Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

Cardiovascular Diseases Clinical Trial

— 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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03171545
• Other study ID #: HUM00125305
• Secondary ID: IHS-1503-27848
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: September 30, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• End Stage Renal Disease
• Hypotension
• Kidney Failure
• Kidney Failure, Chronic
• Patient Safety
• Renal Insufficiency

Intervention

Behavioral:
• Patient Activation
Patients in clinics assigned to this group will be offered peer mentoring and digital resources.
• Provider Education
Staff in clinics assigned to this group will receive team training and a checklist.

Locations

Country	Name	City	State
United States	Fresenius Kidney Care University Of Michigan - Ann Arbor	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Fresenius Medical Care North America, National Kidney Foundation, University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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).

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. — View 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. — View 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. — View 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. Erratum In: J Am Med Inform Assoc. 2021 Aug 02;: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fluid Adherence	Measured by interdialytic weight gain (in Kilograms), which is the weight gained between dialysis sessions.	48 weeks
Secondary	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
Secondary	Dialysis adherence - sessions missed	Measured as the number of missed sessions per week (number of prescribed sessions-number of actual sessions).	48 weeks
Secondary	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
Secondary	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
Secondary	Quality of Life-KDQOL	Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1).	52 weeks
Secondary	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
Secondary	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