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Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial

BACKGROUND: End-stage kidney disease (ESKD) is treated with dialysis or kidney transplantation, with most patients with ESKD receiving in-center hemodialysis treatment. This life-saving treatment can result in cardiovascular and hemodynamic instability, with the most common form being low blood pres...

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Autores principales: Veinot, Tiffany Christine, Gillespie, Brenda, Argentina, Marissa, Bragg-Gresham, Jennifer, Chatoth, Dinesh, Collins Damron, Kelli, Heung, Michael, Krein, Sarah, Wingard, Rebecca, Zheng, Kai, Saran, Rajiv
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10160944/
https://www.ncbi.nlm.nih.gov/pubmed/37079365
http://dx.doi.org/10.2196/46187
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author Veinot, Tiffany Christine
Gillespie, Brenda
Argentina, Marissa
Bragg-Gresham, Jennifer
Chatoth, Dinesh
Collins Damron, Kelli
Heung, Michael
Krein, Sarah
Wingard, Rebecca
Zheng, Kai
Saran, Rajiv
author_facet Veinot, Tiffany Christine
Gillespie, Brenda
Argentina, Marissa
Bragg-Gresham, Jennifer
Chatoth, Dinesh
Collins Damron, Kelli
Heung, Michael
Krein, Sarah
Wingard, Rebecca
Zheng, Kai
Saran, Rajiv
author_sort Veinot, Tiffany Christine
collection PubMed
description BACKGROUND: End-stage kidney disease (ESKD) is treated with dialysis or kidney transplantation, with most patients with ESKD receiving in-center hemodialysis treatment. This life-saving treatment can result in cardiovascular and hemodynamic instability, with the most common form being low blood pressure during the dialysis treatment (intradialytic hypotension [IDH]). IDH is a complication of hemodialysis that can involve symptoms such as fatigue, nausea, cramping, and loss of consciousness. IDH increases risks of cardiovascular disease and ultimately hospitalizations and mortality. Provider-level and patient-level decisions influence the occurrence of IDH; thus, IDH may be preventable in routine hemodialysis care. OBJECTIVE: This study aims to evaluate the independent and comparative effectiveness of 2 interventions—one directed at hemodialysis providers and another for patients—in reducing the rate of IDH at hemodialysis facilities. In addition, the study will assess the effects of interventions on secondary patient-centered clinical outcomes and examine factors associated with a successful implementation of the interventions. METHODS: This study is a pragmatic, cluster randomized trial to be conducted in 20 hemodialysis facilities in the United States. Hemodialysis facilities will be randomized using a 2 × 2 factorial design, such that 5 sites will receive a multimodal provider education intervention, 5 sites will receive a patient activation intervention, 5 sites will receive both interventions, and 5 sites will receive none of the 2 interventions. The multimodal provider education intervention involved theory-informed team training and the use of a digital, tablet-based checklist to heighten attention to patient clinical factors associated with increased IDH risk. The patient activation intervention involves tablet-based, theory-informed patient education and peer mentoring. Patient outcomes will be monitored during a 12-week baseline period, followed by a 24-week intervention period and a 12-week postintervention follow-up period. The primary outcome of the study is the proportion of treatments with IDH, which will be aggregated at the facility level. Secondary outcomes include patient symptoms, fluid adherence, hemodialysis adherence, quality of life, hospitalizations, and mortality. RESULTS: This study is funded by the Patient-Centered Outcomes Research Institute and approved by the University of Michigan Medical School’s institutional review board. The study began enrolling patients in January 2023. Initial feasibility data will be available in May 2023. Data collection will conclude in November 2024. CONCLUSIONS: The effects of provider and patient education on reducing the proportion of sessions with IDH and improving other patient-centered clinical outcomes will be evaluated, and the findings will be used to inform further improvements in patient care. Improving the stability of hemodialysis sessions is a critical concern for clinicians and patients with ESKD; the interventions targeted to providers and patients are predicted to lead to improvements in patient health and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT03171545; https://clinicaltrials.gov/ct2/show/NCT03171545 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46187
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spelling pubmed-101609442023-05-06 Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial Veinot, Tiffany Christine Gillespie, Brenda Argentina, Marissa Bragg-Gresham, Jennifer Chatoth, Dinesh Collins Damron, Kelli Heung, Michael Krein, Sarah Wingard, Rebecca Zheng, Kai Saran, Rajiv JMIR Res Protoc Protocol BACKGROUND: End-stage kidney disease (ESKD) is treated with dialysis or kidney transplantation, with most patients with ESKD receiving in-center hemodialysis treatment. This life-saving treatment can result in cardiovascular and hemodynamic instability, with the most common form being low blood pressure during the dialysis treatment (intradialytic hypotension [IDH]). IDH is a complication of hemodialysis that can involve symptoms such as fatigue, nausea, cramping, and loss of consciousness. IDH increases risks of cardiovascular disease and ultimately hospitalizations and mortality. Provider-level and patient-level decisions influence the occurrence of IDH; thus, IDH may be preventable in routine hemodialysis care. OBJECTIVE: This study aims to evaluate the independent and comparative effectiveness of 2 interventions—one directed at hemodialysis providers and another for patients—in reducing the rate of IDH at hemodialysis facilities. In addition, the study will assess the effects of interventions on secondary patient-centered clinical outcomes and examine factors associated with a successful implementation of the interventions. METHODS: This study is a pragmatic, cluster randomized trial to be conducted in 20 hemodialysis facilities in the United States. Hemodialysis facilities will be randomized using a 2 × 2 factorial design, such that 5 sites will receive a multimodal provider education intervention, 5 sites will receive a patient activation intervention, 5 sites will receive both interventions, and 5 sites will receive none of the 2 interventions. The multimodal provider education intervention involved theory-informed team training and the use of a digital, tablet-based checklist to heighten attention to patient clinical factors associated with increased IDH risk. The patient activation intervention involves tablet-based, theory-informed patient education and peer mentoring. Patient outcomes will be monitored during a 12-week baseline period, followed by a 24-week intervention period and a 12-week postintervention follow-up period. The primary outcome of the study is the proportion of treatments with IDH, which will be aggregated at the facility level. Secondary outcomes include patient symptoms, fluid adherence, hemodialysis adherence, quality of life, hospitalizations, and mortality. RESULTS: This study is funded by the Patient-Centered Outcomes Research Institute and approved by the University of Michigan Medical School’s institutional review board. The study began enrolling patients in January 2023. Initial feasibility data will be available in May 2023. Data collection will conclude in November 2024. CONCLUSIONS: The effects of provider and patient education on reducing the proportion of sessions with IDH and improving other patient-centered clinical outcomes will be evaluated, and the findings will be used to inform further improvements in patient care. Improving the stability of hemodialysis sessions is a critical concern for clinicians and patients with ESKD; the interventions targeted to providers and patients are predicted to lead to improvements in patient health and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT03171545; https://clinicaltrials.gov/ct2/show/NCT03171545 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46187 JMIR Publications 2023-04-20 /pmc/articles/PMC10160944/ /pubmed/37079365 http://dx.doi.org/10.2196/46187 Text en ©Tiffany Christine Veinot, Brenda Gillespie, Marissa Argentina, Jennifer Bragg-Gresham, Dinesh Chatoth, Kelli Collins Damron, Michael Heung, Sarah Krein, Rebecca Wingard, Kai Zheng, Rajiv Saran. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.04.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Veinot, Tiffany Christine
Gillespie, Brenda
Argentina, Marissa
Bragg-Gresham, Jennifer
Chatoth, Dinesh
Collins Damron, Kelli
Heung, Michael
Krein, Sarah
Wingard, Rebecca
Zheng, Kai
Saran, Rajiv
Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial
title Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial
title_full Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial
title_fullStr Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial
title_full_unstemmed Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial
title_short Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial
title_sort enhancing the cardiovascular safety of hemodialysis care using multimodal provider education and patient activation interventions: protocol for a cluster randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10160944/
https://www.ncbi.nlm.nih.gov/pubmed/37079365
http://dx.doi.org/10.2196/46187
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