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| ID | Type | Description | Link |
|---|---|---|---|
| IHS-1503-27848 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
| National Kidney Foundation, United States | OTHER |
| Fresenius Medical Care North America | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Provider Education | Experimental | This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists. |
|
| No Intervention | No Intervention | Patients in clinic receive usual care. | |
| Patient and Provider | Experimental | This arm includes both Patient Activation and Provider Education interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Activation | Behavioral | Patients in clinics assigned to this group will be offered peer mentoring and digital resources. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dialysis Session Stability | Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP during session) if starting SBP ≥100. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 weeks |
| Dialysis Adherence - Average Weekly Minutes Missed Over Intervention Period |
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Selection is at both the clinic level and individual patient level.
Clinic Inclusion Criteria:
Clinic Exclusion Criteria:
Individual Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Veinot, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresenius Kidney Care University Of Michigan - Ann Arbor | Ann Arbor | Michigan | 48104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37079365 | Background | 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. | |
| 36463889 |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention | Patients in clinic receive usual care. |
| FG001 | 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. |
| FG002 | Provider Education | This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists. |
| FG003 | Patient and Provider | This arm includes both Patient Activation and Provider Education interventions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Intervention |
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| Follow up |
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These are all participants who were analyzed for baseline data, i.e. all enrolled participants regardless of how long they were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention | Patients in clinic receive usual care. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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) | Posted | Mean | Standard Deviation | Kg | 24 weeks |
|
Adverse events were monitored throughout all study periods: baseline (12 weeks), intervention (24 weeks), and follow up (12 weeks). Baseline monitoring was limited to counts of all-cause mortality because data for this time period were collected retrospectively.
This was a pragmatic, low-risk trial with no changes to prescribed care. All-cause mortality was tracked. Adverse events relating to a breach in confidentiality were not observed. Other adverse events were not systematically tracked because the patient is very ill at baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Intervention | Patients in clinic receive usual care. | 45 |
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Results displayed for the primary and secondary outcomes are based on data from the 24-week intervention period, with the exception of quality of life measures based on the post-intervention quality of life survey conducted annually in each clinic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tiffany Veinot | University of Michigan | 734-615-8281 | tveinot@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2023 | Oct 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| D007022 | Hypotension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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| Provider Education | Behavioral | Staff in clinics assigned to this group will receive team training and a checklist. |
|
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). |
| 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). | 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. | 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). | 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. | 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. | post-intervention survey |
| Hospitalization | Hospitalization rates, measured as a total number of hospital admission for any reason per total patients year ("all-cause hospitalizations") | 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"). | 24 weeks |
| Background |
| 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. |
| 34121664 | Background | 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. |
| 34117493 | Background | 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. |
| 32103726 | Background | 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. |
| Background | 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). |
| Transferred out of clinic |
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| Death |
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| Recovered renal function |
|
| Received transplant |
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| No longer receiving in-center hemodialysis |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Provider Education | This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists. |
| BG003 | Patient and Provider | This arm includes both Patient Activation and Provider Education interventions |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Dialysis Session Stability | Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP during session) if starting SBP ≥100. | Mean | Standard Deviation | Proportion of sessions |
|
| Provider Education |
This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists. |
| OG003 | Patient and Provider | This arm includes both Patient Activation and Provider Education interventions |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | average weekly minutes | 24 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | average proportion of sessions missed | 24 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Proportion session recovery before home | 24 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). | Posted | Mean | Standard Deviation | Average symptoms reported per session | 24 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score | post-intervention survey |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score | post-intervention survey |
|
|
|
| Secondary | Hospitalization | Hospitalization rates, measured as a total number of hospital admission for any reason per total patients year ("all-cause hospitalizations") | Posted | Number | 95% Confidence Interval | hospitalizations per patient year | 24 weeks |
|
|
|
| Primary | Dialysis Session Stability | Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP during session) if starting SBP ≥100. | Posted | Mean | Standard Deviation | Proportion of sessions | 24 weeks |
|
|
|
| Secondary | 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"). | Posted | Number | 95% Confidence Interval | Deaths per 100 patient years | 24 weeks |
|
|
|
| 382 |
| 0 |
| 382 |
| 0 |
| 382 |
| EG001 | 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. | 30 | 346 | 0 | 346 | 0 | 346 |
| EG002 | Provider Education | This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists. | 35 | 410 | 0 | 410 | 0 | 410 |
| EG003 | Patient and Provider | This arm includes both Patient Activation and Provider Education interventions | 27 | 293 | 0 | 293 | 0 | 293 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |