- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01793220
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)
14. februar 2013 opdateret af: 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
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
600
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Greater London
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London, Greater London, Det Forenede Kongerige, BR3 3BX
- South London and Maudsley NHS Foundation Trust
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Economic outcome: Use of Psychosis Services and impact on cost
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Views and suggestions of services users in relation to the SMS reminders
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Daniel P Hayes, MSc, King's College London
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2013
Primær færdiggørelse (Forventet)
1. marts 2015
Studieafslutning (Forventet)
1. marts 2015
Datoer for studieregistrering
Først indsendt
14. februar 2013
Først indsendt, der opfyldte QC-kriterier
14. februar 2013
Først opslået (Skøn)
15. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. februar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. februar 2013
Sidst verificeret
1. februar 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ECOAPSS1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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