Outcomes and Discharge of Long-stay Psychiatric Patients (PERDOVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni de Girolamo, M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT01701765
First received: October 3, 2012
Last updated: October 6, 2012
Last verified: October 2012
  Purpose

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.


Condition
Mental Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)

Resource links provided by NLM:


Further study details as provided by IRCCS Centro San Giovanni di Dio Fatebenefratelli:

Primary Outcome Measures:
  • Discharge [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Scores of standardized rating scales [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)

  • Satisfaction assessed with the VSSS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.


Enrollment: 403
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients in residential facilities
All patients staying in September 2010 in 23 medium-long term RFs of the St John of God Order in Northern Italy with a primary psychiatric diagnosis and younger than 65 years recruited.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Psychiatric patients staying in residential facilities.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701765

Locations
Italy
IRCSS Sant'Ambrogio
Cernusco sul Naviglio, Milano, Italy, 20063
IRCCS Sacro Cuore di Gesù
San Colombano al Lambro, Milano, Italy, 20078
IRCCS Presidio Ospedaliero Beata Verigine della Consolata
San Maurizio Canavese, Torino, Italy, 10077
IRCCS Centro san Giovanni di Dio
Brescia, Italy, 20125
Sponsors and Collaborators
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Investigators
Principal Investigator: Giovanni de Girolamo, M.D. IRCCS Centro San Giovanni di Dio Fatebenefratelli
  More Information

Additional Information:
No publications provided by IRCCS Centro San Giovanni di Dio Fatebenefratelli

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giovanni de Girolamo, M.D., M.D., IRCCS Centro San Giovanni di Dio Fatebenefratelli
ClinicalTrials.gov Identifier: NCT01701765     History of Changes
Other Study ID Numbers: 2012-2-PEV
Study First Received: October 3, 2012
Last Updated: October 6, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Centro San Giovanni di Dio Fatebenefratelli:
Severe mental disorders
Discharge
Outcome evaluation

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 30, 2014