Trial document





This trial has been registered retrospectively.
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  DRKS00020884

Trial Description

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Title

Accountable Care in Germany

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Trial Acronym

ACD

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URL of the Trial

http://www.acd-projekt.de

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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.

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description 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.

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Organizational Data

  •   DRKS00020884
  •   2020/03/25
  •   [---]*
  •   yes
  •   Approved
  •   6096R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   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
  •   I20-I25 -  Ischaemic heart diseases
  •   I50 -  Heart failure
  •   I05-I09 -  Chronic rheumatic heart diseases
  •   I48 -  Atrial fibrillation and flutter
  •   I70 -  Atherosclerosis
  •   I78 -  Diseases of capillaries
  •   I80 -  Phlebitis and thrombophlebitis
  •   I83 -  Varicose veins of lower extremities
  •   I95 -  Hypotension
  •   R00 -  Abnormalities of heart beat
  •   I74 -  Arterial embolism and thrombosis
  •   J20-J22 -  Other acute lower respiratory infections
  •   J40 -  Bronchitis, not specified as acute or chronic
  •   J41 -  Simple and mucopurulent chronic bronchitis
  •   J42 -  Unspecified chronic bronchitis
  •   J43 -  Emphysema
  •   J44 -  Other chronic obstructive pulmonary disease
  •   J47 -  Bronchiectasis
  •   I10-I15 -  Hypertensive diseases
  •   F10 -  Mental and behavioural disorders due to use of alcohol
  •   F11 -  Mental and behavioural disorders due to use of opioids
  •   M42 -  Spinal osteochondrosis
  •   M47 -  Spondylosis
  •   M53 -  Other dorsopathies, not elsewhere classified
  •   M54 -  Dorsalgia
  •   M50 -  Cervical disc disorders
  •   M51 -  Other intervertebral disc disorders
  •   K52 -  Other noninfective gastroenteritis and colitis
  •   K57 -  Diverticular disease of intestine
  •   K58 -  Irritable bowel syndrome
  •   A00-A09 -  Intestinal infectious diseases
  •   J10 -  influenza due to identified seasonal influenza virus
  •   J18 -  Pneumonia, organism unspecified
  •   H66 -  Suppurative and unspecified otitis media
  •   J01 -  Acute sinusitis
  •   J31 -  Chronic rhinitis, nasopharyngitis and pharyngitis
  •   J06 -  Acute upper respiratory infections of multiple and unspecified sites
  •   J35 -  Chronic diseases of tonsils and adenoids
  •   H73 -  Other disorders of tympanic membrane
  •   J04 -  Acute laryngitis and tracheitis
  •   R07.0 -  Pain in throat
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   M17 -  Gonarthrosis [arthrosis of knee]
  •   E10-E14 -  Diabetes mellitus
  •   E16 -  Other disorders of pancreatic internal secretion
  •   I49 -  Other cardiac arrhythmias
  •   I67 -  Other cerebrovascular diseases
  •   I73 -  Other peripheral vascular diseases
  •   I86 -  Varicose veins of other sites
  •   I87 -  Other disorders of veins
  •   I42 -  Cardiomyopathy
  •   K59 -  Other functional intestinal disorders
  •   J11 -  Influenza, virus not identified
  •   J12 -  Viral pneumonia, not elsewhere classified
  •   J13 -  Pneumonia due to Streptococcus pneumoniae
  •   J14 -  Pneumonia due to Haemophilus influenzae
  •   J15 -  Bacterial pneumonia, not elsewhere classified
  •   J16 -  Pneumonia due to other infectious organisms, not elsewhere classified
  •   J02 -  Acute pharyngitis
  •   J03 -  Acute tonsillitis
  •   J32 -  Chronic sinusitis
  •   H65 -  Nonsuppurative otitis media
  •   E16 -  Other disorders of pancreatic internal secretion
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Interventions/Observational Groups

  •   Receipt of feedback to indicators for the treatment of the above mentioned diseases, invitation to network meetings
  •   Treatment as usual
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Health economics
  •   Parallel
  •   IV
  •   No
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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.

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2018/08/20
  •   6481
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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

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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

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Addresses

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    • Fachbereich Health Services Management - Ludwig-Maximilians-Universität München
    • Ms.  Prof. Dr.  Leonie  Sundmacher 
    • Schackstraße 4
    • 80539  München
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dipl.-Mathematikerin  Birgitt  Wiese 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Direktor des Instituts für Allgemeinmedizin (ifam)
    • Mr.  Prof.  Stefan  Wilm 
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • DLR Projektträger - Bereich Gesundheit - als Projektträger für den Innovationsausschuss beimG-BA
    • Heinrich-Konen-Str. 1
    • 53227  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.