SchizophreniaACCESS-IINCT01888627
Integrated Care in Psychotic Disorders With Severe Mental Illness
A study testing Integrated care in people with Schizophrenia and Schizophreniform Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- Integrated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- May 2007to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 (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.
- Exclusion criteria The only exclusion criterion for treatment participation was a psychotic disorder due to medical condition.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Hamburg-Eppendorf
Hamburg, 202460
Martin Lambert, Professor
About this study
Official title: Integrated Care in Patients With a Psychotic Disorder Fulfilling Definition of Severe Mental Illness (ACCESS-II Study)
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).
Read the detailed description
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 patients with psychotic disorders; (2) The fidelity of the ACT team was further increased by composing a team of highly educated psychosis experts (i.e. consultant psychiatrists, psychiatrists, psychologists, nurses, social worker). Members of the ACT team received diagnosis-specific training in pharmacotherapy, cognitive behavioral (CBT), dynamic, and/or family psychotherapy.
- A specialized day-clinic for first-episode psychosis patients in the age range of 15-29 years managed by the child- and youth and adult psychiatry;
- A working support outpatient center with outpatient and day-clinic treatment facilities;
- 20 private psychiatrists participate in the treatment network of the IC model (their duties and responsibilities are described below).
- Further participants of the network are: a psychiatric nursing service, a specialized housing support service and a specialized psychosis living unit.
Within this network, the main responsibility for the individual patient and his relatives is generally allocated according to need and preferences to two specific members of the ACT team, of which one has to be a psychiatrist responsible for pharmacotherapy. However, when pharmacotherapy is stable and adherence assured, private psychiatrists are allowed to take over this responsibility. In this case, the specific IC contract with the private psychiatrists includes several quality assurance guidelines.
Briefly, the staff/client caseload ratio of a single full time employed ACT team member is 1:15-25. In any case, the first responsibility of the network is a broad assessment of the psychotic disorder, comorbid psychiatric and somatic disorders, traumatic events, previous service engagement and medication adherence, social problems, etc. Thereby, a need-adapted treatment plan will be developed together with the patient, relatives and other caregivers. If the patient starts IC during inpatient, transition from in- to outpatient care will be organized. Participant, relatives and other caregiver receive two telephone numbers: one of the ACT therapists for all contacts within office hours (Monday to Friday from 8 am to 6 pm) and a 24 hours crisis number for all emergencies or questions outside office hours. The primary ACT/private psychiatrists subteam is responsible for high-frequent face-to-face treatment contacts fostering "open-end" continuity of care, coordinating treatment and social support (case management), promoting and ensuring service engagement and medication adherence, and offering intensive need-adapted individual psychotherapy at the earliest possible time point. Crisis intervention is offered at any time and is always conducted by two ACT members of which one is the primary ACT therapist. Access to other need-adapted and diagnosis-specific evidence-based interventions is organized within the specialized psychosis outpatient center or the work support center, e.g. psychoeducation groups, social skills training, meta-cognitive training, bipolar psychotherapy groups, etc. Further, all low-threshold interventions in the outpatient center could be used at any time. Thereby day-clinic equivalent program could be organized while being in outpatient status. As many of these patients are at risk for service disengagement and medication non-adherence, a strict 'no-drop-out' policy is implemented including all admissions out of the catchment area.
Managed Care Briefly, the UKE is the managed care organization for the IC model and has full financial responsibility. The UKE receives a yearly per-patient rate, which was calculated according to real direct health care costs of the individual patient including inpatient-, day-clinic- and outpatient treatment. More then 20% of this rate is caused by 'hospital hopping' and repeated emergency room visits. Within one year the calculated yearly per-patient rate now includes: (1) all inpatient days, (2) all day-clinic, (3) all interventions by the ACT team, (4) all interventions in the Specialized psychosis outpatient center, (5) all interventions by private psychiatrists (they receive 4-times higher finances per-patient per-year from the overall yearly per-patient rate), (6) all psychotherapeutic interventions, (7) all assessments to insure quality of outcome, and (8) all managed care facilities. There two specific arrangements: (1) the IC model starts financially at the first day of admission to hospital. This arrangement supports a quick enter into the new IC model and reduced the financial risks for the health insurances. (2) One specific guideline within the model is to stop hospital hopping. To foster this guideline, the UKE has to pay from the yearly per-patient rate every admission in a hospital outside the network from the 4th day.
Assessments and measures Assessments are carried out at baseline, and at 6 weeks, 3, 6, 12, 18, 24, 30, 36, 42, and 48 months follow-ups. At baseline, following variables were assessed: 1) Diagnosis of the psychotic disorder and co-morbid AXIS I disorder(s) with the Structured Clinical Interview for DSM-IV Axis I disorders (SCID-I). In case of clinical evidence for a co-morbid AXIS II disorder, a SCID-II interview for DSM-IV Personality Disorder was applied40; 2) demographic and illness characteristics were assessed with the German version of Early Psychosis File Questionnaire (EPFQ) including age, gender, marital status, years of school education, completed professional education, employment/occupation at entry, ability of independent living, traumatic events, family history of psychiatric illness, previous suicide attempts, previous hospital admissions including involuntary admissions, insight into illness and forensic history. Duration of untreated prodrome, psychosis (DUP) and untreated illness (DUI) will be assessed with the DUP scale). Medication non-adherence was defined according to Robinson et al. as failure to take medication for 1 week or longer. This definition was chosen because stopping medication for a week clearly indicates a problem with acceptance of pharmacological treatment (as opposed of just forgetting a dose).
At baseline and all follow-up time points following structured assessment are applied: 1) Psychopathology with the Brief Psychiatric Rating Scale (BPRS); 2) severity of illness with the Clinical Global Impression Scale (CGI); severity of illness of affective psychosis with the Clinical Global Impression Scale-Bipolar version (CGI-BP); 3) level of functioning with the Global Assessment of Functioning Scale (GAF), 4) Quality of life 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; 5) 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 disengagement was 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). 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.
- Conditions
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder NOS, Bipolar Disorder
- Being tested
- Integrated care
- Keywords
- Schizophrenia, Bipolar disorder, Assertive community treatment, Integrated care, Severe and persistent mental disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid, Mental Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Integrated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 years
Secondary outcomes (5)
Change of functioning as measured with the Global Assessment of Functioning Scale (GAF)
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.
Measured: 4 years
Change of quality of life as measured with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18)
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;
Measured: 4 years
Change of psychopathology as measured with the Brief Psychiatric Rating Scale (BPRS)
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.
Measured: 4 years
Change of satisfaction with care as measured with the Client Satisfaction Questionnaire (CSQ-8)
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.
Measured: 4 years
Service use data
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startMay 2007
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Martin Lambert, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Martin Lambert, Professor, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888627
- Sponsor's protocol ID
- ACCESS-II
- Acronym
- ACCESS-II
- Status last verified
- Sep 2021
- First submitted
- 20 Jun 2013
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25188752Lambert 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.
PubMed 24062155Karow 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.
PubMed 24062154Rohenkohl 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.
PubMed 36076205Ruppelt 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.
PubMed 32507378Karow 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.
PubMed 31814102Schottle 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.
PubMed 31708810Schottle 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.
PubMed 29485988Lambert 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.
PubMed 28778554
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care in Patients With a Psychotic Disorder Fulfilling Definition of Severe Mental Illness (ACCESS-II Study)
- ClinicalTrials.gov ID
- NCT01888627
- Acronym / sponsor ID
- ACCESS-II / ACCESS-II
- Conditions
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder NOS, Bipolar Disorder
- Keywords
- Schizophrenia, Bipolar disorder, Assertive community treatment, Integrated care, Severe and persistent mental disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 patients with psychotic disorders; (2) The fidelity of the ACT team was further increased by composing a team of highly educated psychosis experts (i.e. consultant psychiatrists, psychiatrists, psychologists, nurses, social worker). Members of the ACT team received diagnosis-specific training in pharmacotherapy, cognitive behavioral (CBT), dynamic, and/or family psychotherapy.
- A specialized day-clinic for first-episode psychosis patients in the age range of 15-29 years managed by the child- and youth and adult psychiatry;
- A working support outpatient center with outpatient and day-clinic treatment facilities;
- 20 private psychiatrists participate in the treatment network of the IC model (their duties and responsibilities are described below).
- Further participants of the network are: a psychiatric nursing service, a specialized housing support service and a specialized psychosis living unit.
Within this network, the main responsibility for the individual patient and his relatives is generally allocated according to need and preferences to two specific members of the ACT team, of which one has to be a psychiatrist responsible for pharmacotherapy. However, when pharmacotherapy is stable and adherence assured, private psychiatrists are allowed to take over this responsibility. In this case, the specific IC contract with the private psychiatrists includes several quality assurance guidelines.
Briefly, the staff/client caseload ratio of a single full time employed ACT team member is 1:15-25. In any case, the first responsibility of the network is a broad assessment of the psychotic disorder, comorbid psychiatric and somatic disorders, traumatic events, previous service engagement and medication adherence, social problems, etc. Thereby, a need-adapted treatment plan will be developed together with the patient, relatives and other caregivers. If the patient starts IC during inpatient, transition from in- to outpatient care will be organized. Participant, relatives and other caregiver receive two telephone numbers: one of the ACT therapists for all contacts within office hours (Monday to Friday from 8 am to 6 pm) and a 24 hours crisis number for all emergencies or questions outside office hours. The primary ACT/private psychiatrists subteam is responsible for high-frequent face-to-face treatment contacts fostering "open-end" continuity of care, coordinating treatment and social support (case management), promoting and ensuring service engagement and medication adherence, and offering intensive need-adapted individual psychotherapy at the earliest possible time point. Crisis intervention is offered at any time and is always conducted by two ACT members of which one is the primary ACT therapist. Access to other need-adapted and diagnosis-specific evidence-based interventions is organized within the specialized psychosis outpatient center or the work support center, e.g. psychoeducation groups, social skills training, meta-cognitive training, bipolar psychotherapy groups, etc. Further, all low-threshold interventions in the outpatient center could be used at any time. Thereby day-clinic equivalent program could be organized while being in outpatient status. As many of these patients are at risk for service disengagement and medication non-adherence, a strict 'no-drop-out' policy is implemented including all admissions out of the catchment area.
Managed Care Briefly, the UKE is the managed care organization for the IC model and has full financial responsibility. The UKE receives a yearly per-patient rate, which was calculated according to real direct health care costs of the individual patient including inpatient-, day-clinic- and outpatient treatment. More then 20% of this rate is caused by 'hospital hopping' and repeated emergency room visits. Within one year the calculated yearly per-patient rate now includes: (1) all inpatient days, (2) all day-clinic, (3) all interventions by the ACT team, (4) all interventions in the Specialized psychosis outpatient center, (5) all interventions by private psychiatrists (they receive 4-times higher finances per-patient per-year from the overall yearly per-patient rate), (6) all psychotherapeutic interventions, (7) all assessments to insure quality of outcome, and (8) all managed care facilities. There two specific arrangements: (1) the IC model starts financially at the first day of admission to hospital. This arrangement supports a quick enter into the new IC model and reduced the financial risks for the health insurances. (2) One specific guideline within the model is to stop hospital hopping. To foster this guideline, the UKE has to pay from the yearly per-patient rate every admission in a hospital outside the network from the 4th day.
Assessments and measures Assessments are carried out at baseline, and at 6 weeks, 3, 6, 12, 18, 24, 30, 36, 42, and 48 months follow-ups. At baseline, following variables were assessed: 1) Diagnosis of the psychotic disorder and co-morbid AXIS I disorder(s) with the Structured Clinical Interview for DSM-IV Axis I disorders (SCID-I). In case of clinical evidence for a co-morbid AXIS II disorder, a SCID-II interview for DSM-IV Personality Disorder was applied40; 2) demographic and illness characteristics were assessed with the German version of Early Psychosis File Questionnaire (EPFQ) including age, gender, marital status, years of school education, completed professional education, employment/occupation at entry, ability of independent living, traumatic events, family history of psychiatric illness, previous suicide attempts, previous hospital admissions including involuntary admissions, insight into illness and forensic history. Duration of untreated prodrome, psychosis (DUP) and untreated illness (DUI) will be assessed with the DUP scale). Medication non-adherence was defined according to Robinson et al. as failure to take medication for 1 week or longer. This definition was chosen because stopping medication for a week clearly indicates a problem with acceptance of pharmacological treatment (as opposed of just forgetting a dose).
At baseline and all follow-up time points following structured assessment are applied: 1) Psychopathology with the Brief Psychiatric Rating Scale (BPRS); 2) severity of illness with the Clinical Global Impression Scale (CGI); severity of illness of affective psychosis with the Clinical Global Impression Scale-Bipolar version (CGI-BP); 3) level of functioning with the Global Assessment of Functioning Scale (GAF), 4) Quality of life 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; 5) 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 disengagement was 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). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated care | Experimental | Other: Integrated careThe 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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 (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);
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated careThe 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 |
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).
5 secondary outcomes
Change of functioning as measured with the Global Assessment of Functioning Scale (GAF)
Time frame: 4 years
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 psychopathology as measured with the Brief Psychiatric Rating Scale (BPRS)
Time frame: 4 years
Change of satisfaction with care as measured with the Client Satisfaction Questionnaire (CSQ-8)
Time frame: 4 years
Service use data
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Results publication: PubMed 25188752Schottle 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.
- Results publication: PubMed 24062155Lambert 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.
- Results publication: PubMed 24062154Karow 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.
- Derived from this study: PubMed 36076205Rohenkohl 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.
- Derived from this study: PubMed 32507378Ruppelt 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.
- Derived from this study: PubMed 31814102Karow 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.
- Derived from this study: PubMed 31708810Schottle 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.
- Derived from this study: PubMed 29485988Schottle 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.
- Derived from this study: PubMed 28778554Lambert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lambert, Professor principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care in people with Schizophrenia and Schizophreniform Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Lambert, Professor (004940741057670, lambert@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to service disengagement (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01888627, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.