Outcomes and Discharge of Long-stay Psychiatric Patients (PERDOVE)
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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 |
|---|
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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) |
- 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)
- 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 |
|---|
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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 |
Psychiatric patients staying in residential facilities.
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| 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 | |
| Principal Investigator: | Giovanni de Girolamo, M.D. | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
More Information
Additional Information:
No publications provided
| 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:
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Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 16, 2013