Integrated Care in Psychotic Disorders With Severe Mental Illness

NCT01888627 | Unknown

• 1 other identifier: ACCESS-II
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Delusional Disorder; Psychotic Disorder NOS; Bipolar Disorder; Severe Major Depression With Psychotic Features

Keywords

Schizophrenia; Bipolar disorder; Assertive community treatment; Integrated care; Severe and persistent mental disorder

Outcome Measures

Primary Outcomes (1)

• Time to service disengagement

  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).

  4 years

Secondary Outcomes (5)

• Change of functioning as measured with the Global Assessment of Functioning Scale (GAF)

  4 years

• Change of quality of life as measured with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18)

  4 years

• Change of psychopathology as measured with the Brief Psychiatric Rating Scale (BPRS)

  4 years

• Change of satisfaction with care as measured with the Client Satisfaction Questionnaire (CSQ-8)

  4 years

• Service use data

  4 years

Study Arms (1)

Integrated care

EXPERIMENTAL

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

Interventions

Integrated care OTHER

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.

Integrated care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Member of one of the following health insurances: DAK Gesundheit, HEK, IKK Classic, AOK Rheinland/Hamburg (Germany);
• Diagnosis of a schizophrenia spectrum disorder (i.e. schizophrenia, schizophreniform 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 ≥ 12 years;
• Fulfillment of the SPMI condition according to Ruggeri et al.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 202460, Germany

RECRUITING

Related Publications (9)

• Schottle D, Schimmelmann BG, Karow A, Ruppelt F, Sauerbier AL, Bussopulos A, Frieling M, Golks D, Kerstan A, Nika E, Schodlbauer M, Daubmann A, Wegscheider K, Lange M, Ohm G, Lange B, Meigel-Schleiff C, Naber D, Wiedemann K, Bock T, Lambert M. Effectiveness of integrated care including therapeutic assertive community treatment in severe schizophrenia spectrum and bipolar I disorders: the 24-month follow-up ACCESS II study. J Clin Psychiatry. 2014 Dec;75(12):1371-9. doi: 10.4088/JCP.13m08817.

  PMID: 25188752 RESULT

• Lambert M, Bock T, Daubmann A, Meigel-Schleiff C, Lange B, Lange M, Ohm G, Bussopulos A, Frieling M, Golks D, Kerstan A, Konig HH, Nika L, Ruppelt F, Schodlbauer M, Schottle D, Sauerbier AL, Rietschel L, Wegscheider K, Wiedemann K, Schimmelmann BG, Naber D, Karow A. [The Hamburg-model of integrated care for patients with psychosis: Part 1. Rationale, treatment concept and results of the pre-study]. Psychiatr Prax. 2014 Jul;41(5):257-65. doi: 10.1055/s-0033-1349497. Epub 2013 Sep 23. German.

  PMID: 24062155 RESULT

• Karow A, Bock T, Daubmann A, Meigel-Schleiff C, Lange B, Lange M, Ohm G, Bussopulos A, Frieling M, Golks D, Kerstan A, Konig HH, Nika L, Lange M, Ruppelt F, Schodlbauer M, Schottle D, Sauerbier AL, Rietschel L, Wegscheider K, Wiedemann K, Schimmelmann BG, Naber D, Lambert M. [The Hamburg-model of integrated care for patients with psychosis: Part 2. Results of the clinical course over 2- and 4-years of treatment]. Psychiatr Prax. 2014 Jul;41(5):266-73. doi: 10.1055/s-0033-1349496. Epub 2013 Sep 23. German.

  PMID: 24062154 RESULT

• Rohenkohl AC, Daubmann A, Gallinat J, Karow A, Kraft V, Ruhl F, Schottle D, Lambert M, Schroter R. Health-related quality of life in severe psychotic disorders during integrated care: 5-year course, prediction and treatment implications (ACCESS II). Health Qual Life Outcomes. 2022 Sep 8;20(1):133. doi: 10.1186/s12955-022-02039-0.

  PMID: 36076205 DERIVED

• Ruppelt F, Rohenkohl A, Kraft V, Schottle D, Schroter R, Gaianigo J, Werkle N, Daubmann A, Karow A, Lambert M. Course, remission and recovery in patients with severe psychotic disorders with or without comorbid substance use disorders: Long-term outcome in evidence-based integrated care (ACCESS II study). Schizophr Res. 2020 Aug;222:437-443. doi: 10.1016/j.schres.2020.03.058. Epub 2020 Jun 2.

  PMID: 32507378 DERIVED

• Karow A, Brettschneider C, Helmut Konig H, Correll CU, Schottle D, Ludecke D, Rohenkohl A, Ruppelt F, Kraft V, Gallinat J, Lambert M. Better care for less money: cost-effectiveness of integrated care in multi-episode patients with severe psychosis. Acta Psychiatr Scand. 2020 Mar;141(3):221-230. doi: 10.1111/acps.13139. Epub 2020 Jan 12.

  PMID: 31814102 DERIVED

• Schottle D, Ruppelt F, Schimmelmann BG, Karow A, Bussopulos A, Gallinat J, Wiedemann K, Luedecke D, Rohenkohl AC, Huber CG, Bock T, Lambert M. Reduction of Involuntary Admissions in Patients With Severe Psychotic Disorders Treated in the ACCESS Integrated Care Model Including Therapeutic Assertive Community Treatment. Front Psychiatry. 2019 Oct 24;10:736. doi: 10.3389/fpsyt.2019.00736. eCollection 2019.

  PMID: 31708810 DERIVED

• Schottle D, Schimmelmann BG, Ruppelt F, Bussopulos A, Frieling M, Nika E, Nawara LA, Golks D, Kerstan A, Lange M, Schodlbauer M, Daubmann A, Wegscheider K, Rohenkohl A, Sarikaya G, Sengutta M, Luedecke D, Wittmann L, Ohm G, Meigel-Schleiff C, Gallinat J, Wiedemann K, Bock T, Karow A, Lambert M. Effectiveness of integrated care including therapeutic assertive community treatment in severe schizophrenia-spectrum and bipolar I disorders: Four-year follow-up of the ACCESS II study. PLoS One. 2018 Feb 27;13(2):e0192929. doi: 10.1371/journal.pone.0192929. eCollection 2018.

  PMID: 29485988 DERIVED

• Lambert M, Ruppelt F, Siem AK, Rohenkohl AC, Kraft V, Luedecke D, Sengutta M, Schroter R, Daubmann A, Correll CU, Gallinat J, Karow A, Wiedemann K, Schottle D. Comorbidity of chronic somatic diseases in patients with psychotic disorders and their influence on 4-year outcomes of integrated care treatment (ACCESS II study). Schizophr Res. 2018 Mar;193:377-383. doi: 10.1016/j.schres.2017.07.036. Epub 2017 Aug 1.

  PMID: 28778554 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid; Mental Disorders; Bipolar Disorder

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Martin Lambert, Professor

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Lambert, Professor

CONTACT

004940741057670; lambert@uke.de

Daniel Schöttle, Doctor

CONTACT

004915222816853; d.schoettle@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Martin Lambert

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 28, 2013
• Study Start: May 1, 2007
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

DE (1)