Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe) (Dialysafe)

Enhancing the Cardiovascular Safety of Hemodialysis Care: A Cluster-Randomized, Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation Interventions (Dialysafe)

The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; End Stage Renal Disease; Hypotension; Kidney Failure; Patient Safety
• Intervention / Treatment: Behavioral: Patient Activation; Behavioral: Provider Education

Detailed Description

When a person's kidneys stop working, he or she has end-stage renal disease (ESRD). Individuals with ESRD cannot live without either dialysis therapy-in which a machine performs the functions of the kidneys-or a kidney transplant. Dialysis must remove fluid as well as toxins in the blood. People with ESRD have a high risk for death, and the usual cause is cardiovascular disease.

Most people in the United States who have ESRD get hemodialysis therapy in a clinic for four hours at a time, three times a week. The stability of hemodialysis sessions varies, and many sessions become unstable from low blood pressure and other complications. Unstable dialysis sessions can result in negative symptoms, like fatigue.

Dialysis instability is an important problem. Session instability is linked to injury to the heart and other organs. Patients who have unstable dialysis sessions are more likely to end up in the hospital or die than are those who have stable sessions. Session instability is preventable. The main causes of instability are removal of fluid from a patient too fast or removal of too much fluid. Session instability results from many factors: decisions made by patients, and decisions by healthcare providers.

Presently, the way to best improve the stability of dialysis is not clear. Dialysis clinics approach this problem differently, and there is variation among clinics in how often hemodialysis sessions become unstable.

In partnership with the National Kidney Foundation and Fresenius Medical Care North America, the investigators will test two interventions designed to increase the stability of patient dialysis. One intervention, multimodal provider education, focuses on dialysis facility care teams. It includes team training, online education, and a checklist. Another intervention, patient activation, focuses on patients. It includes peer mentoring by trained ESRD patients. Mentors will hold with other patients multimedia-aided meetings that include skills instruction and role modeling. These interventions have been successful in hospital care and in chronic disease care, and the investigators will adapt them to dialysis safety.

The investigators will then conduct a study in 20 dialysis facilities in different parts of the United States. Five facilities will get the provider education only; five will get the patient activation intervention only; five will get both interventions; and five will get no interventions. The investigators will test whether session stability improves in the facilities that get either intervention over the 48-week study period. This study is expected to clarify whether these interventions can make dialysis safer for ESRD patients. This will inform hemodialysis care providers on whether to pursue provider-focused or patient-focused safety interventions, or both. People on hemodialysis will also have information to help them decide whether to become engaged in their session stability, and the intervention will help them learn how to do so.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Fresenius Kidney Care University Of Michigan - Ann Arbor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Selection is at both the clinic level and individual patient level.

Clinic Inclusion Criteria:

• outpatient hemodialysis facilities
• at least 70 adult (>21 years old) patients to guarantee sample size

Clinic Exclusion Criteria:

• facilities involved in another study
• facilities in immediate jeopardy
• facilities with 1-star quality ratings
• facilities designated as COVID-19 isolation facilities

Individual Patient Exclusion Criteria:

• individual patients who are currently incarcerated
• individual patients who have poor cognition or cognitive impairment
• individual patients unable to comprehend the patient information sheet due to lack of facility in English or Spanish
• individual patients who have opted out of data collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Activation; This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.	Behavioral: Patient Activation; Patients in clinics assigned to this group will be offered peer mentoring and digital resources.
Experimental: Provider Education; This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.	Behavioral: Provider Education; Staff in clinics assigned to this group will receive team training and a checklist.
No Intervention: No Intervention; Patients in clinic receive usual care.
Experimental: Patient and Provider; This arm includes both Patient Activation and Provider Education interventions	Behavioral: Patient Activation; Patients in clinics assigned to this group will be offered peer mentoring and digital resources.; Behavioral: Provider Education; Staff in clinics assigned to this group will receive team training and a checklist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialysis Session Stability	Binary variable whereby session is labeled unstable (=1) or stable (=0). Sessions will be labeled unstable (=1) if: (1) intradialytic hypotension occurs, which is defined as systolic blood pressure falling below 100.	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid Adherence	Measured by interdialytic weight gain (in Kilograms), which is the weight gained between dialysis sessions.	48 weeks
Dialysis adherence - minutes missed	Measured as the number of minutes of prescribed dialysis time missed per week (number of prescribed minutes-number of actual minutes).	48 weeks
Dialysis adherence - sessions missed	Measured as the number of missed sessions per week (number of prescribed sessions-number of actual sessions).	48 weeks
Patient symptoms - post-dialysis recovery time	Measured at each session as patient recovery time after dialysis, reported on a survey item on an ordinal scale from "within minutes" to "did not recover before the next scheduled dialysis session."	48 weeks
Patient symptoms - symptom burden	Measured as the total number symptoms reported by the patient at each session (each symptom treated as one, then added to create total symptoms).	48 weeks
Quality of Life-KDQOL	Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1).	52 weeks
Hospitalization	Binary variable, measured as whether or not a patient was hospitalized for any reason, where hospitalization=1 and no hospitalization=0 ("all-cause hospitalizations").	48 weeks
Mortality	Binary variable, measured as whether or not a patient died of any cause, where mortality=1 and no mortality=0 ("all-cause mortality").	48 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: University of California, Irvine; Fresenius Medical Care North America; National Kidney Foundation
• Investigators: Principal Investigator: Tiffany Veinot, PhD, University of Michigan

Publications and helpful links

General Publications

• Veinot TC, Gillespie B, Argentina M, Bragg-Gresham J, Chatoth D, Collins Damron K, Heung M, Krein S, Wingard R, Zheng K, Saran R. Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 20;12:e46187. doi: 10.2196/46187.
• Veinot TC, Clarke PJ, Romero DM, Buis LR, Dillahunt TR, Vydiswaran VVG, Beals A, Brown L, Richards O, Williamson A, Antonio MG. Equitable Research PRAXIS: A Framework for Health Informatics Methods. Yearb Med Inform. 2022 Aug;31(1):307-316. doi: 10.1055/s-0042-1742542. Epub 2022 Dec 4.
• Willis M, Brand Hein L, Hu Z, Saran R, Argentina M, Bragg-Gresham J, Krein SL, Gillespie B, Zheng K, Veinot TC. Usability Evaluation of a Tablet-Based Intervention to Prevent Intradialytic Hypotension in Dialysis Patients During In-Clinic Dialysis: Mixed Methods Study. JMIR Hum Factors. 2021 Jun 14;8(2):e26012. doi: 10.2196/26012.
• Willis MA, Hein LB, Hu Z, Saran R, Argentina M, Bragg-Gresham J, Krein SL, Gillespie B, Zheng K, Veinot TC. Feeling better on hemodialysis: user-centered design requirements for promoting patient involvement in the prevention of treatment complications. J Am Med Inform Assoc. 2021 Jul 30;28(8):1612-1631. doi: 10.1093/jamia/ocab033. Erratum In: J Am Med Inform Assoc. 2021 Aug 02;:
• Kuo PY, Saran R, Argentina M, Heung M, Bragg-Gresham J, Krein S, Gillespie BW, Zheng K, Veinot TC. Cramping, crashing, cannulating, and clotting: a qualitative study of patients' definitions of a "bad run" on hemodialysis. BMC Nephrol. 2020 Feb 27;21(1):67. doi: 10.1186/s12882-020-01726-8.
• Kuo PY, Saran R, Argentina M, Heung M, Bragg-Gresham JL, Chatoth D, Gillespie B, Krein S, Wingard R, Zheng K, Veinot TC. Development of a checklist for the prevention of intradialytic hypotension in hemodialysis care: Design considerations based on activity theory. In: Proceedings of the 2019 CHI Conference on Human Factors in Computing Systems 2019 May 2 (pp. 1-14).

Helpful Links

• Veinot T., Bash N., Bragg-Gresham JL. et al. Changing Routine Practice to Enhance the Cardiovascular Safety of Hemodialysis Care Nephrology News & Issues. 5/23/2016

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Checklist; Peer Mentoring; Team Training
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases; Kidney Failure, Chronic; Renal Insufficiency; Hypotension
• Other Study ID Numbers: HUM00125305; IHS-1503-27848 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No