A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol

Abstract

Background: Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patientcentered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients' health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. Methods: The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. Discussion: While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems.

Screening for symptoms of anxiety and depression in patients treated with renal replacement therapy: utility of the Edmonton Symptom Assessment System-Revised

“…Valid, reliable patient reported outcome measures (PROMs) that have good discrimination may be used to screen for emotional symptoms [14][15][16][17]. Recent studies considered the Edmonton Symptom Assessment System (ESAS) to routinely measure symptoms experienced by patients on dialysis [18,19]. Routine symptom assessment with ESAS improved awareness of symptom burden among providers and patients, particularly for psychosocial symptoms but it had minimal impact on symptom management.…”

Patient-reported outcome measures in the care of in-centre hemodialysis patients

“…These interventions were designed based on successes from PROMs studies in oncologic settings[ 10 , 11 ] intending to enhance communication between patients and clinicians, maximize patient participation in decision-making on reducing symptoms, improve HRQL, and facilitate self-management [ 12 ]. From 2018—2020, a multi-centre cluster randomized controlled trial to evaluate the routine reporting of patient report outcomes in hemodialysis care, known as the EMPATHY trial, was implemented in in-centre hemodialysis units across Alberta and in select units in Ontario [ 13 ]. In part, the EMPATHY trial aimed to provide a deeper understanding of how to optimize the implementation and use of PROMs in hemodialysis [ 14 , 15 ].…”

“…It was important to explore whether one single PROM is sufficient to improve patient-provider communication, processes of care, and ultimately patient outcomes, before recommending the use of a combination of generic and disease-specific measures. The following measures were selected for evaluation through the EMPATHY trial (Table 1 ) [ 13 ]: Edmonton Symptom Assessment System Revised: Renal (ESAS-r: Renal) (for AKC-N) Integrated Palliative care Outcome Scale – Renal (IPOS-Renal) (for AKC-S) EQ-5D-5L …”

Burden of mental health symptoms and perceptions of their management in in-centre hemodialysis care: a mixed methods study

“…We employed a concurrent, longitudinal, mixed-methods research design [22][23][24][25]. This was a secondary analysis as part of the "Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY) trial", a multi-centre cluster randomized controlled trial described elsewhere [26]. Each cluster (i.e., in-centre hemodialysis unit) was randomized to one of four study arms: (1) patients complete the Edmonton Symptom Assessment System, revised: Renal (ESAS-r: Renal) [27,28], (2) patients complete EQ-5D-5L [29], (3) Patients complete both ESAS-r: Renal and EQ-5D-5L, (4) Usual care (i.e., control group) (Fig.…”