Condition category
Mental and Behavioural Disorders
Date applied
07/01/2003
Date assigned
07/01/2003
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mike Slade

ORCID ID

Contact details

MRC Clinicial Scientist Fellow
Health Services Research Department
Institute of Psychiatry
Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0795
m.slade@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G108/390

Study information

Scientific title

Acronym

FOCUS

Study hypothesis

The FOCUS Study will test three hypotheses:
1. Baseline level of patient-rated unmet need will predict follow-up level of quality of life
2. The routine collection and feedback of outcome information for seven months will lead to 1.0 fewer patient-rated unmet needs, as measured using Camberwell Assessment of Need Short Appraisal Schedule - Patient version (CANSAS-P)
3. The routine collection and feedback of outcome information for seven months will lead to an increase of 0.25 points in quality of life, as measured using the Manchester Short Assessment (MANSA)

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Mental heath problems

Intervention

The measures that will be used for routine collection and feedback are:
1. The Manchester Short Assessment of Quality of Life (MANSA) (Priebe et al, 1999, see Abstract on PMID: 10443245)
2. The Camberwell Assessment of Need Short Appraisal Schedule (CANSAS) (Slade et al, 1999, The Camberwell Assessment of Need, London: Gaskell)
3. The Helping Alliance Scale (HAS) (Priebe & Gruyters, 1993, see Abstract on PMID: 8245923)
4. The Threshold Assessment Grid (TAG) (Slade et al, 2000, see Abstract on PMID: 10784370)

The staff-completed measures will be TAG, HAS-S and CANSAS-S. According to guidance notes, each completion should take 6 - 11 minutes. The patient-completed measures will be MANSA, HAS-P and CANSAS-P, and completion should take 8 - 13 minutes. The intention is that comparison of the HAS assessments will focus staff and patient on the process of care, comparison of CANSAS assessments will increase collaboration and negotiation, and feedback of the MANSA and TAG assessments will lead to an increased focus on desirable outcomes.

The intervention comprises asking staff and patients each to complete an outcome assessment form every month for six months, with identical feedback provided to both people every three months.

Staff and patients will be asked to complete monthly assessments and will receive three monthly feedback. The intervention will last six months, and follow-up assessments will be made one month later.

Evaluation:
Follow-up is at seven months. The routinely collected data will also be used to investigate the effectiveness of the intervention, supplemented by extra data collected at baseline and follow-up. All measures completed as part of the intervention will be assessed at baseline and follow-up, including the objective questions from MANSA and the qualitative questions from HAS. In addition, the Brief Psychiatric Rating Scale (BPRS) (Overall & Gorham: Psychopharmacol Bull 1988, 24:97-99) will be used to assess symptomatology and the Health of the Nation Outcome Scale (HoNOS) (Wing et al, 1998, see Abstract on PMID: 9534825) will be used to assess social disability in more detail than the ROA measures. To identify changes in the content of care, an assessment of the care actually received will be needed. This will be assessed using the Client Service Receipt Inventory (CSRI) (Beecham & Knapp, 1992 [Costing psychiatric interventions. In Measuring mental health needs edited by Thornicroft G, Brewin C, Wing J. London: Gaskell, 1992:163-183]), which assesses services received over the last 6 months. Since there is emerging evidence of Intelligence Quotient (IQ) as a predictor of response to different service models (Hassiotis et al, 2001, see Abstract on PMID: 11157431), intellectual functioning will be measured at baseline using the National Adult Reading Test (NART) Second Edition (Nelson, 1982 [In National Adult Reading Test {NART}: Test Manual. Windsor: NFER-Nelson]).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Patient-rated unmet need, as measured using CANSAS-P
2. Quality of life, as measured using MANSA

Secondary outcome measures

1. Mental health problem severity
2. Symptoms
3. Social disability

Overall trial start date

01/05/2000

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be included who meet all three of the following criteria:
1. Patient is on the caseload of an adult mental team in Croydon on 1 May 2001
2. Patient has been on the caseload for at least three months
3. Patient is aged between 18 and 65 inclusive

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

Does not comply with above inclusion criteria

Recruitment start date

01/05/2000

Recruitment end date

30/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinicial Scientist Fellow
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Protocol in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids= 12043430

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17012656

Publication citations

  1. Results

    Slade M, McCrone P, Kuipers E, Leese M, Cahill S, Parabiaghi A, Priebe S, Thornicroft G, Use of standardised outcome measures in adult mental health services: randomised controlled trial., Br J Psychiatry, 2006, 189, 330-336, doi: 10.1192/bjp.bp.105.015412.

Additional files

Editorial Notes