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PROMs Assessment for Chronic Kidney Disease (EMPATHY Trial)

N/A

Waitlist Available

Led By Jeffrey Johnson, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing hemodialysis within an eligible in-centre dialysis unit in Alberta or Ontario

18 years or older at the start of the study

Must not have

Cognitive impairment present

Undergoing acute dialysis or transiently dialyzing in the unit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year prior and one year after the study intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will help us understand whether measuring PROMs can improve patient-clinician communication and, ultimately, patient care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study involves completing questionnaires rather than medication or invasive procedures, there are no direct physical side effects expected from participating in the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving hemodialysis in Alberta or Ontario.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cognitive impairment.

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I am currently receiving dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year prior and one year after the study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year prior and one year after the study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year prior and one year after the study intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Communication Assessment Tool (CAT) scores over 12 months

Secondary study objectives

Change in Disease-specific PROM (ESAS or IPOS) scores over 12 months

Change in EQ-5D-5L scores over 12 months

Change in GAD-2 scores over 12 months

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: The generic PROM groupExperimental Treatment1 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 groupExperimental Treatment1 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 groupExperimental Treatment1 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' groupActive Control1 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.

0 / 4Eligibility criteria met