Integrated Care Including Assertive Community Treatment in Early Psychosis
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Improvement of clinical long-term outcome through the implementation of early detection and
      intervention within a specialized network of integrated care (ACT and hometreatment) for
      adolescents and young adults with a first episode of psychosis between 12 and 29 years.
    

Detailed description: 
      The trial is carried out at the Psychosis Center of the Department of Psychiatry and
      Psychotherapy and the Department of Child and Adolescent Psychiatry at the University Medical
      Center Hamburg-Eppendorf (UKE), which has the responsibility to treat all Child, adolescent
      and adult 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 and psychologists 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 units with attached day-clinics for psychotic disorders; Acute
      inpatient units of both Departments; Specialized psychosis outpatient center 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.

      A multidisciplinary assertive community treatment (ACT) team, which was implemented according
      to guidelines of the Assertive Community Treatment Association and according to the Dartmouth
      Assertive Community Treatment Scale (DACTS). Compared to the traditional ACT model there are
      two important differences: (1) While traditional ACT models have a responsibility for
      patients with severe and persistent mental illness (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
      1:25. 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 re-ceive 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 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.

      Primary Outcome:

      Rate of psychofunctional remission after 12 months of treatment in integrated care (ACT and
      hometreatment) versus standard care (SC, historic control group) for the treatment of
      adolescents and young adults with early psychosis (12-29 years)

      Rationale:

      The primary Outcome measure ist the number of patients with psychofunctional remission over
      at least 6 months(t2 - t1). Definition of symptomatic remission is according to the
      standardized remission criteria(siehe Andreasen et al. 2005). Functional remission is
      assessed as GAF ≥ 60. Psychofunctional remission is given, if both criteria are fulfilled
      through 6 months.

      Secondary Outcomes:

      Investigation of the effects of integrated care compared with standard care on:

      A. Improvement of psychopathology, daily function and quality of life, B. Improevemnt of
      service engagement, compliance and satisfaction with care, C. Increase of Quality Adusted
      Life Years (QALY's) through 12 months of treatment.

      D. Duration of untreated psychosis (DUP) and pathway of care
    

Intervention name(s): Early detection and Integrated Care; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive integrated care including therapeutic Assertive Community Treatment (TACT); Standard care as being offered by private psychiatrists
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: integrated care; hometreatment; assertive community treatment (ACT); psychosis; schizophrenia; bipolar disorder; first episode