Trial document




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  DRKS00012944

Trial Description

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Title

Implementation of teledermatologic referrals into general practice - a cluster-randomized controlled trial

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Trial Acronym

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URL of the Trial

https://www.medizin.uni-tuebingen.de/Presse_Aktuell/Einrichtungen+A+bis+Z/Institute/Allgemeinmedizin/Forschung/Forschungschwerpunkte+und+Projekte/Innovative+Versorgungsmodelle+_+Telemedizin/TeleDerm.html

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Brief Summary in Lay Language

The TeleDerm project aims at helping general practitioners diagnose common skin conditions with the help of teledermatologic referrals. Teledermatology is the process of storing and sending pictures of skin conditions and additional relevant information to a dermatologist (physician specialised in skin conditions). The dermatologist looks at these pictures and writes a diagnostic report and treatment plan. He or she then sends this report to the GP.
Patients enrolled in the HZV (General Practitioner Centered Health Care) and are insured by the AOK health insurance company may participate in the study. The study is conducted in four counties in the region of Baden-Württemberg, Germany.
The goal of the study is to reduce the number of physical referrals to dermatologists in the counties mentioned above. These results are compared to four other similar counties, where patients receive care as usual. Patient data, such as number of referrals to dermatologists, is collected via routine data from the insurance company.
Other study goals comprise to learn what patients and physicians think about this type of care.
The study will be conducted from July 2018 till June 2019.

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Brief Summary in Scientific Language

The aim of this study is to implement teledermatologic referrals into general practice in four intervention counties in the Baden-Württemberg region of Germany.
The study is conducted as a cluster-randomized controlled trial. The study population are AOK (Allgemeine Ortskrankenkasse)-insured patients enlisted in the HZV-contract (primare care physician centered health care).
Under the consideration of cluster effects, patients from the counties Böblingen, Calw, Rottweil and Zollernalbkreis are enrolled in the intervention group. The control group is recruited from the counties Freudenstadt, Esslingen, Reutlingen and Tuttlingen.
Primary outcome is the number of physical referrals to dermatologists. Secondary outcome is acceptance and attitudes of physicians, health care center staff and dermatologists towards this new type of care. Data is collected from routine insurance data of the AOK company.
The intervention phase is conducted from July 2018 to June 2019.

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Organizational Data

  •   DRKS00012944
  •   2017/08/31
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  •   yes
  •   Approved
  •   395/2017BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   L00-L99 -  Diseases of the skin and subcutaneous tissue
  •   D03 -  Melanoma in situ
  •   D04 -  Carcinoma in situ of skin
  •   C43 -  Malignant melanoma of skin
  •   C44 -  Other malignant neoplasms of skin
  •   I83 -  Varicose veins of lower extremities
  •   D22 -  Melanocytic naevi
  •   D23 -  Other benign neoplasms of skin
  •   D18.0 -  Haemangioma, any site
  •   D17.0 -  Benign lipomatous neoplasm of skin and subcutaneous tissue of head, face and neck
  •   D17.1 -  Benign lipomatous neoplasm of skin and subcutaneous tissue of trunk
  •   D17.2 -  Benign lipomatous neoplasm of skin and subcutaneous tissue of limbs
  •   D17.3 -  Benign lipomatous neoplasm of skin and subcutaneous tissue of other and unspecified sites
  •   D17.9 -  Benign lipomatous neoplasm, unspecified
  •   R20-R23 -  Symptoms and signs involving the skin and subcutaneous tissue
  •   T20-T32 -  Burns and corrosions
  •   T33-T35 -  Frostbite
  •   C60 -  Malignant neoplasm of penis
  •   D29.0 -  Benign neoplasm: Penis
  •   D28.0 -  Benign neoplasm: Vulva
  •   C51.0 -  Malignant neoplasm: Labium majus
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Interventions/Observational Groups

  •   Intervention group (= AOK HZV Patients allocated to teledermatologic referrals)
  •   Intervention group (= AOK HZV Patients allocated to treatment as usual)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Number of physical referrals to dermatologists during the intervention phase (01.07.2018 - 30.06.2019)

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Secondary Outcome

Qualitative and quantitative parameters researching structures, processes and results on the level of patients, physicians and medical staff (intervention group). Methods used are questionnaires and structured interviews

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/07/01
  •   360
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

AOK-insured patient within HZV-contract. GP allocates patients to telerdermatologic referrals. Patients consent to the process.

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Exclusion Criteria

Patients without HZV insurance status and/or not insured at the AOK company. Patient not willing or able to give informed consent. GP decides he or she can diagnose and treat the condition him- or herself.

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • AOK Baden-Württemberg Hauptverwaltung
    • Presselstraße 19
    • 70191  Stuttgart
    • Germany
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    • Ludwig-Maximilians-Universität München Fachbereich Health Services Management
    • Schackstraße 4
    • 80539  München
    • Germany
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    • Hochschule Reutlingen Fakultät Informatik
    • Alteburgstraße 150
    • 72762  Reutlingen
    • Germany
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    • KSYOS TeleMedisch Centrum Backvinckhouse
    • Professor J. H. Bavincklaan 2-4
    • 1183  AT Amstelveen
    • Netherlands
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    • HÄVG - Hausärztliche Vertragsgemeinschaft AG
    • Edmund-Rumpler-Straße 2
    • 51149  Köln
    • Germany
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    • Universitäts-Hautklinik Tübingen
    • Liebermeisterstraße 25
    • 72076  Tübingen
    • Germany
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    • Institut für Klinische Epidemiologie und angewandte Biometrie
    • Silcherstraße 5
    • 72076  Tübingen
    • Germany
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    • aQua - Institut für angewandte Qualitätsförderung und Forschung im Gesundheitswesen
    • Maschmühlenweg 8-10
    • 37073  Göttingen
    • Germany
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    • Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)
    • Ms.  Prof. Dr. med.  Stefanie  Joos 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)
    • Mr.  Dr. med.  Roland  Koch 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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    • Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)
    • Mr.  Andreas  Polanc 
    • Osianderstraße 5
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsfonds beim Gemeinsamen Bundesausschuss
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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