PMID- 37079365 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240207 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 12 DP - 2023 Apr 20 TI - Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial. PG - e46187 LID - 10.2196/46187 [doi] LID - e46187 AB - 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 x 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. CI - (c)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. FAU - Veinot, Tiffany Christine AU - Veinot TC AUID- ORCID: 0000-0003-1200-9515 AD - School of Information, University of Michigan, Ann Arbor, MI, United States. AD - Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI, United States. AD - Department of Learning Health Sciences, School of Medicine, University of Michigan, Ann Arbor, MI, United States. FAU - Gillespie, Brenda AU - Gillespie B AUID- ORCID: 0000-0003-4488-0612 AD - Department of Biostatistics, Consulting for Statistics, Computing and Analytics Research, University of Michigan, Ann Arbor, MI, United States. FAU - Argentina, Marissa AU - Argentina M AUID- ORCID: 0000-0003-1974-626X AD - National Kidney Foundation, New York, NY, United States. FAU - Bragg-Gresham, Jennifer AU - Bragg-Gresham J AUID- ORCID: 0000-0002-9069-9489 AD - Division of Nephrology, School of Medicine, Ann Arbor, MI, United States. AD - Kidney Epidemiology and Cost Center, University of Michigan, Ann Arbor, MI, United States. FAU - Chatoth, Dinesh AU - Chatoth D AUID- ORCID: 0000-0002-6406-093X AD - Fresenius Medical Care, Waltham, MA, United States. FAU - Collins Damron, Kelli AU - Collins Damron K AUID- ORCID: 0000-0002-1745-3714 AD - National Kidney Foundation, New York, NY, United States. FAU - Heung, Michael AU - Heung M AUID- ORCID: 0000-0002-0533-3192 AD - Division of Nephrology, School of Medicine, Ann Arbor, MI, United States. FAU - Krein, Sarah AU - Krein S AUID- ORCID: 0000-0003-2111-8131 AD - Department of Internal Medicine, School of Medicine, University of Michigan, Ann Arbor, MI, United States. AD - Veterans Affairs Center for Clinical Management Research, US Department of Veterans Affairs, Ann Arbor, MI, United States. FAU - Wingard, Rebecca AU - Wingard R AUID- ORCID: 0000-0002-8339-9605 AD - Fresenius Medical Care, Waltham, MA, United States. FAU - Zheng, Kai AU - Zheng K AUID- ORCID: 0000-0003-4121-4948 AD - School of Information and Computer Sciences, University of California Irvine, Irvine, CA, United States. FAU - Saran, Rajiv AU - Saran R AUID- ORCID: 0000-0001-7317-8756 AD - Division of Nephrology, School of Medicine, Ann Arbor, MI, United States. AD - Kidney Epidemiology and Cost Center, University of Michigan, Ann Arbor, MI, United States. LA - eng SI - ClinicalTrials.gov/NCT03171545 GR - IK6 HX003399/HX/HSRD VA/United States GR - P30 DK092926/DK/NIDDK NIH HHS/United States PT - Journal Article DEP - 20230420 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC10160944 OTO - NOTNLM OT - cluster randomized controlled trial OT - digital checklist OT - hemodialysis care OT - patient peer mentoring OT - pragmatic trial OT - team training OT - telehealth COIS- Conflicts of Interest: DC and RW are employees of Fresenius Medical Care. MA and KCD are employees of the National Kidney Foundation. EDAT- 2023/04/20 13:41 MHDA- 2023/04/20 13:42 PMCR- 2023/04/20 CRDT- 2023/04/20 11:54 PHST- 2023/02/07 00:00 [received] PHST- 2023/02/19 00:00 [accepted] PHST- 2023/04/20 13:42 [medline] PHST- 2023/04/20 13:41 [pubmed] PHST- 2023/04/20 11:54 [entrez] PHST- 2023/04/20 00:00 [pmc-release] AID - v12i1e46187 [pii] AID - 10.2196/46187 [doi] PST - epublish SO - JMIR Res Protoc. 2023 Apr 20;12:e46187. doi: 10.2196/46187.