Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)
14 februari 2013 bijgewerkt door: 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
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Verwacht)
600
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Greater London
-
London, Greater London, Verenigd Koninkrijk, BR3 3BX
- South London and Maudsley NHS Foundation Trust
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Geen tussenkomst: No SMS Reminders
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Economic outcome: Use of Psychosis Services and impact on cost
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Views and suggestions of services users in relation to the SMS reminders
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Daniel P Hayes, MSc, King's College London
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2013
Primaire voltooiing (Verwacht)
1 maart 2015
Studie voltooiing (Verwacht)
1 maart 2015
Studieregistratiedata
Eerst ingediend
14 februari 2013
Eerst ingediend dat voldeed aan de QC-criteria
14 februari 2013
Eerst geplaatst (Schatting)
15 februari 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
15 februari 2013
Laatste update ingediend die voldeed aan QC-criteria
14 februari 2013
Laatst geverifieerd
1 februari 2013
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ECOAPSS1
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .