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

ISRCTN	ISRCTN75841675
DOI	https://doi.org/10.1186/ISRCTN75841675
Protocol serial number	223290
Sponsor	European Commission (Belgium)
Funder	Seventh Framework Programme (HEALTH-2007-3.1-4) (ref: 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

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

Primary study design	Observational
Study design	Multicentre observational longitudinal panel study
Secondary study design	Cohort study
Study type	Participant information sheet
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(s)	Needs (Camberwell Assessment of Need Short Appraisal Schedule [CANSAS]), measured at timepoints t0 - t6
Key secondary outcome measure(s)	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
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
Denmark
Germany
Hungary
Italy
Switzerland

Study participating centre

Ulm University

Günzburg
89312
Germany

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	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
Protocol article	protocol	10/11/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/01/2017: Publication reference added.