NIHB Presentation January 2012
Carlyle Begay
American Indian Health Management Policy
Phone: (602) 206-7992
Email: cbegay@aihmp.com
Wound Healing Model
Oklahoma City Area Indian Health Service:
One Experience
Access to care:
Wounds Have a Golden “Hour”
• From the onset of the wound…IHS patients need wound
care sooner than later
– 30 days to prevent further breakdown, infection,
progression to amputation
– Standard of Care now requires definitive care at or
before 4 weeks with the introduction of advanced
therapy to treat the wound
Complications of Diabetic Foot Ulcers
• DFUs that persist more than 4 weeks have 5-fold higher risk of infection.1
• Development of an infection in a foot ulcer increases the risk for
hospitalization 55.7 times and the risk for amputation 155 times.1
• “Infected neuropathic ulcerations are the leading cause of diabetes-related
partial foot amputations at the Phoenix Indian Medical Center.”2
• Foot ulceration is a significant risk factor for lower-extremity amputation
in Native American Indians.3
Diabetes
1.
2.
3.
Neuropathy
Foot Ulcer
Infection
Amputation
Lavery et al. Risk Factors for Foot Infections in Individuals With Diabetes. Diabetes Care. 2006;29:1288-93.
Dannels E. Neuropathic foot ulcer prevention in diabetic American Indians with hallux limitus. J Am Podiatr Med Assoc. 1989;79:447-50.
Mayfield et al. A foot risk classification system to predict diabetic amputation in Pima Indians. Diabetes Care. 1996;19:704-9.
Amputations are a serious predictor of death…
Consequences of Unhealed
Neuropathic Ulcers
Nearly half of all
unhealed neuropathic
ulcers result in death
within 5 years
Armstrong DG. Int Wound J. 2007;4(4):286-287.
Why Organized Wound Care?
For three reasons:
Access to care for patients
Advanced treatments previously only available
private sector providers
Ability to collaborate no matter the skill level of
the provider for a positive patient outcome
Pre-wound model findings…
• From 2004 to 2005 identified:
• 76% of the patients had untreated or undertreated wound
infections for wound healing
– The number one choice in dressings was ointment and
gauze
– The average treatment time for patients was 26 weeks !
before definitive care was provided
– There was a great variation among IHS clinicians on how
to provide appropriate wound management principles
Barriers to Wound Healing Model
– Lack of “buy in” by clinicians
– Inconsistent off-loading
and other support services
– Lack of wound specific
– Personal preference practice
– Skipping steps in the
pathways/care models
– Failing to recognize and treat
sub-clinical infections
– Inconsistent antibiotic
therapy
supplies/advanced therapy
– Wait and see medicine
– Premature discharges and
inappropriate transfers
– Funding not readily available
for clinic start up
The Solution
• Shift from a cost to treat model to a cost to heal model
– Cost avoidance by early intervention (more cost efficient to heal
simple wounds) and reduction in waste through standardization
• Continue to reduce costs
– Standardize dressings and treatments to optimize results
– Standardize wound care processes at multiple sites for consistent
patient care and to increase patient access
Non-Reimbursement Driven and Cost Efficient
– Best Practice models for advanced therapies designed to
be revenue neutral if not revenue positive; and driven
by the latest best practice guidelines for wound care
Key Clinical Components
• Tested Clinical Pathways that produce a consistent >95% heal rate
• Best Practice advanced therapy models
• Understanding barriers to wound care
• Documentation enhancement specifically for wound care and compliance
• Enhanced clinical training time
Advanced
Treatment Modalities
• Ultra-sound debridement
• Negative pressure wound therapy
• Growth factor therapy
• Pulsed Electromagnetic wound stimulation
• Living Skin Equivalent Grafts for in clinic use
• Oxygen Therapy
Initial Results
• March 1, 2006 thru June 30, 2007
– Average patient load per day: 11 - 14
– 3171 total patient visits
– 446 new patients
– 333 healed patients
– Healing rates reached of 96.86% in 8.43 weeks (industry average of
81-93% in 7 – 16 weeks)
– Reduced amputations in program to <2% with reduced overall Area
amputations of 36%; less than 3% reoccurance rate
– CHS cost savings directly attributed to wound program of over $6
million annually
Indirect Results of the Wound Program
(represents amputations not associated with the Wound Management Program)
CHS Cost Savings
using direct care wound program vs. traditional home self care…for example
when comparing similar wounds/patients
• With Organized Direct Care
Wound Program
– 42 y/o male with scrotal
abscess
• I&D including brief IHS
hospital post-op stay
w/referral to wound care
• Remained outpatient
w/return to work in 5
weeks
• Cost of care: @ $1500
• Without Organized Wound Care
– 44 y/o male with scrotal abscess
referred for care at home/private
sector management
• I&D including brief hospital
post-op stay w/o referral to
wound care
• Became septic w/exacerbation
of other co-morbid conditions
hospital readmission and
transfer to private sector ICU
• Cost of care: >$1 million
Perceived Concerns
• Staffing
• Clinician participation
• Equipment for diagnostics
• Cost of supplies and medications
The solutions to these questions have already been found!
Where do we go from here?
1. Endorsement of the model
2. Further expansion of the model
3. Maintain the model as a proven best practice model
4. Streamline ordering making wound care supplies and
equipment ‘store stock’ items
5. Funding of the model
Economic impact of non-healing
wounds
Don Ayers
A Growing Epidemic
• The worldwide diabetic population is expected
to grow from 171 million to 366 million by
2025
• Foot complications are one of the most
common complications in diabetic patients
• The lifetime risk of a diabetic foot ulcer (DFU)
is 15% to 25%
• Approximately 15% of DFUs result in
amputation
Diabetes Prevalence in Native American Indians
•
Nationwide, diabetes affects more American Indian/Alaska Natives than any
other ethnic group.1
16
Percent with Diabetes
14
12
10
8
6
4
2
0
White
1.
Black
Barnes et al. Advanced Data (CDC) 2005;356 1-24.
American
Indian
Hispanic
Other
Neuropathy Leads to Diabetic Foot
Ulcers

Diabetic neuropathy is a primary cause of diabetic foot ulcers.1

Development of a diabetic foot ulcer increases the risk of a
foot infection over 2,000-fold.2
Percent with Foot Infection
70
60.7%
60
50
40
30
20
10
0.07%
0
No Foot Ulcer
1.
2.
Foot Ulcer
Boulton et al. The global burden of diabetic foot disease. Lancet. 2005;366:1719-24.
Lavery et al. Risk Factors for Foot Infections in Individuals With Diabetes. Diabetes Care. 2006;29:1288-93.
Diabetes and Serious Complications: Neuropathy

"Diabetes is the leading cause of peripheral neuropathy globally."1

American Indians with diabetes have a greater risk (greater than 2
fold) for developing neuropathy when compared to the adult
insured US diabetic population.2
Percent with Neuropathy
16.8%
15
10
7.6%
5
0
Insured Americans with
Diabetes
1.
2.
American Indians with
Diabetes
Habib AA, Brannagan TH 3rd. Therapeutic strategies for diabetic neuropathy. Curr Neurol Neurosci Rep. 2010;10:92-100.
O’Connell et al. Racial Disparities in Health Status: A comparison of the morbidity among American Indian and U.S. adults
with diabetes. Diabetes Care. 2010;33:1463-70.
Complications of Diabetic Foot Ulcers

DFUs that persist more than 4 weeks have 5-fold higher risk of infection.1

Development of an infection in a foot ulcer increases the risk for
hospitalization 55.7 times and the risk for amputation 155 times.1

“Infected neuropathic ulcerations are the leading cause of diabetes-related
partial foot amputations at the Phoenix Indian Medical Center.”2

Foot ulceration is a significant risk factor for lower-extremity amputation in
Native American Indians.3
Diabetes
1.
2.
3.
Neuropathy
Foot Ulcer
Infection
Amputation
Lavery et al. Risk Factors for Foot Infections in Individuals With Diabetes. Diabetes Care. 2006;29:1288-93.
Dannels E. Neuropathic foot ulcer prevention in diabetic American Indians with hallux limitus. J Am Podiatr
Med Assoc. 1989;79:447-50.
Mayfield et al. A foot risk classification system to predict diabetic amputation in Pima Indians. Diabetes Care.
1996;19:704-9.
Diabetes Burden in American Indians;
Lower Extremity Amputation
• The annual rate for a 1st lower extremity amputation in diabetic
Oklahoma Indians is 1.8%.1
• Risk of amputation is 18-times higher in diabetic American Indians
compared to the adult insured US diabetic population.2
1.8%
Percent with Amputation
2
1.5
1
0.5
0.1%
0
Insured Americans with
Diabetes
1.
2.
American Indians with
Diabetes
Lee JS, Lu M, Lee VS, Russell D, Bahr C, Lee ET: Lower extremity amputation. Incidence, risk factors, and mortality in
the Oklahoma Indian Diabetes Study. Diabetes. 1993;42:876-82.
O’Connell et al. Racial Disparities in Health Status: A comparison of the morbidity among American Indian and U.S.
adults with diabetes. Diabetes Care. 2010;33:1463-70.
Healing Neuropathic Ulcers:
Results of a Meta-analysis
Weighted Mean Healing Rates
• These data provide clinicians with a realistic assessment of
their chances of healing neuropathic ulcers
• Even with good, standard wound care, healing neuropathic
ulcers in patients with diabetes continues to be a challenge
Margolis et al. Diabetes Care. 1999;22:692.
Consensus Conference
on Diabetic Foot Wound Care
• American Diabetes Association Consensus
Development Conference on Diabetic Foot Wound
Care convened in April 1999
• Regarding the treatment of diabetic foot wounds,
the panel agreed:
“Any wound that remains unhealed after 4 weeks
is cause for concern, as it is associated with
worse outcomes, including amputations.”
Note: This consensus statement also was reviewed and endorsed by the American Podiatric Association.
Consensus development conference on diabetic foot wound care: 7-8 April 1999, Boston, MA. American Diabetes Association.
Diabetes Care. 1999;22(8):1354-1360.
Continuing Research: Healing of
Diabetic Foot Ulcers After 4 Weeks
>53% area reduction at week 4
<53% area reduction at week 4
• Wounds achieving less than 53% closure at week 4 have
minimal chance of healing with conventional therapy
Sheehan et al. Diabetes Care. 2003;26(6):1879-1882.
Role of Tissue-Engineered Skin in the
Management of Neuropathic Diabetic Foot Ulcers
• In 2004, Boulton and colleagues developed a
Clinical Practice article for neuropathic diabetic
foot ulcers published in The New England Journal
of Medicine
• In discussing tissue-engineered skin, they noted:
– “The failure to reduce the size of an ulcer after
4 weeks of treatment that includes appropriate
debridement and pressure reduction should prompt
consideration of adjuvant therapy.”
Boulton et al. NEJM. 2004;351:48-55.
Association Between PAR at Week 4 &
DFU Closure at Week 12
N=133
N=117
• Data was dichotomized by PAR of <50% or ≥ 50% by week 4 to assess
the association of PAR with DFU closure by 12 weeks
Better Results Using Best Practice Model: Advanced
Therapy
Reduction in days to heal from
previous healing data using
advanced therapy*:
From:
59.01 days to heal
To:
34.09 days to heal
*Dermagraft
Cost of Diabetes and Wound Care

$174 billion: Total costs of diagnosed
diabetes in the United States in 20071

$20 billion: Chronic wounds cost
health care systems annually2
32
Healed Patients
7724-2
-10
9908
-111
-2
-142
12034
42
-35
9420-2
Patient ID
49
-7
-58
50
-240
70
33331-4
-30
-22
33331-2
-30
-22 14
56181
-2
37226
-3
-103
63
-7
17459
-16
-19
10572
-400
14
-140
71
21
-27
-261
-350
-44
-282
13092
-120
42
-211
-300
-250
-200
First Clinic
Visit Date
Therapy
Started
Date
Wound
Accquired
- First
Clinic Visit
Last Visit
Date First Clinic
Visit
7
-218
17921
15948
28
-150
Treatment Day(s)
-100
56
-50
0
50
100