Outcomes and Discharge of Long-stay Psychiatric Patients

NCT ID: NCT01701765

Last Updated: 2012-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 403 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-01-31

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.

Conditions

Mental Disorders

Keywords

Severe mental disorders; Discharge; Outcome evaluation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro San Giovanni di Dio Fatebenefratelli

OTHER

Sponsor Role: lead

Responsible Party

Giovanni de Girolamo, M.D.

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni de Girolamo, M.D.

Role: PRINCIPAL_INVESTIGATOR

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Locations

IRCCS Centro san Giovanni di Dio

Brescia, 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, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 24582503 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23712514 (View on PubMed)

Related Links

http://www.irccs-fatebenefratelli.it/sito/pagine/fatebenefratelli.php

website of the coordinating centre

Other Identifiers

2012-2-PEV

Identifier Type: -

Identifier Source: org_study_id