Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04221932 |
| Other study ID # |
Pro00075274 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2022 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
University of Alberta |
| Contact |
Oleksa G Rewa, MD MSc |
| Phone |
7802313280 |
| Email |
rewa[@]ualberta.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Acute kidney replacement therapy (i.e., dialysis) is used in 6-10% of patients admitted to
intensive care units (ICUs). The amount of acute kidney replacement therapy use has increased
in Canadian ICUs over the last several years. Continuous renal replacement therapy (CRRT)
remains the most common form of acute renal replacement therapy used in ICUs.
Many different parts aspects of CRRT lack a usual way to be done, and because of this, are
done differently in different ICUs. Not having generally accepted markers of the performance
and delivery of CRRT is a main reason that we have these practice difference. This is an
important gap in the way that clinicians deliver this important ICU therapy and is a main
focus of ongoing research in ICU and dialysis.
The proposed project is a continuation of a program of work that first reviewed the current
state of the quality and safety in ICU and dialysis. Then, a systematic review of all
potential quality markers was done to see what options for measures were possible. Next,
following a meeting of leaders of dialysis in the ICU, the most important of these measures
were ranked to decide which ones could be used in monitoring CRRT for patients.
Description:
Background: Renal replacement therapy (RRT) is a core life support technology used in
approximately 1 in 10 ICU patients. RRT can be delivered intermittently or continuously.
While intermittent RRT (IRRT) is used selectively in ICU settings, continuous RRT (CRRT) is
the dominant initial form used worldwide. CRRT is a continuous method of blood purification
that provides slow uninterrupted clearance of uremic toxins and enables acid-base,
electrolyte and volume homeostasis while preserving hemodynamic stability. The,
"Implementation of Continuous Renal Replacement Therapy (CRRT) Key Performance Indicator
(KPI) Reports to Standardize and Improve the Quality of CRRT Delivery in Alberta -
QUALITY-CRRT," is a proposed program of research to standardize and change the practice of
CRRT in Alberta in order to improve the performance and delivery of this therapy to our most
severely critically ill patients.
Last year in Alberta, 55.2% of patients were started on CRRT as an initial form of RRT.
Patients receiving CRRT have greater illness severity (mean APACHE II score of 30.4 vs.
18.9), they are more likely to die (mortality of 41.3% vs. 7.3%) and have significantly
increased healthcare utilization when compared to their non-CRRT receiving critically ill
counterparts. In 2018, Alberta Health Services spent $2,437,097 to operate its CRRT program.
However, these costs only include expendable supplies (i.e., fluids, filters, etc.) and do
not include program maintenance or machine hardware expenses, thus underrepresenting the true
cost of this therapy. In the setting of increasingly constrained healthcare resources,
intervention is needed which may eliminate inefficiencies, improve performance, and decrease
waste while ameliorating provider satisfaction and achieving better patient outcomes.
Currently, clinicians do not routinely measure the performance of CRRT in Alberta (or
elsewhere for that matter), and as such, are not in a position to understand or identify the
inefficiencies or gaps in the quality of care of CRRT provided to critically ill patients.
The performance of CRRT may be measured by monitoring key performance indicators (KPIs). KPIs
are necessary and can facilitate improved reliability of care, homogenize complex
interventions, and provide a platform to measure and monitor performance and the impact of
practice changes, and compliance with evidence-based standards. KPIs can be further used as
targets for continuous quality improvement initiatives aimed at evaluating new or revised
care processes, implementing new protocols or interventions, reducing variability in the
delivery of healthcare and stimulating innovative research. The lack of validated and
routinely reported KPIs for CRRT, however, are viewed as an important knowledge-to-care gap
and may be associated with greater risk for suboptimal quality of CRRT delivery, and has been
identified as a research priority.
To date, no Canadian program that has aimed to implement KPIs of CRRT care and to safeguard
patients with the high-quality delivery of this complex technology. A focused program aimed
to implement an inventory of KPIs for CRRT in order change practice and standardize care
across a healthcare system to align with evidence-based best practices has the potential to
transform the delivery of CRRT to critically ill patients. The proposed program of research
will build upon previous phases of work that have identified and prioritized KPIs for CRRT
care in order to implement these CRRT KPIs to change practice to provide effective, validated
and standardized CRRT and ultimately to improve the quality of care to critically ill
patients receiving CRRT by changing practice in order to decrease variation between all
provincial CRRT programs so as to align with evidence-based CRRT best practices guidelines,
therapies and prescriptions.
The Proposed Trial: QUALITY CRRT is an innovative, population-level, interrupted time series
aimed to evaluate the effectiveness, safety and cost of implementing a multi-faceted CRRT
quality assurance and improvement program in ICU settings. It will further explore the reach
of QUALITY CRRT by extending the ongoing work on public and patient/family understanding of
participation in low-risk ICU research trials focused on generating and implementing best
practices. This work will provide insights into the perceived value of such research for
Canada's healthcare system as well as to demonstrate feasibility, to build capacity for
future population-level pragmatic trials focused on health systems innovations and quality
improvement/assurance in ICU settings, and to continue to engage the public in the healthcare
and critical care research processes.
Prior to the implementation of the CRRT quality assurance and improvement program and
reporting of CRRT KPIs, each ICU will have a minimum 24 months of baseline data analyzed
followed by 24 months of prospective data. Long-term outcomes (i.e., individual and
healthcare systems costs) will be determined through a future outcome modelling process.
During the entire study period participants will be included into the study. Prior to the
reporting of CRRT KPIs, there will be provincial and site educational events to prepare local
experts, champions and educators in preparation for implementation of CRRT KPI reporting.
These reports will be available at each site to their respective healthcare professionals,
local champions, as well as to the study Executive, Steering and Quality Monitoring
Committees. Following the implementation of CRRT KPI reporting, the study team will review
the CRRT KPI reports at each site on a quarterly basis and will relay these results to
individual unit stakeholders and champions. Any educational events of quality initiatives
will be led by individual units but will be recorded as a treatment outcome.
QUALITY CRRT will compare a novel approach to monitoring the delivery of CRRT to critically
ill patients. For the study intervention, a multi-faceted CRRT quality assurance and
improvement program will be implemented to CRRT programs across Alberta. This will include a
review of the individual unit CRRT KPI reports, followed by in person as well as tele/video
targeted information sessions led by members of our steering committee. Reports will also be
provided for each unit that will be distributed to all CRRT providers and stakeholders. The
current practice of CRRT will be determined by interrogating our CIS for 24 months preceding
our study intervention to determine baseline CRRT performance. This will frame the
counterfactual scenario for the interrupted-time series analysis.
In the usual care (i.e., current practice), CRRT will be monitored as per unit-specific
parameters. For the study intervention, each CRRT program will be ensured to have appropriate
leadership and education (i.e., structure KPIs) in place. CRRT KPI reporting (i.e., quarterly
reports for filter life, downtime, delivered dose, access alarms, adverse events and ICU
mortality) will be implemented and reviewed at both a trial, and unit specific level
performed ad hoc and at quarterly intervals. During the systems level implementation of CRRT
KPIs, each ICU will receive a multi-faceted education tailored to each ICU and informed by
local CRRT leaders. The evidence-based multi-faceted strategy will maximize the utilization
of the CRRT KPI reports. Our implementation strategy will include, 1) inter-professional
educational strategies (grand rounds, seminars, webinars), 2) site champions, 3) quarterly
audit and feedback reports and 4) quarterly tele/videoconference and in-person visits. While
the strategy will contain similar themes at each site, individual components will be
customized in order to address unit specific shortcomings in their CRRT KPI performance. Each
site will be encouraged to facilitate and conduct their own audit and educational activities.
A central website repository of typical troubleshooting tools for high-yield interventions on
KPIs not achieving our proposed benchmarks will be developed and available for reference.
QUALITY CRRT will enroll all new ICU admissions receiving CRRT in the 13 adult and 2
pediatric ICUs in Alberta who provide this therapy. In 2018 there were 12,132 adult and 1,592
pediatric admission per year with 5.6% and 1.4% of these patients (i.e., 680 adult and 22
pediatric patients) receiving CRRT in these 15 ICUs. We are planning to conduct this study
over a 2-year period, for a total of approximately 1,500 adult and pediatric participants,
over nearly 25,000 patient-days. As all patient data can be retrieved from our CIS, it is
anticipated that the loss to follow up to be minimal.
Data will be compiled retrospectively prior to the reporting of CRRT KPIs and implementation
of the multi-faceted quality assurance and improvement program; after data will be collected
following this implementation. Analysis will be conducted between the pre- and
post-implementation groups. Analyses of the primary and secondary outcomes will involve
summary measures obtained by aggregating the endpoints. Analyses will be performed using the
Stata software package (StataCorp, Texas, USA). Baseline comparisons will be performed using
chi-squared test for equal proportions with results to be reported as numbers, percentages,
and 95% confidence intervals. Continuous normally distributed variables will be compared
using paired t-tests and reported as means with 95% confidence intervals, while non-normally
distributed will be compared using Wilcoxon rank sum tests and reported as medians and
interquartile ranges (IQRs). In case of small sample size, fisher's exact test will be used.
Descriptive and multivariable analysis will be performed to adjust for important risk factors
and to understand the difference between variables.
Pre-specified subgroup analysis will include ICU patients to 1) adult vs. pediatric, 2)
female vs. male, 3) academic vs. community ICUs, 4) cardiovascular ICUs vs. medical/surgical
ICUs, 5) high volume vs. low volume centers (i.e., as per quartiles). We will perform the
above analyses for health economic evaluations, patient and process of case measures to
include our pre-specified primary and secondary outcomes for each subgroup. Each analysis
will be accompanied by a test for interaction between treatment and subgroup to ascertain
whether effects differ significantly between subgroups.
Trial Management: The data coordinating and management centre is the Institute of Health
Economics (IHE) in Edmonton, Alberta. The IHE will be responsible for data management,
analysis, progress updates and for developing site-specific quarterly CRRT Quality Dashboard
reports. The IHE will liaise with study committees, individual site champions and applicable
partners. The QUALITY CRRT study will have an Executive Committee Responsible to overall
trial management. There will also be a Steering Committee with stakeholders from each site to
review the quarterly reports. Finally, QUALITY CRRT will have an international Quality
Monitoring Committee that the Executive Committee will liaise with the ensure appropriate
trial oversight.
Significance, Capacity Building and Impact: QUALITY CRRT will serve to implement an
evidence-based CRRT Quality Dashboard. The findings of QUALITY CRRT will underscore the
importance and need to widely implement a CRRT Quality Dashboard, not just in Alberta, but in
any healthcare system which provides CRRT.
