Outcomes and Discharge of Long-stay Psychiatric Patients

NCT01701765 | Completed DMC

• 1 other identifier: 2012-2-PEV
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Scores of standardized rating scales

  1 year

• Satisfaction assessed with the VSSS

  1 year

Study Arms (1)

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 Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Psychiatric patients staying in residential facilities.

You may qualify if:

• psychiatric diagnosis
• age \< 65
• staying in september 2010 in any of 23 RFs located in Northern Italy

You may not qualify if:

• elderly patients (over 65 yrs)
• primary diagnosis of organic mental disorder
• refusal of signing an informed consent

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (4)

IRCCS Centro san Giovanni di Dio

Brescia, Brescia, 20125, Italy

Location

IRCSS Sant'Ambrogio

Cernusco sul Naviglio, Milano, 20063, Italy

Location

IRCCS Sacro Cuore di Gesù

San Colombano al Lambro, Milano, 20078, Italy

Location

IRCCS Presidio Ospedaliero Beata Verigine della Consolata

San Maurizio Canavese, Torino, 10077, Italy

Location

Related Publications (2)

• 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.

  PMID: 24582503 DERIVED

• 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.

  PMID: 23712514 DERIVED

Related Links

• website of the coordinating centre

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Giovanni de Girolamo, M.D.

  IRCCS Centro San Giovanni di Dio Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

IT (4)