Clinical trial NCT05932108: Evaluation of the Violence Prevention Initiative TERMA in Forensic Psychiatric Inpatient Care
Official title: Evaluation of the Violence Prevention Initiative TERMA in Forensic Psychiatric Inpatient Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Forensic Nursing
Forensic Psychiatry
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2023-07-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Staff at a forensic psychiatry department. Patients at a forensic psychiatry departmen

Brief summary: The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organizational culture influences the implementation of the TERMA method and the experiences of patients and staff in situations involving threats, violence, and the use of coercive measures.

Detailed description: Overall aim The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organizational culture influences the implementation of the TERMA method and the experiences of patients and staff in situations involving threats, violence, and the use of coercive measures.

Research questions

* To what extent does the implementation of TERMA impact the perceived safety of staff and patients in a forensic psychiatric inpatient setting, as measured by the Perceived Safety Questionnaire (E13)?
* What is the effect of implementing TERMA on the frequency of incidents of aggression and violence, healthcare and occupational injuries, and the use of coercive measures in a forensic psychiatric inpatient setting?
* How does the implementation of TERMA impact the organizational culture of a forensic psychiatric inpatient unit, as measured by changes in perceived safety, incidents of aggression and violence, healthcare and occupational injuries, and the use of coercive measures, as assessed by the Organisations Value Questionnaire (OVQ) questionnaire?
* How do patients perceive threatening and violent situations, exposure to coercive measures, and the implementation of TERMA in a forensic psychiatric inpatient setting?
* What are the attitudes and perceptions of staff towards working with TERMA, how do they respond to threatening and violent situations, and what is the impact of these factors on the work environment in a forensic psychiatric inpatient setting? Introduction Forensic psychiatric care is provided to patients who have been convicted of a crime that was perpetrated while having a severe mental disorder. Severe mental illness is a judicial concept within Swedish law and is not a medical diagnosis. The primary goal of forensic psychiatric care is to rehabilitate the patients so they can be reintegrated into society without risk of committing new crimes. Swedish law states that health care should strive to protect and strengthen the integrity and participation of the patient. This is, however, difficult within forensic psychiatric care, which is not voluntarily, involves mandatory treatment and deprives patients of liberty. Maintaining a therapeutic relationship with patients, while managing their reactions and emotions in high-security wards, can be challenging.

Forensic psychiatric patients are a heterogeneous group, given their various psycho pathologies, criminal histories and risk factors for reoffending. Patients sentenced to forensic psychiatric care are under involuntary care for long periods of time and rehabilitation length of 5-6 years are not unusual. Aggressive and violent behavior among patients is a prevalent occurrence in forensic psychiatry and a hindrance for successful rehabilitation. The complex composition of mental illnesses contributes to an experience of an insecure environment for both patients and healthcare personnel.

There is a need for research on the content and effects of managing aggression and violence. Several methods have been developed to manage and prevent such behaviors. One such method is the Therapeutic Meeting with Aggression (TERMA). It has previously been implemented in inpatient forensic psychiatric care in Sweden but further research is needed in evaluating its usefulness.

Therapeutic meeting with aggression (TERMA) TERMA was developed from the Norwegian Bergen model, with modifications made to align with the Swedish healthcare and legal systems. The primary aim of TERMA is to prevent aggression and violence through a system of low-effective treatment that is divided into escalating levels based on the patient's aggression level, risk of violence, and acts of violence. The TERMA model focuses on treatment, communication, and management of compassionate healthcare in forensic psychiatric settings. The levels of the TERMA model are in a "cascading" order, whereby if the treatment and management of one level are ineffective, the next level is initiated, and so on. The primary level involves the daily behavior and health status of the patient. The secondary level involves risk assessment and violence management, with a focus on creating an understanding of the situation for both the patient and healthcare workers. The tertiary level is utilized when violence cannot be avoided. Each level corresponds to a specific response according to the demands of the situation and environment.

Eligibility criteria: Inclusion Criteria Staff:

* ≥ 18 years of age who
* work in forensic psychiatric inpatient care,
* understand and speak Swedish or English, and are
* willing to participate and sign a consent form.

Exclusion Criteria Staff:

* not willing to participate

Inclusion Criteria Patients:

* ≥ 18 years of age who are
* admitted to forensic psychiatric inpatient care according to the Swedish Forensic Psychiatric Care Act,
* understand and speak Swedish or English,
* have approval to participate from the treating physician, and are
* willing to participate and sign a consent form.

Exclusion Criteria Patients:

* not willing to participate

Primary outcomes:
measure: Perceived Safety Questionnaire (E13)
timeFrame: Change measure (baseline to 6 months)
measure: Perceived Safety Questionnaire (E13)
timeFrame: Change measure (baseline to 1 year)
Secondary outcomes:
measure: Organisations Value Questionnaire (OVQ).
timeFrame: Change measure (baseline to 6 months)
measure: Organisations Value Questionnaire (OVQ).
timeFrame: Change measure (baseline to 1 year)
measure: Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
timeFrame: Baseline
measure: Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
timeFrame: 6 months
measure: Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
timeFrame: 1 year
measure: Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
timeFrame: Baseline (OVQ) and 6 months (E13)
measure: Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
timeFrame: Baseline (OVQ) and 1 year (E13)
measure: Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
timeFrame: Baseline (OVQ) and change in E13 (baseline to 6 months)
measure: Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
timeFrame: Baseline (OVQ) and change in E13 (baseline to 1 year)
measure: Number of coercive measures
timeFrame: From 1 year before baseline to 1 year after study end
measure: Incidence of threat and violence
timeFrame: From 1 year before baseline to 1 year after study end
Other outcomes:
Locations:
Study officials:
affiliation: Västra Götalandsregionen
name: Sara Wallström, PhD
role: PRINCIPAL_INVESTIGATOR
References: