Trial document




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  DRKS00015638

Trial Description

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Title

Assessment and optimization of guideline adherence in the diagnostic process for cardiac catheterization in stable coronary heart disease

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Trial Acronym

ENLIGHT-KHK

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URL of the Trial

https://innovationsfonds.g-ba.de/projekte/versorgungsforschung/enlight-khk-erfassung-und-optimierung-der-leitlinienadhaerenz-im-indikationsstellungsprozess-zur-koronarangiographie-bei-stabiler-koronarer-herzerkrankung.128

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Brief Summary in Lay Language

Coronary heart disease (CHD) is one of the most common cardiovascular diseases in Germany. It is caused by a reduced circulation of the heart muscle, which can lead to discomforts such as impaired performance, chest tightness, shortness of breath during exercise or, even to a heart attack. Diagnosis and treatment of CHD amounts to a relevant part of the health expenditure in Germany. For the diagnostic process of patients at risk of CHD, medical societies developed clinical recommendations based on current scientific knowledge and practical experience. According to recent evidence, in Germany, the diagnostic process for a CHD (e.g. the use of an imaging techniques or a cardiac catheterization procedure) may deviate from these guideline recommendations.

The project aims to analyse the type and extent of such deviations in medical practices and hospitals for patients at risk of CHD. Thereby, it tries to support efforts in the prevention of overuse, underuse and misuse in health care and to allow reducing costs by improving treatment quality.

ENLIGHT-KHK compares the diagnostic process pathway of patients in clinical practice with guideline-based pathways. To identify potential deficits in care, the project will evaluate data from patient surveys, clinical documentation and claims-data from health insurers. The participating clinics will collect data on admission and diagnostic processes of approximately 2,500 patients assigned to cardiac catheterization. In addition, ENLIGHT-KHK compares the costs of the diagnostic process in clinical practice with the expected costs of guideline-adherent care.

Based on the findings obtained, the project aims to develop recommendations of new supply- and reimbursement models for the implementation of a guideline-adherent and resource-efficient care. ENLIGHT-KHK should improve the quality of treatment of patients at risk of CHD. In addition, the project should ensure that the required procedures of CHD-care are affordable on a long-term.

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Brief Summary in Scientific Language

Background: Coronary heart disease (CHD) is associated with a high prevalence, incidence, morbidity and mortality in industrialized countries (e.g. Germany) and contributes significantly to health expenditures. The diagnosis of CHD can be challenging because many potentially cardiac symptoms do not have a cardiac cause. Analyses from routine data of the participating health insurances show a regional heterogeneity of diagnostic pathways in clinical practice in patients at risk of CHD indicating non-adherence to clinical guideline recommendations. Despite the clinical and economic relevance of CHD, prospective and reliable evidence on guideline deviations and for identifying supply deficits is still lacking.

Aims of the project
(1) Analysis of the diagnostic process and indication quality in routine care in patients at risk of CHD.
(2) Cost comparison of the current clinical practice with a hypothetical guideline-adherent care.
(3) Analysis of barriers and facilitators of a guideline-based diagnostic process.
(4) Development of incentive-based contract and reimbursement models stimulating resource-efficient and guideline-based care for patients at risk of CHD.

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

Yes

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Description IPD sharing plan:

Data Sharing for selected data can be requested. For certain data, especially the combinatin of clinical and health claims data, strict data regulation requirements apply.

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Organizational Data

  •   DRKS00015638
  •   2019/02/19
  •   [---]*
  •   yes
  •   Approved
  •   2018361, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   U1111-1227-8055 
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Health Condition or Problem studied

  •   I20 -  Angina pectoris
  •   I25 -  Chronic ischaemic heart disease
  •   R07 -  Pain in throat and chest
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Interventions/Observational Groups

  •   Patients assigned to cardiac catheterization for suspected de novo or progression of known coronary heart disease.

    Patients with inpatient admission with suspected de novo or progress of a known coronary heart disease after exclusion of acute myocardial infarction and clarification by cardiac catheterization.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the guideline adherence of the diagnostic pathways of patients at risk of CHD who are admitted to hospital wards.
The primary safety target parameters are peri-interventional and post-ward complications up to 30 days after cardiac catheterization (death, myocardial infarction, and stroke).

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Secondary Outcome

Secondary target parameters are:
• Coronary revascularization by percutaneous coronary intervention or bypass surgery
• Peri-interventional complications:
o all-cause death, myocardial infarction, or stroke
o Bleeding and vascular complications
• Economically, the costs of real care practice are recorded.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/01/24
  •   1500
  •   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

General:
• Age >18 years
• Signed consent to participate
• Insured at AOK Rheinland/Hamburg or AOK Nordwest

Cohort specific inclusion criteria:
Main cohort for assessing and optimizing guidelines adherence, in the diagnostic process for cardiac catheterization in stable CHD:
• Patients assigned to the cardiac catheterization for suspected de novo or progress of a known coronary heart disease.
• Patients with inpatient admission with suspected de novo or progress of a known coronary heart disease after exclusion of acute myocardial infarction and clarification by a cardiac catheterization.

Three sub-cohorts for explorative assessment of the overall health care provision:
1. Patients with referral for outpatient specialist cardiological consultation in case of suspected de novo or progression of a known coronary heart disease.
2. Patient with admission or self-referral on the emergency department with purely non-invasive clarification.
3. Patients with admission for non-invasive imaging, pre-ward examinations (clarification) without consecutive cardiac catheterization.

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Exclusion Criteria

- acute myocardial infarction
- elevtive clarification before heart surgery
- elective clarification of a heart failure

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Addresses

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    • Contilia GmbH Klinik für Kardiologie
    • Mr.  PD Dr. med  Oliver  Bruder 
    • Klara-Kopp-Weg 1
    • 45138  Essen
    • Germany
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    • AOK Rheinland/ Hamburg
    • Kasernenstraße 61
    • 40213  Düsseldorf
    • Germany
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    •   [---]*
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    • AOK NORDWEST
    • Kopenhagener Straße 1
    • 44269  Dortmund
    • Germany
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    • Institut für Gesundheitsökonomie und Klinische EpidemiologieUniklinik Köln
    • Gleueler Str. 176
    • 50935  Köln
    • Germany
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    • Cardiovascular European Research Center (CERC) Deutschland GmbH
    • Huttropstr. 60
    • 45138  Essen
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    • Herz- und Gefäßzentrum Kempten-Oberallgäu
    • Mr.  Dr. med.  Bastian  Wein 
    • Robert-Weixler-Str. 50
    • 87439  Kempten
    • Germany
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    • Kardiovaskuläres StudienzentrumKlinik für Kardiologie und AngiologieContilia Herz- und GefäßzentrumElisabeth-Krankenhaus Essen
    • Ms.  Melanie  Steffen 
    • Klara-Kopp-Weg 1
    • Essen  45138
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Postfach 12 06 06
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Approved
  •   Version 2
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* This entry means the parameter is not applicable or has not been set.