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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149328
Recruitment Status : Completed
First Posted : May 11, 2017
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 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
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.



Primary Outcome Measures :
  1. Symptoms - Trajectory of Change [ Time Frame: 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.

  2. Person-centred Care - Trajectory of Change [ Time Frame: 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 score = 5. Higher scores indicates higher quality of care.


Secondary Outcome Measures :
  1. Utilization of Health Services [ Time Frame: 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.

  2. Number of Participants Who Selected "1 - Excellent" on Satisfaction With Care [ Time Frame: 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.

  3. Mental Health - Trajectory of Change [ Time Frame: 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.

  4. Quality of Life - Trajectory of Change [ Time Frame: 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/state of health.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Locations
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Canada, Alberta
Sheldon M. Chumir Health Centre
Calgary, Alberta, Canada, T2R 0X7
Aberhart Centre
Edmonton, Alberta, Canada, T6G 2J3
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
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Principal Investigator: Kara Schick-Makaroff, PhD University of Alberta
  Study Documents (Full-Text)

Documents provided by Kara Schick-Makaroff, University of Alberta:
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Responsible Party: Kara Schick-Makaroff, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT03149328    
Other Study ID Numbers: Pro00068365
First Posted: May 11, 2017    Key Record Dates
Results First Posted: March 5, 2021
Last Update Posted: March 5, 2021
Last Verified: February 2021
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/)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Upon publication the data will be available indefinately
Access Criteria: Anyone with a dataverse account will have access to the data

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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:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency