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

NCT ID: NCT03149328

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 594 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2019-10-31

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.

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.

Conditions

Kidney Disease, End-Stage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational Support

Intervention Type: OTHER

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.

Southern Alberta Renal Program (SARP)

In SARP (comparator group), clinicians will not receive PRO feedback or education sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• visual impairment
• cannot read or speak English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Cambian Business Services, Inc.

INDUSTRY

Sponsor Role: collaborator

Intogrey Research and Development Inc.

INDUSTRY

Sponsor Role: collaborator

Alberta Health services

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Kara Schick-Makaroff

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kara Schick-Makaroff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Sheldon M. Chumir Health Centre

Calgary, Alberta, Canada

Aberhart Centre

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37332391 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00068365

Identifier Type: -

Identifier Source: org_study_id