Psychosomatic MedicineEPPIKNCT05240105
Evaluation of the "Platform Model" for Staffing in Psychiatric and Psychosomatic Clinics
An observational study of Psychosomatic Medicine, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
This study aims to evaluate the so-called platform model and its suitability to determine staffing in hospitals for psychosomatic medicine and psychotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosomatic Medicine
- How many people
- 5,961 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jun 2021to 31 Dec 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: nationwide German population of psychosomatic specialist clinics and departments at University hospitals, general hospitals, or psychiatric hospitals
Who may be able to join
- belong to the predefined nationwide population of psychosomatic specialist clinics and departments
- randomly selected for inclusion in the study,
- the clinic management (head physician or comparable) agrees to participation in the study
- possibility of electronic recording of the qualified therapy units for all treating professional groups.
- patient treated in one of the selected clinics on the corresponding ward or day clinic
- at least 18 years old
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Simone University Jennissen
Heidelberg, Baden-Wurttemberg, 69120
Simone U Jennissen, PhD, +4962215634620, simone.jennissen@med.uni-heidelberg.de
Hans-Christoph Friederich, Prof.
About this study
Official title: Evaluation of the Suitability of the "Platform Model" as an Instrument for Staffing in Psychiatric and Psychosomatic Clinics (EPPIK) - Subproject Psychosomatics
This study aims to evaluate the so-called platform model and its suitability to determine staffing in hospitals for psychosomatic medicine and psychotherapy.
Read the detailed description
The aim of the study is to test the suitability of a structural model (so-called platform model) developed by a working group of various scientific societies and professional associations for staffing in psychosomatic medicine and psychotherapy. For this purpose, in three steps (1.) the four treatment clusters developed in the platform model will be quantified and empirically validated on the basis of the therapeutic services provided in health care practice; (2.) the current staffing for the four treatment clusters will be described ("as-is analysis"); and (3.) prototypical therapy plans will be developed as a basis for estimating the target staffing requirements. On this basis, a target staffing estimate will be made for all professional groups.
For the study, a total of 80 psychosomatic clinics from Germany will be randomly selected, belonging in equal parts to the groups of psychosomatic university clinics, psychosomatic specialist hospitals, and psychosomatic departments in somatic or in psychiatric hospitals. In addition, 20 day clinics are included. In these clinics, the structural framework conditions including staffing will be surveyed and the routine documentation of therapy units will be evaluated by cluster analysis in order to empirically validate the presumed treatment clusters and to describe the necessary staffing requirements.
The empirical examination and validation of the platform model, including the four assumed treatment clusters, has the potential to positively influence care practice in the long term by adjusting staffing levels in psychosomatic clinics to actual care requirements.
- Conditions
- Psychosomatic Medicine
- Being tested
- no intervention, purely observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, purely observationalOther
There will be no interventions. The study is purely observational and investigates differences in naturally occuring treatments at these four types of departments for Psychosomatic Medicine.
| Study group | Role | What they receive |
|---|---|---|
| Departments for Psychosomatic Medicine at University Clinics | no study interventions, observational group Receives: Other: no intervention, purely observational | |
| Clinics specialized in Psychosomatic Medicine | no study interventions, observational group Receives: Other: no intervention, purely observational | |
| Departments for Psychosomatic Medicine at general hospitals | no study interventions, observational group Receives: Other: no intervention, purely observational | |
| Departments for Psychosomatic Medicine at psychiatric hospitals | no study interventions, observational group Receives: Other: no intervention, purely observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week one of treatment: assessment of administered treatment units
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week two of treatment: assessment of administered treatment units
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week three of treatment: assessment of administered treatment units
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week four of treatment: assessment of administered treatment units
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week five of treatment: assessment of administered treatment units
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week six of treatment: assessment of administered treatment units
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week seven of treatment: assessment of administered treatment units
Administered Treatments
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Measured: Week eight of treatment: assessment of administered treatment units
Secondary outcomes (1)
HONOS - Health of the Nation Outcome Scales
measure of severity of mental illness
Measured: administered once per patient at week one of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start11 Jun 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosomatic MedicineStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,961 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Krankenhausinstitut, DGPPN, DGKJP, DGPM, Forum für Gesundheitswirtschaft gGmbH
- Responsible party
- Principal investigator, Simone Jennissen, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240105
- Sponsor's protocol ID
- EPPIK
- Acronym
- EPPIK
- Status last verified
- Feb 2022
- First submitted
- 31 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Suitability of the "Platform Model" as an Instrument for Staffing in Psychiatric and Psychosomatic Clinics (EPPIK) - Subproject Psychosomatics
- ClinicalTrials.gov ID
- NCT05240105
- Acronym / sponsor ID
- EPPIK / EPPIK
- Conditions
- Psychosomatic Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,961 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Deutsches Krankenhausinstitut, DGPPN, DGKJP, DGPM, Forum für Gesundheitswirtschaft gGmbH
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- 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.
This study aims to evaluate the so-called platform model and its suitability to determine staffing in hospitals for psychosomatic medicine and psychotherapy.
Detailed description
The aim of the study is to test the suitability of a structural model (so-called platform model) developed by a working group of various scientific societies and professional associations for staffing in psychosomatic medicine and psychotherapy. For this purpose, in three steps (1.) the four treatment clusters developed in the platform model will be quantified and empirically validated on the basis of the therapeutic services provided in health care practice; (2.) the current staffing for the four treatment clusters will be described ("as-is analysis"); and (3.) prototypical therapy plans will be developed as a basis for estimating the target staffing requirements. On this basis, a target staffing estimate will be made for all professional groups.
For the study, a total of 80 psychosomatic clinics from Germany will be randomly selected, belonging in equal parts to the groups of psychosomatic university clinics, psychosomatic specialist hospitals, and psychosomatic departments in somatic or in psychiatric hospitals. In addition, 20 day clinics are included. In these clinics, the structural framework conditions including staffing will be surveyed and the routine documentation of therapy units will be evaluated by cluster analysis in order to empirically validate the presumed treatment clusters and to describe the necessary staffing requirements.
The empirical examination and validation of the platform model, including the four assumed treatment clusters, has the potential to positively influence care practice in the long term by adjusting staffing levels in psychosomatic clinics to actual care requirements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Departments for Psychosomatic Medicine at University Clinics | – | Other: no intervention, purely observationalno study interventions, observational group |
| Clinics specialized in Psychosomatic Medicine | – | Other: no intervention, purely observationalno study interventions, observational group |
| Departments for Psychosomatic Medicine at general hospitals | – | Other: no intervention, purely observationalno study interventions, observational group |
| Departments for Psychosomatic Medicine at psychiatric hospitals | – | Other: no intervention, purely observationalno study interventions, observational group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- nationwide German population of psychosomatic specialist clinics and departments at University hospitals, general hospitals, or psychiatric hospitals
Key inclusion criteria (6 listed)
- belong to the predefined nationwide population of psychosomatic specialist clinics and departments
- randomly selected for inclusion in the study,
- the clinic management (head physician or comparable) agrees to participation in the study
- possibility of electronic recording of the qualified therapy units for all treating professional groups.
- patient treated in one of the selected clinics on the corresponding ward or day clinic
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| no intervention, purely observationalThere will be no interventions. The study is purely observational and investigates differences in naturally occuring treatments at these four types of departments for Psychosomatic Medicine. | Other | Clinics specialized in Psychosomatic Medicine, Departments for Psychosomatic Medicine at University Clinics, Departments for Psychosomatic Medicine at general hospitals, Departments for Psychosomatic Medicine at psychiatric hospitals |
Primary outcome
Administered Treatments
Time frame: Week one of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Administered Treatments
Time frame: Week two of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Administered Treatments
Time frame: Week three of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Administered Treatments
Time frame: Week four of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Administered Treatments
Time frame: Week five of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Administered Treatments
Time frame: Week six of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Administered Treatments
Time frame: Week seven of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
Administered Treatments
Time frame: Week eight of treatment: assessment of administered treatment units
units of psychotherapeutic treatment administered to each patient by physicians, psychologists, nurses, art therapists, social workers, and physiotherapists
1 secondary outcome
HONOS - Health of the Nation Outcome Scales
Time frame: administered once per patient at week one of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosomatic Medicine, run by University Hospital Heidelberg 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 6 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 15 Feb 2022. 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 Simone U Jennissen, PhD (004962215634620, simone.jennissen@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Administered Treatments (time frame: Week one of treatment: assessment of administered treatment units). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2022.