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

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ClinicalTrials.gov Identifier: NCT03149328
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Cambian Business Services, Inc.
Intogrey Research and Development Inc.
Alberta Health Services
Information provided by (Responsible Party):
Kara Schick-Makaroff, University of Alberta

Study Description
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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.


Condition or disease Intervention/treatment Phase
Kidney Disease, End-Stage Other: Educational Support Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 459 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Process evaluation with two phases (Phase 1: Usability Testing; Phase 2: Evaluation)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney)
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Northern Alberta Renal Program (NARP)
Provide 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.
 Other: Educational Support
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.
No Intervention: Southern Alberta Renal Program (SARP)
In SARP (comparator group), clinicians will not receive PRO feedback or education sessions.


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms [ Time Frame: Up to 24 months ]
    Assessed using the symptoms/problems domain of the KDQOL-36

  2. Person-centred care [ Time Frame: Up to 24 months ]
    Assessed using the PACIC-20 scale


Secondary Outcome Measures :
  1. Utilization of health services [ Time Frame: Up to 24 months ]
    Assessed using health services data (i.e., hospital admissions, trips to emergency room) determined through Alberta Health Services database

  2. Satisfaction with care [ Time Frame: Up to 24 months ]
    Assessed using one item added to the end of the PACIC-20 related to care received. This item is from the NHS Outpatient Survey (2011)

  3. Mental health [ Time Frame: Up to 24 months ]
    Assessed using the SF-12 mental component summary (MCS) subscale in the KDQOL-36

  4. Quality of life [ Time Frame: Up to 24 months ]
    Assessed using the EQ-5D-5L


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient inclusion:

  • 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

Clinician inclusion:

  • 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

Patient exclusion criteria:

  • visual impairment
  • cannot read or speak English
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149328


Contacts
Contact: Kara Schick-Makaroff, PhD 780-492-9043 Kara.schickmakaroff@ualberta.ca
Contact: Joanna Czupryn 780-248-1096 jczupryn@ualberta.ca

Locations
Canada, Alberta
Sheldon M. Chumir Health Centre Recruiting
Calgary, Alberta, Canada, T2R 0X7
Contact: Kara Schick-Makaroff, PhD    780.492.9043    kara.schickmakaroff@ualberta.ca   
Aberhart Centre Recruiting
Edmonton, Alberta, Canada, T6G 2J3
Contact: Kara Schick-Makaroff, PhD    780.492.9043    kara.schickmakaroff@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Cambian Business Services, Inc.
Intogrey Research and Development Inc.
Alberta Health Services
Investigators
Principal Investigator: Kara Schick-Makaroff, PhD University of Alberta
More Information
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Responsible Party: Kara Schick-Makaroff, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT03149328     History of Changes
Other Study ID Numbers: Pro00068365
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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/)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kara Schick-Makaroff, University of Alberta:
Home Dialysis
Person-Centred Care
Patient-Reported Outcome Measures
Process Evaluation
 Educational Support
Electronic Patient-Reported Outcome Measures
Patient-Reported Experience Measures

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency