Clinical trial NCT04599361: Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)
Official title: Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Chronic coronary heart disease
myocardial revascularization
heart team
decision making
cardiology
heart surgery
Lead sponsor: InGef - Institute for Applied Health Research Berlin GmbH
Sponsor class: INDUSTRY
Collaborators: name: University of Education Freiburg
name: Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)
name: Stiftung Institut fuer Herzinfarktforschung
name: Universitätsklinikum Köln
name: BARMER
name: Techniker Krankenkasse
First posted: 2020-10-22
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient cardiology practices, hospitals with a cardiology department and hospitals with a cardiology and heart surgery department (n=20) in Germany

Brief summary: Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes of death in Germany. Treatment options include widening of the narrowed / blocked coronary vessel via catheter and stent or bypass surgery in which the narrowed vessel sites are bridged. The "German National Disease Management Guideline on cCHD" helps doctors to decide which treatment is most appropriate for the severity of vascular damage and possible concomitant diseases of the patient. Nevertheless, there are other factors determining treatment decision. For example, the equipment or preferences of the hospital or department in which patients are admitted, play a role in the decision.

The aim of the REVASK project is to investigate whether and to what extent the collaboration of cardiology and heart surgery specialists in so-called "heart teams" influences the decision on therapy.

For this purpose, doctors and patients will be interviewed about how the treatment decision was made and how satisfied both sides are with the outcome of the treatment and the decision. In addition, claims data from several German health insurance companies (Techniker, BARMER, Betriebs- und Innungskrankenkassen) will be analyzed. Treatment data, which is documented as usual by the treating medical staff and passed on to the health insurance companies for accounting purposes, is used. Furthermore, treatment data recorded in the registers of the professional societies is analyzed.


Eligibility criteria: Inclusion Criteria:

* with chronic coronary heart disease
* and 2- or 3-vessel or main-vessel disease
* who are being treated at one of the recruitment sites
* with a promptly planned intervention for myocardial revascularization
* who are insured with pre-specified German health insurance companies (BARMER or TK)

Exclusion Criteria:

-

Primary outcomes:
measure: Guideline compliance
timeFrame: 2 years
Secondary outcomes:
measure: Heart teams
timeFrame: 2 years
measure: Patient participation
timeFrame: 2 years
measure: Decision making process
timeFrame: 2 years
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Pädagogische Hochschule Freiburg Public Health & Health Education
Study officials:
affiliation: InGef - Institute for Applied Health Research Berlin GmbH; Spittelmarkt 12, 10117 Berlin
name: Jochen Walker, Dr. med.
role: STUDY_CHAIR
affiliation: Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie (DGTHG)
name: Andreas Beckmann, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stiftung Institut für Herzinfarktforschung (IHF)
name: Uwe Zeymer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: PMV forschungsgruppe, Universitätsklinikum Köln
name: Peter Ihle
role: PRINCIPAL_INVESTIGATOR
affiliation: BARMER
name: Ursula Marschall, Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Techniker Krankenkasse
name: Ines Meier, Dr.
role: PRINCIPAL_INVESTIGATOR
References: