Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney)
1 other identifier
interventional
594
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Start
First participant enrolled
August 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedResults Posted
Study results publicly available
March 5, 2021
CompletedOctober 5, 2021
September 1, 2021
2.2 years
May 1, 2017
November 4, 2020
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Symptoms - Trajectory of Change
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.
Trajectories of up to 24 months from start of enrollment to study completion
Person-centred Care - Trajectory of Change
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 score = 5. Higher scores indicates higher quality of care.
Trajectories of up to 24 months from start of enrollment to study completion
Secondary Outcomes (4)
Utilization of Health Services
From study enrollment until completion (up to 24 months)
Number of Participants Who Selected "1 - Excellent" on Satisfaction With Care
Up to 24 months from start of enrollment to study completion
Mental Health - Trajectory of Change
Trajectories of up to 24 months from start of enrollment to study completion
Quality of Life - Trajectory of Change
Trajectories of up to 24 months from start of enrollment to study completion
Study Arms (2)
Northern Alberta Renal Program (NARP)
EXPERIMENTALProvide in NARP (intervention group), 1) an electronic tool (ePRO) that facilitates real time PRO data collection and feedback in clinical practice, and 2) educational support to multidisciplinary home dialysis clinicians about how to use PROs routinely in their practice.
Southern Alberta Renal Program (SARP)
NO INTERVENTIONIn SARP (comparator group), clinicians will not receive PRO feedback or education sessions.
Interventions
In the intervention group, clinicians will be provided with PRO feedback for use in their clinical practice. They will also receive educational support on how to use PRO data at point of care.
Eligibility Criteria
You may qualify if:
- home dialysis patients attending regularly scheduled appointments in Edmonton at the Aberhart Clinic (NARP) or in Calgary at the Sheldon M. Chumir Health Centre (SARP)
- ≥18 years old
- able to read and speak English
- can provide written informed consent
- if a patient changes dialysis modality, they can continue to participate
- all clinical staff working with home dialysis patients at the Aberhart clinic in Edmonton (NARP)
- study co-investigators/collaborators who are NARP clinicians may choose to participate
You may not qualify if:
- visual impairment
- cannot read or speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Canadian Institutes of Health Research (CIHR)collaborator
- Cambian Business Services, Inc.collaborator
- Intogrey Research and Development Inc.collaborator
- Alberta Health servicescollaborator
Study Sites (2)
Sheldon M. Chumir Health Centre
Calgary, Alberta, T2R 0X7, Canada
Aberhart Centre
Edmonton, Alberta, T6G 2J3, Canada
Related Publications (1)
Schick-Makaroff K, Klarenbach S, Kwon JY, Cohen SR, Czupryn J, Lee L, Pauly R, MacRae JM, Forde B, Sawatzky R. Electronic patient-reported outcomes in clinical kidney practice (ePRO Kidney): a process evaluation of educational support for clinicians. Ther Adv Chronic Dis. 2023 Jun 12;14:20406223231173624. doi: 10.1177/20406223231173624. eCollection 2023.
PMID: 37332391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kara Schick-Makaroff
- Organization
- University of Alberta
Study Officials
- PRINCIPAL INVESTIGATOR
Kara Schick-Makaroff, PhD
University of Alberta
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 11, 2017
Study Start
August 28, 2017
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
October 5, 2021
Results First Posted
March 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Upon publication the data will be available indefinately
- Access Criteria
- Anyone with a dataverse account will have access to the data
Upon completion of analysis, anonymous, quantitative data will be made available online indefinitely to the public on a database, such as Dataverse. Dataverse is a public repository and the University of Alberta provides the infrastructure support for sharing datasets. (See (http://dataverse.org/)