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

Primary Purpose

Kidney Failure, End Stage Renal Disease, Hypotension

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Activation
Provider Education
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure focused on measuring Peer Mentoring, Team Training, Checklist

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fresenius Kidney Care University Of Michigan - Ann Arbor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

Experimental

Arm Label

Patient Activation

Provider Education

No Intervention

Patient and Provider

Arm Description

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.

This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.

Patients in clinic receive usual care.

This arm includes both Patient Activation and Provider Education interventions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fluid Adherence
Measured by interdialytic weight gain (in Kilograms), which is the weight gained between dialysis sessions.
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).
Dialysis adherence - sessions missed
Measured as the number of missed sessions per week (number of prescribed sessions-number of actual sessions).
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."
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).
Quality of Life-KDQOL
Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1).
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").
Mortality
Binary variable, measured as whether or not a patient died of any cause, where mortality=1 and no mortality=0 ("all-cause mortality").

Full Information

First Posted
May 25, 2017
Last Updated
January 24, 2023
Sponsor
University of Michigan
Collaborators
University of California, Irvine, National Kidney Foundation, Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT03171545
Brief Title
Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)
Acronym
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of California, Irvine, National Kidney Foundation, Fresenius Medical Care North America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, End Stage Renal Disease, Hypotension, Cardiovascular Diseases, Patient Safety
Keywords
Peer Mentoring, Team Training, Checklist

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Activation
Arm Type
Experimental
Arm Description
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.
Arm Title
Provider Education
Arm Type
Experimental
Arm Description
This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Patients in clinic receive usual care.
Arm Title
Patient and Provider
Arm Type
Experimental
Arm Description
This arm includes both Patient Activation and Provider Education interventions
Intervention Type
Behavioral
Intervention Name(s)
Patient Activation
Intervention Description
Patients in clinics assigned to this group will be offered peer mentoring and digital resources.
Intervention Type
Behavioral
Intervention Name(s)
Provider Education
Intervention Description
Staff in clinics assigned to this group will receive team training and a checklist.
Primary Outcome Measure Information:
Title
Dialysis Session Stability
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Fluid Adherence
Description
Measured by interdialytic weight gain (in Kilograms), which is the weight gained between dialysis sessions.
Time Frame
48 weeks
Title
Dialysis adherence - minutes missed
Description
Measured as the number of minutes of prescribed dialysis time missed per week (number of prescribed minutes-number of actual minutes).
Time Frame
48 weeks
Title
Dialysis adherence - sessions missed
Description
Measured as the number of missed sessions per week (number of prescribed sessions-number of actual sessions).
Time Frame
48 weeks
Title
Patient symptoms - post-dialysis recovery time
Description
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."
Time Frame
48 weeks
Title
Patient symptoms - symptom burden
Description
Measured as the total number symptoms reported by the patient at each session (each symptom treated as one, then added to create total symptoms).
Time Frame
48 weeks
Title
Quality of Life-KDQOL
Description
Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1).
Time Frame
52 weeks
Title
Hospitalization
Description
Binary variable, measured as whether or not a patient was hospitalized for any reason, where hospitalization=1 and no hospitalization=0 ("all-cause hospitalizations").
Time Frame
48 weeks
Title
Mortality
Description
Binary variable, measured as whether or not a patient died of any cause, where mortality=1 and no mortality=0 ("all-cause mortality").
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Veinot, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fresenius Kidney Care University Of Michigan - Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

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