NCT03149328

Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney)

Completed NA Results posted Last updated 5 October 2021

What this trial tests

NA trial testing Educational Support in Kidney Disease, End-Stage in 594 participants. Completed in 31 October 2019.

Timeline

28 August 2017

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	594
Start date	28 August 2017
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	2 locations across Canada

Drugs / interventions tested

• Educational Support

Conditions studied

• Kidney Disease, End-Stage — all drugs for Kidney Disease, End-Stage →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Kidney Disease, End-Stage. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Symptoms - Trajectory of Change Primary · Trajectories of up to 24 months from start of enrollment to study completion

Assessed using the symptoms/problems domain of the Kidney Disease Quality of Life 36-Item Short Form Survey (KDQOL-36). The Symptoms/Problems domain has 12 items, each representing a symptom or side effect of kidney disease based on the past 4 weeks with 5 response items ranging from "Not Bothered at all = 100" to "Extremely Bothered = 0". Min Score = 0; Max score = 100. Higher score indicates better health.

Group	Value	95% CI
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic	77.2	± 14.2
Usual Care	76.2	± 15.1

Person-centred Care - Trajectory of Change Primary · Trajectories of up to 24 months from start of enrollment to study completion

Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC-20), a patient-reported experience measure on satisfaction with care over the past 6 months. The PACIC-20 is a 20-item survey based on five subscales: (1) patient activation, (2) delivery system design and decision support, (3) goal setting and tailoring, (4) problem-solving and contextual counselling, and (5) follow-up and coordination. Each item is rated on a five-point scale (from "Almost never = 0" to "Almost always = 5") and the subscale and total scores are based on average scores across items. Min score = 0; Max

Group	Value	95% CI
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic	3.4	± 1.1
Usual Care	3.5	± 1.0

Utilization of Health Services Secondary · From study enrollment until completion (up to 24 months)

Assessed using health services data (i.e. average number of hospital admissions, trips to the emergency room) determined through SPOR Platform and Alberta Health Services electronic health records. Higher numbers indicates worse outcomes.

Hospitalizations

Group	Value	95% CI
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic	1.99	± 2.15
Usual Care	2.33	± 2.52

Emergency Room Visits

Group	Value	95% CI
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic	5.72	± 7.28
Usual Care	4.53	± 5.58

Number of Participants Who Selected "1 - Excellent" on Satisfaction With Care Secondary · Up to 24 months from start of enrollment to study completion

Assessed using one item added to the end of the Patient Assessment of Care for Chronic Conditions 20 item questionnaire (PACIC-20) related to care received. This item is from the NHS Outpatient Survey (2011). (RateClin) related to care received on a Likert-type scale from Excellent = 1 to Very Poor = 6. Min = 1, max = 6. The number of patients who selected "1 - Excellent" was tabulated and compared between the two groups. The higher the number the more patients who felt the care provided to them was excellent.

Group	Value	95% CI
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic	654
Usual Care	547

Mental Health - Trajectory of Change Secondary · Trajectories of up to 24 months from start of enrollment to study completion

Assessed using the SF-12 mental component summary (MCS) subscale in the Kidney Disease Quality of Life 36-item Short-Form Survey (KDQOL-36). The SF-12 uses 2 items (psychological distress and psychological well being) to measure the MCS score. The summary score is transformed using Canadian norm-based scoring. The scores ranged from 0 (worst health) to 100 (best health). The higher the score the better the mental health.

Group	Value	95% CI
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic	50.9	± 8.4
Usual Care	51.0	± 8.3

Quality of Life - Trajectory of Change Secondary · Trajectories of up to 24 months from start of enrollment to study completion

Assessed using the Euro Quality of Life EQ-5D-5L. This assessment uses a descriptive system for health-related Quality of Life states in adults consisting of 5 dimensions; Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is scored between 1 = indicating no problem and 5 = indicating unable to/extreme problems. An EQ-5D summary index is derived by applying a formula (the Canadian standard value set) that attaches values (weights) to each of the levels in each dimension. Index min= 0.0 max = 1.0. The higher the index the better the quality of life/st

Group	Value	95% CI
Clinician Support and Education Around Use of PROs in Home Dialysis Clinic	0.772	± 0.182
Usual Care	0.745	± 0.196

Sponsor's own description

People living with end-stage kidney disease (ESKD) need dialysis or transplantation in order to stay alive. This illness and treatment significantly impact peoples' health, emotions, work and relationships. To promote person-centred care, healthcare professionals should be asking patients about what matters to them and using this feedback to plan and deliver care. Patient-reported outcome and experience questionnaires (jointly referred to as PROs) allow patients to provide information about their quality of life, symptoms and experiences with care. PROs are increasingly used to help healthcare professionals learn about what is important to patients and the impacts of illness or treatments from patients' point of view. Embedding feedback from patients into routine clinical practice is important in end-stage kidney disease because of the physical and quality of life challenges these patients face when living with kidney failure.

PROs provide vital and often missing information that the healthcare team can use to support patients. However, PROs administered via paper questionnaires have been perceived as cumbersome, difficult to integrate with other health information and do not provide immediate feedback.

In this research, home dialysis patients will have the opportunity to complete electronically administered PROs (ePROs) and healthcare professionals will receive education about how to use PRO information. The goal is to learn how to support healthcare professionals to routinely use this information to inform patient care, and see if this makes a difference in patients' symptoms, person-centred care, quality of life and satisfaction with care.

Learning what matters most to patients is essential for healthcare professionals to provide person-centred care. This research will address the gap in our understanding of how to best use patients' reports in healthcare. Findings of this research may ultimately improve the quality of healthcare for Canadians living with end-stage kidney disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Electronic patient-reported outcomes in clinical kidney practice (ePRO Kidney): a process evaluation of educational support for clinicians.
   Schick-Makaroff K, Klarenbach S, Kwon JY, Cohen SR, et al · · 2023 · cited 7× · PMID 37332391 · DOI 10.1177/20406223231173624