Evaluation of Routinely Measured PATtient Reported Outcomes in HemodialYsis Care (EMPATHY) Trial: A Cluster Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 3,977
- Locations
- 3
- Primary Endpoint
- Change in Communication Assessment Tool (CAT) scores over 12 months
Study Overview
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.
Detailed Description
The overall aim of this study is to explore the usefulness of integrating PROM assessments in the clinical management of hemodialysis patients. The specific objectives are as follows:
Primary objective: to determine the effects of routine measurement and reporting to clinicians of PROMs, namely, the Edmonton Symptom Assessment System- revised: Renal (ESAS-r: Renal) or the Integrated Palliative care Outcome Scale - Renal (IPOS-Renal) and/or the EQ-5D-5L on patient-reported experience, particularly patient-clinician communication, measured by the Communication Assessment Tool (CAT), for patients with kidney failure requiring hemodialysis.
Secondary objectives:
- To determine if there is a difference in patient-reported experience and other outcomes induced by a condition-specific (ESAS-r: Renal /IPOS-Renal) versus a generic (EQ-5D-5L) PROM;
- To determine the effects of routinely measuring and reporting the ESAS-r: Renal/IPOS-Renal and/or the EQ-5D-5L on the clinical management of symptoms;
- To determine the effects of routinely measuring and reporting the ESAS-r: Renal /IPOS-Renal and/or the EQ-5D-5L on overall HRQL;
- To determine the effects of routinely measuring and reporting the ESAS-r: Renal/IPOS-Renal and/or the EQ-5D-5L on symptom burden, mental health outcomes and healthcare utilization;
- To determine the cost-effectiveness of routinely measuring the ESAS-r: Renal/IPOS-Renal and/or the EQ-5D-5L for patients with kidney failure requiring hemodialysis;
- To explore the perspectives and experience of patients and clinicians with routine measurement and reporting of PROMs in clinical practice.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: PROMs Assessment (Other)
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.
Intervention: PROMs Assessment (Other)
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.
Intervention: PROMs Assessment (Other)
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.
Outcomes
Primary Outcomes
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 Outcomes
- Symptom treatments initiated(12 month study period)
- Healthcare utilization over 12 months(One year prior and one year after the study intervention)
- Cost-effectiveness/cost-utility analysis(12 month study period)
- Change in EQ-5D-5L scores over 12 months(Measured at baseline, 6 months, and 12 months)
- Change in Disease-specific PROM (ESAS or IPOS) scores over 12 months(Measured at baseline, 6 months, and 12 months)
- Change in PHQ-2 scores over 12 months(Measured at baseline, 6 months, and 12 months)
- Change in PACIC-11 scores over 12 months(Measured at baseline, 6 months, and 12 months)
- Change in GAD-2 scores over 12 months(Measured at baseline, 6 months, and 12 months)