eMeasure Title

CDR 6: Venous Leg Ulcer Healing or Closure

eMeasure Identifier (Measure Authoring Tool) 453 eMeasure Version number 0.0.007
NQF Number None GUID a5f2a331-298f-403b-911b-2854ba79eb8f
Measurement Period January 1, 20XX through December 31, 20XX
Measure Steward US Wound Registry
Measure Developer US Wound Registry
Endorsed By None
Description
Percentage of venous leg ulcers of patients age 18 or older that have achieved healing or closure within 6 months, stratified by the Wound Healing Index. Healing or closure is defined as complete epithelialization without drainage or the need for a dressing over the closed ulceration, although venous compression would still be required.
Copyright
None
Disclaimer
None
Measure Scoring Proportion
Measure Type Outcome
Measure Item Count
Occurrence A of Diagnosis: Venous Leg Ulcer Grouping
Stratification
Many studies over the past 20 years have identified factors known to negatively impact healing. Even though these individual factors are known to be important, they have only recently been successfully been incorporated into a validated model which can predict the likelihood of wound healing. The Wound Healing Index (WHI) was achieved through a collaboration of scientists at the Institute for Clinical Outcomes (Salt Lake City, UT) and Intellicure, Inc. (The Woodlands, TX) using data from the U.S. Wound Registry (USWR).  

We developed a comprehensive stratification system for patients with wounds that predicts healing likelihood. Complete medical record data on 50,967 ulcers from the United States Wound Registry were assigned a clear outcome (healed, amputated, etc.). Factors known to be associated with healing were evaluated. Logistic regression models were created based on variables that were significant (p<0.05) and subsequently tested on a hold-out sample of data. Seven models were developed because a different model predicted healing for each wound type (e.g., diabetic foot ulcers, pressure ulcers, venous ulcers).  
For example, the Venous ulcer WHI contains the following 7 factors:

1. Wound age (duration) in days (calculated from wound onset) at first encounter.
2. Wound area in sq cm (calculated from length x width) at first encounter.
3. Does the patient have peripheral vascular disease (for example, symptoms like claudication, rest pain, gangrenous changes or other findings suggestive of leg ischemia, or studies confirming vascular disease)?
4. What is the patient's primary ambulatory method? (walks unaided, cane, crutches, walker, roll about, scooter, wheelchair bound, bed bound)
5. Was the patient admitted to the hospital or the emergency department on the date of service?
6. How many total wounds or ulcers of any type does the patient have?
7. Does this wound have evidence of infection or bioburden? (evidenced by: purulent, green, malodorous drainage, peri-wound induration, tenderness to palpation, warmth)

We will stratify the venous ulcer outcome measure using the WHI which contains both patient and wound factors to stratify risk.
Risk Adjustment
None
Rate Aggregation
None
Rationale
A rough population prevalence rate for chronic non-healing wounds in the USA is 2% of the general population. Ulcers caused by chronic venous insufficiency constitute 70%–90% of all lower extremity ulcers. A conservative estimate of the staggering cost of caring for chronic wounds in the USA exceeds $50 billion dollars per year. This is 10 times more than the annual budget of the World Health Organization. Despite the fact that the prevalence rate of chronic wounds is similar to that of heart failure, unlike heart failure, little is known regarding the outcome of these patients.  Patients with chronic wounds suffer from a multitude of co-morbid conditions that would have excluded them from nearly every RCT performed in the past 10 years (Carter, Fife 2009). RCTs in wound care have also consistently failed to provide data on the most vulnerable populations such as those with dementia, the disabled, racial minorities, and the very elderly. Nevertheless, most of what we know about wound “outcomes” has been derived from these studies (e.g., healing rates, time to heal). 

Some wound care-related organizations have reported “healing rates” as a measure of the success of their program or product, but these data have been vetted (usually post hoc) by excluding patients retrospectively classified as “palliative care” or those with “anticipated amputations” so that the apparent success of the program is not impacted by patients unlikely to do well. Thus, data regarding “real world outcomes” among outpatients with chronic wounds has been difficult to obtain. The USWR has previously published outcome data on 5,240 patients with 7,099 wounds from 59 hospital based out-patient wound centers (Fife, Carter 2012). The mean age of the patients was 61.7 years and 52.6% were Medicare beneficiaries with nearly 5% being dual eligible (Medicare Medicaid). Other USWR studies focused exclusively on venous ulcer patients have showed that approximately 30% of patients with venous stasis ulcers had diabetes as a co-morbid condition and 70% were obese or morbidly obese. When the USWR evaluated the activities of daily living in 500 patients with venous ulcers, we found that 60% of them were not able to dress their lower bodies unaided (Limitations of Daily Living Activities in Patients With Venous Stasis Ulcers Undergoing Compression Bandaging: Fife, et al, Wounds, Volume 26 (1) Jan 2014 http://www.woundsresearch.com/article/7891). This further emphasizes the importance of the interventions provided by wound care clinicians such as compression bandages.

When the outcomes of patients with chronic leg ulcers were evaluated from 59 hospital outpatient wound centers, nearly one third never healed, even though they were followed for more than one year. The average leg ulcer patient had at least 2 major co-morbid conditions with 10% having peripheral arterial disease and 8% taking steroids or transplant medications. 
The above data have the following implications:
1)	Outcomes from wound care related RCTs fail to provide an accurate picture of real world outcomes for diabetic foot ulcers or other wound types because RCTs a priori exclude patients with serious co-morbid conditions
2)	Outcomes reported by many wound care organizations do not reflect real world realities because they post hoc vet data (reported healing rates > 80% unstratified by risk are unlikely to be realistic).
3)	Data from the USWR emphasize the importance of risk stratification in reporting outcomes.
Clinical Recommendation Statement
 
Improvement Notation
Higher percentage indicates higher quality
Reference
Estimating the applicability of wound-care randomized controlled trials to general wound care populations by estimating the percentage of individuals excluded from a typical wound care population in such trials. Carter MJ, Fife CE, Walker D, Thomson B. Adv Skin Wound Care. 22:316-24, 2009.
Reference
Wound Care Outcomes and Associated Cost Among Patients Treated in U.S. Outpatient Wound Centers: Data from the U.S. Wound Registry, Fife, CE, Carter MJ, Walker D, Thomson B. Wounds 2012; 24(1) 10-17.
Reference
Development of a Wound Healing Index for Patients with Chronic Wounds; S Horn, C Fife, R Smout, R Barrett, B Thomson, Wound Rep Regen (2013) 21 823-832.
Reference
Limitations of Daily Living Activities in Patients With Venous Stasis Ulcers Undergoing Compression Bandaging: Fife, et al, Wounds, Volume 26 (1) Jan 2014 http://www.woundsresearch.com/article/7891
Reference
Bolton L, Corbett L, Bernato L, et al. Development of a content-validated venous ulcer guideline. Ostomy Wound Manage. 2006;52(11):32–48.
Definition
Healing or closure is defined as complete epithelialization without drainage or the need for a dressing over the closed ulceration, although venous compression would still be required.
Guidance
None
Transmission Format
TBD
Initial Population
All venous leg ulcers of patients 18 or older with an encounter during the measurement period.
Denominator
Equal to Initial Population
Denominator Exclusions
Death, Palliative care patients,  VLU patients who have an amputation,  VLU patients seen for consultations only, VLU patients who are lost to follow-up, VLU patients with <2 visits
Numerator
Venous Leg Ulcers within the denominator that achieved healing or closure within 12 months of its initial encounter.
Numerator Exclusions
None
Denominator Exceptions
None
Supplemental Data Elements
For every patient evaluated by this measure also identify payer, race, ethnicity and sex.

Table of Contents


Population Criteria

Data Criteria (QDM Variables)

Data Criteria (QDM Data Elements)

Supplemental Data Elements

Risk Adjustment Variables


Measure Set
None