Welcome
Support Centre
11 February 2012 
Current Controlled Trials - Clinical Trials
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Introduction
English introduction Introduction en français Deutsche einleitung
Introducción española Introduzione in italiano
 
Find trials
active registers
mental health register
archived registers
all registers
tips on searching
 
 
Information
about mRCT
mRCT FAQs

DISCLAIMER
The site should not be used to diagnose or treat a health problem. Please consult your doctor.
Terms & conditions

DUPLICATION
Your search result may contain a number of different records for the same trial. This occurs when the same trial is listed in more than one register.

[ ...Back to search results ] [ Print-friendly version ]
Feedback of OutCome to Users and Staff
Source of recordUK Trials
ISRCTNISRCTN16971059
Date ISRCTN assigned07/01/2003
Local reference number(s)G108/390
Public titleFeedback of OutCome to Users and Staff
Scientific title
AcronymFOCUS
Disease/condition/study domainMental heath problems
Study hypothesisThe 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)
Design/methodologyRandomised controlled trial
Research ethics reviewNot provided at time of registration.
Countries of trialUnited Kingdom
Participants - inclusion criteriaPatients 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 criteriaDoes not comply with above inclusion criteria
Patient information material
Anticipated start date01/05/2000
Anticipated end date30/06/2005
Status of trialCompleted
Target number of participants160
InterventionsThe 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
PublicationsProtocol 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
Sources of fundingMedical Research Council (UK)
Sponsor nameMedical Research Council (UK)
Sponsor details20 Park Crescent
London
United Kingdom
W1B 1AL
Sponsor telephone+44 (0)20 7636 5422
Sponsor fax+44 (0)20 7436 6179
Sponsor emailclinical.trial@headoffice.mrc.ac.uk
Sponsor websitehttp://www.mrc.ac.uk
Contact nameDr Mike Slade
Contact detailsMRC Clinicial Scientist Fellow
Health Services Research Department
Institute of Psychiatry
Denmark Hill
London
United Kingdom
SE5 8AF
Contact telephone+44 (0)20 7848 0795
Contact fax+44 (0)20 7277 1462
Contact emailm.slade@iop.kcl.ac.uk
More informationFor more up-to-date information please go to the ISRCTN link below.
Link to record in ISRCTN RegisterISRCTN16971059
Date last extracted from ISRCTN register17/04/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2012 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement


BioMed Central