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Cost effectiveness of a structured treatment for people with long-term severe non-psychotic disorders


- candidate number14880
- NTR NumberNTR3988
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mei-2013
- Secondary IDs0001 ICPT
- Public TitleCost effectiveness of a structured treatment for people with long-term severe non-psychotic disorders
- Scientific TitleCost effectiveness of a structured treatment for people with long-term severe non-psychotic disorders: design of a multisite cluster randomized trial
- ACRONYMICPT
- hypothesisICPT is more effective in (1) improving patients’ quality of life and social networks, (2) preventing or decreasing professionals’ perception of patients as ‘difficult’, (3) discharging patients to a lower level of care, (4) being less costly in reaching these clinical goals than Care as usual
- Healt Condition(s) or Problem(s) studiedRandomized controlled trial, Efficacy, Cost-effectiveness , Severe mental illness, long-term care, Community mental health care
- Inclusion criteriaParticipants inclusion criteria (patients):
- age between 18-65 years (due to organizational delineations between ‘adults’ between 18 and 65, and ‘elderly’ over 65);
- presence of a non-psychotic psychiatric disorder;
- long-term treatment (>2 years) or high care use (>1 outpatient contact per week or >2 crisis contacts per year or >1 inpatient admission per year) in specialized mental health care.
- Exclusion criteriaParticipants exclusion criteria (patients):
- presence of a psychotic, bipolar I or cognitive disorder;
- lack of skill in understanding of, or communication in Dutch language;
- IQ below 80.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate31-dec-2016
- Target number of participants180
- InterventionsICPT was developed from an empirical study of so-called ‘difficult’ patients, in which it became evident that both patient and professional play an important role in the occurrence of ‘ineffective chronic illness behaviour’. A five-stage heuristic model shows that the 'difficult'-patient label is given by professionals when certain patient characteristics are present and a specific causal attribution about the patient's behaviours is made [18]. The status of 'difficult' patient is easily reinforced by subsequent patient and/or professional behaviour, turning initial unusual elp-seeking behaviour into 'difficult' or ineffective chronic illness behaviour. Furthermore, a lack of resources in the psychiatric service and the patient's social system negatively influence the patient-professional interaction [18]. From this theoretical model we conceptualized a number of stages in the intervention program, each fitting an important step in the theoretical model, resulting in a stage model which fits the patient's level of acceptance of help and cooperation.
- Primary outcomeQuality of life (MANSA)
- Secondary outcomeQuality of life (EQ-5D), costs (TiC-P), therapeutic alliance (STAR), professional-perceived difficulty of patient (DDPRQ), care needs (CANSAS), social contacts (SNM)
- TimepointsTotal treatment period for clients is 18 months; the RCT is 4 years. There is a measurement at baseline, an intermediate measurement (6 months after for baseline-measurement), after intervention period (after an intervention period of 12 months), and a follow-up measurement (6 months after end of intervention). Information will be obtained from different sources (client, professional) using multiple methods (interviews, questionnaires). The same questionnaires will be used in both groups, on all four measuring moments.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Mark Veen, van
- CONTACT for SCIENTIFIC QUERIES Mark Veen, van
- Sponsor/Initiator Social Psychiatry & Mental Health Nursing, University of Applied Science
- Funding
(Source(s) of Monetary or Material Support)
Stichting Innovatie Alliantie (SIA), Ministry of Education, Culture and Science
- Publications
- Brief summaryOBJECTIVE
This study aims for health gain and cost reduction in the care for people with long-term psychiatric disorders. The research questions is what the (cost)effectiveness is of Interpersonal Community Psychiatric Treatment (ICPT), compared to care as usual (CAU).

HYPOTHESIS
ICPT is more effective in (1) improving patients’ quality of life and social networks, (2) preventing or decreasing professionals’ perception of patients as ‘difficult’, (3) discharging patients to a lower level of care, (4) being less costly in reaching these clinical goals than CAU

STUDY DESIGN
Multi-center cluster-randomized clinical trial: participating professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months.

STUDY POPULATION
Patients between 18-65 with non-psychotic disorders who are long-term and/or intensive users of specialty mental health care.

INTERVENTION
ICPT is a structured treatment for people with long-term, often difficult to treat non-psychotic disorders, developed with patients, professionals, and experts. ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study.

OUTCOME MEASURES
Primary: quality of life (MANSA) Secundary: quality of life (EQ-5D), costs (TiC-P), therapeutic alliance (STAR), professional-perceived difficulty of patient (DDPRQ), care needs (CANSAS), social contacts (SNM)

SAMPLE SIZE/DATA ANALYSIS
Based on the primary outcome variable, quality of life (MANSA), and assuming 20-25% attrition we need to include 40 clusters of 6 patients each. Outcomes will be analysed using linear mixed models. All analyses will be performed on the intention-to-treat set.

CEA/BIA
The economic evaluation will be based on the general principles of a cost-effectiveness analysis. Both the cost-utility and cost-effectiveness analysis will be performed from the societal perspective. The BIA will be conducted from 3 perspectives: (1) societal perspective, i.e. including productivity losses, (2) the perspective of the public purse (VWS) (base case), and (3) the perspective of the third party payers.
- Main changes (audit trail)
- RECORD13-mei-2013 - 22-mei-2013


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