Condition category
Mental and Behavioural Disorders
Date applied
16/03/2015
Date assigned
25/03/2015
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Mental disorders affect 38.2% of the EU population. For reducing the associated burden, countries across Europe have been engaging in costly reforms of mental health care organisation. Reforms focus on one controversial core question: should mental health care systems be functional or integrated? In functional systems, separate clinicians and teams in different services are in charge of either inpatient or outpatient community care. This is also known as specialisation. In integrated systems, the same clinicians and teams are responsible for the patient throughout inpatient and outpatient care. So far, there is no sound research evidence to inform the debate regarding which system is best. This has far reaching implications for policy decisions. The aim of this study is to compare the performance and cost-effectiveness of the functional and integrated systems of mental health care in Europe. It will look at clinical and social outcomes and also the patient quality of life, satisfaction with care, safety and cost-effectiveness of care. We will also establish how patients and clinicians experience integrated and functional mental health care. To help us understand the results of the study, we will analyse policy documents on organisation of mental health care in each country. At the end of the study, guidelines for policy-making will be produced, specifying in what context and for which patient groups functional or integrated systems are preferable.

Who can participate?
Adults (aged at least 18) diagnosed with a mental disorder and hospitalised in a psychiatric inpatient unit.

What does the study involve?
Eligible patients are asked about their experience of hospital care, and provide consent for the researcher to access their medical records. Some of the patients are treated via functional systems of health care. Others are treated using integrated systems of health care. Each patient is contacted again 12 months later to assess the results of their treatment. Throughout the study, we work as a multi-disciplinary team (psychiatrists, psychologists, nurses, sociologists, public health experts, health economists) and follow-up at least 6000 patients with major mental disorders. This includes people with psychosis, depressive and anxiety disorders.

What are the possible benefits and risks of participating?
COFI addresses a research question which is of key importance for shaping the future organisation of mental health services and provision of mental health care. We will be able to establish which system of mental health care works best in terms of reduction of hospitalisation, improvement of social outcomes and safety and quality of care. Patients participating in the study and rating their experience of treatment may benefit as evidence suggests that assessing patient satisfaction with treatment may result in improvements. No risks related to participation are identifiable. COFI is not testing new interventions and does not investigate medicinal products. There will be no additional interventions and routine care will not be altered in any way because of a patient’s participation in COFI.

Where is the study run from?
Six different hospitals from Belgium, Germany, Italy, Poland and the UK.

When is the study starting and how long is it expected to run for?
February 2014 to January 2018

Who is funding the study?
European Seventh Framework Programme

Who is the main contact?
Professor Stefan Priebe
s.priebe@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stefan Priebe

ORCID ID

http://orcid.org/0000-0001-9864-3394

Contact details

Unit for Social and Community Psychiatry
WHO Collaborating Centre for Mental Health Services Development
Queen Mary University of London
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 7540 4210
s.priebe@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Comparing policy framework, structure, effectiveness and cost-effectiveness of functional and integrated systems of mental health care

Acronym

COFI

Study hypothesis

Throughout Europe, countries are seeking to improve the organisation of mental health care with often radical reforms. These reforms are associated with far reaching changes for the national health care systems and consume large amounts of funding. Yet, the reforms are inconsistent, and all policies are currently made in the absence of any sound scientific evidence. These reforms focus on one central and controversial issue:
Should mental health care systems be functional or integrated?
The two systems can be summarised as:
1. Functional systems: care is provided by separate staff in distinct services, and the transition between services is coordinated through a network of regulated referrals;
2. Integrated systems: care is provided by the same mental health staff across different services who co-ordinate all interventions.
The overall aim of COFI is to compare the effectiveness and cost-effectiveness of the functional and integrated systems of mental health care in Europe through the use of a natural experiment. The comparison will consider clinical and social outcomes (re-hospitalization rates, symptom levels, social situation) as key performance indicators (KPIs), as well as patients’ quality of life, satisfaction with care, safety and cost-effectiveness of care. Different patients subgroups defined by diagnosis, age, gender, socio-economic and migrant status, and physical comorbidities will be investigated.

Ethics approval

Ethical approval has been obtained in all five countries where the study is being conducted:
1. England: NRES Committee North East - Newcastle & North Tyneside 2, 04/06/2014, ref: 14/NE/1017
2. Belgium: Comité d'Ethique hospitalo-facultaire des Cliniques St-Luc (Ethical Committee for the hospital and faculty of the St-Lucas Clinic), 29/09/2014
3. Germany: Ethical board at the Technische Universität Dresden (Ethikkommission an der Technischen Universität Dresden), 12/05/2014
4. Italy:
4.1. Comitato Etico per la sperimentazione clinica (CESC) delle provincie di Verona e Rovigo– Ethics committee for clinical research of the districts of Verona and Rovigo, 27/08/2014.
4.2. Comitato Etico per le sperimentazioni cliniche (CESC) della provincia di Vicenza –
Ethics committee for clinical research of the district of Vicenza, 14/10/2014
4.3. Comitato Etico per le sperimentazioni cliniche (CESC) della provincia di Treviso – Ethics committee for clinical research of the district of Treviso, 10/10/2014
4.4. Comitato Etico per le sperimentazioni cliniche (CESC) della provincia di Padova – Ethics committee for clinical research of the district of Padova, 17/12/2014
4.5. Poland: Komisja Bioetyczna przy Instytucie Psychiatrii i Neurologii w Warszawie (Bioethics Committee at the Institute of Psychiatry and Neurology in Warsaw), 04/09/2014

Study design

The study is a multisite (multi-country) natural experiment comparing the effectiveness and cost-effectiveness of integrated and functional systems of mental health care.

Primary study design

Observational

Secondary study design

Natural experiment

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Serious mental illness (ICD-10 codes F2 to F4)

Intervention

Two types of mental health systems, co-existing in the participating countries, will be compared in a natural experiment:
1. In integrated systems, after hospital admission the same clinician (psychiatrist, psychologist, nurse, social worker or occupational therapist) is in contact, in face-to-face meetings, with the patient for outpatient treatment after discharge. Thus, there is personal continuity in the treatment of the patient across inpatient and outpatient care.
2. In functional systems, after hospital admission other clinicians are in contact with the patient for outpatient treatment after discharge. Thus, there is no personal continuity in the treatment of the patient across inpatient and outpatient care.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Re-hospitalisation rates

Secondary outcome measures

1. Clinical outcomes: number of re-hospitalisations, compulsory re-hospitalisations, community treatment orders and yearly inpatient bed days.
2. Social outcomes: employment, accommodation, living situation, friendships, total social contacts, perceived socio-economic status and experienced discrimination.
3. Safety of care: deaths, completed suicides, serious assaults committed by patients, physical violence experienced by patients, suicide attempts, serious side effects from treatment requiring hospitalisation.
4. Costs of care: costs related to the use of inpatient services, outpatient services, day centres and other community health services.
5. Patient reported outcomes: subjective quality of life, satisfaction with care.
6. Quality of care: therapeutic alliance, continuity of care, clinical decision making processes and adherence of interventions received by patients to guidelines.

Overall trial start date

01/02/2014

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years of age or older of any gender
2. Diagnosis of psychotic disorder (F20-29), affective disorder (F30-39) or anxiety disorder (F40-49)
3. Being hospitalised in a psychiatric inpatient unit
4. Sufficient command of the language of the host country to provide written informed consent and understand the questions in the research interviews
5. Capacity to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6000

Participant exclusion criteria

1. Diagnosis of organic brain disorders
2. Too severe cognitive impairment for providing meaningful information on the study instruments

Recruitment start date

01/10/2014

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Belgium, Germany, Italy, Poland, United Kingdom

Trial participating centre

Queen Mary University of London
Mile End Road
London
E1 4NS
United Kingdom

Trial participating centre

Universite Catholique De Louvain (UCL)
Place De L'Universite
Louvain-La-Neuve
1348
Belgium

Trial participating centre

Technische Universitaet Dresden (TUD)
Fetscherstrasse
Dresden
01069
Germany

Trial participating centre

Universitá Degli Studi Di Verona (UNIVR)
Via Dell' Artigliere 8
Verona
37129
Italy

Trial participating centre

Institute Of The Psychiatry And Neurology (IPIN)
Sobieskiego
Warsaw
-
Poland

Trial participating centre

King's College London (KCL)
Strand
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Mile End Road
London
E1 4NS
United Kingdom
+44 (0)20 7882 7250
sponsorsrep@barts.nhs.uk

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26608634

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added. 18/11/2015: The following changes were made to the trial record: 1. The target number of participants was changed from 5888 to 6000. 2. The recruitment end date was changed from 30/09/2015 to 31/12/2015.