Kidney FailureDialysafeNCT03171545
Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)
A study testing Patient Activation and Provider Education in people with Kidney Failure and End Stage Renal Disease, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Kidney Failure, End Stage Renal Disease, Hypotension
- What is being tested?
- Patient Activation and Provider Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,431 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 13 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fresenius Kidney Care University Of Michigan - Ann Arbor
Ann Arbor, Michigan, 48104
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Failure, End Stage Renal Disease, Hypotension, Cardiovascular Diseases, Patient Safety
- Being tested
- Patient Activation, Provider Education
- Keywords
- Peer Mentoring, Team Training, Checklist
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Hypotension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient ActivationBehavioural
Patients in clinics assigned to this group will be offered peer mentoring and digital resources.
Provider EducationBehavioural
Staff in clinics assigned to this group will receive team training and a checklist.
| Study group | Role | What they receive |
|---|---|---|
| Patient Activation | Experimental | 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. Receives: Behavioral: Patient Activation |
| Provider Education | Experimental | This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists. Receives: Behavioral: Provider Education |
| No Intervention | No intervention | Patients in clinic receive usual care. |
| Patient and Provider | Experimental | This arm includes both Patient Activation and Provider Education interventions Receives: Behavioral: Patient Activation; Behavioral: Provider Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis Session Stability
Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP during session) if starting SBP ≥100.
Measured: 24 weeks
Secondary outcomes (9)
Fluid Adherence
Measured by interdialytic weight gain (in Kilograms), which is the weight gained between dialysis sessions (presented as average throughout 24 week intervention period)
Measured: 24 weeks
Dialysis Adherence - Average Weekly Minutes Missed Over Intervention Period
Measured as the average number of minutes of prescribed dialysis time missed per week during intervention period (number of prescribed minutes-number of actual minutes/24 week intervention period).
Measured: 24 weeks
Dialysis Adherence - Average Weekly Sessions Missed During Intervention Period
Measured as the average number of missed sessions per week during the intervention period (number of prescribed sessions-number of actual sessions/24 week intervention period).
Measured: 24 weeks
Patient Symptoms - Post-dialysis Recovery Time
Measured at midweek 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." Responses grouped into three categories for analysis: "did not recover," "recovered before reaching home," and "recovered on same day of treatment." Sessions categorized as "recovered before reaching home" used for comparison between study arms.
Measured: 24 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).
Measured: 24 weeks
Quality of Life-KDQOL - MCS
Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1). MCS (mental component summary) subscale ranges from 5.8 - 69.9; higher scores represent better functioning.
Measured: post-intervention survey
Quality of Life-KDQOL - PCS
Total score measured by adding responses on the Kidney Disease Quality of Life survey (KDQOLTM-36 Version 1). PCS (physical component summary) ranges from 7.3 - 70.1; higher scores represent better functioning.
Measured: post-intervention survey
Hospitalization
Hospitalization rates, measured as a total number of hospital admission for any reason per total patients year ("all-cause hospitalizations")
Measured: 24 weeks
Mortality
Mortality rates, measured as a total number of deaths due to any cause per 100 patient years during the study period ("all-cause mortality").
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start11 Jan 2023
- Primary completion17 Nov 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 1,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, National Kidney Foundation, United States, Fresenius Medical Care North America
- Responsible party
- Principal investigator, Tiffany Veinot, University of Michigan
- Investigators
- Tiffany Veinot, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171545
- Sponsor's protocol ID
- HUM00125305
- Other IDs
- IHS-1503-27848
- Acronym
- Dialysafe
- Status last verified
- Dec 2025
- First submitted
- 25 May 2017
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37079365Veinot 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.
PubMed 36463889Willis 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.
PubMed 34121664Willis 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.
PubMed 34117493Kuo 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.
PubMed 32103726Kuo 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).
Wickens M, Bragg-Gresham J, Saran R, Tandan M, Argentina M, Chatoth D, Collins Damron K, Heung M, Krein S, Le V, Licon AL, Eggebrecht K, Murphy B, Zerkle A, Zheng K, Veinot TC. Recruitment, Engagement, Experiences, and Self-Reported Changes in a Digital Patient Activation Intervention to Improve Hemodialysis Session Stability: Mixed Methods Study. J Med Internet Res. 2026 Oct 16;28:e93049. doi: 10.2196/93049.
PubMed 42887003