Exploration of ambulant cardiological supply and process evaluation of the cardiology contract

Organizational Data

DRKS-ID:
DRKS00013070
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2017-10-02
Last update in DRKS:
2022-01-10
Registration type:
Retrospective

Acronym/abbreviation of the study

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URL of the study

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Brief summary in lay language

Evaluation of the implementation and effects of the so-called cardiology contract according to §73c SGB V within the state of Baden-Württemberg. During the first stage, practice-based general practitioners (participants as well as non-participants in the "hausarztzentrierte Versorgung" (general practitioners-centered care)) and cardiologists (participants as well as non-participants in the "FacharztProgramm Kardiologie" (specialist's program in cardiology)) will be interviewed with a basic written questionnaire and orally. Topics mainly include the general state of the art within the medical practice and the handling of patients, especially regarding efficient, prompt care and extensive counseling. The second stage will use three written questionnaires constructed in consideration of the information gathered from the first stage. One questionnaire will be sent out and tailored to every practice-based cardiologist within Baden-Württemberg who participates in the "FacharztProgramm Kardiologie". Another questionnaire will be tailored to practice-based general practitioners in the "hausarztzentrierte Versorgung" within Baden-Württemberg and will be sent out to a random sample of 300 of them. The third questionnaire will be tailored to cardiologists within Baden-Württemberg who do not participate in the "FacharztProgramm Kardiologie" and will be sent out to a random sample with a maximum of 100 of them.

Brief summary in scientific language

Process evaluation of the cardiology contract according to §73c SGB V within the state of Baden-Württemberg. Practice-based general practitioners (paticipants in the "hausarztzentrierte Versorung" (general practitioners-centered care) as well as non-participants) and cardiologists (participants in the "FacharztProgramm Kardiologie" (specialist's program in cardiology) as well as non-participants) will at first be interviewed through a basic written questionnaire (advance-interview regarding practice and doctor's characteristics) as well a a qualitative, guided interview regarding the state of the art within the parctice and the handling of patients, especially regarding efficient, prompt care and extensive anamnesis and counseling. In a second stage, three written questionnaires will be constructed in consideration of the information gathered from the guided interviews. Each questionnaire ist tailored to and will be sent out respectively to one of these groups: 1. All paractice-based cardiologists within Baden-Württemberg who participate in the FacharztProgramm Kardiologie. 2. A random sample of 300 practice-based general practitioners who participate in the hausarztzentrierte Versorgung and cooperate with the FacharztProgramm Kardiologie. 3. A random sample with a maximum of 100 practice-based cardiologists within Baden-Württemberg who do not participate in the FacharztProgramm Kardiologie. This group was supplemented in the course of the study by amendment as a comparison group (Ethics Committee I of the Medical Faculty Heidelberg, S-415/2017, subsequent amendment of 29.05.2018). We hope to gain insight in the implementation of the cardiology contract through the medical practitioners within their practice, a general picture of specialist's care as well as knowledge on differences between participants and non-participants in the program within Baden-Württemberg.

Health condition or problem studied

Free text:
cardiological health services
Healthy volunteers:
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Interventions, Observational Groups

Arm 1:
General practitioners and cardiologists who participate in the "Hausarztzentrierte Versorgung" or the "FacharztProgramm Kardiologie" are interviewed (quantitatively and qualitatively) regarding the general structure of their practice, cooperation between specialists and general practitioners as well as the implementation of the contracts' contents.
Arm 2:
General practitioners and cardiologists who do not participate in the "Hausarztzentrierte Versorgung" or the "FacharztProgramm Kardiologie" are interviewed (quantitatively and qualitatively) regarding the general structure of their practice, cooperation between specialists and general practitioners.
Arm 3:
Stakeholders within the institutions of the contract parties (AOK Baden-Württemberg, Bosch BKK, MEDIVERBUND, BNK, BNFI) as well as the Association of SHI Physicians in Baden-Württemberg (KVBW), the German Association of General Practitioners Baden-Württemberg and the General Practitioners’ Contractual Community AG (HÄVG) will be interviewed regarding implementation strategies as well as positive and negative concomitants of the FacharztProgramm. Furthermore, their insights derived from the development process of the FacharztProgramm will be collected.

Endpoints

Primary outcome:
Exploration: - of the program's fidelity and potential mechanisms behind it - of relevant context factors influencing the implementation and results of the FacharztProgramm - of patient care, praticte structures and cooperation between renderers of service within and outside of the contracts Measurement through a written basic questionnaire, qualitative, structured interviews and an expanded written questionnaire afterwards.
Secondary outcome:
Exploration: - of motivation for participating or not participating in the FacharztProgramm - of characteristics of participating patients from the doctors' point of view - of characteristics of participating as well as non-participating cardiologists and general practitioners - of positive as well as negative by-products of the FacharztProgramm from the doctors' point of view - of strategies supporting the implementation of the FacharztProgramm - of satisfaction of participating doctors with the FacharztProgramm Measurement through a written basic questionnaire, qualitative, structured interviews and an expanded written questionnaire afterwards.

Study Design

Purpose:
Health care system
Retrospective/prospective:
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Study type:
Non-interventional
Longitudinal/cross-sectional:
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Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
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Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Doctor's practice Baden-Württemberg

Recruitment period and number of participants

Planned study start date:
2017-09-29
Actual study start date:
2017-09-30
Planned study completion date:
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Actual Study Completion Date:
2019-01-21
Target Sample Size:
721
Final Sample Size:
236

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Stage 1 (qualitative-explorative): - Cardiologists participating in the FacharztProgramm Kardiologie: the doctors need to be specialists in internal medicine with or without cardiology as a core area. They furthermore need to participate in the FacharztProgramm according to § 73c SGB V either as a single medical practitioner or as an ambulatory healthcare center. - Cardiologists not participating in the FacharztProgramm Kardiologie: the doctors need to be specialists in internal medicine with or without cardiology as a core area. They must not participate in the FacharztProgramm according to § 73c SGB V. - General practitioners participating in the hausarztzentrierte Versorgung and cooperating with the FacharztProgramm Kardiologie: the general practitioners need to be practice-based and enrolled in the HzV-contract of the AOK Baden-Württemberg as well as the general practitioner’s contract of the Bosch BKK. Furthermore, they need to cooperate with the FacharztProgramm according to § 73c SGB V. - General practitioners not participating in the hausarztzentrierte Versorgung and not cooperating with the FacharztProgramm Kardiologie: the general practitioners need to be practice-based and must not be enrolled in the HzV-contract of the AOK Baden-Württemberg and/or as the general practitioner’s contract of the Bosch BKK. Therefore, they must also not cooperate with the FacharztProgramm according to § 73c SGB V. - Stakeholders: stakeholders will be recruited within the institutions of the contract parties (AOK Baden-Württemberg, Bosch BKK, MEDIVERBUND, BNK, BNFI) as well as the Association of SHI Physicians in Baden-Württemberg (KVBW), the German Association of General Practitioners Baden-Württemberg and the General Practitioners’ Contractual Community AG (HÄVG). Stakeholders are persons who were actively involved in the development and execution of the FacharztProgramm Kardiologie and/or who have extensive background knowledge at their disposal. They need to be at least 18 years old. Stage 2 (quantitative): - Cardiologists participating in the FacharztProgramm Kardiologie: the doctors need to be specialists in internal medicine with or without cardiology as a core area. They furthermore need to participate in the FacharztProgramm according to § 73c SGB V either as a single medical practitioner or as an ambulatory healthcare center. All specialists enrolled in the FacharztProgramm within Baden-Württemberg who are practice-based and active in the field of cardiology will be invited to participate in the study. - General practitioners participating in the hausarztzentrierte Versorgung and cooperating with the FacharztProgramm Kardiologie: the general practitioners need to be practice-based and enrolled in the HzV-contract of the AOK Baden-Württemberg as well as the general practitioner’s contract of the Bosch BKK. Furthermore, they need to cooperate with the FacharztProgramm according to § 73c SGB V. A random sample of 300 general practitioners enrolled in the HZV will be invited to participate in the study. - Cardiologists not participating in the FacharztProgramm Kardiologie: the doctors need to be specialists in internal medicine with or without cardiology as a core area. They furthermore must not participate in the FacharztProgramm according to § 73c SGB V. A random sample with a maximum of 100 specialists not enrolled in the FacharztProgramm within Baden-Württemberg who are practice-based and active in the field of cardiology will be invited to participate in the study.

Exclusion Criteria

Cardiologists or general practitioners who are not practice-based and do not have their licence, SHI physician's place of business and main establishment within Baden-Württemberg. Furthermore, unsufficient knowledge of the German language is a criterion for exclusion.

Addresses

Primary Sponsor

Address:
Universitätsklinikum Heidelberg, Abt. Allgemeinmedizin und Versorgungsforschung
Prof. Dr. Michel Wensing
Im Neuenheimer Feld 130.3, Turm West
69120 Heidelberg
Germany
Telephone:
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Fax:
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Contact per E-Mail:
Contact per E-Mail
URL:
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Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Address:
Universitätsklinikum Heidelberg, Abt. Allgemeinmedizin und Versorgungsforschung
Prof. Dr. Michel Wensing
Im Neuenheimer Feld 130.3, Turm West
69120 Heidelberg
Germany
Telephone:
06221568317
Fax:
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Contact per E-Mail:
Contact per E-Mail
URL:
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Contact for Public Queries

Address:
Universitätsklinikum Heidelberg, Abt. Allgemeinmedizin und Versorgungsforschung
Patrick Hennrich
Im Neuenheimer Feld 130.3, Turm West
69120 Heidelberg
Germany
Telephone:
06221568317
Fax:
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Contact per E-Mail:
Contact per E-Mail
URL:
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Principal Investigator

Address:
Universitätsklinikum Heidelberg, Abt. Allgemeinmedizin und Versorgungsforschung
Prof. Dr. Michel Wensing
Im Neuenheimer Feld 130.3, Turm West
69120 Heidelberg
Germany
Telephone:
06221568317
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
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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:
Innovationsausschuss beim Gemeinsamen Bundesausschuss
Wegelystraße 8
10623 Berlin
Germany
Telephone:
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Fax:
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Contact per E-Mail:
Contact per E-Mail
URL:
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Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail:
Contact per E-Mail
URL:
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Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2017-07-18
Ethics committee number:
S-415/2017
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-08-16

Further identification numbers

Other primary registry ID:
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EudraCT Number:
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UTN (Universal Trial Number):
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EUDAMED Number:
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IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
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IPD Sharing Plan:
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Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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