Nationwide Uniform Scientific Evaluation of Flexible and Integrated Treatment Projects From 2022 Onwards

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTechnische Universität Dresden

About this trial

This study is an evaluation of flexible and integrated psychiatric care models (according to § 64b of the German Social Code Book V (SGB V)) (FIT) including new FIT projects starting after 2022 and the prolongation of any of 19 already established FIT projects (mainly at German psychiatric hospitals). The central concern of this evaluation is to answer the question whether FIT care offers advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible psychiatric treatment intensities. However, FIT program structures depend on the individual situation and organization of the FIT hospital together with the participating statutory health insurance (SHI) funds.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

treatment in any of the participating hospitals or control hospitals within recruitment phase (number of hospitals will be fix until June 2026)

being insured with any of the participating SHI funds

Disqualifiers

less than one year follow-up data available

Trial population

anonymized data of the participating SHI funds, all patients being treated in any of the participating FIT hospitals (within FIT model period) or a control hospital within recruitment period

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • FIT model project

    Other intervention

    Several statutory health insurance (SHI) funds have established contracts with hospitals for an alternative remuneration / financing of patients treated in the hospital (FIT hospital). Some of those contracts already started in 2013 and were prolonged. Some FIT contracts will start freshly (until June 2026). These contracts encourage FIT hospitals to test alternative treatment options for their patients (insured with the involved SHI funds), for example fewer inpatient and more outpatient treatment.

Treatment groups

30,000 Participants
are divided into 2 treatment groups
Group A: Intervention Group (IG)1 intervention
Group B: Control Group (CG)0 interventions

Trial outcomes

Primary outcomes

1

Duration of inpatient psychiatric treatment

Days with inpatient stays of each included patient will be marked within the patient-individual follow-up period. A billing matrix defining the type of charge and describing the count will be used to mark days with inpatient stays. Inpatient stays that range outside the patient-specific follow-up time will be censored. The proportion of patients with at least one inpatient stay will be presented. Furthermore, the days of inpatient stays per patient will be added, including the stay that led to inclusion in the evaluation. The classification into inpatient and day care is based on the corresponding charges. If inpatient and day care cases are billed on one day in one hospital, this day will be counted as an inpatient day. It will be analyzed how long patients were treated in hospitals (here only inpatient stays), summed over the entire observation period for each case (all patients).

Time frame
one year prior to recruitment compared to first to max year after recruitment. Max year = latest possible year for maximal observation period depending on the length of FIT project
2

Sick leave days

The number of sick leave days due to any mental disorder will be counted.

Time frame
one year prior to recruitment compared to first to fourth year after recruitment

Secondary outcomes

1

Duration of day care psychiatric treatment

Days with day care stays of each included patient will be marked within the patient-individual follow-up period. A billing matrix defining the type of charge and describing the count will be used to mark days with day care stays. Day care stays that range outside the patient-specific follow-up time will be censored. The proportion of patients with at least one day care stay will be presented. Furthermore, the days of day care stays per patient will be added, including the stay that led to inclusion in the evaluation. The classification into inpatient and day care is based on the corresponding charges. If inpatient and day care cases are billed on one day in one hospital, this day will be counted as an inpatient day. It will be analyzed how long patients were treated in hospitals (here only day care stays), summed over the entire observation period for each case (all patients).

Time frame
one year prior to recruitment compared to first to max year after recruitment
2

Outpatient psychiatric treatment (within and outside the hospital)

The number of days with a contact in the psychiatric outpatients departments (PIA) and with outpatient treatment due to any psychiatric treatment of patients treated in the IG and CG will be recorded and compared.

Time frame
one year prior to recruitment compared to first to max year after recruitment
3

Continuity of care

It will be analyzed how many cases had at least one contact with the outpatient sector after hospital discharge. A distinction will be made between the outpatient sector in the hospital (PIA) and the outpatient sector outside the hospital (contracted medical sector). In addition, the area of continuity of treatment in the "psychiatric sector" (PIA, physician for psychiatry or child and adolescent psychiatry or psychotherapist) will be summarized.

Time frame
one year prior to recruitment compared to first to max year after recruitment
4

Inpatient hospital readmission

The proportion of persons with an inpatient stay who were readmitted as inpatients within one year after discharge from the hospital and the days between first inpatient discharge and second inpatient treatment will be examined. The follow-up period is determined on a patient-specific basis. For this purpose, the first discharge date from an inpatient stay in the reference hospital (IG or CG) after inclusion into the evaluation that allowed a one-year follow-up period will be taken as the basis. Readmission is given if the patient had a hospital stay with any psychiatric diagnosis as main diagnosis and was readmitted with a psychiatric diagnosis as main diagnosis within one year.

Time frame
one year prior to one year after first full inpatient psychiatric discharge after recruitment

Other outcomes

Sponsors and contacts

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Technische Universität Dresden

Lead sponsor

Institute of Social Medicine and Health Services Research, Medical Faculty, Otto-von-Guericke- University Magdeburg, Germany

Collaborator

Scientific Institute for Health Economics and Health System Research

Collaborator