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Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS. (ECO APSS)

Primary Purpose

Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SMS reminder
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • South London and Maudsley NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMS Reminder

No SMS Reminders

Arm Description

A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.

The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service

Outcomes

Primary Outcome Measures

Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
To assess differences in appointment attendance using online patient records in those who receive the SMS appointment reminders and those that do not

Secondary Outcome Measures

Economic outcome: Use of Psychosis Services and impact on cost
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
Clinical outcome: Number of inpatient admissions
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
Clinical outcome: Number of days in inpatient care
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
Clinical outcome: Number of inpatient admissions under the mental health treatment act
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
Clinical outcome: Number of referrals to a home treatment team
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
Clinical outcome: Number of times patient has had changes to their medication
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
Clinical outcome: Level of health and social functioning, as reflected in the patient's score on the Health of the Nation Outcome Scales (HoNOS)
To assess differences in levels of health and social functioning in those who receive the SMS appointment reminders and those that do not
Economic outcome: cost effectiveness of the SMS intervention
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.

Full Information

First Posted
February 14, 2013
Last Updated
February 14, 2013
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT01793220
Brief Title
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS.
Acronym
ECO APSS
Official Title
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS: The ECO APSS Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SMS Reminder
Arm Type
Experimental
Arm Description
A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
Arm Title
No SMS Reminders
Arm Type
No Intervention
Arm Description
The service user will not be sent text message reminders prior to each appointment at their Psychosis Community Service
Intervention Type
Other
Intervention Name(s)
SMS reminder
Intervention Description
A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
Primary Outcome Measure Information:
Title
Outcome of appointment (attended, missed, cancelled by the participant, cancelled by the service)
Description
To assess differences in appointment attendance using online patient records in those who receive the SMS appointment reminders and those that do not
Time Frame
From baseline to end of intervention (6 months)
Secondary Outcome Measure Information:
Title
Economic outcome: Use of Psychosis Services and impact on cost
Description
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
Time Frame
From baseline to end of intervention (6 months)
Title
Clinical outcome: Number of inpatient admissions
Description
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
Time Frame
From baseline to end of intervention (6 months)
Title
Clinical outcome: Number of days in inpatient care
Description
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
Time Frame
From baseline to end of intervention (6 months)
Title
Clinical outcome: Number of inpatient admissions under the mental health treatment act
Description
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
Time Frame
From baseline to end of intervention (6 months)
Title
Clinical outcome: Number of referrals to a home treatment team
Description
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
Time Frame
From baseline to end of intervention (6 months)
Title
Clinical outcome: Number of times patient has had changes to their medication
Description
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
Time Frame
From baseline to end of intervention (6 months)
Title
Clinical outcome: Level of health and social functioning, as reflected in the patient's score on the Health of the Nation Outcome Scales (HoNOS)
Description
To assess differences in levels of health and social functioning in those who receive the SMS appointment reminders and those that do not
Time Frame
Baseline and 6 months
Title
Economic outcome: cost effectiveness of the SMS intervention
Description
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.
Time Frame
1 year after baseline
Other Pre-specified Outcome Measures:
Title
Views and suggestions of services users in relation to the SMS reminders
Description
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.
Time Frame
6 months (end of study participation)
Title
Views and suggestions of mental health professionals in relation to the SMS reminders
Description
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.
Time Frame
After the study has ended (1 year after 1st recruitment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel P Hayes, MSc
Phone
+44 (0) 207 848 0357
Email
daniel.1.hayes@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Eugenia Kravariti, PhD
Phone
+44 (0) 207 848 0331
Email
eugenia.kravariti@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel P Hayes, MSc
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
South London and Maudsley NHS Foundation Trust
City
London
State/Province
Greater London
ZIP/Postal Code
BR3 3BX
Country
United Kingdom

12. IPD Sharing Statement

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Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS.

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