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The Medical Psychiatric Unit (MPU) of the Erasmus MC: a randomized study of effectiveness and costs

The Medical Psychiatric Unit (MPU) of the Erasmus MC: a randomized study of effectiveness and costs - protocol RCT MPU

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46312
Enrollment
146
Registered
2019-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elke mogelijke psychische aandoening in combinatie met elk soort somatische aandoening a behavioral problem together with a physical illness a psychiatric problem together with physical suffering

Interventions

The study design is a randomized clinical trial, where treatment in the MPU is compared with CAU.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who are eligible for inclusion in the study are: Patients with a somatic indication for admission and a psychiatric or behavioral problem that hampers the treatment of the somatic condition, making treatment in a regular department in the hospital or psychiatric hospital difficult

Exclusion criteria

Exclusion criteria: * Patients without indication for somatic treatment * Patients with somatic problems that can only be treated at a high or intensive (coronary) care unit * Patients who require strict isolation in a slothed box. Such a facility is not present on the MPU. * Minors

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is a decrease in disruptive behavior as measured by a newly developed observation list, the Inpatient Disruptive Behavior Index (InDiBI).

Secondary

MeasureTime frame
* Costs and care use: file research and 'micro-costing' methods. * Quality of life: EQ-5D-5L. * Perception and safety of the care provided: patients and caregivers are given a single question with the responses on a three-point scale. In addition, there is a qualitative evaluation among nursing and medical staff, caregivers and patients using semi-structured interviews. * Burden for informal carers: caregiver strain index * Quantity and quality of the interventions used: adherence to treatment protocols suicidality and delirium, freedom-limiting interventions, medication use, calamities / incidents as described under Serious Adverse Events ((S) AEs, section 10.2 of the protocol * Physical and mental health: morbidity and mortality: file research, modified early warning score, Charlson Comorbidity Index, Global Assessment of Functioning (GAF score), Clinical Global Impression (CGI) and the Suicidal Affect Behavior Cognition Scale (SABCS). * Disruptive behavior as experienced by evaluation among nursing and medical staff: qualitative interviews. * Interference of the somatic treatment by the psychiatric condition or behavioral problems: four-point scale to be completed by medical and nursing staff.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)