Outcomes Measurement and Clinical Pathways
Lance O. Hoxie
Outcomes are the "consequences to the
health and welfare of individuals and of
society."
-Avidis Donabedian
University of Michigan, 1980
"A clinical pathway is an optimal sequencing and timing of interventions by
[caregivers] for a particular diagnosis
or procedure designed to minimize delays and resource utilization and to
maximize the quality of care."
-Coffey et al.
QMHC, 1992
ABSTRACT
In the evolution of quality assessment
activities within the healthcare field, outcomes measurement has become the
principal objective for demonstrating
optimal care. Clinical pathways increasingly are being used as the methodology
of choice to achieve acceptable outcomes.
This article briefly describes outcomes and clinical pathways. It also suggests a practical, step-by-step approach
for O&P facilities to use in the development of such pathways for orthotics
and/or prosthetics patients. This approach will facilitate the impact that
each provider and setting of service has
on the patient's outcome. Finally, an abbreviated bibliography is provided as a
resource for further reading.
Introduction
In a previous article by this author (1),
an approach to outcomes measurement
was reviewed in the context of a continuous monitoring and improvement
process. That approach requires an organization to follow five essential steps:
- identifying important aspects of care,
- implementing indicators of performance, 3) collecting and analyzing data,
- isolating common and special causes,
and
- developing and implementing solutions that improve either a process or
an outcome.
In this article, outcomes measurement is further explained, and the concept of clinical pathways as it applies to
achievement of optimal outcomes is
discussed. This approach embraces
steps similar to those illustrated within
a continuous monitoring and improvement process, yet it also involves a
more comprehensive link of the structures and processes to paradigms of
care. The distinguishing feature of clinical pathways is the linkage of caregivers across the milieu of therapeutic
settings to a specific set of guidelines
that direct patient care.
Known by a variety of terms (practice guidelines, treatment algorithms,
care standards, etc.), clinical pathways
have been used by healthcare practitioners since the late 1800s. More recently, however, acute care medical/surgical settings have adopted clinical
pathways as the underlying mechanism
to drive their quality improvement initiatives and improve patient outcomes.
What Are Outcomes?
As noted by Donabedian (2), outcomes
are the result of efforts by healthcare
providers to provide optimal care resulting in optimal outcomes. Outcomes
may be associated with the community
as a whole (epidemiological: e.g., mortality and morbidity); however, the patient or the delivery site of care likely
are the most useful focal points for orthotics and prosthetics (O&P). As such,
O&P outcomes may address at least
three aspects of patient care:
- Clinical. Was the care or service appropriate, and/or did it achieve desired
results, such as restoration of function
or reduction of physiological anomaly?
- Quality of Life. Did the care or service improve the psychosocial well-being of the patient and/or return the patient to his/her previous role in his/her
personal life or work?
- Satisfaction. Was the patient satisfied with the care received, especially in
the context of access, general perceived
quality and cost-effectiveness, timeliness, etc.?
Why Outcomes Measurement?
The advent of outcomes measurement
can be attributed to several dynamics
within the healthcare field and within
those segments of society that have a
direct interest in healthcare delivery:
payers, patients and the general public.
As noted by Slater (3), five major factors have elicited an increasing demand
for demonstrable evidence of optimal
outcomes:
- The continuing escalating costs of
care have generated demands that such
costs effectively achieve desired results.
- There is limited evidence of the effectiveness of medical care in improving the health and well-being of the
population.
- Clinical evidence from studies by
Wennberg, Kohn and Park shows a potential exists for increasing the effectiveness of medical care. These studies,
which focused on the system and patient care levels, demonstrated the use
of explicit criteria and outcomes measurement does have a positive impact
on the quality and effectiveness of
care.
- There is wide, unexplained variation in treatment paradigms and results
for specific medical conditions.
- Despite equivocal efforts by the
federal government, healthcare reform
is a growing phenomenon at the state
level in an attempt to control (or even
reduce) healthcare costs.
As a consequence, outcomes research
and measurement have become the
preferred approach to linking cost,
quality and efficiency to realize "cost-effectiveness." Thus, outcomes measurement attempts to respond to the questions being addressed by current studies
sponsored by the Agency for Health
Care Policy and Research (AHCPR).
AHCPR has engaged in medical
treatment effectiveness (MEDTHP)
research, the goal of which is to "improve the effectiveness and efficiency
of those clinical interventions whose effects are demonstrable and beneficial
from those whose effects are adverse,
equivocal, improbable or unimportant."
The agency is investigating how
healthcare interventions affect patient
outcomes; which treatment option is
better (as measured by cost, efficiency
and outcomes); and whether treatment
alternatives reflect the patient's values.
What Are Clinical Pathways?
Clinical pathways are known by a variety of terms, such as practice guidelines,
clinical protocols, parameters and
benchmarks. Clinical pathways represent a continuum of care that identifies
structures (institutions, facilities, etc.),
caregivers (clinical professionals) and
processes (treatment paradigms) that
intervene at critical points to efficiently
treat the patient and achieve a defined
outcome.
Clinical pathways can be illustrated
by the "Fishbone" (Ishakawa) approach (see Reference 1); however,
pathways do differ from more traditional monitoring and evaluation
(M&E) methodologies. Specifically,
M&E programs tend to concentrate on
component segments of the treatment
experience (e.g., care received within
an acute care setting only). In contrast.
clinical pathways span all possible settings, caregivers and patient care support programs.
Similarly, clinical pathways differ
from the more traditionally understood
practice parameters/guidelines in the
context of timelines and collaborative
relationships among caregivers and settings. For example, practice guidelines
nay not address timeliness of service
whereas pathways typically establish
critical points along the treatment continuum in which interventions occur. In
addition, since guidelines generally focus only on selected segments of the
treatment paradigm, the ability to link
diverse caregivers and settings and
their impacts on outcomes become
more problematic.
In essence, pathways reinforce the
concept of collaboration among a
caregivers and permit the evaluation of
outcomes according to the impact of
each provider and setting of service. Finally, critical pathways facilitate more
meaningful analysis of patient satisfaction (as one measure of outcomes)
since such level of satisfaction can be
traced back to specific components of
the paradigm.
The virtues of clinical pathways,
however, also can present dilemmas for
O&P Current experience with pathways generally has been limited to
acute medical/surgical issues and to circumstances in which direct linkages can
be established among the various settings of care. Thus, pathways usually
have been developed with the hospital
as the focal point; that is, hospital-based
pathways are more easily established
since they may span various departmental services that can be directly
controlled by the institution. When
such pathways account for non-hospital
settings and caregivers, they commonly
do so by linking those settings under
the direct control of the hospital (e.g.,
ambulatory clinics, durable medical
equipment, home health, hospital-owned practices, etc.). In other words,
pathways are more easily formulated in
vertically integrated systems of care in
which some centralized control can be
established over all settings.
In contrast, most O&P practices are
independent entities and are not directly tied in an organizational sense to related settings in which O&P patients receive care. As a consequence, it becomes
more difficult to link the independent
settings (orthopedic practitioners, physical therapists, occupational therapists,
hospitals, nursing homes, etc.) in a cohesive, collaborative relationship. Despite
this problem, critical pathways can be
an integral feature of an O&P outcomes
measurement program.
Developing Clinical Pathways in O&P
Much like the PDCA (plan; do; check;
act) and FOCUS (finding a process to
improve; organizing a team that knows
the process; clarifying knowledge of the
process; understanding sources of process variation; and selecting the process
improvement) approaches to monitoring and evaluation (see Reference 1),
similar methods may be used to define
clinical pathways. Howland (4) suggests
a six-step approach.
Step One: Identifying the Condition,
Patient Group or Service
Clinical pathways can be developed for
medical conditions, specific patient
groups or actual services. For example,
a medical condition such as scoliosis or
multiple sclerosis may be the focus of a
clinical pathway. Similarly, patient
groups may be addressed, such as geriatric or pediatric populations. Finally,
specific services, such as prostheses for
transfemoral amputees, upper-extremity amputees, etc., also can be used to
determine clinical pathways.
High-volume, problem-prone or
high-risk issues may serve as the keys
to identifying the clinical path issue.
Similarly, the dynamics of cost and/or
physician or payer interest may help
isolate the issue to be addressed.
Step Two: Identifying Key Caregivers
and Creating a Team
Caregivers represent the linchpin to
successfully developing and implementing clinical pathways. Essential
healthcare providers, including institutional providers, must be identified to
form a decision team that will define
the scope and format of the pathway. In
addition, these key caregivers will become the managers of their respective
components of the treatment continuum. It also is important to identify peripheral personnel who could be affected by the pathway's requirements, including managed-care case managers
and others who influence the intensity
of care and choice of treatment center.
Step Three: Identifying Current
Processes and Protocols for Treatment
As the initial activity to establish a template of care from which the pathway
will be constructed, the team should
evaluate both internal and external
processes that contribute to and represent the existing treatment parameters
of the issue. The evaluation should respond to such questions as:
- What is done and why?
- What is the value of the current
process?
- How could the care be modified,
refined or performed more efficiently?
- What are the barriers (access, availability, reimbursement limitations, etc.)
to effective treatment?
Step Four: Developing and
Implementing the Pathway
On the basis of what is learned about
the current processes and what can be
identified in the scientific field about
deal protocols, the team should carefully construct the pathway. The process requires the team to identify critical services/procedures by specific time
intervals for each of the relevant caregivers and associated treatment interventions.
Step Five: Defining Key Conformance
Measures and Developing Data
Collection Methods
Conformance measures generally will
center on the use of indicators to determine compliance with the specific elements of the pathway. This will include
adherence to intervention timelines
and involvement of appropriate personnel to deliver the service. Finally, the
team should be prepared to interpose
appropriate changes or modifications
to the pathway to improve performance.
With respect to pathway evaluation
data must be collected based on operational definitions of each point along
the pathway (defining the elements of
the treatment/service and caregiver responsible for the treatment). This face
of the pathway regime also requires the
use of a specific method of data collection, including the identification of responsible individuals for data and
clear explanation of how the data will
be used and/or published.
Step Six: Analyzing Results and
Instituting Appropriate Refinements
As with the M&E model, clinical pathway programs will aggressively evaluate outcomes results for the purpose of
instituting appropriate changes to the
pathway. Analysis will include an examination of changes in use of resources;
deviations from the pathway; changes
in outcomes; and changes or trends in
satisfying patient expectations.
Conclusion
Understanding outcomes measures
become increasingly important in today's managed-care environment. Clinical pathways, which permit the evaluation of outcomes according to the impact of each provider and setting of service, identify the critical points of the
treatment process that lead to the eventual outcome. Howland's six-step approach to identifying clinical pathways
is one useful method for assessing outcomes related to O&P
LANCE 0. HOXIE is executive director of
the American Board for Certification in Orthotics and Prosthetics Inc., 1650 King St.,
Suite 500, Alexandria, VA 22314.
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primer for orthotic and prosthetic care.
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assessment. Ann Arbor, Mich.: Health Administration Press.
- Slater CH. Health Services Organization, University of Texas School of Public
Health, Houston, Texas. Commentary and
outlines.
- Howland R. Presentation on clinical
pathway development, Oct. 26, 1995.
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Joint Commission on Accreditation of
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- Raskin JE, Maklan CW. Medical treatment
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- Tarlov A, Ware J, Greenfield 5, et al. The
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