- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01793220
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)
torstai 14. helmikuuta 2013 päivittänyt: 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
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
600
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Greater London
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London, Greater London, Yhdistynyt kuningaskunta, BR3 3BX
- South London and Maudsley NHS Foundation Trust
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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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Ei väliintuloa: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Economic outcome: Use of Psychosis Services and impact on cost
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Views and suggestions of services users in relation to the SMS reminders
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Daniel P Hayes, MSc, King's College London
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. maaliskuuta 2013
Ensisijainen valmistuminen (Odotettu)
Sunnuntai 1. maaliskuuta 2015
Opintojen valmistuminen (Odotettu)
Sunnuntai 1. maaliskuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 14. helmikuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 14. helmikuuta 2013
Ensimmäinen Lähetetty (Arvio)
Perjantai 15. helmikuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 15. helmikuuta 2013
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 14. helmikuuta 2013
Viimeksi vahvistettu
Perjantai 1. helmikuuta 2013
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ECOAPSS1
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