|
Items in cart [0] |
Questions? Call 888-624-8373 |
| Copyright © 2009. National Academy of Sciences. All rights reserved. Terms of Use and Privacy Statement |
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 111
D
National Guidelines and Local Action:
Priority-Setting for the Development of
Research-Based Protocols
at Intermountain Health Care
Susan D. Horror, Ph.D.
INTRODUCTION
This paper describes how Intermountain Health Care (IHC) selects areas in
which to develop research-based protocols to improve outcomes of care for lower
cost. It also describes the fundamental concept of research-based protocols,
explains how they are developed through clinical practice improvement studies,
and gives an example of their implementation.
PRIORITY SETTING FOR RESEARCH-BASED PROTOCOLS AT IHC
At the corporate level, IHC uses the following process to decide which
clinical areas to focus on across its hospitals or ambulatory care sites. The
pnonty-setting methodology examines four overall factors, each with several
components:
1. Quality
a. Clinical impact (ability to improve or probability of success).
b. Problem proneness (areas with high variation in cost, length of stay,
or clinical outcomes).
Paper prepared by Susan D. Horn, Ph.D., senior scientist at Intermountain Health
Care, Salt Lake City, Utah. Portions of this paper have been adapted from Clinical
Practice Improvement: A New Technology for Delivering Cost-E~ective Quality Health
Care, Susan D. Horn and David S. P. Hopkins, eds. Washington, D.C.: Faulkner &
Gray, Inc., 1994.
111
OCR for page 112
112
compatibility.
SE17Il1G PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
c. Total volume ~igh-volume areas).
2. Finance
a. Fixed-payer payments (not fee-for-service, so IHC is at risk).
3. External Customers
a. Community cost and health needs.
b. Purchaser interest.
4. Operational Feasibility
a. Joint Commission on Accreditation of Healthcare Organizations
b. Clinical champion (clinician with special interest in the area).
c. Availability of measures to assess the area.
For each factor, the components are scored from 1 (low) to 3 (high) on its
importance to IHC and the average of the scores is computed to give a factor
score. Subsequently, the average of the four factor scores is computed to give
an overall score for a clinical area. The higher the overall score, the higher the
priority of that clinical area for study. (See Tables D. 1 and D.2 for examples.)
However, any clinician who wishes to produce a protocol in an area and has the
resources to do so is encouraged to proceed.
IHC divides its hospital-associated functions into three major classes to help
identify key areas to study. Support services include operational and
administrative systems, such as admit/discharge, scheduling, billing, and
purchasing. Clinical infrastructure contains non-condition-specific clinical
processes, such as prevention of adverse drug events, prevention of hospital-
acquired infections, ventilator management, operation of clinical laboratories, and
major medical support departments (e.g., radiology or anesthesiology). Clinical
conditions include clinical processes aimed at specific presenting diagnoses (e.g.,
management of symptomatic benign prostatic hypertrophy or management of
acute myocardial infarction). Since 35-40 clinical conditions often account for
more than 70 percent of total inpatient volume, these high-volume clinical
conditions are an appropriate focus for research-based protocol development
efforts.
After an area is selected for study, a version of the following clinical
practice improvement methodology can be used to acquire the data necessary to
develop or validate a research-based protocol.
OCR for page 113
113
~D
.m
e~
-
o
._
s ~
o
G
_~
· ~
C)
o
.~
C)
V)
o
o
.3
o
g)
~ o
cd _
.a ~
¢ ~
o
C. ~
.
~ o
o
v
~ ."
.
_ ~
o o
~q
~d
.a
.
o o o o o o o o o ooo o o o o
. . . . . . . . . ... . . . .
~ r~ c ~ _ _ _ _ _ __ ~_ _ ~ _
o. o. o. o. o. o. o. o. o. o.o.o. o. o o. o.
~ _ ~ ~ ~ r~ ~ _ ~r ~ _
o o o o o o o o o o
. . . . . . . . . .
r~ r~ r ~ ~ ~ ~ ~ r~ r~
o. o. o. o. o. o.
~ _ rm rm
o o ~o o o o o o oooo o o o
. . .. . . . . . .... . . .
- ~ -- ~ ~ - - - ---- - - , -
o. o. o.o. o. o. o. o. o. o.o.
~ ~ r~ ~ ~ r~ r~
o o oo o o ~ ~
. . .. . . . .
rm r~ ~ ~ r~ ~ ~
o. o. o.o. o. o. o o o o
~i
oo o o o
.. . . .
~ ~ r~ _
o o ~o o o o o
. ... . . . .
r~ ~r~ ~ 0 0
o.o. o. o. o. o.
-- ~ - ~ ~
o. o. o. o. o. o. o. o. o. o. o. o. o. o. o. o.
~ ~ r ~ ~ ~ ~ ~ C~ C ~e ~ ~ -
o o o o o o o o o
. . . . . . . . .
~ r~ ~ ~ ~ rn £~ ~
oooo o o o
.... . . .
- ~ - - ~
~ V ~ . 2u _
E ~ ~ E e E ~ ~ E ~ E o a . ~ ~ ~ y E n
OCR for page 114
114
sol
.~
o
8
o
E~
o . _
·4 - ~
~ .m
o ~
_ CO
Ce tV
X - °
.=
._
Ct
o'
~ \O `~) t<, ~ ~ ~ ~ ~ ~ ~ ~ _ o o ~ oo ~
· . . · . . . . . . . . . . · .
_ _ ~4
o o ~ o ~ o ~ ~ ~ o ~ o
. . . . . . . . . . . . . . . .
~ ~ ~ ~ ~ ~ ~ ~ _ ~ _ ~ _4 ~4
o ~ ~ o ~ ~ o o o o o ~ ~ o o o
. . . . . . . . . . . . . . . .
~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ _ _ ~ ~ _
o o o o o o ~ ~ o o ~ o o o o o
. . . . . . . . . . . . . . . .
~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ o o
o. ~ o. ~ ~ ~ ~ ~ o ~ ~ o o.
_ ~ ~ ~ _ _
o
O °, > 0c ~ ~ 2 ~ ~ ~ ~ · E ~ c
OCR for page 115
APPENDLY D
CLINICAL PRACTICE IMPROVEMENT: THE FUNDAMENTAL
CONCEPT BEHIND RESEARCH-BASED PROTOCOLS
115
Quality improvement in the American medical community is open called
continuous quality improvement (CQI) or total qualify management MOM).
Properly implemented, CQI embodies the principles of the scientific method that
American medical practitioners have always avowed, but have rarely been able
to practice fully (James, 1991; Horn and Hopkins, 1994~. Those principles
remain the foundation of American medical practice: Clinicians commit to
continually assessing the treatments they apply to patients' diseases and the
medical outcomes they achieve, with an aim to improving treatments and
outcomes for future patients. Clinicians also understand the importance of
objective evidence when evaluating treatments and outcomes, and the use ofthe
scientific method to systematically improve them. As it is applied to clinical
medicine, we will refer to TQMlCQI's methodological component as Clinical
Practice Improvement (CPI) (Horn and Hopkins, 1994~.
Clinical Practice Improvement
Many American health care facilities have come to understand that quality
controls cost (James, 1989~. But clinical practice improvement provides amajor
additional benefit: it creates a clinical laboratory, built into the everyday practice
setting, to find and test best practices. Under a fully functional clinical practice
improvement program, every patient automatically enters a clinical trial. Clinical
practice improvement is a system designed to generate valid statistical inferences
about the operational, day-to-day elements of the process of clinical care.
Clinical practice improvement combines major elements of both practice
guidelines and outcomes management. It uses consensus, combined with
measurement and feedback, to eliminate inappropriate treatment variation for
well-defined groups of comparable patients. Clinical practice improvement
carefully tracks medical care process steps and outcomes and feeds the resulting
information back to clinicians so that they can evaluate objectively the effects of
the treatments they apply. To minimize overhead, clinical practice improvement
integrates all of these elements into the routine process of care.
A clinical practice improvement study is act analysis of the content and
tinning ofthe individual steps of a medical care process to produce better medical
outcomes for the least necessary cost over the continuum of a patient's care.
Statistical measures are used to determine whether and how much a particular
step actually improves medical outcomes. Systematic determination of the
individual medical process steps that actually cause improvement in medical
outcomes is of critical importance. This determination permits clinical practice
OCR for page 116
116
SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
improvement studies to develop medical processes that constitute demonstrably
better care and practice.
Comparison of Clinical Practice Improvement
with Randomized Controlled Trials
The gold standard to determine optimal medical practice is the randomized
controlled clinical trial (RCT). However, RCTs are difficult to conduct and
costly to carry out, so relatively few are undertaken, and published results of
completed trials fall far short ofthe medical profession's need for valid scientific
information. As a remedy, several investigators have proposed alternative
structures that allow practitioners to draw valid statistical inferences about patient
care from routine practice, while avoiding the bureaucracy and overhead so often
encountered in traditional RCTs. Clinical practice improvement is one such
structure.
Each step of a properly conducted clinical practice improvement study has
a parallel step in an RCT. However, clinical practice improvement requires
fewer resources than traditional RCTs and so can examine detailed operational
factors, including the cost of care, that resource-intensive RCTs usually fail to
explore. While RCTs may be the best approach for evaluating new clinical
treatments (particularly drugs), clinical practice improvement methods can be
used to optimize established treatments.
Both methods RCTs and clinical practice improvement-describe a
homogenous patient population, balance known and unknown patient factors,
eliminate inappropriate variation in care delivery, and statistically evaluate
predefined outcomes. However, RCTs accomplish these steps as an add-on
effort of limited duration, while clinical practice improvement methods integrate
the steps into the routine practice of medicine. Because clinical practice
improvement methods allow a wide range of study designs, they can be useful
when the rigor of a full RCT is not practical.
In an RCT, patient eligibility criteria are critical, since one does not want the
outcome ofthe study to be influenced by extraneous factors. Therefore, patients
with secondary problems or more severe disease, which might adversely affect
or bias the outcome of the comparison between the treatment and the control
arm, are often rejected from the trial. Only a small percentage of patients with
the condition under study, usually 10 to 15 percent, are eligible. But not all
criteria can be thought of in advance. Therefore, at the end of the trial one may
have to adjust for several variables in an analysis of covariance.
In clinical practice improvement, every patient is allowed to enter a study.
The patient's severity of illness, detailed process steps, and outcomes are
assessed, and statistically valid inferences of their interrelationships are
determined by multiple regression analyses (see Figure D.1~. Clinical practice
OCR for page 117
APPENDLY D
Contro' for:
Patient Factors
· Disease
· Severity of Disease
- Physiologic signs and symptoms
- Complexity/Psychosocial factors
· Multiple points in time
I m prove/Stan d ard ize:
Process Factors
· Medications
· Interventions
· Develop protocols
_
lilGURE D.l Study design clinical practice improvement model.
117
Measure:
Outcomes
· End Results
- Cost/Length of stay
- Clinical
- Health status
improvement integrates a clinical quality monitor a data system that follows
important patient, process, and outcome information into the care delivery
infrastructure. Quality monitors may be employed in circumstances in which
traditional RCTs are not practical to track and improve common process of care
factors, which may not warrant the expense and effort of a traditional clinical
trial. But as the Japanese (and later the Americans) have shown in
manufacturing, a series of manly small advances may result in a greater total
improvement than a few large breakthroughs (Imai, 1986~.
RCTs use a protocol document to create act artificial practice environment
that allows valid statistical inference. While that structure eliminates practice
variation, it usually covers a very limited subset of patients and practices.
Clinical practice improvement addresses the same issues-practice variation and
OCR for page 118
118
SETTING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
valid statistical inference- from another point of view. It measures process
variation, then eliminates it through a combination of consensus, measurement,
and feedback. Under a quality monitor, large groups of similar patients receive
the same treatment, and valid statistical inference is possible. RCTs also tend
to be limited in time in most circumstances, they explicitly modify clinician
behavior only for the duration of a study and only for the individuals directly
involved in the trial. In contrast, clinical practice improvement establishes a
permanent measurement and feedback loop aimed at all clinicians in an
Institution, providing the information necessary to understand and modify their
own activities at a detailed, operational level.
Specific Components of Clinical Practice Improvement
A clinical practice improvement study includes four major components:
· quality planning,
· quality monitor,
· process stabilization, and
· systematic improvement
Quality Planning (select key processes to monitor)
A health care delivery system contains tens of thousands of interlocking
processes. The first step is to prioritize-to find and focus on the most
important processes.
Quality Monitor Guild an integrated measurement system)
A clinical quality monitor works best when built into the infrastructure of
the health care delivery system, where it can function inexpensively and
unobtrusively as part of routine operations. It captures data items that are crucial
to the delivery of care items that must be collected in the medical record in any
circumstance, as they are often essential to a patient's description, treatment, and
recovery. Clinical quality monitors are most efficient as part of an electronic
medical record, although they can arid do work in traditional manually operated
record systems as well. If a monitor is in simultaneous operation at several
facilities, it can act as a multicenter clinical practice improvement data system.
A clinical quality monitor collects three major classes of information:
patient eligibility and patient attributes (severity of illness), major process of care
factors, and outcomes.
OCR for page 119
APPENDIX D
119
For a particular clinical condition, a team of clinical experts identifies the
data elements In each class during the quality planning phase. The team
typically uses the medical literature, practice guidelines, critical paths, other
organizations' quality monitors, and its own expertise.
Patient Factors. Patient eligibility factors (severity of illness measurement
and specific indications for treatments define a group of patients who should
receive the same process of care, except for small, random variations as
clinicians respond to minor patient differences. Within a well-defined patient
group, one would expect to observe the same outcomes of care, except for
random, patient-based differences. Clinical practice improvement requires
disease-specific physiologic data such as those contained in the Computerized
Severity Index and the Ambulatory Patient Severity systems (Horn and Hopkins,
1994~. This part of a quality monitor is analogous to the eligibility and
stratification factors used in RCTs. If a detailed physiologic severity system is
not available, then the clinical practice improvement team determines what data
are needed to define patients with similar levels of illness so that a decidable and
executable treatment protocol can be developed, based on the patient's
derangements.
Major Process Factors. A process of care consists of a series of linked,
usually sequential steps designed to cause a set of desired patient outcomes to
occur. The aim is to find a measurable factor that describes each major process
step. The quality monitor usually does not specify thresholds for a process step,
unless there is a scientifically defensible "best practice" that should be applied
to all cases in the patient cohort.
Outcome Factors. In theory, processes of care do not just happen they are
designed to achieve specific medical outcomes. Among the outcomes commonly
encountered in clinical quality monitors are patient functional status, diagnosis-
specific complications, diagnosis-specific long-tern medical outcomes (which
may be assessed by both clinicians and patients), patient satisfaction, and cost.
Outcome factors parallel the assessment endpoints included in an RCT.
Because a quality monitor is an ongoing, long-term measurement system (as
opposed to a one-time RCT), quality improvement principles may be applied to
iteratively improve the measurement system itself. It is therefore possible to start
a quality monitor even when some details necessary for a full study are
unknown. With a quality monitor, the chief principle is to start-initiate
measurement and feedback and then iteratively improve both patient care and
the measurement system.
OCR for page 120
120
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
Process Stabilization (identify and eliminate inappropriate variation in
process steps)
Once a clinical quality monitor is designed and implemented, and is actively
collecting data, the next objective is to eliminate inappropriate variation within
me process of care. Process stabilization is the act of identifying and
eliminating inappropriate variation. Not all variation is inappropriate. Some
clinical practice improvement programs use statistical process control to separate
random variation (clinicians' adaptation to random patient factors at such a fine
level of detail that they escape control through the eligibility or severity criteria,
or other random variations associated with environmental factors or the
measurement system itself) from attributable variation (consistent inappropriate
variation in major delivery steps, environmental factors, or measurement)
(Berwick, 19911.
There are at least three methods to stabilize process performance across
~ · · .
groups or clinicians.
Method 1: Measure pe~forr,~ance without setting explicit process thresholds.
The resulting comparative data are presented to the clinical group, usually in
subspecialty medical section meetings or clinical practice improvement team
meetings. Over time, attributable variation declines as clinicians discuss,
consider, and compare their own techniques to those of their peers. When more
than three or four patient and process variables have to be taken into account,
multiple regression analyses can be used to model the effects of these factors on
the outcome-dependent variables. The coefficients of the independent variables
in the regression equations tell which process steps, controlling for patient
factors, lead to better outcomes. For example, the analysis can help answer the
question "What is the best prophylactic antibiotic to use in a coronary bypass
artery graph surgery?"
Method 2: Bring all practitioners treating a particular clinical condition
together for a series of meetings at which they agree upon clear statements
detailing the process steps that should be performed, taking into account the
severity of the patient's signs and symptoms. A quality monitor then measures
performance against the agreed-upon specifications. Ongoing meetings allow the
clinicians to reassess the specifications in light of compliance data and their own
experience. The structure of the protocol improvement process requires that, if
a clinician fails to follow a step in the protocol at some point, she or he gives
substantive, nonstylistic reasons for doing so, and the corresponding protocol
element is automatically placed on the agenda for the next clinical practice
improvement train meeting. The team always starts from the assumption that the
protocol is incorrect or incomplete with regard to the clinical point under
discussion. The reasoning is that, if the protocol were correct, then all clinicians
in the group would follow it. The clinician who disagrees with the protocol step
OCR for page 121
APPENDLY D
121
has an opportunity to present his or her reasoning to the team, in the context of
a real patient, so that the group can modify the protocol step or reach consensus
that the protocol, as written, does represent best practice. Even after much
refinement, usually 5 to 10 percent of the protocol steps are not followed, due
to patient differences not accounted for by the protocol.
Method 3: Use a set of process specifications generated by an external
group (e.g., a national consensus panel) or a subset of local clinicians working
in isolation from their local peers. Even when external guidelines and
parameters are developed by well-respected groups, distributed widely, and
supported by respected clinical leaders and professional specialty societies, it may
still be necessary to establish a measurement and feedback system to achieve
guideline and parameter compliance.
The goal of the clinician group is to generate a decidable and executable
research-based protocol over time through measurement, feedback, and
stabilization. A protocol is decidable if it tells precisely under what
circumstances to do something; it is executable if it tells exactly what to do
under these circumstances. External information, such as medical literature
synthesis, other practice guidelines, or results from other external clinical practice
improvement groups, may be employed. But, regardless of the source of
information, the clinicians in the group choose their own collective "best
practice" based on data associating patient severity characteristics and process
steps with outcomes.
A stabilized process corresponds to the treatment protocols that describe the
control and test arms of an RCT. RCTs achieve stable processes by explicitly
specifying every important element of the process of care, for both the test and
control arms. RCT protocol violations occur when a treatment step deviates
from the RCT protocol's specification. Such violations can seriously damage an
RCT: if treatment on one or more of the arms of a trial is not applied
consistently, it is impossible to tell whether differences in outcomes between the
trial's control and test arms are due to the specified treatments or to the
variations that occurred. Within clinical practice improvement, process
stabilization involves the same principle: it is impossible to assess the outcomes
of a process unless that process is stable.
Systematic Improvement (generate valid information and document continuous
improvement in patient outcomes)
Once study results are available, the clinical practice improvement team
evaluates them and makes fact-based decisions about the proposed process
change. The team can change the standard process of care to follow the newly
tested process step, modify the clinical quality monitor and repeat a modified
OCR for page 122
122
SEWING PRIORITIES FOR CLINICALPRACTICE GUIDELINES
trial, or reject the proposed process change and go on to test others. In such a
setting, changes to the process of care rest on experimental results rather than
· · . ~
c 1nlca opmlon.
While formal patient randomization (e.g., an RCT) is the safest approach, the
alternative study designs used in clinical practice improvement may provide a
more pragmatic balance of study overhead, clinician participation, rapid patient
accrual, and need for timely information, versus potential bias. This is
particularly true when permanent quality monitors routinely track patient and
process factors, so that invalid inferences are likely to be found and corrected
over time and when examining operational process of care factors as opposed to
major new treatments.
Clinical Practice Improvement and Outcomes Research
The foregoing discussion illustrates the fact that clinical practice
improvement is a superset of outcomes research. Clinical quality monitors track
a full set of outcomes as well as patient factors (severity data) and process
factors. They permit care delivery teams to understand and stabilize process
steps, so that outcomes can be compared accurately and understood. They also
provide the means to relate outcomes to process steps that are under an
individual clinician's control. Through that mechanism, clinical practice
improvement provides a means to unite effectiveness research (the study of
medicine as it is really practiced in the community) with efficacy research (the
study oftightly deigned treatments in carefully controlled patient groups) (Palmer,
1976~.
Clinical Practice Improvement and Practice Guidelines and Parameters
Clinical practice improvement and practice guideline and parameters are
complementary. Well-designed practice guidelines and parameters can form the
core of a clinical quality monitor. On the other hand, clinical quality monitors
can be used to generate research-based protocols, implement them, measure their
impact, and improve them over time. Appropriate use of quality monitors
provides clinicians with the necessary tools to build, use, and systematically
improve research-based protocols.
OCR for page 123
APPENDIX D
DEVELOPMENT OF RESEARCH-BASED PROTOCOLS
THROUGH CLINICAL PRACTICE IMPROVEMENT STUDIES
123
A research-based protocol is a detailed process of care based on a clinical
practice improvement study showing that the process has achieved better care
and practice for the least necessary cost over the continuum of a patient's care.
Research-based protocols significantly narrow the otherwise wide variation
normally observed in the medical care process because they are very precise and
comprehensive in defining the process of care steps (i.e., they are decidable and
executable). Research-based protocols are much more detailed than general
checklists or traditional practice guidelines and parameters.
Research-based protocols typically are developed in two stages, using
clinical practice improvement methodology:
In the first stage, called stabilization, detailed steps of a diagnostic or
therapeutic process for similarly sick patients (controlling for severity) are
determined through discussion of the medical literature and the clinical
experience and judgment of the clinicians, resulting in consensus on the detailed
steps that the clinicians will follow. If this process does not result in consensus,
the detailed steps of each clinician's existing practice patterns for similarly sick
patients, along with their common medical outcomes, are measured and fed
back to the clinicians, resulting in increased communication among the clinicians
and consensus on the detailed steps that the clinicians agree to follow and then
implement.
In the second stage, called validation, there is measurement and feedback of
the detailed steps of the diagnostic or therapeutic process of similarly sick
patients, and analysis to statistically associate each process step with medical
outcomets) to more clearly determine the degree of effectiveness of each step in
a protocol to achieve better outco~nefs). The second stage is done initially and
then repeatedly thereafter to continuously attain better research-based protocols.
Inherent in the methodology of research-based protocol development is:
1. An ongoing process to improve the protocol by continuous measurement
and feedback of selected changes (adding, subtracting, and/or modifying) in the
detailed steps of the medical process, and analysis to statistically associate the
changes with better medical outcomes.
2. The essential part played by clinicians in research-based protocol
development. Research-based protocols must reflect clinicians' actual practice.
In contrast, traditional guidelines and parameters developed through synthesis of
medical literature and expert consensus by third-party developers, are typically
not, without additional material incentivets), accepted and followed by clinicians.
OCR for page 124
124
SEITING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
3. Formal measurement ofthe degree of clinician compliance with research-
based protocols, including the usual requirement that the clinician state and
record the specific reasonfs) (substantive and not stylistic) for his or her
noncompliance with the research-based protocol.
AN EXAMPLE OF THE DEVELOPMENT OF A
RESEARCH-BASED PROTOCOL: PREVENTION
AND TREATMENT OF PRESSURE ULCERS
Conservative estimates indicate that well over one million hospital and
nursing home patients suffer frown pressure ulcers each year (NPUAP, 1989~.
Estimates of costs to heal one ulcer range from $5,000 to $50,000 with annual
costs for pressure ulcer treatment thought to exceed $5 billion ~Iaklebust,
Mondoux, and Sieggreen, 1986; Frantz, 1989~. Few precise data are available
on ulcer treatment by stage of lesion or by concomitant health problems and their
influence on cost of treatment; hospital costs are not typically broken down to
identify multiple services involved in treating patients with pressure ulcers.
Definition Problems
There are several methodologic limitations to assessing the incidence and
prevalence of pressure ulcers in various health care settings. Differences about
such basic matters as definition of act ulcer and its stage make it difficult to
analyze and interpret many of the published studies (NPUAP, 19891.
Variation in Process of Care to Prevent and Treat Pressure Ulcers
There is great variation in the treatment of pressure ulcer patients. In a
pressure ulcer quality of care assessment carried out at IHC-affiliated hospitals,
we found that guidelines differed between facilities and between neighboring
nursing units within a facility. In a small study of six patients, two skilled
nurses agreed on the level of risk (low, medium, and high) only twice. The great
variation among clinicians in determining risk makes it very difficult to identify
correctly high-risk patients and to use preventive measures appropriately. In
addition, great variation in treatment methods was fouled from nurse to nurse in
treating the same ulcer. One impediment to wound healing is the combination
of many different methods and products used in pressure ulcer management
(Lidowski, 1988~. Great variation occurs because there is little scientific
evidence to indicate which process or therapy is best; even available scientific
evidence has not been translated into a protocol or plan (Wennberg, 1987~.
OCR for page 125
APPENDLY D
125
The single most important aspect of pressure ulcer care is prevention
(Ameis, Chiarcossi, and Jimenez, 1980~. Many clinicians have indicated that
pressure ulcers are entirely preventable (Dyson, 1978; Fugill, 1980; Kosiak,
1991~. Since nurses can devote 1,000 extra hours of care to heal a major ulcer
in one patient, an effective program to prevent pressure ulcers could have a
major impact on lowering nursing costs (Makelbust, 19873.
Methods
The two main questions we consider here are:
1. Are pressure ulcers related to the severity of illness of the patient beyond
risk factors contained in the Braden Scale?
2. Does implementation of a research-based protocol to stabilize the process
of care for prevention of pressure ulcers reduce the incidence of pressure ulcers?
The Clinical Practice Improvement Team
The first step was to form a multidisciplinary clinical practice improvement
team composed of physicians, nursing skin care specialists, staff nurses, nurse
educators, nursing information systems experts, physical therapists, nutritionists,
and health services researchers. The team created two research-based protocols:
one for prevention of pressure ulcers in high-risk patients and another for
treatment of pressure ulcers.
AHCPR's Guideline
In May, 1992, the Agency for Health Care Policy and Research (AHCPR)
published Pressure Ulcers in Adults. Prediction and Prevention, Clinical Practice
Guideline No. 3 (AHCPR, 1992~. This publication was the first major attempt
to synthesize available research on pressure ulcer risk assessment, prevention,
and early intervention. The guideline provided recommendations to relevant care
providers physicians, nurses, physical therapists, patients, and families risk
assessment tools and risk factors, skin care and early treatment, mechanical
support surfaces, and education. Our clinical practice improvement team used
the AHCPR Clinical Practice Guideline as a starting point for its own research-
based protocol. Since most hospital providers who manage skin assessment are
nurses, this research-based protocol was developed as a nursing department
policy-procedure.
OCR for page 126
126
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
To assess the risk of a patient developing a pressure ulcer, we used the
Braden Scale for Predicting Pressure Ulcer Risk, which was used in the AHCPR
Guideline (Bergstrom and Braden, 19874. The six subscales ofthe Braden Scale
are derived from a conceptual schema identifying two major factors responsible
for pressure ulcer development: the amount and duration of pressure, and the
tolerance of the tissue for pressure.
Development of a Research-based Prevention Protocol
For each level of each of the six subscales in the Braden Scale, the clinical
practice improvement team determined which interventions should be performed
to stabilize the process of care with the intent of achieving better outcomes at
lower cost. For example, if the patient is completely immobile (does not make
even slight changes in body or extremity position without assistance), the
protocol treatment specifies that the nurse is to turn and position the patient
every 2 hours, observe skin when positioning, and perform a daily skin
assessment between 0600 and 1200 hours. If the patient is constantly moist (skin
is kept moist almost constantly by perspiration, urine, etc.), the nurse is to bathe
with soap and water and pat dry, use moisture barrier ointment and cream,
contain incontinence (condom, foley catheter, pouch), and perform daily skin
assessment between 0600 and 1200 hours. If the patient has very poor nutrition
(never eats a complete meal, rarely eats more than one-third of any food offered,
etc.), then the nurse is to contact the dietician to evaluate nutritional status, assist
and encourage oral intake to increase protein, increase calorie diet, and use
frequent small feedings, tube feedings, or total parenteral nutrition.
Neither of our research-based protocols recommended the use of low air-loss
specialty beds or other special mattresses for either prevention or treatment of
pressure ulcers. After extensive discussion, the clinical practice improvement
team did not think there was sufficient evidence in the literature or in their own
experience to warrant their use. The prevention protocol represented the clinical
practice improvement team's best assessment of optimal prevention treatment.
Development of a Research-Based Treatment Protocol
Using the medical literature, the team developed a uniform staging system
for ulcers and developed standardized treatments for each stage, including
appropriate care to reduce and relieve pressure, reduce and relieve friction/shear,
reduce and relieve excess skin/surface moisture, maintain good nutrition, and the
like.
OCR for page 127
APPENDLY D
127
Controlling for Severity of Illness
The Computerized Severity Index (ASIA, a disease-specific, physiologic-
based severity system, was employed to stratify patients for analysis on the basis
of the severity of their underlying illnesses on admission, maximum severity
throughout the hospital stay, and severity at discharge (Horn and Hopkins, 1994~.
Education
A one-hour inservice training program was developed to train nurses to use
both protocols. It involved a knowledge pretest about measurement of risk
assessment and pressure ulcer formation, instruction about using the Braden
Scale and pressure ulcer staging (NPUAP, 1989), and a presentation on
appropriate nursing interventions. The education inservice was designed to
ensure that all nurses would have adequate information about risk assessment and
about staging of ulcers, if present. The education intervention also included a
paper clinical quality monitor to help determine the patient's risk of developing
a pressure ulcer, or the stage of the pressure ulcer, and the treatment that should
be followed in each case. To facilitate documentation, special Morons were
developed for nurses to use during the study period. Since these forms could be
used elsewhere, our study is generalizable to other institutions.
Data Collection
We studded three different time periods. The time period 7/92-12192 was the
pre-intervention time period (time period 1~; the protocols were being developed
but no floor nurses had yet been trained. The time period 1/93- 6/93 was the
training time period (time period 2~; the nurses were trained and, hence, knew
about the protocols, but were not required to follow them until 7/93. The time
period 7193-12193 was the post-intervention time period (time period 3~; by 7/93
the nurses were trained and were expected to follow the protocols and use the
Braden Scale to collect information about immobile patients. During time
periods 1 and 2 (when Braden Scale data were not being collected by the
nurses), we considered a patient to be at risk for developing a pressure ulcer if
at least one risk indicator in Table D.3 was present in the HELP system (IHC's
computerized clinical data system).
Results
The preliminary results we discuss here refer primarily to time periods 1 and
2. Patients at risk for pressure ulcers were divided into three groups:
OCR for page 128
128
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
· Group 1: Patients at risk who were admitted without a pressure ulcer and
did not develop a pressure ulcer during the admission.
· Group 2: Patients at risk who were admitted without a pressure ulcer but
developed a pressure ulcer after admission.
· Group 3: Patients who were admitted with a pressure ulcer.
The mean admission CSI continuous severity scores for the patients in
Groups 1 through 3 for time periods 1 and 2 show clearly that patients who
developed a pressure ulcer (average admission CSI = 39) or patients who entered
the hospital with a pressure ulcer (average admission CSI = 42) had higher
admission CSI scores on average than patients at risk who did not develop
pressure ulcers (average admission CSI = 22~. Similarly, higher maximum and
discharge CSI scores were found for patients admitted with or who developed
pressure ulcers than at-risk patients without ulcers. Thus, it appears that at-risk
patients who develop pressure ulcers are sicker on average than those who do
not. All the differences in average admission, maximum, and discharge severity
levels for the three groups were significant by the analysis of variance test, p <
.0001.
Figure D.2 shows the pressure ulcer rate by admission CSI discrete levels,
O through 4, for time periods 1 and 2; within each admission CSI level and for
all the at-risk patients at that level, the rate plotted is the number of patients who
developed pressure ulcers during their hospitalization divided by the total number
of patients. Although use of the pressure ulcer protocols was not required during
time period 2, the data show that knowing about them (as a result of the trainings
was associated with a large decrease in the rate of pressure ulcers by admission
severity level. For each severity level 2, 3, and 4, the decreases in rates of
pressure ulcers Mom time period 1 to time period 2 are significant, p < .002. We
are considering how to use admission CSI level as an additional prospective risk
factor to identify patients who are at highest risk of developing a pressure ulcer.
The portion of at-risk patients who used low air-loss specialty beds declined hom
6.2% to 5.8% to 3.5% during the three time periods, respectively.
Discussion of Pressure Ulcer Protocol Study
The goal of this clinical practice improvement study was to improve the
outcomes of patients with, or at risk of developing, pressure ulcers by stabilizing
the process of care. We developed one research-based protocol for prevention
and one for treatment of pressure ulcers by consensus of the clinical practice
improvement team. A one-hour formal inservice training program was used to
educate the nursing staff on the use of the protocols. Compared with the 6-
month pre-protocol time period, the 6-n~onth interim time period when the
protocols were being taught showed a significant decrease in the incidence of
OCR for page 129
APPENDLY D
TABLE DO Risk Indicators for Developing Pressure Ulcers
129
Glascow Coma Score < 7
Unable to detect pressure
Unable to detect pain
Numbness
Paralyzed induced 2 3 days
Paralyzed
Presence of coma findings
ICD-9 codes
806: Fracture of vertebral column with spinal cord injury
808: Fracture of pelvis
820: Fracture of femur
821: Fracture of other and unspecified parts of femur
823: Fracture of tibia and fibula
827: Other, multiple, and ill-defined fractures of lower limbs
953.9: Injury to nerve roots and spinal plexus
437.8: Other and ill-defined cerebrovascular disease
344.1: Quadriplegia
728.3: Other specific muscle disorders ignobility syndrome
pressure ulcers and the use of specialty beds. These preliminary results indicate
that stabilizing the process of care has all effect on improving outcomes and
decreasing costs. The clinical practice improvement study team is now training
the remaining nursing units in the hospital with the research-based protocols and
is implementing them on the HELP system for more consistent practice. Full
results of this study, including the financial ramifications, will be presented in
detail in future reports. The estimated cost savings per year, based on ulcers
prevented, was about $500,000. The study cost about $50,000 to conduct,
including the costs of the hourly salaries of the 500 nurses while they were
trained, the person hours to develop the protocol, the person hours to collect the
CSI data, and the cost to analyze the data.
OCR for page 130
130
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
40
30
10
326%
297%
194/'
it, 1
O-' ~.~5% 1
0 1 2 3 4
Admission CSI Level
7/92 - 12/92 1/93 - 6/93
time period 1 time period 2
~+
FIGURE D.2 Pressure ulcer rate by admission CSI level.
LESS PRIORITY SETTING NEEDED WITH
CLINICAL PRACTICE IMPROVEMENT
The clinical practice improvement framework to improve quality of care
requires much less prioritization thank do RCTs or traditional national guideline
and parameter development. This is because clinical practice improvement
studies are usually much less costly to conduct than RCTs and traditional
national guidelines and parameters development. RCTs require an add-on effort
to select eligible patients, maintain study design, and collect required data. The
traditional national guideline arid parameter development methodology requires
performing thorough literature synthesis arid obtaining multiple clinicians'
opinions and judgments in order to base the guidelines arid parameters on expert
national consensus. This methodology leads not only to high cost but also to less
OCR for page 131
APPENDLY D
131
detail in the guidelines and parameters than in the typical, locally produced
decidable and executable research-based protocol. If many research-based
protocols are produced by different groups of clinicians for a particular medical
problem, they can be shared, perhaps through a national data bank. Researchers
and practitioners could use than as a starting point to develop even better
research-based protocols in the future.
Why do clinicians change their behavior as a result of a clinical practice
improvement study? We believe they change because:
· they help develop the criteria used to determine better processes and
outcomes,
results.
· they are involved in the analyses and hence are vested in the study and its
· they can violate protocols when they think they are not right, and
· they are not profiled arid need not feel threatened.
Although clinical practice improvement studies focus on improving clinical
outcomes, they often decrease the cost of care as well by preventing
complications or using more efficient processes of care. In this way an
environment is created in wluch clinicians continually seek better methods of
treatment based on scientifically sound data.
REFERENCES
Agency for Health Care Policy and Research (AHCPR) Pressure Ulcers in
Adults: Prediction arid Prevention. Clinical Practice Guideline No. 3.
USDHHS, AHCPR Pub. No. 92-0047, May 1992.
Ameis, A., Chiarcossi, A., and Jimenez, J. Management of Pressure Sores:
Comparative Study in Medical and Surgical Patients. Postgraduate
Medicine 67~2~:177-84, 1980.
Bergstrom, N., and Braden, B. A Conceptual Schema for the Study of the
Etiology of Pressure Sores. Rehabilitation Nursing 12:81, 1987.
Berwick, D.M. Controlling Variation in Health Care: A Consultation Tom Walter
Shewhart. Medical Care 29~12~:1212-25, 1991.
Dyson, R. Bedsores: The Injuries Hospital Staff Inflict on Patients. Nursing
Mirror June 15:30-32, 1978.
Frantz, R.A. Pressure Ulcer Costs in Long Term Care. Decubitus 2~3~:5~57,
1989.
Fugill, G.C. Pressure Sores. Pl~ysiot1`erapy 66~21:46~7, 1980.
Horn, S.D., and Hopkins, D.S.P. Clinical Practice Improvement: A New
Technology for Developing Cost-Effective Quality Health Care. Volume 1,
OCR for page 132
132
SETTING PRIORITIES FOR CLINICAL PRACTICE GUIDELINES
Medical Outcomes and Practice Guidelines Library. Washington, D.C.:
Faulkner & Gray, 1994.
Imai. M. Kaizen: The Key to Japan 's Competitive Success. New York: Random
House Business Division, 1986.
James, B.C. TOM and Clinical Medicine. Frontiers of Health Services
Management 7~4~:42~6, 1991.
James, B.C. Quality Management for Health Care Delivery. Hospital Research
and Educational Trust (American Hospital Association), Chicago, 1989.
Kosiak, M. Prevention and Rehabilitation of Pressure Ulcers. Decubitus
4~2~:60~8, 1991.
Lidowski, H. NAMP: A System for Preventing arid Managing Pressure Ulcers.
Decubitus 1~2~:28-37, 1988.
Maklebust, J. Pressure Ulcers: Etiology arid Prevention. Nursing Clinics of
North America 22~2~:359-377, 1987.
Maklebust, J., Mondoux, L., Sieggreen, M. Pressure Relief Characteristics of
Various Support Surfaces Used in Prevention and Treatment of Pressure
Ulcers. Journal of Enterostomal Therapy 13~3~:85, 1986.
National Pressure Ulcer Advisory Panel (NPUAP). Pressure Ulcers Prevalence,
Cost and Risk Assessment: Consensus Development Conference Statement.
Decubitus 2~2~:2~28, 1989.
Palmer H. Definitions aIld Data. In Assuring Quality in Medical Care. Richard
Green, ed. Cambridge, MA.: Ballinger Publishing Co., 1976.
Wennberg, J.E. The Paradox of Appropriate Care. Journal of the American
Medical Association 258:2568-9, 1987.
Representative terms from entire chapter:
practice improvement
