Evaluation of GP-centred care in the German state of Thuringia

ISRCTN	ISRCTN29418540
DOI	https://doi.org/10.1186/ISRCTN29418540
Secondary identifying numbers	N/A

Submission date: 19/05/2014
Registration date: 17/06/2014
Last edited: 21/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Unlike other countries, such as the UK, general practitioners (GPs) in Germany have not typically acted as the gatekeepers to the countries' healthcare system. GP-centred health care (HzV), in which German GPs are the first point of contact to the rest of the healthcare system, is a medical care concept that allows GPs to act as coordinator, referring patients to other healthcare providers according to their medical needs. The benefits of this system have included an improvement in medical care and a decrease in the financial burden on the healthcare system. In the German state of Thuringia AOK PLUS beneficiaries can choose the GP-centered care contract since January 2011. It is designed as an add-on to regular care.

Who can participate?
Adult patients living in Thuringa and beneficiaries to the statutory health insurance fund AOK PLUS who entered the GP-centred health care programme between 1st Jan 2011 and 30th June 2011.

What does the study involve?
Participants are randomly allocated to one of two groups: one group receives GP-centered care for 18 months and the other receives usual care. The cost-effectiveness of the GP-centered care is assessed by comparing the costs to the healthcare system.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
The Department of General Practice and Family Medicine, Jena University Hospital, Germany.

When is the study starting and how long is it expected to run for?
The study started in July 2012 and runs until December 2014.

Who is funding the study?
AOK PLUS (statutory health insurance fund for Saxony and Thuringia, Germany).

Who is the main contact?
Prof Jochen Gensichen
jochen.gensichen@med.uni-jena.de

Study website

Contact information

Prof Jochen Gensichen
Scientific

Department of General Practice and Family Medicine
Jena University Hospital
Bachstr. 18
Jena
07743
Germany

Phone	+49 (0) 364 1939 5800
Email	jochen.gensichen@med.uni-jena.de

Prof Jürgen Wasem
Scientific

Institute for Health Care Management and Research
University Duisburg-Essen
Schützenbahn 70
Essen
D-45127
Germany

Email	juergen.wasem@uni-due.de

Study information

Study design	Retrospective case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	GP-centered care evaluation in the state of Thuringia: a retrospective case-control intervention study
Study objectives	The health care costs of patients that are AOK PLUS beneficiaries receiving GP-centred care in Thuringia are lower than those of patients receiving conventional care after 18 months. On 21/04/2015 the overall trial end date was changed from 31/12/2014 to 31/12/2015.
Ethics approval(s)	Local Ethics Committee of Jena University Hospital, 28/04/2014, ref. 4058-04/14
Health condition(s) or problem(s) studied	GP-centered health care programme
Intervention	Group 1 = GP-centred programme: participants receive total coordinated health care over 18 months. The GP-centred health care programme includes morbidity lump sums, bonuses for rational pharmacotherapy, obligation for general practitioners to take part in quality circles, obligation of implementation of IT tools for supporting pharmacotherapy and extra payment for the utilisation of specialised health care assistants. Group 2 = Conventional care.
Intervention type	Other
Primary outcome measure	Direct total health care costs to the sickness funds (in-patient hospital care, outpatient physician care, drugs, remedies, therapeutic aids, sick leave payment, home care, rehabilitation, post-acute care) - measured after 18 months
Secondary outcome measures	1. Share of patients with different GPs contacted 2. Share of patients with different specialists contacted 3. Share of specialist contacts without referal 4. Share of hospital procedures with potential of substitution by outpatient prodcedure 5. Number of hospital emergency cases 6. Number of home visits by GPs 7. Development of nursing care status 8. Number of prevention procedures by GPs 9. Number of different drugs (ATC Code) 10. Share of patients with polymedication (>5 drugs) 11. Share of patients older than 64 years with polymedication (>5 drugs) 12. Costs of hospital care cases 13. Number of in-patient cases 14. Costs of GP contacts 15. Number of GP contacts 16. Costs of specialist contacts 17. Number of specialist contacts 18. Costs of home care 19. Number of home care prescriptions 20. Costs of remedies 21. Number of remedies prescripted 22. Costs of therapeutic aids 23. Number of therapeutic aids prescripted 24. Costs of rehabilitation (in- and outpatient) 25. Number of rehabilitation prescripted (in- and outpatient) 26. Costs of subsequent nursing treatment 27. Number of subsequent nursing treatment prescriptions 28. Costs of sick leave payment 29. Number of cases of sick leave and days of sick leave 30. Costs of drug prescriptions 31. Number of drug prescriptions All to be measured after 18 months
Overall study start date	01/07/2012
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40,000
Key inclusion criteria	1. Patients living in Thuringia 2. Beneficiaries to the statutory health insurance fund AOK PLUS 3. Entry into GP-centered health care programme between 01/01/2011 and 30/06/2011
Key exclusion criteria	Patients aged < 18
Date of first enrolment	01/07/2012
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

Germany

Study participating centre

Jena University Hospital

Jena
07743
Germany

Sponsor information

AOK PLUS (Germany)
Industry

Sternplatz 7
Dresden
01067
Germany

Website	https://www.aokplus-online.de
"ROR"	https://ror.org/004cmqw89

Funders

Funder type

Industry

AOK PLUS, statutory health insurance fund for Saxony and Thuringia (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan