Effect evaluation of a tele-neurologic intervention in primary care in a rural area in Germany—the NeTKoH study protocol of a stepped-wedge cluster randomized trial

BMC Health Services Research

Study Protocol

Jean-François Chenot¹  Simone Kiel¹  Agnes Flöel²  Felix von Podewils²  Anselm Angermaier²  Ricarda S. Schulz³  Tobias Kurth³  Kerstin Wainwright³  Imke Mayer³  Ana S. Oliveira Gonçalves³ 

[1] Department of General Practice, Institute for Community Medicine, University Medicine Greifswald, Greifswald, Germany;Department of Neurology, University Medicine Greifswald, Greifswald, Germany;Institute of Public Health, Charité – Universitätsmedizin Berlin, Berlin, Germany;

关键词: Tele-neurology;    Teleconsultation;    Telemedicine;    Primary care;    Outpatient general practitioner;    Health care management;    Integrated care;    Stepped-wedge cluster randomized trial;   

DOI  :  10.1186/s12913-023-09724-w

 received in 2023-05-17, accepted in 2023-06-21,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundNeurological disorders account for a large and increasing proportion of the global burden of disease. Therefore, it is important to strengthen the management of neurologic care, particularly in rural areas. The use of tele-neurology in primary care in rural areas is internationally considered to have the potential to increase access to health care services and improve the quality of care in these underserved areas. NeTKoH aims to address the existing knowledge gap regarding the effects of a tele-neurologic intervention in primary care under real-world conditions in a rural area in Germany.MethodsNeTKoH is a cluster-randomized controlled trial with a stepped-wedge design involving 33 outpatient general practitioner’s (GP) offices (clusters) in a rural area in Northeast Germany. During 11 predetermined steps, all clusters are randomized before they cross over into groups from the control to the intervention arm. The targeted sample size is 1,089 patients with neurologic symptoms that are continuously being recruited. In the intervention arm, tele-neurologic consultations will be provided via a face-to-face video conferencing system with a neurologic expert at a university hospital. The control arm will receive usual care. The primary outcome is the proportion of neurologic problems being solved at the GP’s office. Secondary outcomes will comprise hospital stays and days, time until neurologic specialist appointments and diagnostics, patients’ health status and quality of life, outpatient and inpatient referrals.A concurrent observational study, together with a process, implementation, and health economic evaluation, will also be conducted.DiscussionUsing a stepped-wedge cluster design in a real-life situation can help with logistic challenges and enhance the motivation of the participating GPs, as all, at some point, will be in the intervention phase. With the additional implementation evaluation pertaining to external validity, an observational study, and a health economic evaluation, NeTKoH will be able to provide an extensive evaluation for health policy decision-makers regarding the uptake into standard care.Trial registrationGerman Clinical Trials Register (DRKS00024492). Date registered: September 28, 2021. Date and protocol version: June 2023, version 1.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 6

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