Effect of Aggression Management Care Bundle

NCT06661824 | Completed

• 1 other identifier: AIBU-PSK-MB-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 1.The aggression management care bundle applied to patients with psychotic disorders in a psychiatric clinic will reduce the risk of developing aggression.
2. 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. 3.The use of restrictive aggression management techniques in the clinic will decrease.
4. 4.The clinical compliance rate of the developed aggression management care bundle will be 95% and above.

Conditions

Aggression

Keywords

Psychotic disorders; Psychiatric wards; Psychiatric care; Care bundle; Aggression management; Care package

Outcome Measures

Primary Outcomes (3)

• Change in aggression risk during hospitalization

  The primary outcome 1 measure of the study is change in aggression during hospitalization. Aggression risk will be measured in both groups with scales: Buss-Perry Aggression Questionnaire (BAQ):29-item scale measuring four aggression sub-dimensions on a 5-point Likert scale. Total score: 29-145. Higher scores indicate higher aggression risk. Change in aggression risk will be compared between hospitalization and discharge, and between control and experimental groups.

  up to 6 weeks (routine hospitalization period)

• Change in aggressive events during hospitalization

  The primary outcome 2 measure of the study is change in aggression during hospitalization. Aggressive events will be measured in both groups with this scale: Overt Aggression Scale:Assesses aggression through professional observation. Two sections: Aggressive Behavior and Attempts. Scores: Total Aggression (max 26) and Aggression Score (max 21). Measures severity and frequency of aggressive behavior. Change in aggressive events will be compared between hospitalization and discharge, and between control and experimental groups.

  up to 6 weeks (routine hospitalization period)

• Change in aggression risk during 24 hours

  The primary outcome 3 measure of the study is change in aggression during 24 hours. Aggression risk will be measured in both groups with scale: Broset Violence Checklist (BVC):Estimates 24-hour violence risk in acute psychiatric settings. Six behaviors scored 0 or 1. Total score: 0-6. 0 = low risk, 1-2 = medium risk, \>2 = high risk. Change in aggression risk in during 24 hours will be compared between hospitalization and discharge, and between control and experimental groups.

  up to 6 weeks (routine hospitalization period)

Secondary Outcomes (1)

• care bundle compliance rate

  up to 6 weeks (routine hospitalization period)

Study Arms (2)

Control group (routine care)

NO INTERVENTION

Patients in the control group will be given routine care by clinic nurses. There are aggression management interventions that the clinic has adopted so far. In the face of an aggressive event, 1. contact the patient, 2. notify the physician and perform chemical restraint according to the order, 3. perform mechanical restraint and seclusion according to the patient's condition. The researcher will not be involved and will not intervene at this stage. The same scales will be applied to the patients as the experimental group.

experimental group (aggression management care bundle)

EXPERIMENTAL

The elements of the aggression management care bundle (risk assessment, cognitive remediation training, social skills training, tension reduction techniques, environmental therapy, improving sleep) developed for the experimental group will be applied by the clinical nurses and the researcher. Data will be collected by applying the same scales to the patients as the control group.

Behavioral: Aggression management care bundle

Interventions

Aggression management care bundle BEHAVIORAL

The aggression management care bundle consists of six components. All of these are high-evidence level interventions consisting of behavioral and nursing interventions aimed at managing aggression. These six interventions are: Risk Assessment, Cognitive Remediation Training, Social Skills Training, De-Escalation Techniques, Milieu Therapy, Improving Sleep.

experimental group (aggression management care bundle)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Gender assignment is made according to gender identity. In the hospital, admissions to the psychiatry clinic are made to separate clinics according to the gender of the patient. There are no mixed clinics. Clinic names are male 1, male 2, female 1, female 2, etc.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Mental Health and Diseases Hospital

Bolu, Bolu, 141000, Turkey (Türkiye)

Location

Related Publications (9)

• Ajnakina O, Stubbs B, Francis E, Gaughran F, David AS, Murray RM, Lally J. Hospitalisation and length of hospital stay following first-episode psychosis: systematic review and meta-analysis of longitudinal studies. Psychol Med. 2020 Apr;50(6):991-1001. doi: 10.1017/S0033291719000904. Epub 2019 May 6.

  PMID: 31057129 BACKGROUND

• di Giacomo, E. et al. (2020). Prevalence and Risk Factors of Violence by Psychiatric Acute Inpatients: Systematic Review and Meta-Analysis-A 2019 Update. In: Carpiniello, B., Vita, A., Mencacci, C. (eds) Violence and Mental Disorders. Comprehensive Approach to Psychiatry, vol 1. Springer, Cham. https://doi.org/10.1007/978-3-030-33188-7_10

  BACKGROUND

• Dike CC, Lamb-Pagone J, Howe D, Beavers P, Bugella BA, Hillbrand M. Implementing a program to reduce restraint and seclusion utilization in a public-sector hospital: Clinical innovations, preliminary findings, and lessons learned. Psychol Serv. 2021 Nov;18(4):663-670. doi: 10.1037/ser0000502. Epub 2020 Sep 17.

  PMID: 32940500 BACKGROUND

• Fernandez-Costa D, Gomez-Salgado J, Fagundo-Rivera J, Martin-Pereira J, Prieto-Callejero B, Garcia-Iglesias JJ. Alternatives to the Use of Mechanical Restraints in the Management of Agitation or Aggressions of Psychiatric Patients: A Scoping Review. J Clin Med. 2020 Aug 29;9(9):2791. doi: 10.3390/jcm9092791.

  PMID: 32872463 BACKGROUND

• Gautam S, Gautam M, Yadav KS, Chaudhary J, Jain A. Clinical Practice Guidelines for Assessment and Management of Aggressive and Assaultive Behaviour. Indian J Psychiatry. 2023 Feb;65(2):131-139. doi: 10.4103/indianjpsychiatry.indianjpsychiatry_518_22. Epub 2023 Jan 30. No abstract available.

  PMID: 37063635 BACKGROUND

• Gaynes BN, Brown CL, Lux LJ, Brownley KA, Van Dorn RA, Edlund MJ, Coker-Schwimmer E, Weber RP, Sheitman B, Zarzar T, Viswanathan M, Lohr KN. Preventing and De-escalating Aggressive Behavior Among Adult Psychiatric Patients: A Systematic Review of the Evidence. Psychiatr Serv. 2017 Aug 1;68(8):819-831. doi: 10.1176/appi.ps.201600314. Epub 2017 Apr 17.

  PMID: 28412887 BACKGROUND

• Huckshorn KA. Reducing seclusion restraint in mental health use settings: core strategies for prevention. J Psychosoc Nurs Ment Health Serv. 2004 Sep;42(9):22-33. doi: 10.3928/02793695-20040901-05.

  PMID: 15493493 BACKGROUND

• Kernaghan K, Hurst K. Reducing violence and aggression: a quality improvement project for safety on an acute mental health ward. BMJ Open Qual. 2023 Dec 28;12(4):e002448. doi: 10.1136/bmjoq-2023-002448.

  PMID: 38154818 BACKGROUND

• Lavallee JF, Gray TA, Dumville J, Russell W, Cullum N. The effects of care bundles on patient outcomes: a systematic review and meta-analysis. Implement Sci. 2017 Nov 29;12(1):142. doi: 10.1186/s13012-017-0670-0.

  PMID: 29187217 BACKGROUND

Related Links

• IHI The Institute for Healthcare Improvement. (2012). What is a bundle?
• Resar R, Griffin FA, Haraden C, Nolan TW. Using Care Bundles to Improve Health Care Quality. IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement; 2012.

MeSH Terms

Conditions

Aggression; Psychotic Disorders

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Melisa Bulut, RN, PhD cand

  Bolu Abant İzzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients and nurses do not know which group they are in, or which experimental or control groups they are in. The first tests were taken after patient consent to ensure blinding, but without assignment to groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 28, 2024
• Study Start: July 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)