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Evaluation of Routinely Measured Patient-reported Outcomes in Hemodialysis Care (EMPATHY)

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ClinicalTrials.gov Identifier: NCT03535922
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : April 27, 2021
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Jeffrey Johnson, University of Alberta

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Requiring Chronic Dialysis Other: PROMs Assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Routinely Measured PATtient Reported Outcomes in HemodialYsis Care (EMPATHY) Trial: A Cluster Randomized Controlled Trial
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The disease-specific PROM group
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.
Other: PROMs Assessment
Routine measurement and reporting of disease-specific PROMs, generic PROMs, or combination of both

Experimental: The generic PROM group
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.
Other: PROMs Assessment
Routine measurement and reporting of disease-specific PROMs, generic PROMs, or combination of both

Experimental: Disease-specific and generic PROMs group
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.
Other: PROMs Assessment
Routine measurement and reporting of disease-specific PROMs, generic PROMs, or combination of both

No Intervention: The control or 'usual care' group
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.



Primary Outcome Measures :
  1. Change in Communication Assessment Tool (CAT) scores over 12 months [ Time Frame: Measured at baseline, 6 months, and 12 months ]
    The CAT assesses patient perceptions of clinicians' interpersonal and communication skills. 'Communication' refers to the interactions between members of the healthcare team (i.e., nurses, nephrologists) and the patient.


Secondary Outcome Measures :
  1. Change in EQ-5D-5L scores over 12 months [ Time Frame: Measured at baseline, 6 months, and 12 months ]
    The EQ-5D-5L is a standardized generic measurement of health-related quality of life. This measure provides a simple descriptive profile and single index value for health status. The intended purpose of this measure for this survey is for clinical and economic evaluation of healthcare.

  2. Change in Disease-specific PROM (ESAS or IPOS) scores over 12 months [ Time Frame: Measured at baseline, 6 months, and 12 months ]
    Measure of symptom burden (choice of instrument depends on regional dialysis program). The purpose of this outcome measure is to enable tracking of the effectiveness of targeted symptom management strategies at the patient and program levels.

  3. Symptom treatments initiated [ Time Frame: 12 month study period ]
    Chart review for action taken as result of PROMs measurement

  4. Change in GAD-2 scores over 12 months [ Time Frame: Measured at baseline, 6 months, and 12 months ]
    Measured by the Generalized Anxiety Disorder 2 item questionnaire (GAD-2). The GAD-2 is a screening tool for anxiety.

  5. Change in PHQ-2 scores over 12 months [ Time Frame: Measured at baseline, 6 months, and 12 months ]
    Measured by the Patient Health Questionnaire- 2 items (PHQ-2). The PHQ-2 is a screening tool for depression.

  6. Change in PACIC-11 scores over 12 months [ Time Frame: Measured at baseline, 6 months, and 12 months ]
    The 'Patient Assessment of Chronic Illness Care-11 item questionnaire' measures a number of aspects of care, including patient activation; delivery system design and decision support; goal setting and tailoring; problem-solving and contextual counselling; follow-up and coordination.

  7. Healthcare utilization over 12 months [ Time Frame: One year prior and one year after the study intervention ]
    Survey and clinical data will be linked to administrative data on healthcare utilization of participants

  8. Cost-effectiveness/cost-utility analysis [ Time Frame: 12 month study period ]
    A cost-effectiveness analysis of the different study groups, compared to the usual care arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Undergoing hemodialysis within an eligible in-centre dialysis unit in Alberta or Ontario
  • 18 years or older at the start of the study
  • Willing and able to complete the PROMs as part of the trial

Exclusion criteria:

  • Cognitive impairment present
  • Undergoing acute dialysis or transiently dialyzing in the unit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535922


Contacts
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Contact: Hilary Short, MSc 780-492-5233 heshort@ualberta.ca

Locations
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Canada, Alberta
Alberta Kidney Care - South Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Natalie Ilkiw, MBA         
Principal Investigator: Braden Manns, MD,MSc,FRCPC         
Alberta Kidney Care - North Active, not recruiting
Edmonton, Alberta, Canada, T6G 2E1
Canada, Ontario
Ontario Renal Network Recruiting
Toronto, Ontario, Canada, M5G 2L3
Contact: Alysha Glazer, MPH         
Principal Investigator: Michael Walsh, MD, MSc, PhD         
Sponsors and Collaborators
University of Alberta
Alberta Health Services
Investigators
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Principal Investigator: Jeffrey Johnson, PhD University of Alberta
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey Johnson, PhD, Professor, Chair, and Associate Dean, University of Alberta
ClinicalTrials.gov Identifier: NCT03535922    
Other Study ID Numbers: RES0034066
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Johnson, University of Alberta:
Hemodialysis
Chronic Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency