Accountable Care in Germany

Organizational Data

DRKS-ID:
DRKS00020884
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-03-25
Last update in DRKS:
2020-09-01
Registration type:
Retrospective

Acronym/abbreviation of the study

ACD

URL of the study

http://www.acd-projekt.de

Brief summary in lay language

In international comparison, Germany’s health care system is efficient and provides a high standard of care covering nearly the entire population. The overall numbers of physicians as well as hospital beds (per population) in Germany are significantly above EU average. Due to absence of gatekeeping, patients generally have free choice of GPs, medical specialists and hospitals for their care. However, the system has been traditionally fragmented within and across levels of care. Vertical integration is complicated by a multiplicity of structural factors, such as the differing provider remuneration schemes between primary health care (PHC) and secondary health care (SHC), which can give rise to competition instead of cooperation across the care trajectory. This fragmented nature of the system specifically affects optimal management of multi-morbid patients with chronic diseases like the selected ACSCs, for whom optimal care would require well-coordinated, integrated health services delivery structures encompassing providers across the care trajectory. The project "Accountable Care in Germany" aims to improve coordination and communication among providers within the ambulatory care sector and across the sectors. Using routine data for 150 000 patients with ambulatory care sensitive diagnoses in Germany, providers who treat the same patient population will be identified and be grouped into physician networks. The networks will be randomised in two groups, one of which will receive exhaustive information on processes (hospitalisations following ambulatory care sensitive diagnoses as the primary outcome) and characteristics of their networks generated using routine data. Following the feedback the networks will be invited to so called “quality circles” to discuss the indicators and potential measures to improve coordination among their network.

Brief summary in scientific language

In international comparison, Germany’s health care system is efficient and provides a high standard of care covering nearly the entire population. The overall numbers of physicians as well as hospital beds (per population) in Germany are significantly above EU average. Due to absence of gatekeeping, patients generally have free choice of GPs, medical specialists and hospitals for their care. However, the system has been traditionally fragmented within and across levels of care. Vertical integration is complicated by a multiplicity of structural factors, such as the differing provider remuneration schemes between primary health care (PHC) and secondary health care (SHC), which can give rise to competition instead of cooperation across the care trajectory. This fragmented nature of the system specifically affects optimal management of multi-morbid patients with chronic diseases like the selected ACSCs, for whom optimal care would require well-coordinated, integrated health services delivery structures encompassing providers across the care trajectory. The project "Accountable Care in Germany" aims to improve coordination and communication among providers within the ambulatory care sector and across the sectors. Using routine data for 150 000 patients with ambulatory care sensitive diagnoses in Germany, providers who treat the same patient population will be identified and be grouped into physician networks. The networks will be randomised in two groups, one of which will receive exhaustive information on processes (hospitalisations following ambulatory care sensitive diagnoses as the primary outcome) and characteristics of their networks generated using routine data. Following the feedback the networks will be invited to so called “quality circles” to discuss the indicators and potential measures to improve coordination among their network.

Health condition or problem studied

Free text:
Ambulatory care senstive conditions with high prevalence and interdisciplinary treatment I20, I25 I21, I22, I23, I24 I50 I05, I06, I07, I09, I08, I49, I48, I67, I70, I73, I78, I80, I83, I86, I87, I95, R00, I42, I74 J20, J21, J22, J40, J41, J42, J43 J44, J47 F10, F11 M42, M47, M53, M54, M50, M51 I10-I15 K52, K57, K58, K59 A00 - A09 J10, J11, J13, J14, J15, J16, J18, J12 H66, J01-J03, J06, J31, J32, J35, H65, H73, J04, R07.0 F32, F33 E10, E11, E13, E14, E16 M17
ICD10:
I20-I25 - Ischaemic heart diseases
ICD10:
I50 - Heart failure
ICD10:
I05-I09 - Chronic rheumatic heart diseases
ICD10:
I48 - Atrial fibrillation and flutter
ICD10:
I70 - Atherosclerosis
ICD10:
I78 - Diseases of capillaries
ICD10:
I80 - Phlebitis and thrombophlebitis
ICD10:
I83 - Varicose veins of lower extremities
ICD10:
I95 - Hypotension
ICD10:
R00 - Abnormalities of heart beat
ICD10:
I74 - Arterial embolism and thrombosis
ICD10:
J20-J22 - Other acute lower respiratory infections
ICD10:
J40 - Bronchitis, not specified as acute or chronic
ICD10:
J41 - Simple and mucopurulent chronic bronchitis
ICD10:
J42 - Unspecified chronic bronchitis
ICD10:
J43 - Emphysema
ICD10:
J44 - Other chronic obstructive pulmonary disease
ICD10:
J47 - Bronchiectasis
ICD10:
I10-I15 - Hypertensive diseases
ICD10:
F10 - Mental and behavioural disorders due to use of alcohol
ICD10:
F11 - Mental and behavioural disorders due to use of opioids
ICD10:
M42 - Spinal osteochondrosis
ICD10:
M47 - Spondylosis
ICD10:
M53 - Other dorsopathies, not elsewhere classified
ICD10:
M54 - Dorsalgia
ICD10:
M50 - Cervical disc disorders
ICD10:
M51 - Other intervertebral disc disorders
ICD10:
K52 - Other noninfective gastroenteritis and colitis
ICD10:
K57 - Diverticular disease of intestine
ICD10:
K58 - Irritable bowel syndrome
ICD10:
A00-A09 - Intestinal infectious diseases
ICD10:
J10 - Influenza due to identified seasonal influenza virus
ICD10:
J18 - Pneumonia, organism unspecified
ICD10:
H66 - Suppurative and unspecified otitis media
ICD10:
J01 - Acute sinusitis
ICD10:
J31 - Chronic rhinitis, nasopharyngitis and pharyngitis
ICD10:
J06 - Acute upper respiratory infections of multiple and unspecified sites
ICD10:
J35 - Chronic diseases of tonsils and adenoids
ICD10:
H73 - Other disorders of tympanic membrane
ICD10:
J04 - Acute laryngitis and tracheitis
ICD10:
R07.0 - Pain in throat
ICD10:
F32 - Depressive episode
ICD10:
F33 - Recurrent depressive disorder
ICD10:
M17 - Gonarthrosis [arthrosis of knee]
ICD10:
E10-E14 - Diabetes mellitus
ICD10:
E16 - Other disorders of pancreatic internal secretion
ICD10:
I49 - Other cardiac arrhythmias
ICD10:
I67 - Other cerebrovascular diseases
ICD10:
I73 - Other peripheral vascular diseases
ICD10:
I86 - Varicose veins of other sites
ICD10:
I87 - Other disorders of veins
ICD10:
I42 - Cardiomyopathy
ICD10:
K59 - Other functional intestinal disorders
ICD10:
J11 - Influenza, virus not identified
ICD10:
J12 - Viral pneumonia, not elsewhere classified
ICD10:
J13 - Pneumonia due to Streptococcus pneumoniae
ICD10:
J14 - Pneumonia due to Haemophilus influenzae
ICD10:
J15 - Bacterial pneumonia, not elsewhere classified
ICD10:
J16 - Pneumonia due to other infectious organisms, not elsewhere classified
ICD10:
J02 - Acute pharyngitis
ICD10:
J03 - Acute tonsillitis
ICD10:
J32 - Chronic sinusitis
ICD10:
H65 - Nonsuppurative otitis media
ICD10:
E16 - Other disorders of pancreatic internal secretion
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Receipt of feedback to indicators for the treatment of the above mentioned diseases, invitation to network meetings
Arm 2:
Treatment as usual

Endpoints

Primary outcome:
Ambulatory care senstive hospitalizations due to the above mentioned conditions These Hospital cases are derived from routine data of two Major Health insurance funds prior to the Intervention as well as until end of 2019. Cases of ambulatory care sensitive conditions are analysed using multilevel models and an Intention to treat approah.
Secondary outcome:
The secondary outcomes are indicators of the proportion of guideline-based treatments and acceptance among service providers. Indicators of Guideline-based Treatments are derived in Routine data of the two Major Health insurance funds. Data is available Prior to the intervetion and during the Intervention until the end of 2019. Acceptance among providers is analysed based on a process Evaluation encluding interviews and questinnaires. Moderators receive questionnaires in the moderator Training. Furthermore, questionnaires are filled out by Moderators and participants of the Network Meetings after the Network Meetings. Additionally, Moderators and participants of the Network Meetings are interviewed to assess their acceptance of the Meetings.

Study Design

Purpose:
No Entry
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
IV
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Kassenärztliche Vereinigung Schleswig-Holstein
  • Other Kassenärztliche Vereinigung Schleswig-Holstein
  • Other Kassenärztliche Vereinigung Westfalen-Lippe
  • Other Kassenärztliche Vereinigung Nordrhein
  • Other Kassenärztliche Vereinigung Hamburg

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2018-08-20
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
6481
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
A total of 6.481 physicians which are part of one of the 100 intervention networks are recruited. The physician networks were constructed based on physician-patient visits based on routine data of patients with the above mentioned diseases. Networks were cluster-randomized based on region, rural/urban area, size of the network. Networks: consisting of 20-120 physicians, working in one of the 4 physician association regions. 100 intervention, 100 controllnetworks Physicians: Identified in an intervention / control network, practicing in one of the 4 defined regions Patients: Insurees in one of the participating insurances (AOK Rheinland-Hamburg / AOK Nordwest / TK), living in the intervention region, at least one diagnosis of the above mentioned ambulatory care sensitive conditions

Exclusion Criteria

Participants: patients in a dialysis treatment Physicians: Pediatricians incl. Pediatric disciplines, laboratory medicine, microbiology, virology and infection epidemiology, maxillofacial surgeons, pathology, radiology, neuroradiology, radiation therapy, transfusion medicine, child and adolescent psychotherapist

Addresses

Primary Sponsor

Address:
Fachbereich Health Services Management - Ludwig-Maximilians-Universität München
Prof. Dr. Leonie Sundmacher
Schackstraße 4
80539 München
Germany
Telephone:
089 2180 3110
Fax:
089 2180 99 3110
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.hsm.bwl.uni-muenchen.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Medizinische Hochschule Hannover
Dipl.-Mathematikerin Birgitt Wiese
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
+49 (511) 532-4414
Fax:
+49 (511) 69688873
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.mhh.de/allgmed

Contact for Public Queries

Address:
Direktor des Instituts für Allgemeinmedizin (ifam)
Prof. Stefan Wilm
Moorenstr. 5
40225 Düsseldorf
Germany
Telephone:
0211/81-17771
Fax:
0211/81-18755
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.uniklinik-duesseldorf.de/allgemeinmedizin

Principal Investigator

Address:
Medizinische Hochschule Hannover
Dipl.-Mathematikerin Birgitt Wiese
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
+49 (511) 532-4414
Fax:
+49 (511) 69688873
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.mhh.de/allgmed

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
DLR Projektträger - Bereich Gesundheit - als Projektträger für den Innovationsausschuss beimG-BA
Heinrich-Konen-Str. 1
53227 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
Moorenstr. 5
40225 Düsseldorf
Germany
Telephone:
+49-211-8119591
Fax:
+49-211-8119592
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2017-09-22
Ethics committee number:
6096R
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-01-22

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
Routine data will only be analysed by the project team. Data of patients and participants of the study will not be shared with the public due to data protection issues.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry