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
Feedback of OutCome to Users and Staff
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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
1. 2002 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/12043430
2. 2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/?term=17012656
Publication citations
-
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.