Condition category
Not Applicable
Date applied
19/05/2014
Date assigned
17/06/2014
Last edited
21/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.aokplus-online.de

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

Publication citations

Additional files

Editorial Notes