The primary goal is to investigate whether treatment on the MPU leads to a reduction of 'disruptive behavior' compared to CAU. Secondary goals are: to investigate whether treatment at the MPU influences the costs of care for patients,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
elke mogelijke psychische aandoening in combinatie met elk soort somatische aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* 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.
Background summary
Many hospitalized patients have psychiatric comorbidity or behavioral problems.
Behavioral problems can hinder somatic treatment and are a burdenfor
caregivers, staff and other patients. These behavioral problems can be called
'disruptive behavior'. Medical Psychiatric Units (MPUs) are departments that
treat patients with combined severe somatic and psychiatric suffering.
Important goals of MPUs are 1) improving quality and safety of care and 2)
effective care. Research into the effectiveness and cost-effectiveness of MPUs
is scarce, often observational in nature and concerns the quantity and quality
of the care process. Research into the outcomes of care is also scarce. In
particular, there is no research into one of the primary goals of an MPU,
namely a decrease of 'disruptive behavior'. It is therefore still an open
question whether disruptive behavior can indeed be treated more effectively in
an MPU.
The MPU at Erasmus MC focuses on the short-term treatment of disruptive
behavior in patients who have been hospitalized because of a serious physical
illness. In a randomized study, this MPU will be compared with care as usual
(CAU): a 'consultative psychiatric team' either in consultation or as
co-therapist in a medical ward. This CAU is the current form of treatment for
these patients at Erasmus MC. The hypothesis is that 'disruptive behavior' at
the MPU is dealt with more effectively and that therefore the disruptive
behavior in the MPU condition will decrease earlier and / or more than with
CAU.
Study objective
The primary goal is to investigate whether treatment on the MPU leads to a
reduction of 'disruptive behavior' compared to CAU. Secondary goals are: to
investigate whether treatment at the MPU influences the costs of care for
patients, quality of life, experience and safety of the care provided, as
preceived by patients and their environment, the burden for caregivers, the
quantity and quality of the interventions used by practitioners regarding the
behavioral problems and the effects on the physical and psychological health of
the patients, disruptive behavior as perceived by nursing and medical staff.
Study design
Phased, randomized clinical trial. The randomization is adjusted to the demand:
only when a waiting list is created, patients will be randomized. This prevents
the frustration that patients are rejected for the MPU while there are beds
available.
Intervention
The study design is a randomized clinical trial, where treatment in the MPU is
compared with CAU.
Study burden and risks
Risks
Moving patients to the MPU could cause an increase in psychiatric or behavioral
discomfort because the patients are moved, and because the environment is less
'normal'. That is conceivable, but also unlikely: The MPU is designed to manage
behavioral and psychiatric disruptions. The expectation is therefore that this
risk will be minimal and that not only the psychiatric or behavioral symptoms
will decrease compared to CAU.
A second risk is that patients do not receive the optimal somatic treatment
because they are no longer in the somatic ward in question. That is also
conceivable, but unlikely: at the MPU, the internist is the main physician,
regardless of the specialist treatment that the patient undergoes. The
referring specialist remains in co-treatment and is therefore always involved.
In addition, the MPU is designed to provide complex somatic care.
Benefits
It is expected that patients, caregivers and employees will experience greater
satisfaction with treatment of patients in the MPU, because this unit is better
equipped to handle disruptive behavior. Therefore, patients will probably feel
more 'understood' and ,as a result, can be treated better.
doctor molewaterplein 40
rotterdam 3015 GD
NL
doctor molewaterplein 40
rotterdam 3015 GD
NL
Listed location countries
Age
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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL68431.078.18 |