- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01793220
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)
14. februar 2013 oppdatert av: 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
Studieoversikt
Studietype
Intervensjonell
Registrering (Forventet)
600
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Greater London
-
London, Greater London, Storbritannia, BR3 3BX
- South London and Maudsley NHS Foundation Trust
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
|
|
Ingen inngripen: No SMS Reminders
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Economic outcome: Use of Psychosis Services and impact on cost
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Views and suggestions of services users in relation to the SMS reminders
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Daniel P Hayes, MSc, King's College London
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2013
Primær fullføring (Forventet)
1. mars 2015
Studiet fullført (Forventet)
1. mars 2015
Datoer for studieregistrering
Først innsendt
14. februar 2013
Først innsendt som oppfylte QC-kriteriene
14. februar 2013
Først lagt ut (Anslag)
15. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. februar 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. februar 2013
Sist bekreftet
1. februar 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ECOAPSS1
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .