Una breve intervención de gestión de casos para personas ingresadas involuntariamente en un hospital psiquiátrico (CARP)
Apoyo a las personas ingresadas involuntariamente en un hospital psiquiátrico mediante una breve intervención de gestión de casos que promueve la recuperación personal y reduce los efectos negativos de la coerción: un estudio piloto
The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are:
- Is the case management intervention acceptable and feasible?
- What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care?
Participants will be asked to take part in:
- the five sessions of the case management intervention;
- two evaluation sessions (pre and post-intervention);
- a final in-depth semi-structured interview (optional).
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Canton of Vaud
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Lausanne, Canton of Vaud, Suiza, 1003
- Lausanne University Hospital
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- To have been involuntarily admitted by a medical doctor
- To be aged between 18 and 65 years
Exclusion Criteria:
- Patients unable to provide written consent due to a lack of discernment
- Patients unable to speak French well enough to participate in the study without the help of an interpreter
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Intervention group
Brief case management intervention group |
The brief case management intervention aims to support patients during the difficult phase of involuntary hospitalisation and reduce the impact of this short-term event on their long-term recovery process. The intervention starts during the hospital stay, at the latest one week after admission, and lasts for a maximum of one month after discharge. The intervention consists of five sessions, the order of which may vary according to the specific needs of the patient:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Eligibility Rate
Periodo de tiempo: From start of study recruitment through study recruitment completion, on average 6 months
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Number of eligible patients/number of patients involuntarily hospitalised on site during study period as reported in a structured flowchart by the case managers after each site visit |
From start of study recruitment through study recruitment completion, on average 6 months
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Participation Rate
Periodo de tiempo: From start of study recruitment through study recruitment completion, on average 6 months
|
Number of patients accepting to participate/number of approached patients as reported in a structured flowchart by the case managers after each site visit and based on the number of signed consent forms |
From start of study recruitment through study recruitment completion, on average 6 months
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Drop-out Rate
Periodo de tiempo: Up to 2 weeks from hospital admission and 2 months after hospital discharge
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Number of patients who completed the programme/number of recruited patients as reported by case managers in a structured questionnaire detailing which intervention sessions were delivered to each patient |
Up to 2 weeks from hospital admission and 2 months after hospital discharge
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Intervention Dosage
Periodo de tiempo: Post-intervention, up to 2 months post hospital discharge
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Mean number of sessions delivered per participant as reported by case managers in a structured questionnaire detailing which intervention sessions were delivered to each patient |
Post-intervention, up to 2 months post hospital discharge
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Missing Data Rates
Periodo de tiempo: Up to 2 weeks from hospital admission and 2 months after hospital discharge
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Number of missing data |
Up to 2 weeks from hospital admission and 2 months after hospital discharge
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Number of Unexpected Adverse Events
Periodo de tiempo: Up to 2 weeks after hospital admission through up to 2 months post hospital discharge
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Number of unexpected adverse events related to the intervention reported in a structured form by the case managers or the investigator |
Up to 2 weeks after hospital admission through up to 2 months post hospital discharge
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Participants' Acceptance and Degree of Satisfaction
Periodo de tiempo: Post-intervention, up to 2 months post hospital discharge
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Patients' acceptability of, and satisfaction with, the intervention and the research process were assessed qualitatively after the intervention, using semi-structured interviews with open-ended questions. Patients' verbatim responses were categorised according to four components of the Theoretical Framework for Acceptability (TFA): affective attitude, burden, ethicality, and perceived effectiveness. The table below shows, for each TFA component (one per row), the number of participants whose responses were coded to that component, out of all participants interviewed. |
Post-intervention, up to 2 months post hospital discharge
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recovery Assessment Scale : Total Score (RAS-Total)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The French validated version of the Recovery Assessment Scale (24 item) is a patient-reported outcome measure of personal recovery. The instrument provides a total score of personal recovery as well as sub-scores on five specific dimensions : personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, no domination by symptoms. The RAS Total score is derived from 24 items rated on a 5 point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating better recovery. Scores on a scale: the total score ranges from 24 to 120 and is calculated by summing all item responses |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Recovery Assessment Score : Personal Confidence and Hope Subscale (RAS-PCH)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The French validated version of the Recovery Assessment Scale (24 item) is a patient-reported outcome measure of personal recovery. The instrument provides a total score of personal recovery as well as sub-scores on five specific dimensions : personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, no domination by symptoms. The Personal Confidence and Hope dimension is assessed with a subscale scored on a 5 point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating better outcomes (greater personal confidence and hope). The Personal Confidence and Hope subscale score ranges from 9 to 45 and is calculated by summing the corresponding item responses. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Recovery Assessment Scale : Willingness to Ask for Help Subscale (RAS-WAH)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The French validated version of the Recovery Assessment Scale (24 item) is a patient-reported outcome measure of personal recovery. The instrument provides a total score of personal recovery as well as sub-scores on five specific dimensions : personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, no domination by symptoms. The Willingness to Ask for Help dimension is assessed with a subscale scored on a 5 point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating better outcomes (greater willingness to ask for help). The Willingness to Ask for Help subscale score ranges from 3 to 15 and is calculated by summing the corresponding item responses. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Recovery Assessment Scale : Goal and Success Orientation Subscale (RAS-GSO)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The French validated version of the Recovery Assessment Scale (24 item) is a patient-reported outcome measure of personal recovery. The instrument provides a total score of personal recovery as well as sub-scores on five specific dimensions : personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, no domination by symptoms. The Goal and Success Orientation dimension is assessed with a subscale scored on a 5 point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating better outcomes (greater goal and success orientation). The Goal and Success Orientation subscale score ranges from 5 to 25 and is calculated by summing the corresponding item responses. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Recovery Assessment Scale : Reliance on Others Subscale (RAS-RO)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The French validated version of the Recovery Assessment Scale (24 item) is a patient-reported outcome measure of personal recovery. The instrument provides a total score of personal recovery as well as sub-scores on five specific dimensions : personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, no domination by symptoms. The Reliance on Others dimension is assessed with a subscale scored on a 5 point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating better outcomes (greater reliance on others). The Reliance on Others subscale score ranges from 4 to 20 and is calculated by summing the corresponding item responses. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Recovery Assessment Scale : No Domination by Symptoms Subscale (RAS-NDS)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The French validated version of the Recovery Assessment Scale (24 item) is a patient-reported outcome measure of personal recovery. The instrument provides a total score of personal recovery as well as sub-scores on five specific dimensions : personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, no domination by symptoms. The No Domination by Symptoms dimension is assessed with a subscale scored on a 5 point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating better outcomes (greater non-domination by symptoms). The No Domination by Symptoms subscale score ranges from 3 to 15 and is calculated by summing the corresponding item responses. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Empowerment Scale (ES)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Empowerment Scale (ES) is a 28 item self report instrument assessing subjective feelings of empowerment. It is scored on a 4 point Likert scale ranging from 1 ('strongly agree') to 4 ('strongly disagree'), with higher scores indicating greater perceived empowerment. The total Empowerment Scale score is obtained by summing the 28 item scores and ranges from 28 to 112. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Rosenberg Self-Esteem Scale (RSS)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The French validated version of the Rosenberg Self-Esteem Scale (RSS), a very short 10-item inventory measuring self-esteem on a four-point Likert scale from 1="strongly disagree" to 4="strongly agree". The RSS total score may range between 10 and 40, with higher scores indicating higher level of self-esteem. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Paradox of Self-Stigma Scale: Stereotype Endorsement Subscale (PaSS-24 SE)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The Paradox of Self-Stigma scale (PaSS-24) is a 24-item self-report instrument measuring self-stigma and related constructs (stereotype endorsement, righteous anger, and non disclosure) in French language. The Stereotype Endorsement (PaSS-24 SE) dimension is assessed with an 8-item subscale scored on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating better more endorsement of common stereotypes about one's condition. The Stereotype Endorsement subscale score is obtained by summing the corresponding item scores and ranges from 8 to 40. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Paradox of Self-Stigma Scale: Righteous Anger Subscale (PaSS-24 RA)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The Paradox of Self-Stigma scale (PaSS-24) is a 24-item self report instrument measuring self stigma and related constructs (stereotype endorsement, righteous anger, and non disclosure) in French. The Righteous Anger (PaSS 24 RA) dimension is assessed with an 8-item subscale scored on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating more righteous anger. The Righteous Anger subscale score is obtained by summing the corresponding item scores and ranges from 8 to 40. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Paradox of Self-Stigma Scale: Non-Disclosure Subscale (PaSS-24 ND)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
|
The Paradox of Self-Stigma scale (PaSS-24) is a 24-item self report instrument measuring self stigma and related constructs (stereotype endorsement, righteous anger, and non disclosure) in French. The Non-Disclosure (PaSS-24 RA) dimension is assessed with an 8-item subscale scored on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), with higher scores indicating greater openness to disclose about one's condition. The Non-Disclosure subscale score is obtained by summing the corresponding item scores and ranges from 8 to 40. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Beck Hopelessness Scale (BHS)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The French validated version of the Beck Hopelessness Scale (BHS), an inventory of 20 true-false items which assess negative expectations about the future on three dimensions: feeling about the future, decrease in motivation and expectations. BHS total score can range between 0 and 20, with higher scores reflecting higher levels of hopelessness. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The French-validated version of the World Health Organization Quality of Life - Brief version (WHOQOL-BREF) is a 26-item self-report questionnaire. Two items assess overall quality of life and overall health, the remaining 24 items assess four domains (physical health, psychological health, social relationships and environment). The instrument's items rely on 5-point Likert scales, with values going from 1 ('Not at all satisfied') to 5 ('Completely satisfied'), with reverse scoring for items 3, 4 and 26. Each domain score is the mean of its items multiplied by 4 (range 4-20), which makes it comparable with the original WHOQOL-100. It is then transformed to a 0-100 scale: (domain score - 4) × (100/16). The WHOQOL-BREF total score ranges from 0 to 100, where higher scores indicate better quality of life. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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International Trauma Questionnaire Post Traumatic Stress Disorder (ITQ PTSD)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The French validated version of the International Trauma Questionnaire (ITQ), a scale to assess Post Traumatic Stress Disorder (PTSD) and Complex Post Traumatic Stress Disorder (C-PTSD) symptoms among adults. The inventory includes 18 items: six to assess the PTSD, six to assess the Disorders in Self Organisation (DSO), and six to assess functional impairment in several important areas of life. Respondents are required to indicate, on a five-point scale from 0="not at all" to 4="extremely", how much each symptom has bothered them in the past month. A total score, ranging between 0 and 24, can be calculated for the PTSD and DSO subscale. A C-PTSD score, ranging between 0 and 48, can also be calculated by adding the PTSD and DSO subscales. Both the PTSD and the C-PTSD total scores will be used in the study. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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International Trauma Questionnaire Complex Post Traumatic Stress Disorder (ITQ C-PTSD)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The French validated version of the International Trauma Questionnaire (ITQ), a scale to assess Post Traumatic Stress Disorder (PTSD) and Complex Post Traumatic Stress Disorder (C-PTSD) symptoms among adults. The inventory includes 18 items: six to assess the PTSD, six to assess the Disorders in Self Organisation (DSO), and six to assess functional impairment in several important areas of life. Respondents are required to indicate, on a five-point scale from 0="not at all" to 4="extremely", how much each symptom has bothered them in the past month. A total score, ranging between 0 and 24, can be calculated for the PTSD and DSO subscale. A C-PTSD score, ranging between 0 and 48, can also be calculated by adding the PTSD and DSO subscales. Both the PTSD and the C-PTSD total scores will be used in the study. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Coercion Ladder (CL)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Coercion Ladder (CL), a single-item instrument asking patients to rate their experience of care on a visual analogue scale ranging from 1="minimum use of coercion" to 10="maximum use of coercion". |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Index of Fairness
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Index of Fairness is a 4-item self-administered inventory that assesses whether participants perceived the experienced treatment-related pressures as fair. It is rated on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), yielding a total score ranging from 4 to 20. The Index of Fairness score is obtained by summing the four item scores, with higher values indicating better outcomes (greater perception of treatment leverage and pressures as fair). |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Index of Effectiveness
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Index of Effectiveness is a 4-item self-administered inventory that assesses whether participants perceived the experienced treatment-related pressures as effective. It is rated on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'), yielding a total score ranging from 4 to 20. The Index of Effectiveness score is obtained by summing the four item scores, with higher values indicating better outcomes (greater perception of treatment leverage and pressures as effective). |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Satisfaction With Psychiatric Hospital Care (ANQ-Psy)
Periodo de tiempo: Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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The Satisfaction with Psychiatric Hospital Care questionnaire (ANQ-Psy) is a 6-item patient-reported measure developed by the Swiss National Association for Quality Development in Hospitals and Clinics (ANQ). It evaluates inpatients' experiences and satisfaction with quality of care, clarity of information, explanations about medication, involvement in treatment decisions, and how well discharge planning meets their needs. Each item is rated on a 5-point verbal Likert scale ranging from 1 ('Poor'/'Never') to 5 ('Excellent'/Always'). The total satisfaction score is the sum of all six items, ranging from 6 to 30, with higher scores indicating greater satisfaction with hospital care. |
Two time points assessment: up to 2 weeks after hospital admission (pre-intervention) and up to 2 months post hospital discharge (post-intervention)
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Brief INSPIRE Scale
Periodo de tiempo: Post-intervention, up to 2 months after hospital discharge
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The Brief INSPIRE scale, a service user-rated measure assessing perceived staff support for personal recovery. The Brief INSPIRE consists of five items, one for each personal recovery domain. Responders are asked to rate on a five-point Likert scale, from 0="not at all" to 4="very much", how much they feel supported by staff in each domain of their personal recovery. A total score between 0 and 100 can be computed, with higher scores indicating higher perceived support. |
Post-intervention, up to 2 months after hospital discharge
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Silla de estudio: Charles Bonsack, Centre hospitalier universitaire vaudois (CHUV)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2024-00095
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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