Condition category
Mental and Behavioural Disorders
Date applied
25/09/2013
Date assigned
07/01/2014
Last edited
07/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anorexia nervosa is a serious mental health problem that can last for many years and carries a high risk of death from malnutrition. It is harmful for those affected and can place a considerable burden on families. Anorexia nervosa can be an expensive condition to treat, often involving lengthy admissions to hospital, which additionally has a negative impact on school and social life. Hospital admissions are not always helpful and readmission to hospital after discharge is common. In contrast, those who respond well to outpatient family therapy have lower rates of readmission to hospital inpatient care.
There are two main community-based services available for young people with anorexia nervosa. The first is standard care provided by general Child and Adolescent Mental Health Services (CAMHS). The second is specialist eating disorder care provided by dedicated, multi-disciplinary teams. There is some evidence that these specialist services are better at preventing hospital admissions and may be more acceptable to patients and their families than general CAMHS teams. Even so, specialist community services for young people with eating disorders are still rare in the British Isles and vary depending on geographical location.
One of the reasons why specialist services are rare is that they would require additional financial investment. Given the current financial difficulties facing the National Health Service, specialist services for anorexia nervosa are unlikely to be funded without clear evidence that savings will be made from this investment, alongside evidence that these services will have a positive effect on the health of patients and the quality of life of both patients and their families. This study will help to provide this evidence.
Our plan is to study the cost and the effectiveness of existing models of community services for young people with anorexia nervosa (either specialist or general CAMHS models of service). This will help us to determine whether increasing investment in specialist CAMHS services will be beneficial to patients and their families and will also be good value for money.

Who can participate?
We will include in the study any young person aged between 8 and 18 seen by a child and adolescent psychiatrist in a community-based CAMHS team and diagnosed with anorexia nervosa.

What does the study involve?
The study will collect information about all new cases of young people with anorexia nervosa across the British Isles over a 12-month period. We will use a survey system called the Child and Adolescent Psychiatric Surveillance System (CAPSS), which asks all child and adolescent psychiatrists to report new cases of particular mental health diagnoses.
Based on this information, we will study the different types of community-based care provided to each young person who enters the study and determine whether they are specialist services or general CAMHS services. This will enable us to classify all the different models of care available to young people with anorexia nervosa in the British Isles.
Nine months and 18 months later, we will contact each referring psychiatrist again in order to collect information on the services each young person received and the outcomes for young people, in terms of their health status. We will calculate the cost of the care provided and explore the cost-effectiveness of the different models of care (the benefits generated by each model of care in relation to the amount of money spent).
We will then look at the impact on cost and cost-effectiveness of possible changes to the provision of specialist services in the British Isles. In other words, we will look at the effect of increasing the provision of specialist services on the cost of services for child and adolescent anorexia nervosa and the benefits for young people of increased access to these services.

What are the possible benefits and risks of participating?
This study will help improve our understanding of the models of care currently available to young people with anorexia nervosa in the British Isles and help us to evaluate whether or not increased investment in specialist services is affordable to the NHS and would be of benefit to these young people.
We will collect good quality, real-world evidence of the costs, cost-effectiveness and potential cost-savings associated with different models of community-based care. This should help the NHS to organise services for young people with anorexia nervosa in a way that maximises the benefits to patients and their families, given the funding currently available.
The study aims to support improvements in the organisation of community-based services for anorexia nervosa that may lead to better use of NHS resources, better outcomes for young people, fewer hospital admissions, and less disruption to family, school and social life.
The risks to patients and their families are minimal because they will not be directly involved in the study. Data will be collected from child and adolescent psychiatrists and the information they provide will be anonymised to ensure it is not possible to identify any particular young person.

Where is the study run from?
The study will be led by Professor Sarah Byford at the Institute of Psychiatry, King’s College London. This is a collaborative project involving 12 investigators from a range of organisations (including the NHS, universities and national charities) and covering the British Isles.

When is the study starting and how long is it expected to run for?
The study began in December 2013 and will run until May 2016.

Who is funding the study?
The National Institute for Health Research (NIHR) Health Services and Delivery Research (HS&DR) programme and the Health and Social Care (Northern Ireland) Research & Development Division, UK.

Who is the main contact?
Professor Sarah Byford
s.byford@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sarah Byford

ORCID ID

Contact details

Centre for the Economics of Mental and Physical Health (CEMPH)
Box PO24
Institute of Psychiatry
King’s College London
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0043
s.byford@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/1023/17

Study information

Scientific title

The cost and cost-effectiveness of community-based models of care for child and adolescent anorexia nervosa

Acronym

COSTED

Study hypothesis

1. Assessment and treatment by highly specialist or tertiary specialist community-based eating disorder services for child and adolescent anorexia nervosa (AN) in the British Isles will be less costly to the health service over 18 months than assessment and treatment by or referral via generic (non-specialist) child and adolescent mental health services (CAMHS) or eating disorder teams located within generic community CAMHS.
2. Assessment and treatment by highly specialist or tertiary specialist community-based eating disorder services for child and adolescent AN in the British Isles will be more cost-effective from the health service perspective over 18 months than assessment and treatment by or referral via generic (non-specialist) CAMHS or eating disorder teams located within generic CAMHS.
3. Increasing the availability of highly specialist or tertiary specialist community-based eating disorder services for child and adolescent AN will be cost-saving to the health service over the medium to long term.

Ethics approval

Application in progress with the Health Research Authority (HRA) Confidentiality Advisory Group (CAG) (previously National Information Governance Board for Health and Social Care [NIGB] Ethics and Confidentiality Committee [ECC])

Study design

Observational multi-centre naturalistic surveillance study and decision analytic modelling

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Treatment

Patient information sheet

The data will be collected through the Child and Adolescent Psychiatric Surveillance System from reporting clinicians via clinical records. Patients will not be contacted directly. The ethical approvals we are applying for include approval for the use of patient data without consent and therefore no patient information sheet is needed.

Condition

Child and adolescent anorexia nervosa

Intervention

This is a naturalistic study that will involve mapping alternative models of care provided to young people with anorexia nervosa across the British Isles and the Republic of Ireland. The research will explore the costs and effects of different types of community-based care provided to young people with anorexia nervosa and create a classification of service types available. Whilst classification will form part of the research, we anticipate services will fall into three main categories: generic Child and Adolescent Mental Health Services, specialist Child and Adolescent Mental Health Services and tertiary specialist Child and Adolescent Eating Disorder Service. Observation will take place at baseline, when young people referred to community-based services are notified to us via the Child and Adolescent Psychiatric Surveillance System (CAPPS) and at two follow-up points, 9 months and 18 months after baseline, when data on health service use and health outcomes will be collected. The data will be used to estimate the cost-effectiveness of the different models of care (the effects generated by each model of care in relation to the amount of money spent) and to determine whether increasing the provision of specialist services would be beneficial to young people and their families and good value for money.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Health service use including frequency and length of inpatient admissions and number of hospital or community-based outpatient contacts, and the cost of these services. Measured at baseline, 9 and 18 months after baseline.

Secondary outcome measures

1. Age-adjusted percentage median body mass index (BMI)
2. Health of the Nation Outcome Score for Children and Adolescents (HoNOSCA), a routine outcome measurement tool that assesses behaviours, impairments, symptoms, and social functioning of children and adolescents with mental health problems.
3. Outcome category according to the Morgan and Russell criteria, a widely used measure of outcome for anorexia nervosa.

Outcomes will be measured at baseline, 9 and 18 months after baseline.

Overall trial start date

01/12/2013

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female aged 8 to 18 years
2. In contact with community-based mental health services
3. Meeting diagnostic criteria for anorexia nervosa or eating disorders not otherwise specified that closely resemble anorexia nervosa (EDNOS-AN)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

675

Participant exclusion criteria

We will only exclude those cases of young people whose clinician-reported data is insufficient to assess eligibility

Recruitment start date

01/12/2013

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Centre for the Economics of Mental and Physical Health (CEMPH)
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King’s College London (UK)

Sponsor details

c/o Keith Brennan
Director of Research Management
Room 1.8
Hodgkin Building
Guy’s Campus
London
SE1 1UL
United Kingdom
+44 (0)20 7848 6960
Keith.brennan@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Government

Funder name

The National Institute for Health Research (NIHR) (UK) - Health Services and Delivery Research (HS&DR) programme; 11/1023/17

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Health and Social Care (Northern Ireland) Research & Development Division (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes