Prevention of admission to psychiatric hospital. A randomised controlled trial of service use, health and social care outcomes of a community mental health team intervention specific to dual diagnosis (psychosis and substance misuse) patients

ISRCTN	ISRCTN98891022
DOI	https://doi.org/10.1186/ISRCTN98891022
Protocol serial number	GTCUL
Sponsor	Kings College London (UK)
Funder	Culyer grant. Ref: GTCUL (UK)

Submission date: 07/02/2007
Registration date: 14/03/2007
Last edited: 16/03/2007

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 Graham Thornicroft
Scientific

Health Services and Population Research (PO29)
Institute of Psychiatry, Kings College, London
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom

Phone	+44 (0)207 848 0735
Email	g.thornicroft@iop.kcl.ac.uk

Study information

Primary study design	Interventional
Study design	A cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	COMO (Mental health care for dual diagnosis COMOrbidity)
Study objectives	Outcomes were investigated at both staff and patient levels. At the patient level, the primary hypotheses were that, compared with patients on control group care coordinators caseloads, patients on caseloads of the experimental group key workers, would have: 1. diminished use of in-patient services, reflected in significantly lower bed day use over an 18-month follow-up period 2. reduced alcohol and drug consumption, reflected in lower quantity of alcohol and drugs consumed over the month before interview Secondary hypotheses were that the intervention would also be associated with significantly: 1. diminished levels of homelessness, violence, suicidal behaviour, imprisonment and detention under the Mental Health Act 2. better social functioning, particularly in relation to self care and hostile and aggressive behaviour 3. diminished symptom severity 4. increased adherence to treatment 5. greater satisfaction with services 6. lower overall costs of care Regarding staff, the main hypotheses were that a significant increase: 1. in knowledge about dual diagnosis 2. in substance abuse intervention skills and more positive attitudes to working with this client group would be observed in staff receiving the experimental training and supervision package
Ethics approval(s)	Institute of Psychiatry, Kings College London, Research Ethics Committee, approved in 1999, Ref: 075/99
Health condition(s) or problem(s) studied	Severe and enduring mental illness and comorbid substance abuse or dependence
Intervention	Each cluster consisted of the clients on a particular case managers' caseload. The unit of randomisation was the case manager. The experimental group consisted of case managers (and the service users with dual diagnosis on their case load) who had been randomly allocated to receive training in dual diagnosis interventions and the control group were case managers (and the service users with dual diagnosis on their case load) who had not been allocated to receive training. Case managers in the experimental group received a 5 day training course in detection, assessment and interventions for people with dual diagnosis that aims to increase engagement with care and increase motivation to reduce or abstain from using drugs and alcohol.
Intervention type	Other
Primary outcome measure(s)	Service users: Hospital bed use over the preceding 18 months, including admission to hospitals outside the catchment area on an extra-contractual referral basis. Other service use recorded using the Client Service Receipt Inventory Case managers: Alcohol and Alcohol Problems Perceptions Questionnaire
Key secondary outcome measure(s)	Service users: 1. Current adherence to medication, rated using the Medication Compliance Scale, which yields a single rating for the extent to which the patient is believed to adhere to prescribed medication 2. Stage of treatment rated using the Substance Abuse Treatment Scale (SATS), which yields a single rating of the extent to which a patient with dual diagnosis is motivated for and engaged in substance misuse treatment 3. Met and unmet needs, rated using the Camberwell Assessment of Need Short Assessment Schedule (CANSAS), which elicits ratings of patients needs in 22 social and clinical domains 4. Social functioning, rated using the Life Skills Profile (LSP) 5. Drug and alcohol consumption and associated problems, measured using the section of the Maudsley Addictions Profile (MAP) which records consumption over a month, the Alcohol Use Disorders Identification Test (AUDIT), which screens for alcohol-related problems and may be used to categorise drinking as hazardous or harmful, and the DALI, a screening instrument for problematic drug and alcohol use developed specifically for severely mentally ill populations 6. Service satisfaction, measured by the brief global Client Satisfaction Questionnaire (CSQ-8) and the Treatment Perception Questionnaire, a short instrument developed specifically to assess satisfaction with substance misuse treatment 7. Physical symptoms, rated using the section of the MAP which enquires how often 10 common physical symptoms have been experienced in the past 30 days 8. Psychiatric symptoms, rated using the Brief Psychiatric Rating Scale (extended version)
Completion date	01/09/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	220
Key inclusion criteria	All case managers were invited to participate unless they were temporary staff or had firm plans to leave during the next 18 months. Service user inclusion: a clinical diagnosis (made by psychiatrists and recorded in casenotes) of schizophrenia or schizoaffective disorder (ICD 10 codes F20, F25), delusional disorder and other non-affective psychotic illnesses (F22, F29) or bipolar affective disorder (F31) on the caseloads of participating case managers and in addition a rating of substance "abuse" or "dependence" on the Clinician Alcohol Use Scale (CAUS) and the Clinician Drug Use Scale (CDUS) based on DSMIII-R criteria.
Key exclusion criteria	Case managers excluded if they had immediate plans to leave or be absent for the study period service users were excluded if they had diagnoses other than stated above.
Date of first enrolment	01/09/1999
Date of final enrolment	01/09/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Health Services and Population Research (PO29)

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	01/04/2003		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes