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Feedback of OutCome to Users and Staff
ISRCTN ISRCTN16971059
DOI 10.1186/ISRCTN16971059
ClinicalTrials.gov identifier
EudraCT number
Public title Feedback of OutCome to Users and Staff
Scientific title
Acronym FOCUS
Serial number at source G108/390
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)
Lay summary
Ethics approval Not provided at time of registration.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Mental heath problems
Participants - 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
Participants - exclusion criteria Does not comply with above inclusion criteria
Anticipated start date 01/05/2000
Anticipated end date 30/06/2005
Status of trial Completed
Patient information material
Target number of participants 160
Interventions 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]).
Primary outcome measure(s) 1. Patient-rated unmet need, as measured using CANSAS-P
2. Quality of life, as measured using MANSA
Secondary outcome measure(s) 1. Mental health problem severity
2. Symptoms
3. Social disability
Sources of funding Medical Research Council (UK)
Trial website
Publications 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
Contact name Dr  Mike  Slade
  Address MRC Clinicial Scientist Fellow
Health Services Research Department
Institute of Psychiatry
Denmark Hill
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Tel +44 (0)20 7848 0795
  Fax +44 (0)20 7277 1462
  Email m.slade@iop.kcl.ac.uk
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 07/01/2003
Last edited 20/12/2007
Date ISRCTN assigned 07/01/2003
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