- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01793220
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)
14 febbraio 2013 aggiornato da: 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
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Anticipato)
600
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Greater London
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London, Greater London, Regno Unito, BR3 3BX
- South London and Maudsley NHS Foundation Trust
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
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Nessun intervento: No SMS Reminders
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Lasso di tempo: From baseline to end of intervention (6 months)
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To assess differences in appointment attendance using online patient records in those who receive the SMS appointment reminders and those that do not
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From baseline to end of intervention (6 months)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Economic outcome: Use of Psychosis Services and impact on cost
Lasso di tempo: From baseline to end of intervention (6 months)
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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
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of inpatient admissions
Lasso di tempo: From baseline to end of intervention (6 months)
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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
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of days in inpatient care
Lasso di tempo: From baseline to end of intervention (6 months)
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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
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of inpatient admissions under the mental health treatment act
Lasso di tempo: From baseline to end of intervention (6 months)
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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
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of referrals to a home treatment team
Lasso di tempo: From baseline to end of intervention (6 months)
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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
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From baseline to end of intervention (6 months)
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Clinical outcome: Number of times patient has had changes to their medication
Lasso di tempo: From baseline to end of intervention (6 months)
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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
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From baseline to end of intervention (6 months)
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Clinical outcome: Level of health and social functioning, as reflected in the patient's score on the Health of the Nation Outcome Scales (HoNOS)
Lasso di tempo: Baseline and 6 months
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To assess differences in levels of health and social functioning in those who receive the SMS appointment reminders and those that do not
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Baseline and 6 months
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Economic outcome: cost effectiveness of the SMS intervention
Lasso di tempo: 1 year after baseline
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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.
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1 year after baseline
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Views and suggestions of services users in relation to the SMS reminders
Lasso di tempo: 6 months (end of study participation)
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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.
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6 months (end of study participation)
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Views and suggestions of mental health professionals in relation to the SMS reminders
Lasso di tempo: After the study has ended (1 year after 1st recruitment)
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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.
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After the study has ended (1 year after 1st recruitment)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Daniel P Hayes, MSc, King's College London
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2013
Completamento primario (Anticipato)
1 marzo 2015
Completamento dello studio (Anticipato)
1 marzo 2015
Date di iscrizione allo studio
Primo inviato
14 febbraio 2013
Primo inviato che soddisfa i criteri di controllo qualità
14 febbraio 2013
Primo Inserito (Stima)
15 febbraio 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
15 febbraio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 febbraio 2013
Ultimo verificato
1 febbraio 2013
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ECOAPSS1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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