Outcomes and Discharge of Long-stay Psychiatric Patients

Mental Disorders Clinical Trial

— PERDOVE  

Official title:

Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701765
• Other study ID #: 2012-2-PEV
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: October 6, 2012
• Start date: September 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2012
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

An increasing number of severely ill patients require long-term care in non-hospital Residential Facilities (RFs). Despite the magnitude of this development, only a few detailed longitudinal studies on fairly larger samples of residents have provided important information about this population. The PERDOVE study is the first study carried out in Italy aimed at obtaining comprehensive data about the course and outcome of patients living in RFs, and test whether discharge to independent accommodations is a real option for many patients. The major aims are three: (1) to describe the sociodemographic, clinical, and treatment-related characteristics of patients treated in RFs during an index period in 2010; (2) to identify predictors, and characteristics associated to discharge at 1-year follow-up; and (3) to evaluate clinicians' predictions about the likelihood of home discharge for each individual patient. The primary endpoint was discharge within one year as a measure of good outcome. The PERDOVE study is an observational cohort study, involving 23 RFs all belonging to the St John of God Order, located in Northern Italy. The first step involves the evaluation of all RFs with a Structure Schedule, which assesses the following areas: logistics structure, general organization: internal rules, meals, clothing and personal hygiene; staff and users' characteristics and meetings, documentation system and evaluation activities; rehabilitative activities provided inside the RF itself. In the second step a research assistant completed a standardised assessment of each resident with the manager and staff; clinical diagnoses were made by treating clinicians. A number of standardised instruments were administered. At one year follow-up, changes in clinical and life conditions of the patients were evaluated and selected rating scales were administered again. For patients discharged to the community or to other RFs, a research assistant contacted the patient's psychiatrist and asked him/her to fill out the follow-up documentation. With regard to residents' discharge, investigators hypothesised that the likelihood of community discharge would be associated both with the level of social support outside the facilities, and with the degree of patients' psychological and social impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• psychiatric diagnosis

• age < 65

• staying in september 2010 in any of 23 RFs located in Northern Italy

Exclusion Criteria:

• elderly patients (over 65 yrs)

• primary diagnosis of organic mental disorder

• refusal of signing an informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
Italy	IRCCS Centro san Giovanni di Dio	Brescia
Italy	IRCSS Sant'Ambrogio	Cernusco sul Naviglio	Milano
Italy	IRCCS Sacro Cuore di Gesù	San Colombano al Lambro	Milano
Italy	IRCCS Presidio Ospedaliero Beata Verigine della Consolata	San Maurizio Canavese	Torino

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro San Giovanni di Dio Fatebenefratelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discharge	Percentage of patients discharged home one year after the baseline assessment compared to patients staying in the same residential facility or transferred to other institutions (e.g., other residential facilities, nursing homes, jails, etc)	1 year	No
Secondary	Scores of standardized rating scales	Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)	1 year	No
Secondary	Satisfaction assessed with the VSSS	Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.	1 year	No

External Links

•   website of the coordinating centre