PROMs Assessment for Chronic Kidney Disease

(EMPATHY Trial)

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

3977 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Patient-reported outcome measures (PROMs) are reports coming directly from patients about how they function or feel in relation to a health condition and its therapy, without interpretation of the patient's responses by a clinician or anyone else. PROMs capture patients' experiences of symptoms and impact of disease on functioning and can support clinicians to monitor disease progression and facilitate patient-centered care. The EMPATHY trial will determine the effects of routinely measuring PROMs on the experiences of patients undergoing hemodialysis in Alberta and Ontario. In this study, two kinds of PROMs will be used: a disease-specific PROM and a generic PROM. The disease-specific PROM focuses on health symptoms related to kidney failure and the generic PROM focuses on general health. In the trial, patients will be invited to complete the PROMs, and results of the measures will be linked to treatment aids for clinicians, providing specific information on how symptoms can best be managed. These care pathways will also be available to patients not receiving PROMs. The main outcome of this study will be patient-clinician communication, which will be assessed using a questionnaire called the "Communication Assessment Tool". In addition to assessing the effect of using these questionnaires on patient-provider communication, this study will allow us to explore whether their use affects patient management and symptoms, use of healthcare services, and the overall cost of implementing these questionnaires in clinical practice. Each dialysis unit (including all patients) will be randomized to one of four study groups: 1) Patients will complete the disease-specific PROM; 2) Patients will complete the generic PROM; 3) Patients will complete both the disease-specific and generic PROM; 4) Patients will receive usual care. Clinicians (in dialysis units randomized to PROMs, groups 1-3) will receive the results of the questionnaires completed by the patients. This is intended to trigger the clinician to ask the patient about certain symptoms if any exist. All clinicians in all study groups will have access to the clinical "treatment aids", which are tools that help identify and manage certain symptoms that patients might have. For example, people with severe itching will be cared for based on a step-wise treatment algorithm. Patients will also receive a report of their questionnaire(s) results, with an explanation of what it means.

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.

Is it safe to use PROMs for chronic kidney disease patients?

PROMs (patient-reported outcome measures) are tools used to gather information about patients' health experiences and are generally considered safe for use in chronic kidney disease care. They help improve the understanding of patients' symptoms and experiences, which can enhance safety and care quality. ^{1 2 3 4 5}

How does this treatment differ from other treatments for chronic kidney disease?

This treatment is unique because it focuses on using patient-reported outcome measures (PROMs) to assess the quality of life and health experiences of patients with chronic kidney disease, which is not typically captured by standard laboratory tests. This approach aims to incorporate the patient's voice into their care, making it more personalized and comprehensive. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Patient-reported outcome measures (PROMs) for chronic kidney disease?

Research shows that PROMs can provide valuable insights into patients' symptoms and experiences, which are not captured by lab tests alone. This approach helps tailor care to individual needs, improving the quality of health care for patients with kidney disease. ^{1 2 4 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. England pubmed.ncbi.nlm.nih.gov

Collection and determinants of patient reported outcome measures in haemodialysis patients in Scotland. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures for Adults With Kidney Disease: Current Measures, Ongoing Initiatives, and Future Opportunities for Incorporation Into Patient-Centered Kidney Care. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Changes in quality of life (QoL) and other patient-reported outcome measures (PROMs) in living-donor and deceased-donor kidney transplant recipients and those awaiting transplantation in the UK ATTOM programme: a longitudinal cohort questionnaire survey with additional qualitative interviews. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Responsiveness and minimal important change of seven PROMIS computerized adaptive tests (CAT) in patients with advanced chronic kidney disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Exploring the use of tablet computer-based electronic data capture system to assess patient reported measures among patients with chronic kidney disease: a pilot study. [2018]

6. Canada 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Routinely measuring symptom burden and health-related quality of life in dialysis patients: first results from the Dutch registry of patient-reported outcome measures. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 and -29 item short forms among kidney transplant recipients. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: A systematic review. [2022]