Plain English Summary
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
Trial website
http://www.allgemeinmedizin.uni-jena.de/content/research/hzv_evaluation/index_eng.html
Contact information
Type
Scientific
Primary contact
Prof Jochen Gensichen
ORCID ID
Contact details
Department of General Practice and Family Medicine
Jena University Hospital
Bachstr. 18
Jena
07743
Germany
+49 (0) 364 1939 5800
jochen.gensichen@med.uni-jena.de
Type
Scientific
Additional contact
Prof Jürgen Wasem
ORCID ID
Contact details
Institute for Health Care Management and Research
University Duisburg-Essen
Schützenbahn 70
Essen
D-45127
Germany
-
juergen.wasem@uni-due.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
GP-centered care evaluation in the state of Thuringia: a retrospective case-control intervention study
Acronym
Study hypothesis
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
Local Ethics Committee of Jena University Hospital, 28/04/2014, ref. 4058-04/14
Study design
Retrospective case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2012
Overall trial end date
31/12/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40,000
Participant exclusion criteria
Patients aged < 18
Recruitment start date
01/07/2012
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Germany
Trial participating centre
Jena University Hospital
Jena
07743
Germany
Sponsor information
Organisation
AOK PLUS (Germany)
Sponsor details
Sternplatz 7
Dresden
01067
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AOK PLUS, statutory health insurance fund for Saxony and Thuringia (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary