Clinical trial NCT01701765: Outcomes and Discharge of Long-stay Psychiatric Patients
Official title: Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Keywords: Severe mental disorders
Discharge
Outcome evaluation
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatric patients staying in residential facilities.

Brief 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.


Eligibility 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

Primary outcomes:
measure: Discharge
timeFrame: 1 year
Secondary outcomes:
measure: Scores of standardized rating scales
timeFrame: 1 year
measure: Satisfaction assessed with the VSSS
timeFrame: 1 year
Other outcomes:
Locations:
city: Cernusco sul Naviglio
country: Italy
facility: IRCSS Sant'Ambrogio
state: Milano
city: San Colombano al Lambro
country: Italy
facility: IRCCS Sacro Cuore di Gesù
state: Milano
city: San Maurizio Canavese
country: Italy
facility: IRCCS Presidio Ospedaliero Beata Verigine della Consolata
state: Torino
city: Brescia
country: Italy
facility: IRCCS Centro san Giovanni di Dio
Study officials:
affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
name: Giovanni de Girolamo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lanfredi M, Candini V, Buizza C, Ferrari C, Boero ME, Giobbio GM, Goldschmidt N, Greppo S, Iozzino L, Maggi P, Melegari A, Pasqualetti P, Rossi G, de Girolamo G; PERDOVE group. The effect of service satisfaction and spiritual well-being on the quality of life of patients with schizophrenia. Psychiatry Res. 2014 May 15;216(2):185-91. doi: 10.1016/j.psychres.2014.01.045. Epub 2014 Feb 6.
citation: de Girolamo G, Candini V, Buizza C, Ferrari C, Boero ME, Giobbio GM, Goldschmidt N, Greppo S, Iozzino L, Maggi P, Melegari A, Pasqualetti P, Rossi G. Is psychiatric residential facility discharge possible and predictable? A multivariate analytical approach applied to a prospective study in Italy. Soc Psychiatry Psychiatr Epidemiol. 2014 Jan;49(1):157-67. doi: 10.1007/s00127-013-0705-z. Epub 2013 May 28.