| Chronic
Kidney Disease (CKD) Guideline Materials |
| Chronic
Kidney Disease Guideline materials posted with permission from
Kaiser Permanente Hawaii:
Note: Evidence-based process
used with reliance upon some secondary sources which were not critically
appraised. See Web Documentation.
Important
Note: On March 9, 2007
the FDA released a Public Health Advisory stating that, “A higher
chance of death was reported and an increased number of blood clots, strokes,
heart failure, and heart attacks was reported in patients with chronic
kidney failure when ESAs were given to maintain hemoglobin levels of more
than 12 g/dL.”
This advisory was also driven
by many studies of cancer patients.
Erythropoiesis stimulating
agents now carry this warning in their labels: “WARNINGS: Increased
Mortality, Serious Cardiovascular and Thromboembolic Events Aranesp and
other erythropoiesis-stimulating agents (ESAs) increased the risk for
death and for serious cardiovascular events in controlled clinical trials
when administered to target a hemoglobin of greater than 12 g/dL. There
was an increased risk of serious arterial and venous thromboembolic events,
including myocardial infarction, stroke, congestive heart failure, and
hemodialysis graft occlusion. A rate of hèmoglobin rise of greater
than 1 g/dL over 2 weeks may also contribute to these risks. To reduce
cardiovascular risks, use the lowest dose of Aranesp that will gradually
increase the hemoglobin concentration to a level sufficient to avoid the
need for RBC transfusion. The hemoglobin concentration should not exceed
12 g/dL, the rate of hemoglobin increase should not exceed 1 g/dL in any
2-week period (see DOSAGE AND ADMINISTRATION)."
The materials
available above have not yet been updated with this important information.
|
| Update
01/01/07: Chronic Kidney Disease
(CKD) Guideline Outcomes |
|
We were pleased to learn that our Kaiser Permanente Chronic Kidney Disease
Guideline Team in Hawaii is seeing improved referral rates and clinical
outcomes in patients with CKD. Key elements in the success include:
- A great team with great
leaders
- A 1 pager with actionable
information for clinician
- An electronic system
that allows:
- Nephrologists to
quickly access medical records to analyze cases and create messages
with suggestions for management to primary care physicians
- Outcomes from 6/5/05 to
10/30/06 include:
- Identification and greater
attention to adults not yet on dialysis with a GFR under 60 ml/min
- Protein quantification
by Upr/cr, microalbum/cr or 24 hour urine protein
- 2005: 26.8 %
- 2006: 37.2 %
|
| Project
Outline |
|
Phase
I: Identify Team |
.........
Leaders from Medical Education and the EBM Working Group solicited interest
among clinical staff and identified Nephrology as the pilot group. With
Delfini's guidance, a multidisciplinary team was formed including nephrologists,
nutrition, primary care, pharmacy and an EBM working group leader. |
|
Phase
II: Select Project |
.........
Delfini provided advice and training in successful project selection. Chronic
kidney disease management by primary care providers and guidance on referral
to nephrology was identified as an area in which there was a gap between
current and optimal care. The team agreed upon development and implementation
of a clinical practice guideline as their EBM clinical improvement project. |
|
Phase
III: Develop Project Outline
Read Reference
Letter
from Renal Nutritionist,
Carrie Mukaida, MS, RD, CSR
|
.........
Existing guidelines were reviewed for applicability, validity, appropriateness
and currency. Focus statements, "straw" algorithm and key statements
were drafted to help frame project scope.
Team members received training
in effective searching of the medical literature, critical appraisal for
validity and usefulness of primary and secondary sources, measures of
outcomes, "intention-to-treat analysis project rescue" and evidence
grading.
The training was hugely successful
and was met with great enthusiasm by both members and leadership. Members
reported feeling "psyched" and motivated. Leadership expressed
gratitude that Delfini was helping the group to create a workable "map"
for both real life problem solving and providing "on-the-job"
EBM training. |
Phase IV: Obtain,
Evaluate & Synthesize Evidence & Phase V: Create Clinical Recommendations
|
.........
Potentially useful evidence was obtained through a systematic search and
appraisal process. Following evidence evaluation, the best available valid
and useful evidence was identified and prepared for evidence synthesis.
In an on-site working session,
and following the working session, team members reviewed, discussed, made
decisions about and created —
- Draft Evidence Synthesis
(Delfini)
- Secondary Studies: Cochrane
& Clinical Evidence Review (Team)
- Primary Studies: Included
and Excluded Studies Summary Tables (Team)
- Listing of K/DOQI Guidelines
("seed" guideline) Statements Voted on by Team Members (Team)
- Draft "Straw"
Clinical Recommendations (Delfini)
Draft Evidence Tagging Statements (Delfini)
Draft Algorithm (Team modified algorithm created by Delfini
Team members graded the evidence
and converted evidence synthesis statements into clinical recommendations
that will serve as the basis for the guideline. |
|
Phase
VI: Assess Impacts of Practice Change |
.........
Formal impact assessment was not done. |
|
Phase
VII: Create information, Decision & Action Aids |
.........
Following training in information, engagement, communication strategies,
decision-making, visual display of information and tool construction, team
members will select content, communication vehicles and communication formats
to convey guideline information, and they will develop tools to facilitate
clinical change and to provide guidance on clinical care and referral. |
|
Phase
VIII: Implement Guideline |
.........
The following implementation strategies have been used and additional
strategies will be added as necessary depending upon performance measurements:
- Approved by KP Hawaii
Quality Council –Jan 2006
- All Hawaii KP physicians
notified of guidelines via e-mail in January 2006
- Guidelines have been
posted on the Kaiser intranet
- Clinician Education is
being conducted through CME and other educational initiatives
- Family Practice Grand
Rounds Honolulu –May 2006
- Family Practice Grand
Rounds-Maui – July 2007
- Regional Dietitians’
Meeting – August 2006
- Internal Medicine Grand
Rounds – Sept 2006
- Presentation of the guideline
at an evidence-based CME conference conducted Nov 6-9, 2006 in Maui
- Patient Care Material
– “Chronic Kidney Disease Checklist”
- Anemia Management Service
– renal clinical pharmacists
- Health connect integration
(referral criteria are now listed on the electronic nephrology referral
form)
- Decision support in Panel
Support Tool
- The use of administrative
and clinical databases to create a registry used by the guideline leaders.
Basically this consists of pro-actively emailing or phoning primary
care physicians to assist with care.
|
|
Phase
IX: Implement Measurement & Reporting Plan |
.........
Outcomes (As of 2/15/07; for additional outcomes also see Update
7/8/09 below):
- Decrease in rate of late
referrals
- Increase in Arterio-venous
fistula (AVF) rate
- Increase in outpatient/inpatient
starts
- Decrease ESRD rate
- Decrease ESRD prevalence
- Increase in urine protein
testing (Adults not yet on dialysis with a GFR under 60 ml/min within
the last 2 yrs)
Measures being considered
- Number of patients with
up/c over 1 and GFR less than 60 ml/min on ACEI or ARB
- Number of patients with
GFR under 60 ml/min with blood pressure under 130/80
- Anemia management service
referrals from PCPs
|
|
Phase
X: Continuous Improvement |
.........
Strategies and techniques for keeping guideline content and tools up-to-date
will be applied by the team leaders. |
Published
in BMJ: Quality Improvement Report — The role of specialists in
managing the health of populations with chronic illness: the example of
chronic kidney disease
Article
Key Points
|
Update
7/8/09: (BMJ: Lee BJ, Forbes K. Quality Improvement Report — The
role of specialists in managing the health of populations with chronic
illness: the example of chronic kidney disease. BMJ 2009;339:b2395.)
Introduction
The Lee 2009 BMJ article summarizes some of the key elements of the Kaiser
Permanente Hawaii (KPHI) Nephrology EBM Guideline Project.
The KPHI Chronic Kidney
Disease Guideline Workgroup which was formed in January 2005 (see Web
Documentation
for details) with the goal of assisting with the management of stable
chronic kidney disease (CKD). As described in the Lee 2009 paper, KPHI
is now documenting improved referral rates and other important outcomes
in CKD patients.
Late referrals of
CKD patients from primary care to Nephrologists have been associated with
higher mortality rates, higher hospitalization rates (if CKD patients
lack permanent access for hemodialysis), higher early failure rates of
arteriovenous fistulas, as well as decreased quality of life. Approximately
one third or more of referrals to nephrologists are late. This article
documents improved late referral rates following implementation of the
CKD project initiated in 2005.
Key Outcome
Measures in the Lee 2009 Paper
- Rate of late referrals
to nephrology care, defined as occurring within four months of end stage
renal disease;
- The proportions
of patients starting hemodialysis with a mature arteriovenous fistula
and starting dialysis in the outpatient setting; and,
- The proportion
of patients starting hemodialysis as outpatients.
Results
- Between 2004 and
2008, the proportion of referrals occurring within four months of onset
of end stage renal disease dropped from 37 of 116 (32%) to 10 of 84
(12%), P=0.001;
- The proportion
of patients starting hemodialysis with a mature arteriovenous fistula
increased from 19 of 108 (18%) to 27 of 76 (36%), P=0.006;
- The proportion
of patients who started hemodialysis as outpatients increased from 39
of 113 (35%) to 47 of 84 (56%), P=0.003.
- In 2004, the percentage
of low risk CKD patients referred to nephrology (frequently best managed
in primary care) was 50%. As the primary care physicians learned the
criteria for referral and gained more expertise in the management of
early chronic kidney disease, the total number of referrals dropped.
In 2007 the percentage of low risk referrals had dropped to 30%; P value
for difference between 2004 and 2007 was 0.0001;
- Starting in late
2007, low risk patients returned to primary care were monitored. After
an average follow-up 409 days none of the patients reached end stage
renal disease or were referred to Nephrology a second time; and,
- In 2004, the percentage
of high risk CKD patients referred to Nephrology (frequently best managed
by nephrologists) was 16%. In
2007 the percentage of high risk CKD patients increased to 35%; P value
for difference between 2004 and 2007 was 0.0001.
Key Points
and Conclusions
- The KPHI CKD Guideline
demonstrates how an evidence-based QI approach can be used by health
care organizations and other groups to improve health care quality and
outcomes for patients;
- The CKD project
utilized the principles, methods and tools of applied EBM and included
key questions, a literature search, critical appraisal of the relevant
literature, evidence grading, “tagged” clinical recommendations
based on the evidence and judgments of the guideline team and carefully
developed implementation and measurement strategies;
- A team composed
of engaged stakeholders using transparent EBM processes including posing
key questions to the medical literature, effective searching, critical
appraisal of medical literature for validity and usefulness, evidence
grading, interpreting results, creating evidence statements and a synthesis
of the evidence, crafting clinical recommendations and other decision-support
materials for targeted groups and creating administrative, system and
measurement processes to ensure effective implementation and ongoing
improvement;
- A unique feature
of the evidence-based QI project is the innovative use of KP’s
electronic medical system, KP HealthConnect (see Lee 2009 for details).
The system includes electronic registration and scheduling, billing,
clinical information systems — both inpatient and outpatient,
laboratory and X-ray information, pharmacy records, the ability to annotate
for individualized care, alert and flagging features and staff messaging.
- The system allows
primary care physicians rapid access to important CKD decision-support
and management information such as lab testing recommendations, blood
pressure management recommendations, use of angiotensin converting
enzyme inhibitors and angiotensin receptor blockers, avoiding nephrotoxic
drugs, etc. (See Algorithm.)
- The system also
allows nephrologists to stratify KPHI CKD patients by risk category
and provide electronic or real-time consults, resulting in ongoing,
efficient management of low-risk patients in primary care with solicited
and unsolicited consultations, mentoring and avoidance of inappropriate
referrals but prompt referral of higher risk or more complicated patients
to nephrology and retraction of premature referrals;
- Nephrologists
use the KP CKD Population Management System to target every CKD patient
not optimally managed.
- The Lee 2009 paper
documents (see above) some of the improved outcomes seen following the
implementation of this evidence-based CKD quality improvement project.
- Evidence-based
decision support together with risk driven consultations and educational
mentoring of primary care physicians using their own patients and enabled
by KP HealthConnect provide a novel and effective method of improving
care in CKD.
This evidence-based approach could be used in other conditions (e.g.,
in diabetes, heart failure) where there are gaps between optimal and
current clinical care.
- BMJ: The
role of specialists in managing the health of populations with chronic
illness: the example of chronic kidney disease
- BMJ Delfini Rapid
Response Letter: Re:
The role of specialists, information systems and an evidence-based approach
in managing the health of populations with chronic illness
Delfini
Response Letter Key Points
- This work represents
an important contribution to the evidence-based quality improvement
(QI) literature. Lee and Forbes report success in the use of an evidence-based
QI approach that can be used by others health care quality and patient
outcomes including patient safety for patients using implementation
strategies consistent with what is currently reported in the literature
as most effective.
- A combination approach
was utilized.
- Importantly,the
information upon which the guidelines were based was developed through
a systematic approach to obtaining potentially relevant clinical trials
and evaluating them through a rigorous critical appraisal approach.
- An evidence-based
process is important to provide patients with the best available care.
- An evidence-based
process is important for effective implementation. Rigorously appraised
evidence can increase trust by providing tags that clearly label information
as being based on high quality evidence or expert opinion.
- Process information,
decision support materials, documentation and tools used by Kaiser Permanente
Hawaii are available here: www.delfini.org/Showcase_Project_NephrologyCPG.htm
and http://www.delfini.org/delfiniTools.htm.
- In addition, key
features appear to be a combination of unsolicited, risk-driven nephrology
consultations enabled by the innovative use of Kaiser Permanente’s
electronic medical system not only to improve referrals to nephrology
but also to provide evidence-based decision-support to generalists.
- This system allows
nephrologists to stratify CKD patients by risk category and provide
electronic or real-time communications, resulting in ongoing, efficient
management of low-risk patients in primary care using solicited and
unsolicited consultations, mentoring and avoidance of inappropriate
referrals.
- Kaiser Permanente’s
electronic medical system allows generalists rapid access to important
evidence-based CKD decision-support and management information.
BMJ Delfini Rapid
Response Letter: Re:
The role of specialists, information systems and an evidence-based approach
in managing the health of populations with chronic illness
|
| Message
from
Delfini
|
|
Kaiser
Permanente: Hawaii Nephrology EBM Guideline Project 2005
At the beginning of the year,
we were invited to work with Kaiser Permanente Hawaii to help advance
EBM within their organization. KP Hawaii has a strong commitment to evidence-
and value-based care. Their leaders are committed to supporting EBM. They
frequently sponsor outstanding EBM conferences and retreats which are
very well attended, and they have an impressive and active EBM working
group.
They were desirous of taking
EBM to a new level and expanding and embedding evidence-based clinical
improvement skills and techniques more solidly and more broadly into their
culture. We came up with an idea for a working project that would provide
just-in-time practical training, advance clinical care and help further
"seed" cultural change. Thus the Hawaii Nephrology EBM Guideline
Project 2005 was conceived. We are working with an incredible team, and
the project is well underway and progressing nicely.
We live for projects like
this. It is exciting to us to be able to combine our training and facilitation
expertise, project management know-how and EBM skills and tools in a real-world
setting and over a truly compelling clinical challenge where we can help
effect real change.
The benefits of this project
are numerous:
- Chronic kidney disease
patients will be helped and will receive care based on the best available
valid and useful evidence combined with clinical expertise and judgment.
- Primary care physicians
will receive clear and practical help in a challenging area.
- The renal care team will
extend its help and expertise into other disciplines — and will
directly benefit by patients being referred to them at the most appropriate
time.
- Team members will both
directly and indirectly help expand EBM clinical improvement methods
and solutions further into other clinical areas within their organization
— this project will help further "seed" an evidence-based
culture throughout.
- By operating as an evidence-based
organization, this health care system will further its ability to provide
evidence- and value-based care to its members, reducing waste and harms
and improving the quality of care.
From Kaiser Permanente Hawaii
leadership to team members to support staff, Delfini is impressed with
the level of enthusiasm and commitment for the principles of evidence-based
medicine and for this project. The group is dedicated, responsive and
delightful to work with. We are grateful for this wonderful experience.
We are honored to serve. We are gratified when we can help others learn
and apply their learnings. And as continuous learners, we too learn.
Mahalo,
 &
|
| Delfini |
Noteworthy