Clinical trial NCT06661824: Effect of Aggression Management Care Bundle
Official title: Effect of Using Care Bundle in the Aggression Management of Patients With Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aggression
Keywords: Psychotic disorders
Psychiatric wards
Psychiatric care
Care bundle
Aggression management
Care package
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: In order to keep the clinic, health worker and other conditions that may affect the development of aggression constant, a sequential design was preferred. A single clinic was determined for the study. The care bundle is a clinical tool. Therefore, the interventions begin when the patient is admitted to the clinic and end with discharge. First, the routine care and routine aggression management interventions adopted in the clinic will be applied to the control group. At this stage, the staff and patients are blinded. After the control group sample size determined according to the sample calculation is completed, the experimental group intervention will begin. Training will be given to the clinic nurses regarding the care bundle to be applied. Then, the experimental group will be recruited and the experimental group application will begin.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this sequential randomized controlled experimental design study is to develop an aggression care bundle approach in psychiatric care for patients with psychotic disorders, to use it in a psychiatric clinic, and to evaluate its results. The hypotheses it aims to test are as follows:

1. The aggression management care bundle applied to patients with psychotic disorders in a psychiatric clinic will reduce the risk of developing aggression.
2. The number of aggressive events in the patient group to whom the aggression management care bundle is applied will be less than the control group receiving routine care.
3. The use of restrictive aggression management techniques in the clinic will decrease.
4. The clinical compliance rate of the developed aggression management care bundle will be 95% and above.

Detailed description: Psychopathology plays an important role in the emergence of aggression. Having a diagnosis of psychotic disorder or schizophrenia is an important psychopathology that leads to aggression. For these reasons, aggression and how to manage it is an ongoing problem in psychiatric clinics. The prevalence of aggressive behavior in psychiatric wards varies between 8-76%. The prevalence of aggression in schizophrenia patients is stated as 33.3%. This aggression can be verbal, directed towards objects/spaces, towards oneself or physical aggression towards others. Healthcare professionals in psychiatric wards are exposed to these aggressive events carried out by patients. It is reported that 25-85% of healthcare professionals working in psychiatric wards are exposed to aggressive events; the prevalence of aggression towards nurses varies between 11.4-97.6%. Over the years, some methods have been developed and used to manage aggression in psychiatric wards. Chemical and mechanical restraint and seclusion methods are still the leading methods used. There is a need for alternative and evidence-based interventions based on therapeutic nursing approaches to manage aggression in psychiatric wards, which can be easily adopted and implemented in the clinic. Therefore, it was aimed to develop and use the "care bundle" approach, which has been shown to improve patient outcomes in the literature, for aggression management in psychiatric wards. Care bundles are care tools that target a specific patient population, consist of 3-5 evidence-based approaches, and improve patient outcomes when used together. In this study, it was planned to develop the aggression management care package in phase 1, and evaluate the clinical use of the aggression management care bundle in phase 2. The aggression management care bundle was developed following the guidelines of The Institute for Healthcare Improvement.

Eligibility criteria: Inclusion Criteria:

* Being between 18-65 years of age,
* Being able to speak and understand Turkish,
* Having one of the disorders within the scope of Schizophrenia and psychosis,
* Being newly admitted to Bolu İzzet Baysal Mental Health and Diseases Hospital during the period the research was conducted,
* Having scored 1 point or more on the Broset Violence Checklist or 65 points or more on the Buss-Perry Aggression Questionnaire.

Exclusion Criteria:

* Not being able to give written informed consent,
* Being the first time a patient has been admitted to a psychiatric clinic,
* Having developmental delay or any other significant organic brain pathology.

Primary outcomes:
measure: Change in aggression risk during hospitalization
timeFrame: up to 6 weeks (routine hospitalization period)
measure: Change in aggressive events during hospitalization
timeFrame: up to 6 weeks (routine hospitalization period)
measure: Change in aggression risk during 24 hours
timeFrame: up to 6 weeks (routine hospitalization period)
Secondary outcomes:
measure: care bundle compliance rate
timeFrame: up to 6 weeks (routine hospitalization period)
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Mental Health and Diseases Hospital
state: Bolu Province
Study officials:
affiliation: Bolu Abant İzzet Baysal University
name: Melisa Bulut, RN, PhD cand
role: PRINCIPAL_INVESTIGATOR
References:
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