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Integrated Care in Psychosis (ACCESS-II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Martin Lambert, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01888627
First received: June 20, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention
Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Delusional Disorder
Psychotic Disorder NOS
Bipolar Disorder
Severe Major Depression With Psychotic Features
Other: Integrated care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Care in Patients With a Psychotic Disorder Fulfilling Definition of Severe Mental Illness (ACCESS-II Study)

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Time to service disengagement [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Change of functioning as measured with the Global Assessment of Functioning Scale (GAF) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated care
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. Integrated Care involves ACT treatment within this network. Patients have access to all evidence-based interventions according to need.
Other: Integrated care
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. Integrated Care involves ACT treatment within this network. Patients have access to all evidence-based interventions according to need.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

Inclusion criteria for trial participation are identical with the IC model participation criteria and are part of IC contracts with the health insurances. Both, treatment and trial participation were voluntary and needed separate informed consent. Following inclusion criteria will be applied:

  • Member of one of the following health insurances: DAK Gesundheit, HEK, IKK Classic, AOK Rheinland/Hamburg;
  • Diagnosis of a schizophrenia spectrum disorder (i.e. schizophrenia, schizophreni-form disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS), bipolar disorder, severe major depression with psychotic features, and substance-induced psychotic disorder, all assessed according to DSM-IV with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I);
  • Present confinement for hospitalization because of an acute illness state as assessed by a psychiatrists;
  • Presence of a certain severity of illness as assessed with the Brief Psychiatric Rating Scale (BPRS; 24-item version) with a) BPRS total score > 40 points and b) fulfillment of one of the following sub syndromes: ≥ 6 points on item 10 (hallucinations), ≥ 6 points on item 11 (unusual thought content), ≥ 6 points on item 15 (conceptual disorganization), ≥ 10 points on items 3 plus 4 (depressive-suicidal syndrome), ≥ 6 points on item 4 (suicidality), ≥ 15 points on items 8, 9 plus 21 (manic syndrome), ≥ 15 points on items 6, 12 plus 20 (disruptive behavior syndrome) and ≥ 15 points on items 13, 16 plus 17 (negative syndrome);
  • Age of ≥ 18 years;
  • Fulfillment of the SPMI condition according to Ruggeri et al.

Exclusion criteria The only exclusion criterion for treatment participation was a psychotic disorder due to medical condition.

Exclusion Criteria:

  • The only exclusion criterion for treatment participation was a psychotic disorder due to medical condition. Patients with mental retardation (defined as IQ lower than 70 points) are able to participate in treatment, but were excluded for analysis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888627

Contacts
Contact: Martin Lambert, Professor 004940741057670 lambert@uke.de
Contact: Daniel Schöttle, Doctor 004915222816853 d.schoettle@uke.de

Locations
Germany
University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany, 202460
Principal Investigator: Martin Lambert, Professor         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Martin Lambert, MD, Professor Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Martin Lambert, Prof. Dr. Martin Lambert, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01888627     History of Changes
Other Study ID Numbers: ACCESS-II
Study First Received: June 20, 2013
Last Updated: June 25, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Schizophrenia
Bipolar disorder
Assertive community treatment
Integrated care
Severe and persistent mental disorder

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Schizophrenia and Disorders with Psychotic Features
Bipolar Disorder
Depression
Depressive Disorder, Major
Disease
Schizophrenia
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014