4 months
|
|
Symptoms/functioning and recovery
Periodo de tiempo: 12 months
|
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lasse Eriksen, PhD, St. Olavs Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Moljord IE, Helland-Hansen KA, Salvesen O, Olso TM, Gudde CB, Rise MB, Steinsbekk A, Eriksen L. Short time effect of a self-referral to inpatient treatment for patients with severe mental disorders: a randomized controlled trial. BMC Health Serv Res. 2016 Sep 22;16(1):513. doi: 10.1186/s12913-016-1712-z.
- Moljord IEO, Lara-Cabrera ML, Salvesen O, Rise MB, Bjorgen D, Antonsen DO, Olso TM, Evensen GH, Gudde CB, Linaker OM, Steinsbekk A, Eriksen L. Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study. Patient Educ Couns. 2017 Jun;100(6):1144-1152. doi: 10.1016/j.pec.2017.01.008. Epub 2017 Jan 11.
- Sigrunarson V, Moljord IE, Steinsbekk A, Eriksen L, Morken G. A randomized controlled trial comparing self-referral to inpatient treatment and treatment as usual in patients with severe mental disorders. Nord J Psychiatry. 2017 Feb;71(2):120-125. doi: 10.1080/08039488.2016.1240231. Epub 2016 Oct 14.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2009/1704 (Otro número de subvención/financiamiento: St Olavs Hospital)
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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