Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03149328 |
| Other study ID # |
Pro00068365 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 28, 2017 |
| Est. completion date |
October 31, 2019 |
Study information
| Verified date |
September 2021 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
