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

14 février 2013 mis à jour par: 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

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

600

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Royaume-Uni
    • Greater London
      • London, Greater London, Royaume-Uni, BR3 3BX
        • South London and Maudsley NHS Foundation Trust

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Aucune intervention: No SMS Reminders
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Economic outcome: Use of Psychosis Services and impact on cost
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Views and suggestions of services users in relation to the SMS reminders
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

King's College London

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2013

Achèvement primaire (Anticipé)

1 mars 2015

Achèvement de l'étude (Anticipé)

1 mars 2015

Dates d'inscription aux études

Première soumission

14 février 2013

Première soumission répondant aux critères de contrôle qualité

14 février 2013

Première publication (Estimation)

15 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

15 février 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 février 2013

Dernière vérification

1 février 2013

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ECOAPSS1

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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