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performance and delivery of continuous
renal replacement therapy (CRRT) to
critically ill patients across a healthcare
system: QUALITY CRRT: a
study protocol
Dawn Opgenorth,1 Ellen Reil,2 Vincent Lau,1 Nancy Fraser,3 Danny Zuege,4
Xiaoming Wang,2 Sean M Bagshaw,1 Oleksa Rewa 1
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constrained healthcare resources, intervention is needed, 2. Will the implementation of standardised CRRT pro-
which may identify and eliminate inefficiencies, improve grammes our healthcare system’s ICUs result in de-
performance and decrease waste while improving creased healthcare systems costs?
provider satisfaction and achieving better patient 3. What is the impact of a multifaceted quality assurance
outcomes.5 6 Currently, performance indicators for CRRT and improvement programme on the efficacy and safe-
are not routinely measured, and as such, we are not in ty of care in critically ill patients requiring CRRT across
a position to understand or identify the inefficiencies our healthcare system?
or gaps in the quality of care of CRRT delivered to our
sickest patients.6
METHODS
Trial design
Current CRRT practices are not standardised
The QUALITY CRRT trial is a pragmatic, multicentre,
In our healthcare system, CRRT is delivered as per indi-
population- level, stepped-
wedged, ITS evaluation of
vidual unit protocols and practice patterns and is not
the implementation of an evidence-based CRRT quality
consistently monitored (ie, initiation strategies, antico-
assurance and improvement programme to standardise
agulation techniques, dose delivered, ultrafiltration, etc).
the delivery of CRRT in the 15 adult general and cardiac
Discrepancies from best practices and lack of standardi-
ICUs and 3 paediatric ICUs in our healthcare system that
sation of CRRT delivery can result in unplanned CRRT
provide CRRT (table 1). It conforms with the Standard
interruptions, decreased treatment time, inadequate
Protocol Items: Recommendations for Interventional
dose delivery and impaired clearance of toxic metabo-
Trials Checklist for study protocols (see online supple-
lites, which can lead to worsened patient outcomes.7 8
mental appendix 1).
Such suboptimal practice variation may relate to the
lack of well-developed key performance indicators (KPIs) Trial oversight
for CRRT delivery and performance, and the associated QUALITY CRRT will be led by a small but specialised
audit and feedback function such KPIs can facilitate. KPIs steering committee, whose members bring extensive
are measures that can be used to monitor the perfor- experience with CRRT programmes and clinical lead-
mance of healthcare delivery.9 They are necessary and ership, implementation science and healthcare systems
can improve reliability of care, standardise complex inter- research. This pan-provincial team will be based at the
ventions and provide a platform to measure and monitor University of Alberta Hospital and will include represen-
performance and the impact of practice changes.10 11 tation from the Critical Care Strategic Network of Alberta
Recently, previous phases of work have identified and Health Services (the provincial body which provides
prioritised KPIs for CRRT care.12 13 Implementing these provincial liaison, networking and coordination of adult
CRRT KPIs may change practice to provide effective, and paediatric critical care in Alberta).17 The steering
validated and standardised CRRT.12 13 Though several committee will be responsible for programme manage-
previous programmes of work have looked to implement ment, development and implementation of minimum
these CRRT KPIs into clinical practice, but no programme standards for CRRT programmes, KPI reporting, targeted
has rigorously tested the implementation of this structure education and overall trial management.
and monitoring across an entire healthcare system.14–16
Patient and public involvement
While this study currently does not directly include
OBJECTIVES AND RESEARCH QUESTIONS patients in its design, the Critical Care Strategic Clin-
Primary objective ical Network includes patient representatives on its core
The primary objective is to improve the quality of care committee and is represented on the study team. The
delivered to critically ill patients receiving CRRT in study objectives and research hypotheses have been
Alberta, as measured by CRRT KPI development, moni- developed along with these members. Finally, the results
toring and performance. of this study will be disseminated to patients and fami-
lies leveraging the strengths of the Critical Care Strategic
Secondary objectives Clinical Network. This will be conducted through online
These will include patient-centred outcomes (ie, Inten- resources, publications and public engagement events
sive Care Units (ICU) mortality and length of stay, dura- (ie, Café Scientifiques).
tion of CRRT therapy and 90-day renal recovery) and cost
of health services, including unit-specific CRRT costs. Population and eligibility
This study will be conducted at all ICUs in Alberta capable
Research hypotheses of providing CRRT. All subjects in this study will be criti-
1. Can we improve the performance of CRRT pro- cally ill patients (ie, paediatric and adult) receiving CRRT
grammes through the implementation of evidence- as part of their care. There will be no exclusion criteria.
based clinical practice guidelines and provision of The inclusion criteria are purposely broad in scope to
targeted multifaceted CRRT audit, feedback and edu- capture a system-level sample of critically ill patients. This
cation sessions? will be done so that these new KPI monitoring processes
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Table 1 Alberta ICUs delivered CRRT
Site City ICU type Hospital type Beds
University of Alberta Hospital General Systems ICU Edmonton Mixed Academic 32
Mazankowski Alberta Heart Institute Cardiovascular ICU Edmonton Cardiac surgery Academic 24
Mazankowski Alberta Heart Institute Cardiac ICU Edmonton Cardiac Academic 8
Royal Alexandra Hospital ICU Edmonton Mixed Academic 25
Grey Nuns Hospital ICU Edmonton Mixed Community 8
Misericordia Hospital Edmonton Mixed Community 10
Sturgeon Hospital ICU Edmonton Mixed Community 5
Stollery Children’s Hospital Paediatric ICU Edmonton Mixed Academic 16
Stollery Children’s Hospital Paediatric Cardiac ICU Edmonton Cardiac Academic 16
Foothills Medical Centre ICU Calgary Mixed Academic 28
Foothills Medical Centre Cardiovascular ICU Calgary Cardiac surgery Academic 16
Foothills Medical Centre Cardiac ICU Calgary Cardiac Academic 18
Peter Lougheed Centre ICU Calgary Mixed Academic 18
Rockyview General Hospital ICU Calgary Mixed Community 10
South Health Campus ICU Calgary Mixed Community 10
Chinook Regional Hospital ICU Lethbridge Mixed Regional 7
Red Deer Regional Hospital ICU Red Deer Mixed Regional 12
Alberta Children’s Hospital Paediatric ICU Calgary Mixed Academic 15
CRRT, continuous renal replacement therapy; ICU, intensive care unit.
may be developed and implemented as policy, and KPIs to measure at their ICU during the intervention
outcomes measured on a population level. phase. The survey will be administered through Survey
All new ICU admissions receiving CRRT in the 15 adult Monkey (www.surveymonkey.com).
and 3 paediatric ICUs in Alberta who provide this therapy
will be included in this project. In 2019, there were 12 Intervention phase
132 adult and 1592 paediatric admissions per year with KPI benchmark reporting
5.6% and 1.4% of these patients (ie, 680 adult and 22 The primary study intervention will be the implemen-
paediatric patients) receiving CRRT. As this study will be tation of audit and feedback on CRRT KPI benchmarks
conducted over a 4-year period, thus data on approxi-
identified by the individual ICU teams in the baseline
mately 3000 adult and paediatric (ie, 2900 adult and 100
survey. We will implement a minimal bundle of potential
paediatric) patients will be included in this project.
CRRT KPIs with evidence to measure will include CRRT
Interventions, duration and frequency of follow-up programme structure, filter life, downtime, delivered
The project consists of a 24- month baseline phase to dose, ultrafiltration achieved, alarms, adverse events, ICU
measure current CRRT practice and a 24-month interven- mortality and renal recovery (table 2).6 12 13 Reports will
tion phase to implement a standardised CRRT programme be implemented and reviewed with ICU stakeholders ad
targeting ICUs- based CRRT KPIs and monitor perfor- hoc and at quarterly intervals.
mance and compliance of participating sites. Data from Prior to implementation of the reports, each ICU will
the 24-month intervention phase will be used to model receive multifaceted education strategies tailored to their
long-term health economic outcomes. site and informed by local CRRT leaders, champions and
stakeholders (table 3). Education strategies will include,
Baseline phase
(1) interprofessional grand rounds, seminars and webi-
Baseline data collection
nars supported by a web-based information repository
Baseline clinical and resource utilisation data will be
and (2) identification of site champions to provide onsite
collected on all patients having received receiving CRRT
advocacy and education. The intervention will be multi-
between 1 November 2017 and 31 October 2019.
disciplinary, targeting CRRT prescribers, nurses, unit
Stakeholder survey operational leaders and educators. After the intervention
A healthcare system-wide survey of care providers and is implemented, quarterly audit and feedback reports and
stakeholders at participating ICUs will be conducted to quarterly tele/videoconference and/or in- person visits
identify and establish agreement on the most appropriate will be conducted to support the ICUs. The content of
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Table 2 Standardised elements of CRRT programmes
Programme element Operational definition Benchmark
CRRT leadership Presence of both CRRT physician and clinical nurse educator 100%
CRRT education Number of CRRT providers with training/ total number of CRRT providers 100%
Filter life Number of filters lasting 72 hours/total number of filters used >50% of filters
Delivered dose Actual delivered dose in mL/kg/hour/prescribed dose in mL/kg/hour >85% of dose and
between 25 mL/kg/
hour and 30 mL/kg/
hour
Downtime Time CRRT not running per day/each day of CRRT prescription <15%
Ultrafiltration Actual ultrafiltration achieve in mL/kg/hour/prescribed ultrafiltration in mL/kg/hour >85% of prescription
Access alarms Number of alarms recorded per machine per day of therapy <5 alarms
Adverse events Number of adverse events as per RLS per quarter 0 events
ICU mortality Patient survival to ICU discharge >50%
Renal recovery Number of patients still requiring RRT at 90 days <10%
CRRT programme elements are shaded from white to light grey to dark grey as per the Donabedian framework of structure, process
and outcome. Specific CRRT KPIs are in bold. Benchmarks have been taken from our internal and external validation of the KPIs. Our
primary outcome will measure the performance of specific CRRT process KPIs.
CRRT, continuous renal replacement therapy; KPIs, key performance indicators.
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no patient-level interventions. Accordingly, there will be
Table 3 Components of the multifaceted intervention and
knowledge implementation strategy no limitations to co-enrolment or specific patient or clini-
cian practices.
Strategy Description
Education ► Site grand rounds and Statistical analyses
interprofessional seminars
Analysis will be conducted between the pre-
► Monthly video/teleconferencing
implementation and post- implementation groups.
sessions
► Site-specific educational sessions Analyses of the primary and secondary outcomes will
by interprofessional content experts involve summary measures obtained by aggregating the
and local champions endpoints. Analyses will be performed using SAS Enter-
► Provide a summary of current prise Guide V.7.1 (Cary, North Carolina, USA). Baseline
guidelines and best practice comparisons will be performed using χ2 test for equal
► Development of website for proportions with results to be reported as frequencies
repository of evidence supporting with percentages. Continuous normally distributed
implementation, including banked variables will be compared using t-tests and reported as
webinar of project
means with SD, while non-parametrically distributed will
► In-person or virtual visits with
ICU leadership, champions and
be compared using Wilcoxon rank sum tests and reported
investigator teams as medians and IQRs. In case of small sample size, Fisher’s
exact test will be used.
Coaching ► Provide ongoing resources for
interpretation of KPI reports ITS analyses using autoregressive integrated moving
► Common troubleshooting advice average models will be employed for important risk
cards factors to account for temporal trends and to determine
► Provide clinical decision support whether there were changes in the clinic outcomes at the
resources intervention period (compared with the baseline period)
Audit and feedback ► Baseline and monthly reports and associated with implementation of the evidence-
of process of care indicators of based acute RRT pathway.
implementation of the intervention Cost-effectiveness or net- benefit (investment–return)
► Comparative performance relative analysis using a decision tree will be adopted to compare
to peer ICUs across province return (or benefit, B) and investment (or cost, C) of the
► Quarterly video/teleconferencing evidence- based RRT pathway. Reduction of healthcare
sessions to discuss provincial KPI
systems costs, including inpatient services (length of
reports
stay of primary admission, number of readmissions and
Reminders ► Promotional items (posters and
readmission LOS), outpatient services (emergency room
bulletins)
visits and clinic visits), physician services (specialist visits
► Weekly electronic communication
to local site champions to ensure and general practitioner visits) and ongoing new end-
ongoing review of KPI reports and stage renal disease, will be estimated based on gener-
access to additional resources alised linear models. Cost effectiveness will be analysed
by estimating incremental cost and effectiveness based
KPIs, key performance indicators.
on QALYs gained. QALYs will be calculated based on
HRQoL as measured by the EQ-5D-5L in adults and the
PedsQL in children. Patients will be sent letters with study
events, re-
hospitalisations and progression of renal team contact information in order for them to contact
disease). A schedule of data variables to be captured is our team in order to complete these questionnaires.
summarised in online supplemental appendix 2.
Data sources will include TRACER and Enterprise
data repository, AHS Data Integration, Management Performance of CRRT KPIs
and Reporting administrative databases, the Nephrology Our primary outcome will be the iterative performance
Information System, the Patient-based Renal Information of selected CRRT KPIs. Based on prior work, KPIs might
System and Baxter Healthcare.18 include filter life (measured in hours), delivered dose
All study documents will be kept in a locked filling (measured in mL/kg/hour), downtime (measured in
cabinet in a locked office, and computer files will be percentage of time), ultrafiltration realised (measured in
encrypted and stored on a secure network for 5 years percentage of prescribed) and access alarms (measured
following completion of the study. in total number per day). We will aim to both compare
the performance of these KPIs to historical controls, as
Co-enrolment well as prospectively through an ITS analysis. The ITS
QUALITY CRRT is a pragmatic, real- world, quality analysis will allow us to follow variable changes over time,
improvement and assurance programme. Due to the will allow for assessment of gradual change and is consis-
healthcare systems scope of the programme, there are tent with traditional quality improvement initiatives.
Activity by quarter 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3
January– April– July– October– January– April– July– October– January– April– July– October– January– April– July–
March June September December March June September December March June September December March June September
Approvals
Ethics approval/
renewal: HREB
Ethics approval/
renewal: CHREB
CTA/administrative
approvals
DDA: Edmonton/
Calgary/regional
Baseline phase
Recruit executive/
steering committee
Conduct survey
Extract baseline
data: UAH
Extract baseline
data: all sites
Develop education
strategies
Intervention phase
Initiate pilot GSICU
Initiate other sites
Implement
education strategies
CRRT KPI reporting
Protocol manuscript
Extract intervention
phase data
Study manuscript
7
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Open access
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Patient-centred outcomes analysis fundamentally different patient populations and deserve
The patient-centred outcome analysis will include ICU, specific study.
hospital and 90-day mortalities, ICU and hospital lengths Cardiovascular ICU patients differ from general
of stay, duration of CRRT treatment and renal recovery medical/surgical patients as often these patients are
measured at 90- day months. While this study is not immediately postoperative, have a specific timing of
designed to evaluate the effect that the implementation insult (ie, cardiac surgery) and hence have different
of the reporting of CRRT KPIs will have on mortality, pathophysiology related to their critical illness. It is
lengths of treatment and stay or renal recovery, these important to delineate academic versus community ICUs
are important patient-centred outcomes that will need as, for mechanically ventilated patients (ie, another form
to be considered as balancing measures for CRRT KPI of critical life-sustaining therapy) with acute respiratory
reporting and implementation of our multifaceted knowl- distress syndrome (ARDS), mortality rates differ signifi-
edge translation intervention. cantly.19 Finally, higher ARDS hospital case volume has
also been associated with lower ARDS hospital mortality
Health economic evaluation and it will be important to determine if this association
The economic evaluation will comprise two parts: (1) a is present in CRRT.20 We will perform the above analyses
within-study analysis and (2) a longer-term, model-based for health economic evaluations, patient and process of
analysis. case measures to include our prespecified primary and
The within- study analysis will focus on costs and secondary outcomes for each subgroup. Each analysis will
outcomes collected during the study period. It will be accompanied by a test for interaction between treat-
include total quarterly unit-specific CRRT-associated costs ment and subgroup to ascertain whether effects differ
significantly between subgroups.
following the implementation of the CRRT KPI reporting
programme. This endpoint will be determined from
Ethics approval and consent to participate
our provincial CIS and Alberta Blue Cross databases.
This project is an evaluation of impact of a multifaceted
Specifically, we will evaluate and compare the (1) costs
CRRT quality assurance and improvement programme
of supplying CRRT filters, (2) costs of CRRT fluids, (3)
on patient outcomes and healthcare resource utilisa-
cost of CRRT anticoagulation and (4) costs and utilisa-
tion in Alberta ICUs delivering CRRT. All diagnostic and
tion of dialysis catheters. Costs will be calculated in part
management strategies are within standard of care and
using CRRT process measures captured by our CRRT
all data with relevance to the project are already routinely
KPIs (ie, filter life and number of filters used, anticoagu-
captured as part of standard patient care by means of
lation modality, dose delivered, effluent used, etc). CRRT-
machine- specific data cards or clinical charting. No
associated costs were selected as an important secondary
added trial-specific investigations or clinical documenta-
outcome as these will be most immediately affected with
tion is required.
the implementation of the CRRT KPI quality assurance
This evaluation was reviewed by the University of
programme across unit.
Alberta’s Health Research Ethics Board (study ID:
We will also determine healthcare systems costs to
Pro00075274; 22 January 2020) and a waiver of consent
include total ICU and hospital stay associated costs, was granted based on the premise this project represents
ongoing new end-stage renal disease (ie, chronic RRT) health services implementation and evaluation compat-
costs, total healthcare costs and outcomes (mortality and ible with a quality assurance and improvement initiative
QALYs). Modelling analysis will provide cost estimates (see online supplemental appendix 3).
from both a healthcare system and societal perspective Any protocol modifications will be submitted to the
(capturing costs to the health service, social care providers appropriate relevant parties.
and patients). Results will be reported as the incremental
net benefit and incremental cost- effectiveness ratios. Dissemination
Uncertainty will be captured in the analyses through The findings of QUALITY CRRT will directly inform and
probabilistic sensitivity analysis and reported using cost- guide policy on establishing evidence-based best-practices
effectiveness acceptability curves, showing the likelihood guidelines for delivering CRRT in Alberta ICUs. In addi-
the intervention will be cost effective over a range of tion, establishing evidence-based benchmarks across the
values of willingness-to-pay for specific outcomes. entire healthcare system will enable systematic evaluation
of CRRT performance. These outcomes will help create a
Planned subgroup analyses framework for the standardisation of CRRT programmes
Pre-specified subgroup analysis will include ICU patients across Alberta and other jurisdictions providing CRRT
to (1) adult versus paediatric, (2) female versus male, (table 2).
(3) academic versus community ICUs, (4) cardiovascular Alberta’s comprehensive ICU clinical information
ICUs versus medical/surgical ICUs, (5) high volume and analytics infrastructure (Connect Care, eClinical
versus low volume centres (ie, as per quartiles) and (6) TRACER) will be leveraged to implement a CRRT Quality
patients requiring acute RRT versus those on chronic Dashboard, accessible to all Alberta ICU practitioners.
dialysis. Adult, paediatric, female and male patients are The dashboard will contain statistics on KPI benchmarks
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to provide real-time feedback on individual ICUs perfor- Strengths and limitations
mance in delivering CRRT. While QUALITY CRRT focuses on standardising CRRT
A central website containing a summary of CRRT guide- programmes across an entire provincial healthcare
lines and best practices and a repository of troubleshooting system by ensuring a robust framework is in place and the
tools on attaining KPI benchmarks will be developed and monitoring of CRRT performance and delivery occurs,
made available to all Alberta CRRT practitioners. this is limited to only continuous RRT. Intermittent RRT
We are proposing to publish the study results. Further- can also occur in the acute setting for critically ill patients
more, this work will be presented at local, provincial and in the ICU. Accordingly, the experience and infrastruc-
national critical care and nephrology meetings. Finally, ture realised in QUALITY CRRT will pave the work for
QUALITY CRRT will serve as the basis for a broader additional critical care nephrology programmes aimed at
programme of work, dialysing wisely, which will aim to improving all forms acute RRT (ie, continuous and inter-
transform the fashion in which acute dialysis is conducted mittent) in the ICU.
in Alberta.
Author affiliations
1
Faculty of Medicine and Dentistry, Department of Critical Care Medicine, University
of Alberta, Edmonton, Alberta, Canada
DISCUSSION 2
Alberta Health Services, Edmonton, Alberta, Canada
The importance of the quality and management for criti- 3
Critical Care Strategic Clinical Network, Alberta Health Services, Edmonton, Alberta,
cally ill patients with acute kidney injury requiring CRRT Canada
has been previously recognised.5 6 Previous studies have
4
Department of Critical Care Medicine and Cumming School of Medicine, University
focused on single unit or individual hospital-level quality of Calgary, Calgary, Alberta, Canada
improvement and assurance interventions (table 5).14–16
Contributors SMB and OR were responsible for the conception, design and
Griffin et al, first conducted such a quality improvement planning of this study. ER assisted in the development of continuous renal
study at the University of Colorado Hospital, where they replacement therapy key performance indicators. VL and XW have assisted in
assessed the magnitude in variability in CRRT dosing. creating the analysis plan and will work with interpretation the data. DO, NF and DZ
They followed specific implementation that included assisted with manuscript preparation. All authors approved the final drafting of this
manuscript.
optimising their electronic medical record to calculate
Funding QUALITY continuous renal replacement therapy was supported by
CRRT dosing in real time to then comment on dosing
University of Alberta Hospital's Fund (grant number: RES0040497) and Baxter
and provide guidance and education in order to better Healthcare's investigator initiated research (grant number: RES0044818).
adhere to national guidelines. This led to the doubling Competing interests SMB and OR have received honoraria from Baxter
of the rate of appropriate CRRT dosing and reduction Healthcare. The study sponsors had no role in protocol development, trial
in variability.14 Mottes et al, at the University of Cincin- management or data analysis and reporting.
nati Children’s Hospital, created a ‘CRRT Dashboard’ Patient consent for publication Not applicable.
which tracked important KPIs such as ‘filter life’, ‘mean Provenance and peer review Not commissioned; externally peer reviewed.
prescription dose’ and ‘fluid balance’, and found that Supplemental material This content has been supplied by the author(s). It has
this platform provided a significant means for measuring not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been
adherence to robust standards on the delivery of CRRT, peer-reviewed. Any opinions or recommendations discussed are solely those
specifically in the process of care.15 Finally, most recently of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and
responsibility arising from any reliance placed on the content. Where the content
a group from the University of Kentucky Medical Centre includes any translated material, BMJ does not warrant the accuracy and reliability
reported the development, implementation and subse- of the translations (including but not limited to local regulations, clinical guidelines,
quent outcomes associated with a quality assurance terminology, drug names and drug dosages), and is not responsible for any error
system to support the provision of CRRT in the ICU.16 and/or omissions arising from translation and adaptation or otherwise.
This was the largest programme to date, numbering 1185 Open access This is an open access article distributed in accordance with the
adult patients on CRRT over a 34-month period. Using Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
the monitoring of evidence- based KPIs and targeted and license their derivative works on different terms, provided the original work is
education, they doubled the appropriate use of citrate- properly cited, appropriate credit is given, any changes made indicated, and the use
based anticoagulation, improved the appropriateness is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
of CRRT dosing, increased filter life while decreasing ORCID iD
machine alarms and maintaining similar CRRT duration Oleksa Rewa http://orcid.org/0000-0002-8718-0547
and patient mortality while reducing CRRT costs. While
these programmes demonstrate that the implementation
of evidence-derived KPI-based CRRT quality assurance
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