Clinical decision making and outcome in routine care for people with severe mental illness

ISRCTN	ISRCTN75841675
DOI	https://doi.org/10.1186/ISRCTN75841675
Secondary identifying numbers	223290

Submission date: 11/08/2010
Registration date: 15/09/2010
Last edited: 25/01/2017

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

Study website

Contact information

Dr Bernd Puschner
Scientific

Ulm University
Department of Psychiatry II
Ludwig-Heilmeyer-Str. 2
Günzburg
89312
Germany

Phone	+49 (0)8221 962 866
Email	bernd.puschner@bkh-guenzburg.de

Study information

Study design	Multicentre observational longitudinal panel study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Can be found at http://www.cedar-net.eu
Scientific title	Clinical decision making and outcome in routine care for people with severe mental illness: a multicentre observational longitudinal study
Study acronym	CEDAR
Study objectives	The main objective of this project is to develop a methodology to assess the scope and quality of clinical decisions in the care of people with severe mental illness (SMI) from both the patient and clinician perspective, and to specify how and to what degree clinical decision making (CDM) in routine care affects patient behaviour and short- and long-term treatment outcome. The main study hypotheses are: 1. The quality of CDM is positively related to treatment outcome in the routine care of people with SMI 2. The quality of CDM can be adequately described by taking into account decision making styles, satisfaction with decision making, and type of decision making ("paternalistic" versus "shared" versus "informed") 3. Actual CDM in routine care depends on the context, i.e. varies for different kinds of decisions and is susceptible to change over time 4. The relation between quality of CDM and outcome is affected by a number of covariates
Ethics approval(s)	Ulm University Ethics Commission, 15/12/2008, ref: 241/08
Health condition(s) or problem(s) studied	Severe mental illness
Intervention	Before the start of recruitment, specific instruments were developed to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Together with established instruments to assess outcome, these are being put to use in the longitudinal study in order to examine the study hypothesis. Total duration of observation per subject is 12 months.
Intervention type	Other
Primary outcome measure	Needs (Camberwell Assessment of Need Short Appraisal Schedule [CANSAS]), measured at timepoints t0 - t6
Secondary outcome measures	1. Quality of life (Manchester Short Assessment of Quality of Life [MANSA]), measured at timepoints t0 - t6 2. Service use (Client Sociodemographic and Service Receipt Inventory - European version [CSSRI]), measured at timepoints t0 and t6 3. Symptomatic impairment (Health of the Nation Outcome Scales [HoNOS] and Outcome Questionnaire [OQ-45]), measured at timepoints t0 and t6
Overall study start date	01/11/2009
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	560
Key inclusion criteria	1. Adult, aged 18 - 60 years at intake, either sex 2. Main diagnoses mental disorder of any kind established by case notes or staff communication using Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (SCID) criteria 3. Presence of severe mental illness based upon validated criteria including symptom severity (Threshold Assessment Grid [TAG] greater than or equal to 5) and illness duration (greater than or equal to 2 years) 4. Expected contact with mental health services (excluding inpatient services) during the time of study participation 5. Sufficient command of the host country's language 6. Capable of giving informed consent
Key exclusion criteria	1. Main diagnosis of mental retardation, dementia, substance use or organic brain disorder 2. Cognitive impairment severe enough to make it impossible to give meaningful information on study instruments 3. Treatment by forensic psychiatric services
Date of first enrolment	01/11/2009
Date of final enrolment	31/10/2011

Locations

Countries of recruitment

Denmark
Germany
Hungary
Italy
Switzerland
United Kingdom

Study participating centre

Ulm University

Günzburg
89312
Germany

Sponsor information

European Commission (Belgium)
Government

Research Directorate General
Directorate F2 - Public Health
CDMA 2/30
Brussels
1049
Belgium

Website	http://cordis.europa.eu/fp7/health/
"ROR"	https://ror.org/00k4n6c32

Funders

Funder type

Government

Seventh Framework Programme (HEALTH-2007-3.1-4) (ref: 223290)
Government organisation / National government

Alternative name(s): EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

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	Peer reviewed?	Patient-facing?
Protocol article	protocol	10/11/2010	Yes	No
Results article	results	04/02/2013	Yes	No
Results article	results	01/02/2015	Yes	No
Results article	results	01/03/2015	Yes	No
Results article	results	01/05/2015	Yes	No
Results article	results	23/01/2017	Yes	No

Editorial Notes

25/01/2017: Publication reference added.