Clinical Trial: Integrated Care in Psychotic Disorders With Severe Mental Illness

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Integrated Care in Patients With a Psychotic Disorder Fulfilling Definition of Severe Mental Illness (ACCESS-II Study)

Brief Summary: The study examine the effectiveness of an integrated care program including therapeutic assertive community treatment (ACT) for people with psychotic disorders fulfilling severe and persistent mental illness (SPMI, ACCESS-II study).

Detailed Summary:

The trial is carried out at the Psychosis Center of the Department of Psychiatry and Psychotherapy at the University Medical Center Hamburg-Eppendorf (UKE), which has the responsibility to treat all adult psychosis patients within its catchment area of approximately 300.000 habitants.

The IC model was implemented into a network of the Psychosis Center of the University hospital (UKE), private psychiatrists of the UKE catchment area and other outpatient facilities. As such, following health care structures are part of the model and could be used by each patients and its relatives according to need:

• Specialized inpatient unit with attached day-clinic for psychotic disorders;
• Acute inpatient unit of the Department;
• Specialized psychosis outpatient center separated into a schizophrenia-spectrum and bipolar outpatient teams with a variety of diagnosis-specific evidence-based individual- and group therapies, low-threshold offers to promote day structure (e.g., cooking, sport or art groups), an early detection and intervention service with a mobile early detection team with professionals from the child- and youth and adult psychiatry, possibility of peer-to-peer and relatives-to-relatives counseling, relative groups, etc.;
• A multidisciplinary assertive community treatment (ACT) team, which was basically implemented according to guidelines of the Assertive Community Treatment Association and according to the Dartmouth Assertive Community Treatment Scale (DACTS). However, compared to the traditional ACT model there are two important differences: (1) While traditional ACT models have a responsibility for SPMI patients independent from the underlying diagnosis, the present model solely focus on pati
  Sponsor: Universitätsklinikum Hamburg-Eppendorf
  

  Current Primary Outcome: Time to service disengagement [ Time Frame: 4 years ]

  This primary aim was chosen because the assertive approach of ACT is to prevent service disengagement and because service disengagement is a major predictor for relapse and thereby a poor long-term outcome. Service disengagement is present, if a patient repeatedly refuses further treatment despite need and several attempts of re-engagement (phone calls of patient and potentially home visits of the ACT team).
  
  
  

  Original Primary Outcome: Time to service disengagement [ Time Frame: 4 years ]

  This primary aim was chosen because the assertive approach of ACT is to prevent service disen- gagement and because service disengagement is a major predictor for relapse and thereby a poor long-term outcome. Service disengagement is present, if a patient repeatedly refuses further treatment despite need and several attempts of reengagement (phone calls of patient and potentially home visits of the ACT team).
  
  
  

  Current Secondary Outcome:

  • Change of functioning as measured with the Global Assessment of Functioning Scale (GAF) [ Time Frame: 4 years ]
    Change of functioning from baseline to 4-year endpoint will be measured with the Global Assessment of Functioning Scale (GAF) total score. Change from baseline to endpoint is the secondary endpoint.
  • Change of quality of life as measured with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18) [ Time Frame: 4 years ]
    Change of quality of life as measured with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18). The Q-LES-Q-18 is a self-report instrument scored on a 5-point scale ('not at all or never' to 'frequently or all the time') with higher scores indicating better enjoyment and satisfaction with specific life domains. The global QOL index is the average score of all 18 items; a score of 4.1 points characterize a quality of life comparable with healthy controls;
  • Change of psychopathology as measured with the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 4 years ]
    Change of psychopathology from baseline to 4-year endpoint will be measured with the Brief Psychiatric Rating Scale (BPRS) total score. Change from baseline to endpoint is the primary endpoint of the study.
  • Change of satisfaction with care as measured with the Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 4 years ]
    Patients' satisfaction with care with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a 8-item instrument that is scored from 1 to 4. The total score ranges from 8 to 32; the mean satisfaction score is computed with a minimum score of 1 and a maximum of 4.
  • Service use data [ Time Frame: 4 years ]
    Service used data were assessed from the official IC database, which covers inpatient admissions, day-clinic admissions, and treatment contacts by the ACT team, in the psychosis outpatient center or by the private psychiatrists.
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Universitätsklinikum Hamburg-Eppendorf
  

  Dates:
  Date Received: June 20, 2013
  Date Started: May 2007
  Date Completion: December 2018
  Last Updated: May 21, 2016
  Last Verified: May 2016