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Completed

NCT Number: NCT01701765

Outcomes and Discharge of Long-stay Psychiatric Patients

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Centro san Giovanni di Dio, Brescia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Discharge

    Time frame: 1 year

    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 outcomes

  1. Scores of standardized rating scales

    Time frame: 1 year

    Clinical psychopathology (BPRS), psychosocial functioning (PSP, HONOS, SLOF), Quality of life (WHOQOL, WHOQOL-SRPB, SWBS), physical conditions (PHI)

  2. Satisfaction assessed with the VSSS

    Time frame: 1 year

    Satisfaction with the treatment received assessed with the Verona Service Satisfaction Scale.

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Registry information

Official study title

Epidemiological Study on Outcomes and Discharges of Psychiatric Patients Living in Italian Residential Facilities (PERDOVE)

Acronym: PERDOVE

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 5, 2012
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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