- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01793220
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)
14. února 2013 aktualizováno: 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
Přehled studie
Typ studie
Intervenční
Zápis (Očekávaný)
600
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Greater London
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London, Greater London, Spojené království, BR3 3BX
- South London and Maudsley NHS Foundation Trust
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Economic outcome: Use of Psychosis Services and impact on cost
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Views and suggestions of services users in relation to the SMS reminders
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Daniel P Hayes, MSc, King's College London
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2013
Primární dokončení (Očekávaný)
1. března 2015
Dokončení studie (Očekávaný)
1. března 2015
Termíny zápisu do studia
První předloženo
14. února 2013
První předloženo, které splnilo kritéria kontroly kvality
14. února 2013
První zveřejněno (Odhad)
15. února 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
15. února 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
14. února 2013
Naposledy ověřeno
1. února 2013
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ECOAPSS1
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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