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

• 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: University of Alberta
• 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

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

Detailed Description:

Objectives:

1. Understand the process of supporting clinicians to utilize PROs in multidisciplinary, home dialysis practice.
2. Examine to what extent utilization of PRO information is associated with differences in symptoms and person-centred care [primary outcomes], as well as satisfaction with care, utilization of health services, mental health, and QOL [secondary outcomes].

Approach:

To achieve these goals, a mixed methods design of process evaluation will be used to compare two groups: Northern and Southern Alberta Renal Programs, NARP (Edmonton) and SARP (Calgary). In Edmonton (Intervention group), patients and clinicians will be invited to participate in the study. Only patients will be invited to take part in the study in Calgary (Comparison group). The research study will be undertaken collaboratively with a Patient Advisory Committee and knowledge users.

Setting:

This research will be conducted among patients receiving home dialysis across Alberta Kidney Care, from its two units: Aberhart Clinic in the Northern Alberta Renal Program (NARP), and Sheldon M. Chumir Health Centre in the Southern Alberta Renal Program (SARP). NARP and SARP have 305 and 350 home dialysis patients respectively.

Methods:

The study is divided into two phases: Phase 1-Year 1 (Usability Testing) and Phase 2-Year 2 (Evaluation). SARP and NARP participants will be invited to complete ePROs for each of their scheduled appointments, every three months, throughout Phases 1 and 2.

Phase 1:

In NARP, the intervention group, interested patients will be approached and consent will be obtained. Before the clinic visit, the patient will complete a demographic survey, and the Edmonton Symptom Assessment Scale revised for renal patients (ESASr:Renal) using Cambian Navigator, a web-based ePRO system hosted by Cambian Business Services Inc. Survey results will be printed and given to the nurse, transcribed and placed in the patient' chart as well as on their electronic chart. NARP patients will also complete the Kidney Disease Quality of Life (KDQOL-36), the Patient Assessment of Care for Chronic Conditions (PACIC-20), and the EQ-5D-5L after their clinic appointment. These 3 outcome evaluation measures will not be included in patient charts, or be used by clinicians at point of care. Usability testing and formative evaluation with NARP patients will also include up to 5 focus groups and 10 interviews to discuss how they would like their PRO information to be used by clinicians. Usability testing and formative evaluation with NARP multidisciplinary clinicians will include a series of focus groups (3-4) to discuss the ideal process for ePROs surveys to be integrated in existing work structures. Findings from these focus groups will be used to refine the targeted workshops provided as an intervention in Phase 2.

In SARP, the comparator group, all patients meeting inclusion criteria will be invited to complete the consent form, demographic survey, and the ePRO survey tools collected in NARP, but not to participate in focus groups and interviews. The ePRO surveys will not be seen by the clinicians, but they will be informed of the study.

Phase 2:

Using a prospective design, the workshops (intervention) will occur in NARP. Clinicians will receive ePRO feedback as well as targeted education about how to use PRO information. Workshops will be offered every 1.5 months over the 6-month intervention period. Evaluation survey feedback will be sought at the end of each workshop to tailor information to clinicians' needs. In NARP, patients will continue to complete the PRO surveys before and after their clinic appointments. If other PRO measures are requested by clinicians in Phase 1, these will be added to Phase 2 data collection. Additionally, clinicians will be invited to complete an anonymous ticky-box form every 2 weeks, indicating if they reviewed the PRO information, and changed their decision-making based on the PRO information. All NARP clinicians will also be invited to participate in 1 interview (n=20). They will be asked to share examples of how they have used PRO information in their practice, and the challenges, benefits and facilitators of integrating ePROs in practice. Patient participants will also be invited to take part in a focus group (n=6) or interview (n=6) to discuss how they see clinicians following up on their PRO information.

In SARP, clinicians will provide usual care. Clinicians will not receive PRO information or participate in workshops. Education will be provide to SARP clinicians following completion of the study, as a form of knowledge translation.

Quantitative Evaluation:

Descriptive methods and statistical tests will be used to examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Analysis of covariance (ANCOVA) will be used as the method of analysis to compare AUC scores of outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type.

Qualitative Evaluation:

Qualitative data from focus groups and interviews will be recorded, transcribed verbatim and analyzed using the methodology of interpretive description. NVIVO, a qualitative software system, will be used to create a filing system and coding database. The first focus group/interview transcript in each phase will be read and re-read to generate an initial codebook. The codebooks will be iteratively refined throughout the analysis. Codes will be categorized and analyzed thematically. Patient and clinician data will be analyzed separately. Differences between pre- and post-implementation in NARP will also be examined.

Study Design

• 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

Arms and Interventions

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

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.

Eligibility Criteria

• 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

Locations

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

• Principal Investigator: Kara Schick-Makaroff, PhD; University of Alberta

  Study Documents (Full-Text)

Documents provided by Kara Schick-Makaroff, University of Alberta:

Study Protocol and Statistical Analysis Plan  [PDF] August 12, 2019

More Information

• Responsible Party: Kara Schick-Makaroff, Principal Investigator, University of Alberta
• ClinicalTrials.gov Identifier: NCT03149328
• Other Study ID Numbers: Pro00068365
• First Posted: May 11, 2017
• 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

• 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