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

14 de fevereiro de 2013 atualizado 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

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

600

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: 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.
Sem intervenção: No SMS Reminders
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Economic outcome: Use of Psychosis Services and impact on cost
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Views and suggestions of services users in relation to the SMS reminders
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

King's College London

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2013

Conclusão Primária (Antecipado)

1 de março de 2015

Conclusão do estudo (Antecipado)

1 de março de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

14 de fevereiro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de fevereiro de 2013

Primeira postagem (Estimativa)

15 de fevereiro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

15 de fevereiro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de fevereiro de 2013

Última verificação

1 de fevereiro de 2013

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ECOAPSS1

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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