Feedback of OutCome to Users and Staff
| ISRCTN | ISRCTN16971059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16971059 |
| Secondary identifying numbers | G108/390 |
- 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
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 |
|---|---|
| m.slade@iop.kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| 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 | 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 study start date | 01/05/2000 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
MRC Clinicial Scientist Fellow
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2002 | Yes | No | |
| Results article | results | 01/10/2006 | Yes | No |
Editorial Notes
18/12/2017: internal review.
