Evaluation of Excellence in Italy's Residence for Execution of Security Measure (ITAL-EE-REMS)

August 31, 2023 updated by: Felice Carabellese, University of Bari

Evaluation of Excellence in Italy's Residences for Execution of Security Measures

The model of care for forensic psychiatry in Italy was changed by law (Law 81/2014) so that the six legacy secure forensic hospitals (Judicial Psychiatric Hospitals, OPG) were closed and new secure community residences for the execution of security measures (REMS) were opened in each of the 20 regions of Italy. This transition was in place by 2015. This observational study evaluates the health gains for patients both previously in OPGs and those admitted first to REMS. Health gains assessed include recovery measured by symptoms, function, need for therapeutic security and recovery of legal autonomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All those detained in REMS in the twelve month period 2019 to 2020 form the reference population. Samples are assessed for symptom severity (BPRS), global function (GAF), cognitive function (MMSE), risk and protective factors for violence (HCR-20, SAPROF), personality factors (PCL-R), measures of need for therapeutic security (DUNDRUM-1), treatment response relevant to violence and mental illness (DUNDRUM-3) and forensic recovery (DUNDRUM-4).

Outcome measures include violent and challenging behaviour (MOAS), length of stay, conditional (legal) discharge.

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • University of Bari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Residents admitted to Residences for the Execution of Security Measures (REMS) under court orders: found by the court to be partially responsible (Penal Code 89) or completely not criminally responsible (Penal Code 88) for a crime and also found socially dangerous (Penal Code 203).

Description

Inclusion Criteria:

  • admitted to REMS
  • voluntarily consents to participate

Exclusion Criteria:

  • MMSE less than 19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Therapeutic security
assessment of residents in REMS for need for therapeutic security, treatment response relevant to forensic need and forensic recovery.
Other: Treatment as usual (TAU)
the components of treatment as usual (TAU) are summarised and assessed by the items of the DUNDRUM-3: physical health, mental health, substance misuse, problem behaviours, self care and activities of daily living, education occupation and creativity, family and intimacy.
Risk Measures of Need (RISKMON)
assessed symptom severity, risk and protective factors for violence, global function, personality factors.
Other: Treatment as usual (TAU)
the components of treatment as usual (TAU) are summarised and assessed by the items of the DUNDRUM-3: physical health, mental health, substance misuse, problem behaviours, self care and activities of daily living, education occupation and creativity, family and intimacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
violence while in REMS
Time Frame: Date of first, second and third assessments in REMS through study completion, an average of 18 months
MOAS in the intervals between first, second and third assessments in REMS an average of 18 months
Date of first, second and third assessments in REMS through study completion, an average of 18 months
Readmission to REMS
Time Frame: date of discharge from REMS to date of readmission to REMS, if any.
time (days) until readmission to REMS following discharge from REMS an average of 18 months
date of discharge from REMS to date of readmission to REMS, if any.
length of stay in REMS
Time Frame: date of admission to REMS through study completion, an average of 18 months
time (days) from admission to move out of REMS
date of admission to REMS through study completion, an average of 18 months
Functional recovery
Time Frame: Date of first, second and third assessments in REMS through study completion, an average of 18 months
change in GAF over time
Date of first, second and third assessments in REMS through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
conditional discharge
Time Frame: date of assessment to date of conditional discharge an average of 18 months
time (days) from date of assessment to date of conditional discharge
date of assessment to date of conditional discharge an average of 18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: from date of admission to date of death while in REMS, if any up to two years
death while in REMS, if any
from date of admission to date of death while in REMS, if any up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Collaborators

University of Dublin, Trinity College

Investigators

  • Study Director: Felice F Carabellese, MD, University of Bari
  • Principal Investigator: Lia Parente, PsyD, University of Bari
  • Principal Investigator: Harry G Kennedy, MD, University of Dublin Trinity College (TCD)
  • Principal Investigator: Mary Davoren, MD, University of Dublin Trinity College (TCD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

December 3, 2022

Study Completion (Actual)

December 3, 2022

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITAL-EE-REMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In view of the sensitive nature of the data, aggregated anonymised data may be provided to accredited researchers on a case by case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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