Clinical trial NCT03171545: Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)
Official title: Enhancing the Cardiovascular Safety of Hemodialysis Care: a Cluster-Randomized, Comparative Effectiveness Trial of Multimodal Provider Education and Patient Activation Interventions (Dialysafe)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure
End Stage Renal Disease
Hypotension
Cardiovascular Diseases
Patient Safety
Keywords: Peer Mentoring
Team Training
Checklist
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
name: National Kidney Foundation, United States
name: Fresenius Medical Care North America
First posted: 2017-05-31
Enrollment: 1431
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study is a 2X2 factorial design, such that 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.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dialysis Session Stability
timeFrame: 48 weeks
Secondary outcomes:
measure: Fluid Adherence
timeFrame: 48 weeks
measure: Dialysis adherence - minutes missed
timeFrame: 48 weeks
measure: Dialysis adherence - sessions missed
timeFrame: 48 weeks
measure: Patient symptoms - post-dialysis recovery time
timeFrame: 48 weeks
measure: Patient symptoms - symptom burden
timeFrame: 48 weeks
measure: Quality of Life-KDQOL
timeFrame: 52 weeks
measure: Hospitalization
timeFrame: 48 weeks
measure: Mortality
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Fresenius Kidney Care University Of Michigan - Ann Arbor
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tiffany Veinot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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).