Feedback of OutCome to Users and Staff

ISRCTN	ISRCTN16971059
DOI	https://doi.org/10.1186/ISRCTN16971059
Protocol serial number	G108/390
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Submission date: 07/01/2003
Registration date: 07/01/2003
Last edited: 18/12/2017

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

Dr Mike Slade
Scientific

MRC Clinicial Scientist Fellow
Health Services Research Department
Institute of Psychiatry
Denmark Hill
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0795
Email	m.slade@iop.kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Feedback of OutCome to Users and Staff
Study acronym	FOCUS
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Patient-rated unmet need, as measured using CANSAS-P 2. Quality of life, as measured using MANSA
Key secondary outcome measure(s)	1. Mental health problem severity 2. Symptoms 3. Social disability
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	160
Key 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
Key exclusion criteria	Does not comply with above inclusion criteria
Date of first enrolment	01/05/2000
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

MRC Clinicial Scientist Fellow

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	01/10/2006		Yes	No
Protocol article	protocol	01/01/2002		Yes	No

Editorial Notes

18/12/2017: internal review.