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

Organizational Data

DRKS-ID:
DRKS00012944
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2017-08-31
Last update in DRKS:
2023-01-18
Registration type:
Prospective

Acronym/abbreviation of the study

No Entry

URL of the study

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

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.

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.

Health condition or problem studied

ICD10:
L00-L99 - Diseases of the skin and subcutaneous tissue
ICD10:
D03 - Melanoma in situ
ICD10:
D04 - Carcinoma in situ of skin
ICD10:
C43 - Malignant melanoma of skin
ICD10:
C44 - Other malignant neoplasms of skin
ICD10:
I83 - Varicose veins of lower extremities
ICD10:
D22 - Melanocytic naevi
ICD10:
D23 - Other benign neoplasms of skin
ICD10:
D18.0 - Haemangioma, any site
ICD10:
D17.0 - Benign lipomatous neoplasm of skin and subcutaneous tissue of head, face and neck
ICD10:
D17.1 - Benign lipomatous neoplasm of skin and subcutaneous tissue of trunk
ICD10:
D17.2 - Benign lipomatous neoplasm of skin and subcutaneous tissue of limbs
ICD10:
D17.3 - Benign lipomatous neoplasm of skin and subcutaneous tissue of other and unspecified sites
ICD10:
D17.9 - Benign lipomatous neoplasm, unspecified
ICD10:
R20-R23 - Symptoms and signs involving the skin and subcutaneous tissue
ICD10:
T20-T32 - Burns and corrosions
ICD10:
T33-T35 - Frostbite
ICD10:
C60 - Malignant neoplasm of penis
ICD10:
D29.0 - Penis
ICD10:
D28.0 - Vulva
ICD10:
C51.0 - Labium majus
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Intervention group (= AOK HZV Patients allocated to teledermatologic referrals)
Arm 2:
Intervention group (= AOK HZV Patients allocated to treatment as usual)

Endpoints

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

Study Design

Purpose:
Diagnostic
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Doctor's practice Landkreise Böblingen, Calw, Rottweil, Zollernalbkreis

Recruitment period and number of participants

Planned study start date:
2018-07-01
Actual study start date:
2018-07-01
Planned study completion date:
No Entry
Actual Study Completion Date:
2019-06-30
Target Sample Size:
360
Final Sample Size:
452

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
AOK-insured patient within HZV-contract. GP allocates patients to telerdermatologic referrals. Patients consent to the process.

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.

Addresses

Primary Sponsor

Universitätsklinikum Tübingen
Geissweg 3
72076 Tübingen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)
Prof. Dr. med. Stefanie Joos
Osianderstraße 5
72076 Tübingen
Germany
Telephone:
07071 2985213
Fax:
07071 295896
Contact per E-Mail
URL:
https://www.medizin.uni-tuebingen.de/Zuweiser/Institute/Allgemeinmedizin.html

Contact for Public Queries

Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)
Andreas Polanc
Osianderstraße 5
72076 Tübingen
Germany
Telephone:
07071 2985285
Fax:
07071 295896
Contact per E-Mail
URL:
https://www.medizin.uni-tuebingen.de/Zuweiser/Institute/Allgemeinmedizin.html

Principal Investigator

Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)
Prof. Dr. med. Stefanie Joos
Osianderstraße 5
72076 Tübingen
Germany
Telephone:
07071 2985213
Fax:
07071 295896
Contact per E-Mail
URL:
https://www.medizin.uni-tuebingen.de/Zuweiser/Institute/Allgemeinmedizin.html

Other contact for scientific queries

Institut für Allgemeinmedizin und Interprofessionelle Versorgung (IAIV)
Dr. med. Roland Koch
Osianderstraße 5
72076 Tübingen
Germany
Telephone:
07071 2985223
Fax:
07071 295896
Contact per E-Mail
URL:
https://www.medizin.uni-tuebingen.de/Zuweiser/Institute/Allgemeinmedizin.html

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.)

Innovationsfonds beim Gemeinsamen Bundesausschuss
Wegelystr. 8
10623 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
Gartenstr. 47
72074 Tübingen
Germany
Telephone:
+49-7071-2977661
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-06-16
Ethics committee number:
395/2017BO1
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-08-21

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Prüfprotokoll TeleDerm
Koch R, Polanc A, Haumann H, Kirtschig G, Martus P, Thies C, Sundmacher L, Gaa C, Witkamp L; TeleDerm Study Group, Joos S. Improving cooperation between general practitioners and dermatologists via telemedicine: study protocol of the cluster-randomized controlled TeleDerm study. Trials. 2018 Oct 24;19(1):583. doi: 10.1186/s13063-018-2955-2. PMID: 30355358; PMCID: PMC6201508.
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Koch R, Rösel I, Polanc A, et al. TELEDerm: Implementing store-and-forward teledermatology consultations in general practice: Results of a cluster randomized trial. Journal of Telemedicine and Telecare. 2022;0(0). doi:10.1177/1357633X221089133
Gemeinsamer Bundesausschuss (Innovationsausschuss): Beschlusstext - Ergebnisbericht - Evaluationsbericht
Date of first publication of study results:
2022-05-16
DRKS entry published for the first time with results:
2023-01-18

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry