PROMs Assessment for Chronic Kidney Disease

(EMPATHY Trial)

Not currently recruiting at 2 trial locations

Overseen By Alysha Glazer, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Cognitive impairment, Acute dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how patient-reported outcome measures (PROMs) can improve care for individuals on hemodialysis. PROMs allow patients to express how they feel and how their condition impacts their daily life. The trial will determine if these tools enhance communication between patients and doctors and improve symptom management. It targets patients receiving dialysis in Alberta and Ontario who are comfortable completing these questionnaires. Participants will join one of four groups to assess whether these tools affect their treatment experience. As an unphased trial, this study provides patients the chance to contribute to research that could enhance communication and care in hemodialysis.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on assessing patient-reported outcomes during hemodialysis, so it's likely you can continue your current treatments, but please confirm with the trial coordinators.

What prior data suggests that these PROMs are safe for patients undergoing hemodialysis?

Research shows that patient-reported outcome measures (PROMs) are generally safe for people with chronic kidney disease. These surveys allow patients to share their feelings and describe their symptoms. Since they don't involve medication or physical procedures, they pose no risk of side effects.

Studies have found that specific PROMs for kidney disease, like the Edmonton Symptom Assessment System-revised: Renal, are well-received by patients. These surveys focus on symptoms directly related to kidney issues.

General PROMs, such as the EQ-5D-5L, also have a good reputation. They assess overall health and can be used by anyone, not just those with kidney disease. Research indicates that most patients find them easy to complete and understand.

Using both specific and general PROMs together is common. This method provides a complete picture of a patient's health. Research supports this practice, showing it is safe and useful in managing kidney disease. Overall, PROMs offer a low-risk way to improve communication between patients and doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of patient-reported outcome measures (PROMs) for chronic kidney disease management in a way that could enhance patient care. Unlike standard treatment options, which typically focus on clinical measures like blood tests and dialysis efficiency, this approach empowers patients to actively participate in their care by regularly assessing their own symptoms and quality of life. The trial is testing different types of PROMs: disease-specific, generic, and a combination of both, to see which provides the most helpful insights. By integrating these self-reported assessments into patient charts and treatment plans, clinicians can more effectively tailor care to individual needs, potentially improving outcomes and quality of life for those on dialysis.

What evidence suggests that this trial's PROMs could be effective for improving patient-clinician communication in chronic kidney disease?

Studies have shown that patient-reported outcome measures (PROMs) can track symptoms and improve communication between patients and doctors. In this trial, participants in the disease-specific PROM group will use a PROM focused on symptoms related to kidney failure, which research has shown effectively monitors these health issues. Participants in the generic PROM group will use a PROM that measures overall health and has been linked to better assessments of quality of life for patients with kidney disease. The trial also includes a group using both types of PROMs together, which is suggested to provide a complete picture of a patient's health, allowing for better symptom management. This combined approach may improve patient care by offering detailed insights into both specific and general health concerns. ^{3 6 7 8 9}

Who Is on the Research Team?

Jeffrey Johnson, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Alberta or Ontario who are undergoing regular hemodialysis. Participants must be able to complete patient-reported outcome measures (PROMs). Those with cognitive impairments, on acute dialysis, or temporarily dialyzing aren't eligible.

Inclusion Criteria

Willing and able to complete the PROMs as part of the trial

I am currently receiving hemodialysis in Alberta or Ontario.

Exclusion Criteria

I have cognitive impairment.

I am currently receiving dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Preparation

Administrative approvals, completing ethics requirements, and training of clinicians on the use of PROMs

6 months

Intervention

Implementation of PROMs assessments and interventions across randomized groups

12 months

Every 2 months

Follow-up

Participants are monitored for changes in communication, symptom management, and healthcare utilization

12-24 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient-reported outcome measures (PROMs)

Trial Overview The EMPATHY trial tests if using PROMs—surveys about patients' health directly from them—improves communication between patients and clinicians. It compares the effects of disease-specific, generic, both types of PROMs, and usual care without PROMs in managing kidney failure symptoms.

How Is the Trial Designed?

Group I: The generic PROM group Experimental Treatment 1 Intervention

HD units randomized to this PROMs assessment group will administer a generic PROM every 2 months to all patients able to complete the instrument independently or with assistance for a period of 12 months. Patients will receive a copy of their PROM results in report form and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM. The generic PROM report will also be added to the patient's medical chart for review by clinicians. The report will display each patient's most recent results in comparison with their previous results, and in comparison with the general dialysis population. The PROM report will be accompanied by treatment aids for all symptoms. The proposed generic PROM is the EQ-5D-5L.

Group II: The disease-specific PROM group Experimental Treatment 1 Intervention

Hemodialysis (HD) units randomized to this PROMs assessment group will administer a disease-specific PROM every 2 months to all patients able to complete the instrument independently or with assistance for a period of 12 months. Patients will receive a copy of their PROM results in report form and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM. The disease-specific PROM report will also be added to the patient's medical chart for review by clinicians. The report will display each patient's most recent results in comparison with their previous results, and in comparison with the general dialysis population. The PROM report will be accompanied by treatment aids for all symptoms. The proposed disease-specific PROM is the ESAS-r:Renal or the IPOS-Renal.

Group III: Disease-specific and generic PROMs group Experimental Treatment 1 Intervention

HD units randomized to this PROMs assessment group will administer a disease-specific and generic PROM every 2 months to all patients able to complete the instrument for a period of 12 months. Patients will receive a copy of both their PROMs results in report form and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the two PROMs. The disease-specific and generic PROMs reports will also be added to the patient's medical chart for review by clinicians. The report will display each patient's most recent results in comparison with their previous results, and in comparison with the general dialysis population. The PROMs reports will be accompanied by treatment aids for all symptoms.

Group IV: The control or 'usual care' group Active Control 1 Intervention

HD units randomized to this group will follow usual care and patients will not have any PROMs assessment; however, all the treatment aids will be made available for clinicians in this study group during the 12 months trial period.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

In a study involving 738 haemodialysis patients in Scotland, the collection of Patient Reported Outcome Measures (PROMs) was found to be feasible and highlighted significant differences in quality of life based on age, social class, and primary renal diagnosis.

Higher PROMs were associated with achieving a urea reduction ratio of over 65% and using arteriovenous access for dialysis, indicating that meeting certain care standards can improve patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collection and determinants of patient reported outcome measures in haemodialysis patients in Scotland. Nimmo, A., Bell, S., Brunton, C., et al.[2022]

In a 6-month study involving 52 Stage III-V CKD patients, the interactive voice-inquiry dial-response system (IVRDS) detected significantly more adverse safety events (54% of participants) compared to a paper diary (15%), highlighting its effectiveness in monitoring patient-reported outcomes.

The IVRDS not only identified a higher rate of clinically significant events, such as hypoglycemia, but also received positive feedback from participants, suggesting it could enhance patient safety in chronic kidney disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. Fink, JC., Doerfler, RM., Yoffe, MR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03535922?intr=proms&rank=6&checkSpell=

Evaluation of Routinely Measured Patient-reported ... The disease-specific PROM focuses on health symptoms related to kidney failure and the generic PROM focuses on general health.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8511202/

Patient-reported outcome measures in the care of in-centre ... The EMPATHY trial is intended to comprehensively evaluate the effectiveness of disease-specific and generic PROMs-based interventions, the adoption and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272638623008922

Patient-Reported Outcome Measures for Patients With CKD Patient-reported outcome measures (PROMs) assess symptom severity; physical, psychological, social, and cognitive functioning; treatment-related side effects; ...

4. ajkd.org ajkd.org/article/S0272-6386(23)00892-2/abstract

Patient-Reported Outcome Measures for Patients With CKD Patient-reported outcome measures (PROMs) assess symptom severity; physical, psychological, social, and cognitive functioning; treatment-related side effects; ...

5. clinicaltrial.be clinicaltrial.be/en/details/7255?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Evaluation of Routinely Measured Patient-reported ... The overall aim of this study is to explore the usefulness of integrating PROM assessments in the clinical management of hemodialysis ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6875620/

Patient-Reported Outcome Measures for Adults With Kidney ... We provide nephrologists with a comprehensive list of existing PROMs developed for adults with kidney disease with information on their gaps and limitations.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5775264/

Patient-Reported Outcomes in Patients with Chronic ... Chronic-kidney-disease-specific instruments are PROMs that are tailored to the specific symptom burden and disease experience by patients with CKD (see Table 2 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0270929524000846

Measuring Symptoms Across the Spectrum of Chronic ... The PROMs that have evidence for validity in people with CKD are described in Table 3. The Edmonton Symptom Assessment System-revised: Renal (ESAS-r: R) and the ...

9. ajkd.org ajkd.org/article/S0272-6386(19)30728-0/fulltext

Patient-Reported Outcome Measures in CKD Care Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: a systematic review.