Description

This study will determine the effects of routinely measuring patient-reported outcome measures (PROMs) on the experiences of patients undergoing hemodialysis in Canada. PROMs are questionnaires that ask individuals to report on certain aspects of their health. In this study, the following two questionnaires will be used:

• The modified Edmonton Symptom Assessment Scale – renal (mESASr): This questionnaire focuses on health symptoms related to kidney disease
• The 5 level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L): This questionnaire focuses on general health

In both cases, patients identifying problems on these measures will be linked to treatment aids (see below) providing specific information on how symptoms can best be managed. These care pathways will also be available to patients not receiving PROMs. In terms of patient experience, the main outcome of this study, the focus will be on patient-clinician communication, which will be assessed using a questionnaire called “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 (including anxiety and depression), 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 the study groups:

Clinicians 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 receive “treatment aids”, which are tools that helps them identify and manage certain symptoms that patients might have. For instance, people with severe itching will be cared for based on a step-wise treatment algorithm. Patients will also receive a report of their questionnaires results, with an explanation of what it means. As part of evaluating the implementation of this trial, we will conduct interviews with several patients and clinicians involved in the trial to get their feedback. These interviews will be conducted at 6 months and at the end of the study and will provide a rich source of information about what patients and clinicians liked or did not like about the questionnaires, and whether the process was deemed acceptable, and if not, how to improve it.

Study Team

Role	Name(s)	Responsibilities
Principal Investigators	Jeffrey A. Johnson   Michael Walsh	Oversee and guide the overall planning and implementation of the trial
Co-investigators	Braden Manns; Addera Levin; Scott Klarenbach; Sara Davison; Kara Schick-Makaroff; Maria Santana; Feng Xie; Lehana Thabane; Chandra Thomas; Fatima Al Sayah	Provide support and guidance for the overall planning and implementation of the trial
Patient Partner Co-investigators	Paul D.; Gwen H.; Nicolas F.; Robert B.; Don S.; Barbara L
Study Coordinator	Hilary Short

 

Funding Agencies

Can-SOLVE CKD

EuroQol