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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).
Full 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:
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.
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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:
Exclusion criteria The only exclusion criterion for treatment participation was a psychotic disorder due to medical condition.
Exclusion Criteria:
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400 participants in 1 patient group
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Central trial contact
Daniel Schöttle, Doctor; Martin Lambert, Professor
Data sourced from clinicaltrials.gov
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