Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial

Publikation: Beitrag in FachzeitschriftArtikelForschungPeer-Review

Autoren

  • D. Stelzer
  • H. Binder
  • M. Glattacker
  • E. Graf
  • M. Hahn
  • M. Hollenbeck
  • K. Kaier
  • B. Kowall
  • N. Kuklik
  • G. Metzner
  • N. Mueller
  • L. Seiler
  • S. Stolpe
  • C. Blume

Organisationseinheiten

Externe Organisationen

  • Universitätsklinikum Freiburg
  • Knappschaft Kliniken Solution GmbH (KKSG)
  • Universität Duisburg-Essen
  • KfH-Stiftung Präventivmedizin
Forschungs-netzwerk anzeigen

Details

OriginalspracheEnglisch
Aufsatznummer368
Seitenumfang15
FachzeitschriftTRIALS
Jahrgang25
PublikationsstatusVeröffentlicht - 7 Juni 2024

Abstract

Background: Early identification of patients with chronic kidney disease (CKD) and advancing kidney insufficiency, followed by specialist care, can decelerate the progression of the disease. However, awareness of the importance and possible consequences of kidney insufficiency is low among doctors and patients. Since kidney insufficiency can be asymptomatic even in higher stages, it is often not even known to those belonging to risk groups. This study aims to clarify whether, for hospitalised patients with advanced chronic kidney disease, a risk-based appointment with a nephrology specialist reduces disease progression. Methods: The target population of the study is hospitalised CKD patients with an increased risk of end-stage renal disease (ESRD), more specifically with an ESRD risk of at least 9% in the next 5 years. This risk is estimated by the internationally validated Kidney Failure Risk Equation (KFRE). The intervention consists of a specific appointment with a nephrology specialist after the hospital stay, while control patients are discharged from the hospital as usual. Eight medical centres include participants according to a stepped-wedge design, with randomised sequential centre-wise crossover from recruiting patients into the control group to recruitment to the intervention. The estimated glomerular filtration rate (eGFR) is measured for each patient during the hospital stay and after 12 months within the regular care by the general practitioner. The difference in the change of the eGFR over this period is compared between the intervention and control groups and considered the primary endpoint. Discussion: This study is designed to evaluate the effect of risk-based appointments with nephrology specialists for hospitalised CKD patients with an increased risk of end-stage renal disease. If the intervention is proven to be beneficial, it may be implemented in routine care. Limitations will be examined and discussed. The evaluation will include further endpoints such as non-guideline-compliant medication, economic considerations and interviews with contributing physicians to assess the acceptance and feasibility of the intervention. Trial registration: German Clinical Trials Register DRKS00029691. Registered on 12 September 2022.

ASJC Scopus Sachgebiete

Zitieren

Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial. / Stelzer, D.; Binder, H.; Glattacker, M. et al.
in: TRIALS, Jahrgang 25, 368, 07.06.2024.

Publikation: Beitrag in FachzeitschriftArtikelForschungPeer-Review

Stelzer, D., Binder, H., Glattacker, M., Graf, E., Hahn, M., Hollenbeck, M., Kaier, K., Kowall, B., Kuklik, N., Metzner, G., Mueller, N., Seiler, L., Stolpe, S., & Blume, C. (2024). Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial. TRIALS, 25, Artikel 368. https://doi.org/10.1186/s13063-024-08182-x
Stelzer D, Binder H, Glattacker M, Graf E, Hahn M, Hollenbeck M et al. Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial. TRIALS. 2024 Jun 7;25:368. doi: 10.1186/s13063-024-08182-x
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title = "Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial",
abstract = "Background: Early identification of patients with chronic kidney disease (CKD) and advancing kidney insufficiency, followed by specialist care, can decelerate the progression of the disease. However, awareness of the importance and possible consequences of kidney insufficiency is low among doctors and patients. Since kidney insufficiency can be asymptomatic even in higher stages, it is often not even known to those belonging to risk groups. This study aims to clarify whether, for hospitalised patients with advanced chronic kidney disease, a risk-based appointment with a nephrology specialist reduces disease progression. Methods: The target population of the study is hospitalised CKD patients with an increased risk of end-stage renal disease (ESRD), more specifically with an ESRD risk of at least 9% in the next 5 years. This risk is estimated by the internationally validated Kidney Failure Risk Equation (KFRE). The intervention consists of a specific appointment with a nephrology specialist after the hospital stay, while control patients are discharged from the hospital as usual. Eight medical centres include participants according to a stepped-wedge design, with randomised sequential centre-wise crossover from recruiting patients into the control group to recruitment to the intervention. The estimated glomerular filtration rate (eGFR) is measured for each patient during the hospital stay and after 12 months within the regular care by the general practitioner. The difference in the change of the eGFR over this period is compared between the intervention and control groups and considered the primary endpoint. Discussion: This study is designed to evaluate the effect of risk-based appointments with nephrology specialists for hospitalised CKD patients with an increased risk of end-stage renal disease. If the intervention is proven to be beneficial, it may be implemented in routine care. Limitations will be examined and discussed. The evaluation will include further endpoints such as non-guideline-compliant medication, economic considerations and interviews with contributing physicians to assess the acceptance and feasibility of the intervention. Trial registration: German Clinical Trials Register DRKS00029691. Registered on 12 September 2022.",
keywords = "Chronic kidney disease (CKD), Cluster-randomised trial (CRT), End-stage renal disease (ESRD), Estimated glomerular filtration rate (eGFR), Kidney failure risk equation (KFRE), Stepped-wedge design",
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Download

TY - JOUR

T1 - Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial)

T2 - study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial

AU - Stelzer, D.

AU - Binder, H.

AU - Glattacker, M.

AU - Graf, E.

AU - Hahn, M.

AU - Hollenbeck, M.

AU - Kaier, K.

AU - Kowall, B.

AU - Kuklik, N.

AU - Metzner, G.

AU - Mueller, N.

AU - Seiler, L.

AU - Stolpe, S.

AU - Blume, C.

N1 - Publisher Copyright: © The Author(s) 2024.

PY - 2024/6/7

Y1 - 2024/6/7

N2 - Background: Early identification of patients with chronic kidney disease (CKD) and advancing kidney insufficiency, followed by specialist care, can decelerate the progression of the disease. However, awareness of the importance and possible consequences of kidney insufficiency is low among doctors and patients. Since kidney insufficiency can be asymptomatic even in higher stages, it is often not even known to those belonging to risk groups. This study aims to clarify whether, for hospitalised patients with advanced chronic kidney disease, a risk-based appointment with a nephrology specialist reduces disease progression. Methods: The target population of the study is hospitalised CKD patients with an increased risk of end-stage renal disease (ESRD), more specifically with an ESRD risk of at least 9% in the next 5 years. This risk is estimated by the internationally validated Kidney Failure Risk Equation (KFRE). The intervention consists of a specific appointment with a nephrology specialist after the hospital stay, while control patients are discharged from the hospital as usual. Eight medical centres include participants according to a stepped-wedge design, with randomised sequential centre-wise crossover from recruiting patients into the control group to recruitment to the intervention. The estimated glomerular filtration rate (eGFR) is measured for each patient during the hospital stay and after 12 months within the regular care by the general practitioner. The difference in the change of the eGFR over this period is compared between the intervention and control groups and considered the primary endpoint. Discussion: This study is designed to evaluate the effect of risk-based appointments with nephrology specialists for hospitalised CKD patients with an increased risk of end-stage renal disease. If the intervention is proven to be beneficial, it may be implemented in routine care. Limitations will be examined and discussed. The evaluation will include further endpoints such as non-guideline-compliant medication, economic considerations and interviews with contributing physicians to assess the acceptance and feasibility of the intervention. Trial registration: German Clinical Trials Register DRKS00029691. Registered on 12 September 2022.

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KW - Cluster-randomised trial (CRT)

KW - End-stage renal disease (ESRD)

KW - Estimated glomerular filtration rate (eGFR)

KW - Kidney failure risk equation (KFRE)

KW - Stepped-wedge design

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