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Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)

14 de febrero de 2013 actualizado por: Daniel Hayes, King's College London

Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS: The ECO APSS Randomized Controlled Trial

The aim of this research is to find out if mobile phone text message reminders of appointments can help to address missed appointments in Psychosis Community Services. Another aim is to examine if fewer missed appointments result in clinical benefits for service users and in lower costs for Psychosis Community Services over a period of 6 months. 600 users from 2 London Psychosis Community Services will take part in this research. Each participant will be put into one of two groups, as s/he joins the study: In the first (experimental) group, each participant will receive appointment reminders for 6 months (7 and 1 day/s before each appointment), starting with the first available opportunity upon joining the study. In the second (control) group, each participant will not receive appointment reminders for 6 months. The choice of group for each individual will be made at random by a computer. Clinical information will be collected for 6 months from the time each participant joins the study, using, with his or her consent, their anonymised electronic medical records. The following clinical information will be compared between the experimental and control groups: Attendance of appointments, number of inpatient admissions, number of days in inpatient care, number of inpatient admissions under the mental health treatment act, number of referrals to a home treatment team, number of times patient has changed medication, health and social functioning. Service use, service costs and the cost-effectiveness of the reminder system will also be examined. Towards the end of their participation, service users, as well as mental health professionals, will be invited to express their views, concerns and suggestions in relation to the reminder service by completing a brief anonymised (service users) or anonymous (staff) questionnaire

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

600

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Greater London
      • London, Greater London, Reino Unido, BR3 3BX
        • South London and Maudsley NHS Foundation Trust

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Be a user of Psychosis Community Services
  • Manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and adequate capacity to consent, as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale.
  • Own a mobile phone.
  • Be willing to receive SMS reminders of appointments with the Psychosis Community Service.
  • Provide written informed consent to participate in the study.

Exclusion Criteria:

  • Is not a user of Psychosis Community Services.
  • Cannot manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and/or adequate capacity to consent, as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale.
  • Does not own a mobile phone.
  • Is under 18 years of age.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: SMS Reminder
A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
Sin intervención: No SMS Reminders
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Periodo de tiempo: From baseline to end of intervention (6 months)
To assess differences in appointment attendance using online patient records in those who receive the SMS appointment reminders and those that do not
From baseline to end of intervention (6 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Economic outcome: Use of Psychosis Services and impact on cost
Periodo de tiempo: From baseline to end of intervention (6 months)
Data on the use of services over the follow-up period will be combined with appropriate unit cost information (Curtis, 2011; Department of health, 2012). Service costs will be compared between the experimental (SMS intervention) and control (No SMS intervention)groups. Cost data often follow a skewed distribution and so bootstrap methods will be employed
From baseline to end of intervention (6 months)
Clinical outcome: Number of inpatient admissions
Periodo de tiempo: From baseline to end of intervention (6 months)
To assess differences in the number of inpatient admissions using online patient records in those who receive the SMS appointment reminders and those that do not
From baseline to end of intervention (6 months)
Clinical outcome: Number of days in inpatient care
Periodo de tiempo: From baseline to end of intervention (6 months)
To assess differences in number of days in inpatient care using online patient records in those who receive the SMS appointment reminders and those that do not
From baseline to end of intervention (6 months)
Clinical outcome: Number of inpatient admissions under the mental health treatment act
Periodo de tiempo: From baseline to end of intervention (6 months)
To assess differences in number of inpatient admissions under the mental health act using online patient records in those who receive the SMS appointment reminders and those that do not
From baseline to end of intervention (6 months)
Clinical outcome: Number of referrals to a home treatment team
Periodo de tiempo: From baseline to end of intervention (6 months)
To assess differences in the number of times a patient has been referred to a home treatment team, using online patient records (a crisis team who further support those with declining mental health) in those who receive the SMS appointment reminders and those that do not
From baseline to end of intervention (6 months)
Clinical outcome: Number of times patient has had changes to their medication
Periodo de tiempo: From baseline to end of intervention (6 months)
To assess differences in the number of times patient has had changes to their medication using online patient records in those who receive the SMS appointment reminders and those that do not
From baseline to end of intervention (6 months)
Clinical outcome: Level of health and social functioning, as reflected in the patient's score on the Health of the Nation Outcome Scales (HoNOS)
Periodo de tiempo: Baseline and 6 months
To assess differences in levels of health and social functioning in those who receive the SMS appointment reminders and those that do not
Baseline and 6 months
Economic outcome: cost effectiveness of the SMS intervention
Periodo de tiempo: 1 year after baseline
The cost of the actual intervention will be negligible given the extent of general SMS use. However, there could be an impact on service costs and this will be estimated. Data on the use of services over the follow-up period (see below for details) will be combined with appropriate unit cost information (Curtis, 2011; Department of health, 2012). Cost-effectiveness will be assessed by combining the cost data with HoNOS scores using an incremental cost-effectiveness ratio. Uncertainty around the cost-effectiveness estimates will be explored using cost-effectiveness planes and cost-effectiveness acceptability curves.
1 year after baseline

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Views and suggestions of services users in relation to the SMS reminders
Periodo de tiempo: 6 months (end of study participation)
At the end of their participation, service users will be invited to complete an optional brief questionnaire (designed for the purposes of the study by the research team), to express their views, concerns and suggestions in relation to the SMS service. This information will be collected in an anonymised format. The questionnaires will be posted to the study participants, or alternatively, administered to them over the telephone or in person (whichever they prefer) by a research worker.
6 months (end of study participation)
Views and suggestions of mental health professionals in relation to the SMS reminders
Periodo de tiempo: After the study has ended (1 year after 1st recruitment)
At the end of ths study, staff from participating services will be invited to complete an optional brief questionnaire (designed for the purposes of the study by the research team), to express their views, concerns and suggestions in relation to the SMS service. This information will be collected in an anonymous format. The questionnaires will be given to staff and posted back to the researcher.
After the study has ended (1 year after 1st recruitment)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Daniel P Hayes, MSc, King's College London

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2013

Finalización primaria (Anticipado)

1 de marzo de 2015

Finalización del estudio (Anticipado)

1 de marzo de 2015

Fechas de registro del estudio

Enviado por primera vez

14 de febrero de 2013

Primero enviado que cumplió con los criterios de control de calidad

14 de febrero de 2013

Publicado por primera vez (Estimar)

15 de febrero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de febrero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

14 de febrero de 2013

Última verificación

1 de febrero de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • ECOAPSS1

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. .

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