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Wound Healing Outcomes: The Impact of Site of

Care and Patient Stratification


William J. Ennis, DO, MBA, FACOS, Emily Fibeger, DO, Katie Messner, MS,
Patricio Meneses, PhD
Wounds. 2007;19(11):286-293.
Abstract and Introduction
Abstract
As healthcare providers prepare for pay for performance (P4P) and
outcomes-based reimbursement strategies, it is increasingly important to
document clinical results. Historically, healing rates have been reported
from hospital-based, outpatient wound clinics. Time-to-healing curves from
one site of care may not accurately reflect the entire healing "episode of
care." Few outpatients from a wound clinic require hospitalization and even
fewer are admitted to sub-acute care. Care setting and population risk
strata must be clearly identified before comparing wound outcomes data.
Aim. Primary objectives were to determine comparability of complete
healing and 50% wound volume reduction of current and prior sub-acute
care programs. Predictive value of Minimum Data Set (MDS 2.0) items on
admission was also explored in discriminating healing versus nonhealing
patients. Methods. Wound outcomes were analyzed for all patients (N =
101) treated at a dedicated sub-acute wound unit from January 2006
through April 2007 in a prospective, longitudinal, intent-totreat, cohort
study. Results were compared to prior sub-acute care wound outcomes
reported by a similarly composed team using similar protocols. Results. Of
101 evaluable patients with 209 wounds, 41.6% healed in a median of 7.9
weeks while 31.6% achieved >50% volume reduction. Outcomes were
similar to prior sub-acute results, but less than the 72%-74% healing rate
reported by a similar team in hospital outpatient clinic programs. Minimum
Data Set comorbidities analyzed did not significantly predict nonhealing.
Conclusion. To allow risk-adjusted P4P and reimbursement metrics, wound
outcome reports should include clinical team involved, protocol utilization,

care setting, and case mix severity to control for variables associated with
different settings.
Introduction
Healing rates have become both clinical and marketing tools for many
wound care centers. The recording and reporting of clinical results are
imperative in today's health care marketplace. Published articles, however,
rarely stratify a patient's risk in outpatient settings. Patients not seen in
clinic for 30 consecutive days are considered lost to follow-up and that
clinical episode is closed out from the data set. For example, a patient
presents for a consult with a venous leg ulceration of 1-year duration that
was unsuccessfully treated in a primary care physician's office. The wound
carries a heavy bioburden and fibrin load requiring an office-based
debridement followed by 3 weeks of moist dressings and compression. The
patient fails to improve and is admitted to the hospital for 1 week of
treatment including intravenous (IV) antibiotics and surgical debridement.
On discharge from the hospital, the patient is transferred for a 6-week stay
in a sub-acute unit. A total of 8 weeks later, the same patient returns to the
outpatient clinic from home due to a plateau in healing after 2 weeks of
home health therapy and is re-enrolled in the clinic as a new patient. The
wound is now 75% smaller in area than at the time of the original consult.
Compression and moist dressings are again applied and the wound
completely heals in 5 weeks. The various outcomes from this single case
include, 1 year of treatment without improvement in a primary care office, a
new consult lost to follow-up without healing in 3 weeks in the wound clinic,
a hospital stay of 5 days with an increase in wound size status post surgical
debridement, a 6 week sub-acute stay with a 50% volume reduction in 6
weeks, home health care for 2 weeks with no change in wound size, and a
completely healed wound treated in 5 weeks in the outpatient clinic. The
"episode of care" outcome, however, describes a venous leg ulceration that
required 69 weeks of therapy including primary care visits, wound clinic

treatment for 8 weeks, home health care for 2 weeks, a sub-acute care stay
of 6 weeks, and 1-week hospitalization. This clinical example is a common
scenario and represents the importance of defining the site of care when
analyzing wound healing data. Each point along the continuum of care acts
as a "silo" of care and not part of a larger system of care. Additionally,
current reimbursement policies create the potential for each site of care to
maximize economic outcomes that may not make clinical or economic sense
if the entire "episode of care" was integrated across settings. Concepts such
as pay for performance are a step in the right direction, but also focus on
achieving benchmarks from individual sites of care and, therefore, fail to
achieve true integration across care settings.
The authors have created an integrated care approach to wound
healing using a combination of strategically aligned groups that do not
function under the same corporate umbrella. Patients are seen in an
outpatient, not for- profit, hospital-based wound clinic. In addition, inpatient
wound care is provided for a second hospital that belongs to a completely
different not-for-profit organization. The clinic admits directly to both of the
hospitals in which inpatient care is provided. The authors' sub-acute wound
unit is a privately owned for-profit center with no formal business
relationship to either hospital. The home health agencies are operated by
each of the 2 previously described hospitals. The authors' prosthetics and
orthotics group provide services at all locations and are a small privately
held firm. The specialists that consult and work with the authors' team are
mainly from private practice models. The entire team, including physicians,
are salaried and have no volume or procedure-driven economic incentives at
any of the sites of care. The single most difficult aspect of providing care in
this model is case management. Not only does it represent the most time
consuming component of overall patient care, it is the least economically
productive. It seems paradoxical that the most critical piece of the final
clinical outcome carries with it no form of reimbursement. The current
model encourages procedure volume and fails to reward outcomes.

With that as a backdrop, if there is to be any change in the financial


structure of wound care, wound care clinicians need to collect, analyze, and
publish outcomes from all sites of care and for all strata of patient risk and
wound complexity. Therefore, the authors set out to validate earlier
published results from a sub-acute wound program run by the authors a few
years ago. Validating those outcomes would confirm reproducibility of the
clinical model across settings. The hypothesis was that a systematic
approach to patient care could be reproduced in a similar, but new facility,
given that the clinical wound team was held constant.
Objective
The primary objective of the study was to identify the healing
outcomes both as a percentage of the total population and in relation to
time of treatment. Another primary objective of the study was to validate
the results from an original pilot program conducted at a similar private,
for-profit facility that was part of a large, national chain of nursing homes. A
secondary objective was to identify any patient characteristics on admission
to the unit, using the US Centers for Medicare and Medicaid Minimum Data
Set 2.0, which could be used to predict final outcomes. (The Minimum Data
Set 2.0 is a US Centers for Medicare and Medicaid [CMS] initiative that was
introduced as a part of the Nursing Home Reform Act of the Omnibus
Budget Reconciliation Act of 1987).
Study Design
The entire study was conducted at the authors 25-bed, sub-acute
wound unit dedicated to the treatment of patients admitted with nonhealing
wounds. The unit resides within a 300-bed, privately owned, for-profit
nursing home/long-term care facility, one of several facilities owned by the
company. The executive team was highly involved and encouraged the
development of a clinically focused, outcomes driven unit. The nurse and
physical therapists on the unit treat only patients with chronic wounds and

have worked with the authors implementing prior programs. Patients


originate from a hospital based wound clinic that receives more than 2500
patient visits per year (on average). A previously published systematic
approach and treatment protocol is utilized for all patients with nonhealing
wounds of any etiology.[1] The clinic has generated an average of 150
hospital admissions per year for the past 6 years. A percentage of patients
are then transitioned from the inpatient unit to the sub-acute wound unit for
advanced inpatient care. This group of patients is either too debilitated or
their wound care requirements exceed those fulfilled in the home or
outpatient clinic. Results obtained from this sub-group of patients constitute
the basis of this report.
The current sub-acute program was created January 1, 2006. All patients
admitted to the program between January 1, 2006 and May 1, 2007 were
included in intent to- treat analysis, with a statistical significance criterion
of P 0.05. The only patients excluded were those with either no wound (ie,
a wound recently closed with a myocutaneous flap, admitted for offloading
and antibiotics) or patients who had a single visit (patients seen once and
then transferred to an acute care hospital). This group contained 8 patients.
Each patient was admitted to an internal medicine or family medicine unit
for general medical care by the attending physician. A wound physician saw
the patient on admission and weekly on rounds. A comprehensive wound
treatment plan was designed and care was delivered by the nurse and
wound care physical therapists. All advanced wound care products were
available, as well as IV antibiotics, total parenteral nutrition, rehabilitation
services, pharmacy, and nutritional consultative support. Wound modalities
including negative pressure wound therapy, ultrasound -- both Megahertz
and MIST Ultrasound Therapy (Celleration, Eden Prairie, Minn) -electrical stimulation, and ultraviolet light, were employed when indicated.
The physical therapist or physician performed wound debridement as
needed. Each week the wound physician selected the modality and dressing
treatment plan to meet the needs of the wound and the patient as identified

by standardized assessments. Orthotic and prosthetic consultation was


available on site for offloading and compression. A physician specializing in
infectious disease evaluated all patients weekly to monitor culture results
and antibiotic levels. The wound nurse and wound clinic staff communicated
daily to organize patient transition to and from the hospital for staged
procedures, and ensured that on discharge patients were transitioned
smoothly back to the outpatient program.
As part of the admitting process, the nursing home conducted a
formal intake history and completed the Minimum Data Set (MDS 2.0)
forms. The nursing home MDS coordinator completed this form on
admission, every 90 days, and each time a patient was either admitted to
the hospital setting or when a significant clinical event occurred. The MDS
data were captured electronically and translated into a format compatible
with SPSS software. Each weekly clinical visit was entered into this
electronic database. Parameters including wound length, width, depth,
dressings utilized, procedures performed, admissions to the acute care
setting, as well as wound area and volume, were recorded. When the
patient's wound was either healed, or the patient was ready to be
transitioned to the next site of care, a final disposition was recorded
electronically -- wound outcomes were reported as "healed,""more than 50%
volume reduction," or "50% or less volume reduction. "A large database was
constructed combining the admitting MDS information with the complete
clinical record for each patient's entire sub-acute care stay. After all
information was entered for an individual patient, all identifiers were
eliminated to protect patient privacy.
The study was a prospective, longitudinal, outcomes analysis from a
sub-acute wound care unit. Patients were not randomized.All patients with
wounds and more than 1 visit were included in the intent-to-treat analysis.
The comprehensive wound assessment and treatment system was utilized as
standard of care.[1] The results were compared to previously published
outcomes as a historical control.[2]

Results
A total of 109 patients were enrolled in the database. There were 101
patients with 209 evaluable wounds, excluding 8 patients who had 1 visit or
a closed wound on admission. Demographics are described in Table 1 .
Although there were more women enrolled in the study, the number did not
achieve statistical significance. There were statistically more patients in the
61- to 70-year-old group than in any other group (P = 0.039). Neither age
nor sex was correlated with healing outcomes ( Table 2 ). Outcomes were
divided into 2 distinct groups. Group 1 included those patients achieving
complete healing and those with marked improvement (defined as >50%
reduction in wound volume). Group 2 consisted of patients who improved
but did not achieve 50% volume reduction, patients whose wound size
remained unchanged, and those with a deteriorating wound. Kaplan-Meier
derived median time to healing was 7.9 weeks for patients in Group1
(Figure 1). A statistically significant difference was noted when wound
outcomes were separated by wound etiology ( Table 3 ). Traumatic wounds
were noted to heal in a short time interval compared with other wound
etiologies.Wound location and initial wound volumes are described in Table
4.
Discussion
Previously published data from a single clinical team working from
two distinctly different hospital based wound programs, demonstrated that
consistent outcomes are achievable using a uniform clinical approach to
wound care.[3] Patients in that study were analyzed from a 200-bed
community hospital based wound program, and a 700-bed level 1 tertiary
center. Those outcomes, while consistent, were taken from a single care
setting. Even prior data[2] from the present authors single sub-acute
program can be further analyzed. For example, the overall healing and 50%
volume reduction group totaled only 53% in a study of 346 patients with
680 wounds published by the authors using the same clinical team that

conducted the present study (Program 1 in Table 6 ).[3] An overall


comparison of 3 data sets from sub-acute wound programs clinically
managed by the authors and their clinical team is shown in Table 6 . The
data[2] from Program 2 and the current study represent patients who were
accepted only from the authors' two hospital programs. The wound care
team case managed these patients starting from the outpatient center
through the hospital admission, and subsequently in the sub-acute wound
program.

Long-term

IV

access,

surgical

debridement,

and

medical

stabilization of the patient occurred before discharge to the sub-acute unit.


These 2 programs demonstrated statistically significant increases in healing
and 50% wound volume reduction compared to Program 1. Hospital length
of stay can be minimized using these specialized units, which benefits the
economics for the hospital while minimizing unnecessary risks of prolonged
hospitalization for the patient. When patients are admitted to a sub-acute
wound program from outside hospitals, as was the case in Program 1, it is
difficult to achieve equivalent outcomes as the critical steps along the
continuum of care may not have been optimized. The healing rates from
hospital outpatient clinic programs range from 72%-74% compared to
41.6%-45.9% in the sub-acute programs.[3] Evaluating these publications
separately, one would conclude that the clinical success rates were
excellent in the outpatient setting and sub-optimal in the sub-acute
program, but might not notice that the publications were written by the
same clinical team, applying the same standardized wound and patient
assessments and protocols of care. Outcomes data in wound care, therefore,
need to address the clinical team involved and its point of involvement
along the continuum of care, the setting of care, and an analysis of the
patient population (case mix/severity indexed, etc.).
The results of this study represent strong patient selection bias. For
example, over the past 8 years the authors have generated a hospital
admission for every 20 clinic patient visits. An average patient accumulates
10 visits during therapy.With 2500 patient visits per year, this yields

approximately 250 new patients to the program per year. On average, 100
patients are admitted to the hospital, with 150 admissions overall during a
1-year period (a 50% re-admission rate). Therefore, 40% of all patients seen
in the clinic require at least a 1-day stay in the acute care setting.
Approximately 25% of admitted patients are transferred to the sub-acute
program. In total, therefore, only 10% of all patients seen in the authors'
outpatient wound clinic are admitted to the sub-acute program. It is fair to
assume that these patients represent a medically complex subgroup from
the original cohort.The healing rates in the acute care and sub-acute care
settings, therefore, would not be expected to mirror each other.
Predictors of Healing
Specialized wound centers have been shown to achieve improved
healing rates compared to more fractionated care. [4] However, comparisons
between centers are difficult and possibly misleading. Would an outpatient
center that primarily focuses on venous leg ulcers demonstrate an
equivalent healing rate compared to a vascular surgery based program that
treats critical limb ischemia? Keyser[5] reported an 88% healing rate for
diabetic foot ulcers, while others report healing rates of 38%. [6,7] One report
in the literature quotes 100% healing in an outpatient clinic. [8] Further
research is needed to define the parameters that underlie such varying
outcomes. Outcomes of success and mortality are now in the public domain
for coronary artery bypass grafting at most hospitals. Clearly, there are
differences in outcomes between high volume centers of excellence and
those from less experienced centers. The wide variation in healing rates -reported in the literature from 38% to 100% -- probably reflect case mix and
reporting differences rather than wide clinical variation. [6-8]
In addition to the outcomes reporting problem, there is a relative
absence of wound care education for healthcare professionals. A recent
survey of medical school curricula reveals, on average, a medical student
receives only 9 hours of education on wound healing over a 4-year

undergraduate medical degree program.[9] As no single provider group has


complete

expertise

in

wound

healing,

it

is

not

surprising

that

multidisciplinary teams can achieve improved clinical and economic


outcomes, especially in the nursing home environment.[10]
In an effort to assist clinicians in determining which patients will
respond to treatment, the authors hypothesized that there might be a
clinical/functional "profile" that could be used as a predictive tool. The MDS
2.0 is a US Centers for Medicare and Medicaid (CMS) initiative that was
introduced as a part of the Nursing Home Reform Act of the Omnibus
Budget Reconciliation Act of 1987. MDS is part of a comprehensive resident
assessment

instrument

(RAI)

which

contains

information

on

clinical,behavioral, and social status of nursing homes. [11,12] The RAI consists
of the MDS, utilization guidelines, and Resident Assessment Protocols
(RAP).[11] When a patient has a particular MDS status that matches a trigger
for a RAP,1 or more of 18 problem-based RAPs are performed. Several MDS
criteria have been validated as predictors of pressure ulcer development.
Vap et al[13] determined that the MDS was less sensitive but more specific in
predicting the development of a pressure ulcer compared with the more
popular Braden Score. Bates-Jensen et al[14] found problems using a
patient's bed bound status, one of the MDS quality indicators, because of
significant underreporting in the facility. In another study, Bates-Jensen et
al[15] were unable to correlate nursing homes with low pressure ulcer
prevalence with improved clinical care processes.
Despite conflicting reports it appears that overall quality of care has
improved in nursing homes since the release of the MDS. [16] Although Jones
et al have recently tried to identify clinical and functional aspects of the
patient history to predict pressure ulcer healing there is minimal published
literature on the topic.[17] Vap et al,[13] found that specific MDS components
correlate with pressure ulcer risk. We attempted to utilize some of these
parameters to determine if they could be used as predictors of wound
healing. Bedfast status, bowel incontinence, use of bed rails for transfer,

and the use of a transfer aide, were not found to have statistical correlation
with the ultimate outcome of healing or marked improvement ( Table 7 ).
Conclusion
In this prospective, longitudinal, intent-to-treat study of patients
within a comprehensive sub-acute wound program, a 41.6% healing rate
and a >50% wound volume reduction rate of 31.6% were achieved in a
median time to healing of 7.9 weeks. These results were similar to
published outcomes from a previous program managed by the authors. [2]
The similar outcomes of this study support the primary conclusion that a
wound program can be reproduced if the same clinical approach is taken,
regardless of physical plant, staffing, and ownership of a nursing home.
However, a comparison of these results to published healing rates from an
outpatient, hospital based wound clinic run by the same clinical team using
the same protocols of assessment and care, highlight the importance of
identifying the population under study, early intervention, and the clinical
site of care. Additionally, readily available MDS criteria may prove useful for
the prediction of wound development, but are unlikely to assist a clinician in
predicting who will respond to therapy.
It is evident that some form of wound indexing or severity indices are
needed to help wound care clinicians maximize clinical outcomes and select
therapeutic options from the myriad currently available to the wound care
clinician.The wound care field is unique in that therapeutic options have
outpaced diagnostic and predictive innovation. Part of the problem is that
woundcare societies have been unable to translate cognitive and case
management work efforts into meaningful, appropriate evaluation and
management codes, and ultimately reimbursement. Wound care clinicians
can look forward to wound profiling, bioassay development, wound severity
scoring, and gene expression changes in wound tissue as described in the
eloquent work by Brem et al,[18] as a potential means to predict outcomes,
prevent occurrence, determine debridement margins, and to select the most

economical and clinical effective therapies available for patients. A useful


wound scoring system will need to include patient comorbid conditions and
quality of life parameters. The APACHE score (acute physiology and chronic
health evaluation) score used in the critical care industry provides a useful
analogy.[19] Outcomes data are very important and there is a need for all
clinicians in various sites of care to report on their work.The larger task at
hand will be to string these outcomes together in order to provide accurate
clinical and economical episode of care data.
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