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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


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          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.


          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.


          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.


          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.


          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)


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              Diffusion of innovations in service organizations: systematic review and recommendations.

              This article summarizes an extensive literature review addressing the question, How can we spread and sustain innovations in health service delivery and organization? It considers both content (defining and measuring the diffusion of innovation in organizations) and process (reviewing the literature in a systematic and reproducible way). This article discusses (1) a parsimonious and evidence-based model for considering the diffusion of innovations in health service organizations, (2) clear knowledge gaps where further research should be focused, and (3) a robust and transferable methodology for systematically reviewing health service policy and management. Both the model and the method should be tested more widely in a range of contexts.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                20 April 2023
                : 12
                : e46187
                [1 ] School of Information University of Michigan Ann Arbor, MI United States
                [2 ] Department of Health Behavior and Health Education School of Public Health University of Michigan Ann Arbor, MI United States
                [3 ] Department of Learning Health Sciences School of Medicine University of Michigan Ann Arbor, MI United States
                [4 ] Department of Biostatistics, Consulting for Statistics, Computing and Analytics Research University of Michigan Ann Arbor, MI United States
                [5 ] National Kidney Foundation New York, NY United States
                [6 ] Division of Nephrology School of Medicine Ann Arbor, MI United States
                [7 ] Kidney Epidemiology and Cost Center University of Michigan Ann Arbor, MI United States
                [8 ] Fresenius Medical Care Waltham, MA United States
                [9 ] Department of Internal Medicine School of Medicine University of Michigan Ann Arbor, MI United States
                [10 ] Veterans Affairs Center for Clinical Management Research US Department of Veterans Affairs Ann Arbor, MI United States
                [11 ] School of Information and Computer Sciences University of California Irvine Irvine, CA United States
                Author notes
                Corresponding Author: Tiffany Christine Veinot tveinot@ 123456umich.edu
                Author information
                ©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.

                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.

                : 7 February 2023
                : 19 February 2023
                Custom metadata
                The proposal for this study was reviewed by the CORI Funding Announcement: Large Pragmatic Studies to Evaluate Patient-Centered Outcomes - Improving Healthcare Systems (Patient-Centered Outcomes Research Institute, USA). See the Multimedia Appendix for the peer-review report;

                hemodialysis care,patient peer mentoring,telehealth,digital checklist,team training,cluster randomized controlled trial,pragmatic trial


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