Towards more effective European Community care for patients with severe psychosis

ISRCTN ISRCTN75571732
DOI https://doi.org/10.1186/ISRCTN75571732
Secondary identifying numbers QLG5-CT-2002-01938
Submission date
25/08/2005
Registration date
23/09/2005
Last edited
04/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stefan Priebe
Scientific

Unit for Social and Community Psychiatry
Academic Unit
Newham Centre for Mental Health
London
E13 8SP
United Kingdom

Phone +44 (0)20 7540 4210
Email s.priebe@qmul.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleTowards more effective European Community care for patients with severe psychosis
Study acronymMECCA
Study objectivesThe MECCA study is a cluster randomised controlled trial following the same protocol in community mental health teams in six European countries. The trial tests the hypothesis that the new intervention – as compared to current best standard practice - will lead to a better outcome in terms of quality of life, compliance with medication, needs for care, treatment satisfaction, and the quality of the therapeutic relationship between keyworker and patients with psychotic disorders over a one year period. Changes in psychopathology are not hypothesised to differ between the two groups. The research question regarding costs is purely exploratory.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPsychosis
InterventionKey workers are randomly assigned to either the intervention or treatment as usual condition. Randomisation of key workers will be stratified by professional background (ASW, CPN, psychiatrist etc.) and by the number of patients within each key worker's caseload consenting to participate. Patients would be asked for informed consent prior to their key worker being randomised. Whilst the control group will receive treatment as usual in line with current best practice, the intervention group will, in addition to treatment as usual, receive an innovative intervention. The key worker asks patients about their subjective quality of life, treatment satisfaction and wishes for additional/different support using a brief questionnaire. The questionnaire (MECCA) consists of satisfaction ratings with eight life domains (satisfaction with mental and physical health, accommodation, job situation, leisure activities, friendships, relationship with family/partner, personal safety) and three aspects of treatment (satisfaction with practical help, psychological help and medication). Each satisfaction item will be rated on a 1 to 7 rating scale and followed by a question on whether the patient wishes for additional/different support in the given area reflecting subjective needs for change. The assessment is completed by the key worker and patient every two months. Key workers will enter patients answers onto a laptop or palm top computer using software specifically designed for the project, with patients’ ratings presented in a user-friendly colour display detailing scores on each outcome measure. It is expected that the results will directly feed into the therapeutic dialogue and be discussed by the patient and key worker together. The discussion is intended to address in particular all areas where the patients expressed dissatisfaction and ratings that have changed since the previous assessment.
Intervention typeOther
Primary outcome measureOutcome in the two groups will be compared in a pre-post-design. The primary outcome is quality of life. To assess objective and subjective quality of life, the Manchester Short Assessment of Quality of Life (MANSA) will be used at baseline and follow-up (12 months).
Secondary outcome measuresSubjective outcome criteria include satisfaction with treatment, needs, treatment compliance, assessment of the therapeutic relationship and patient empowerment. Objective outcome criteria are observer rated psychopathology and costs.
Overall study start date01/07/2002
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants480
Key inclusion criteriaInclusion criteria for key workers are a professional qualification in mental
health and a minimum of one-year professional experience in an outpatient setting. Out of the caseload of each key worker patients who fulfil the following criteria will be identified: living in the community and treated as outpatients by community mental health teams; a history of at least 3 months of continuous care in the current service; a diagnosis of functional psychosis according to International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10), i.e. schizophrenia and other psychotic disorders; aged between 18 and 65 years of age; having at least one contact with their key worker every two months; capable of giving informed consent; and sufficient knowledge of the language of the host country.
Key exclusion criteriaLiving in 24 hour supported hostel type of accommodation; severe physical handicap, organic psychiatric illness or primary substance abuse (however, dual diagnosis as such is not an exclusion criterion); expectation of clinicians to discharge the patient from the service within the next 12 months.
Date of first enrolment01/07/2002
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Unit for Social and Community Psychiatry
London
E13 8SP
United Kingdom

Sponsor information

European Commission
Other

DGRTD-F5
Brussels
B-1049
Belgium

Phone +32 2 299 9726
Email research@cec.eu.int
Website http://www.cordis.lu/fp5/
ROR logo "ROR" https://ror.org/00k4n6c32

Funders

Funder type

Other

European Commission (Contract number: QLG5-CT-2002-01938)
Government organisation / National government
Alternative name(s)
European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/07/2002 Yes No
Results article results 01/11/2007 Yes No

Editorial Notes

04/10/2018: Publication reference added.