Trial document




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  DRKS00013114

Trial Description

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Title

Evaluation of the “specialist program” for care in the fields of neurology, psychiatry, psychosomatics and psychotherapy in Baden-Wuerttemberg in accordance with §73c SGB V

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A German health insurance, the AOK Baden Wuerttemberg (AOK BW), is pursuing the goal of improving treatment of chronically ill people by improving networks of practitioners, training of practitioners and treatment contents, which reflect the current medical knowledge. “Specialist programs” are based on the “general practitioner program”. The so-called PNP contract, which regulates the care in the fields of neurology, psychiatry, psychosomatics and psychotherapy, is one of these “specialist programs”.
The aim of the present study is to evaluate the effectiveness and usefulness of the PNP contract.
For this purpose, care in the “specialist program” will be compared to care in the “general practitioner program” and to usual care (care without a program).
Effectiveness:
We want to assess whether patients receiving care in the “specialist program” (PNP contract) will experience higher health-related quality of life, a lower burden of complaints and a higher degree of treatment satisfaction compared to patients receiving usual care or patients receiving care in the “general practitioner program”.
In addition, we want to examine whether patients with severe and chronic diseases will benefit more from treatment within the “specialist program” (PNP contract).
Further, we would like assess whether the group receiving care within the “specialist program” (PNP contract) will produce lower costs for in-patient stays and will have fewer days of incapacity to work compared to the other groups.
We would like to explore how practitioners working in the “specialist program” evaluate the program. In addition, we want to investigate if they are able to make diagnoses more accurately compared to practitioners not working in the “specialist program”.
Patients fulfilling following criteria can be included in the study:
- insured by the AOK BW
- at least 18 years old
- treated by a practitioner or therapist with admission in Baden-Württemberg, Germany
- have no guardian
- are on sick leave due to a mental or neurological disorder (bipolar disorder, depressive disorder, anxiety disorder, adaptation disorder, somatoform disorder, alcohol abuse disorder, schizophrenia, multiple sclerosis)
- were not on sick leave due to a mental disorder or multiple sclerosis during the least year

All patients who will meet these inclusion criteria will receive a questionnaire at the beginning of the study and 12 months later. In the questionnaires, we will ask patients about their condition and their experience with treatment.

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Brief Summary in Scientific Language

A German health insurance, the AOK Baden Wuerttemberg (AOK BW), is pursuing the goal of improving treatment of chronically ill people by improving networks of practitioners, training of practitioners and treatment contents, which reflect the current medical knowledge. “Specialist programs” are based on the “general practitioner program”. The so-called PNP contract, which regulates the care in the fields of neurology, psychiatry, psychosomatics and psychotherapy, is one of these “specialist programs”.

The purpose of this study is to evaluate the effectiveness of the PNP contract (IG-PNP) in comparison to the “general practitioner program” (CG-GP) and to usual care (CG-UC) among patients mental or neurological disorders.
We focused on bipolar disorders (F31.x), depressive disorders (F32.x, F33.x, F34.1), anxiety disorders (F40.x, F41.x), adaptation disorders (F43.2), somatoform disorders (F45.x), disorders of alcohol abuse (F10.x), schizophrenia (F20.x) and multiple sclerosis (G35.x).
Study aims:
IG-PNP will be evaluated with regard to (a) effectivenesse (patient reported outcomes - PROs) (b) cost effectiveness, (c) accuracy of diagnoses, and (d) structural and process quality.
Hypotheses and questions:
a1) Is treatment within the PNP contract more effective compared to the treatment in control groups (CG-GP, CG-UC) with regard health related quality of life among patients with mental or neurological disorders. (Main question)
a2) Which patient group benefits most from the PNP contract?
b1) Can costs for in-patient treatment (due to the focus diagnoses) be reduced by participating in the PNP contract?
b2) Can participation in the PNP contract reduce the number of days of incapacity to work (due to the focus diagnoses)?
c) Is the diagnostic accuracy higher in the PNP contract?
d) How do the PNP-practitioners evaluate the contract?
Study design:
(a) Effectiveness: prospective non-randomized controlled trial (quasi-experimental): Measurement of health-related quality of life, patient-relevant symptom severity and satisfaction with care at t0 (date of sick leave) and t1 (12 months later) among all participants (IG-PNP, CG-GP, CG-UC)
(b) Cost comparison analysis: Retrospective secondary data analysis using a quasi-experimental design: comparison of costs caused by service utilization and by sick pay over a period of 12 months between IG-PNP and CG-GP, CG-UC.
(c) Accuracy of diagnoses: Exploratory, retrospective secondary data analysis: Trend analysis of diagnoses, stratified according to the intervention and control groups.
(d) Structure and process quality: Quantitative cross-sectional survey of practitioners working in the PNP contract.
Primary and secondary outcomes:
Primary data collection:
primary: health-related quality of life
secondary: functional health, disease-specific symptom severity, patient satisfaction, treatment satisfaction
Secondary data analysis:
primary: costs due to service utilization
secondary: incapacity to work, sick pay, routine diagnoses
Statistical analysis:
We will use Entropy Balancing (EB) to control for differences between IG-PNP, CG-GP and CG-UC. EB will be stratified for the primary diagnosis and based on patient characteristics (e.g. age, gender, region, type of insurance, costs of service utilization, mental comorbidity and the Combined Comorbidity Index (CCI) from ICD-10 for inpatient stays). The CCI is determined based on the ICD-10 codes belonging to the hospital stays, in order to take the severity of somatic comorbidities into account.
(a) Effectiveness: mixed linear models with fixed effects for group (IG-PNP / CG-GP / CG-UC) and quality of life at t0 and with a random effect for medical practice to adjust for possible clustering;
(b) Cost comparison analysis: comparisons between IG-PNP and CGs (CG-GP / CG-UC) matched with Entropy Balancing using generalized linear mixed models;
(c) Accuracy of diagnoses: exploratory analyses for specific diagnoses in the 12-month follow-up period, stratified according to IG-PNP and CG-GP or CG-UC;
d) Structural and process quality: descriptive-statistical analyses.
Sample:
Patients fulfilling following criteria can be included in the study:
- insured by the AOK BW
- at least 18 years old
- treated by a practitioner or therapist with admission in Baden-Württemberg, Germany
- have no guardian
- are on sick leave due to a mental or neurological disorder (bipolar disorders, depressive disorders, anxiety disorders, adaptation disorders, somatoform disorders, alcohol abuse disorders, schizophrenia, multiple sclerosis)
- were not on sick leave due to a mental disorder or multiple sclerosis during the least year

Adapted sample size calculation from N = 1221 to N = 536:
Because the expected response rate of 40% clearly differs from the current response rate of ca. 7% (probably due to a different response behavior than expected of the target population compared to similar studies with health insures conducted of our group) and because of new information about the first respondents, we provided a more precise power calculation. We changed the power from 0.90 to 0.80.
Based on the first 626 respondents, we could provide a more precise calculation of the number of health care providers per group and the allocation ratio between groups compared to the date of registration.
These amendments are documented in the author comments of the study protocol:
https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-018-1914-5/open-peer-review

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013114
  •   2017/10/06
  •   [---]*
  •   yes
  •   Approved
  •   PV5621, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   F31 -  Bipolar affective disorder
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F43.2 -  Adjustment disorders
  •   F45 -  Somatoform disorders
  •   F10 -  Mental and behavioural disorders due to use of alcohol
  •   F20 -  Schizophrenia
  •   G35 -  Multiple sclerosis
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Interventions/Observational Groups

  •   Treatment at a medical specialist, taking part in the PNP contract.
    The PNP contract in Baden-Wuerttemberg is implemented by AOK BW according to § 73c SGB V. The aim of the PNP contract is to improve quality and economic aspects of health care for people with mental and neurological disorders. The AOK BW developed the PNP contract jointly with representatives from associations of psychiatric, neurological and psychotherapeutic professionals. The contract was developed and implemented by the AOK BW in a comprehensive manner (Partner: Bosch BKK, MEDI Baden-Wuerttemberg e.V., MEDIVERBUND AG, BVDN eV, Freie Liste der Psychotherapeuten und DPtV e.V.).
    The focus of the PNP contract is a guideline-based treatment, coordinated by specialists, psychotherapists and practitioner from the “general practitioner program”. In order to improve the quality of care, the treatment is based on early and specific diagnoses and a reduction of waiting times for a specialist’s or psychotherapist’s appointment. Other key components are an expanded spectrum of billable treatment methods (including systemic psychotherapy), the possibility of close monitoring and the reduction of maltreatment by means of the appropriate allocation to psycho- and / or pharmacotherapy. A high quality, comprehensive care provided by psychiatrists and psychotherapists in collaboration with GPs enables a mainly outpatient care. Through the cooperation and networking, in particular with the GPs, and the focus on outpatient care, this contract aims to optimize medical care and, at the same time, to make it more economical.
  •   The first control group (CG-GP) includes patients who participate in the “general practitioners program”, but not the “specialist program” (IG-PNP).
    With the “general practitioners program” the AOK BW, Medi Baden-Wuerttemberg and the association of GPs in Baden-Wuerttemberg are implementing the contents of § 73 b SGB V.
    The AOK BW strengthens the role of GPs due to the “general practitioners program”. In this program the GP is the gatekeeper for the patient, coordinates the care and involves specialists, when necessary.
  •   The second control group (CG-UC) includes patients who receive usual care in Germany.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

a) Effectiveness: health-related quality of life measured by the short-form health survey SF-36 (mental health score) (surveyed at study inclusion (sick leave, t0) and 12 months later (t1), group comparison at t1)
b) Comparison of costs: costs caused by outpatient and inpatient service utilization and medication within one year following diagnosis, measured by account data

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Secondary Outcome

a) Effectiveness: functional health (SF-36, physical health score), EQ-5D, disease-specific symptom severity (PHQ-9, GAD-7, SSS-8, AUDIT, ESI, ADNM-20, MSIS-29), patient satisfaction measured by the questionnaire of satisfaction with ambulatory care (ZAPA) (group comparison at t1)
b) Comparison of costs (routine records): inpatient and outpatient service utilization, days of incapacity to work and sick pay (during a 12-months period after sick leave)
c) Accuracy of diagnoses: accuracy of diagnoses in the 12-month period: For this purpose, the diagnoses F32.x and F33.x are classified as specific (F32.0-F32.3, F33.0-F33.4) and unspecific diagnoses (F32.8, F32.9, F33.8, F33.9).
d) Structure and process quality: Reasons for participating in the PNP contract, overall evaluation and use of the elements of the contract, satisfaction with inter-professional cooperation and with the process of referral (semi-structured interviews with a selection of approx. 10 PNP health practinioners as preperation for a quantitative survey, quantitative survey (one time of measurement) of all PNP health practitioners

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/12/12
  •   536
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- insured by the AOK BW
- at least 18 years old
- treated by a practitioner or therapist with admission in Baden-Württemberg, Germany
- are on sick leave (for the first time since one year) due to a mental or neurological disorder (bipolar disorder, depressive disorder, anxiety disorder, adaptation disorder, somatoform disorder, alcohol abuse disorder, schizophrenia, multiple sclerosis)

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Exclusion Criteria

- have a guardian
- were on sick leave due to a mental disorder or multiple sclerosis during the least year
subsequently:
- patients who have changed the group (IG-PNP, CG-GP, CG-UC) during the study period (i.e. have quitted the contract after baseline assessment or entered into a new contract)

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Institut und Poliklinik für Medizinische PsychologieZentrum für Psychosoziale MedizinUniversitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. med. Dr. phil.   Martin  Härter 
    • Martinistr. 52, W 26
    • 20246  Hamburg
    • Germany
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    •   040 / 7410-52978
    •   040 / 7410-58170
    •   m.haerter at uke.de
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    • Institut und Poliklinik für Medizinische PsychologieZentrum für Psychosoziale Medizin Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Julia  Magaard 
    • Martinistr. 52, W26
    • 20246  Hamburg
    • Germany
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    •   040 / 7410-56683
    •   040 / 7410-54940
    •   j.magaard at uke.de
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim G-BA
    • Postfach 12 06 06
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Magaard, J. L., Liebherz, S., Melchior, H., Engels, A., König, H.-H., Kriston, L., . . . Härter, M. (2018). Collaborative mental health care program versus a general practitioner program and usual care for treatment of patients with mental or neurological disorders in Germany: protocol of a multiperspective evaluation study. BMC psychiatry, 18(1), 347. doi:10.1186/s12888-018-1914-5
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