Comfort Shield®

An Innovative Approach to Incontinence Care

Risk Factors for Pressure Ulcer Development

• Impaired Mobility 87.0%

• Fecal Incontinence 56.7%

• Malnutrition 54.4%

• Decreased Mental Status 50.7%

• Peripheral Vascular Disease 28.1%

• Urinary Incontinence 27.0%

• Diabetes 23.7%

Maklebust J, Magnan MA, Adv Wound Care. Nov 1994;7(6):25, 27-8, 31-4 passim .

Risk Factors for Pressure Ulcer Development

JoAnn Maklebust, MSN, RN, CS, NP and Morris A. Magnan, MSN, RN, “Risk Factors Associated with Having a Pressure Ulcer: A Secondary Data Analysis”, Advances in Wound Care, November 1994

“…The odds of having a pressure ulcer were

22 times greater for hospitalized adult patients

with fecal incontinence compared to hospitalized patients

without fecal incontinence…and 37.5 times greater in

patients who had both impaired mobility and fecal

incontinence”

Facts About Pressure Ulcers• 80% of pressure ulcers in hospital are Stage I or Stage II.1

• Almost half of all pressure ulcers form on the sacrum (36.9%) and ischium (8.0%).2

• A healthcare facility will spend between $400K and $700K annually on pressure ulcer treatment.3

• JCAHO lists prevention of health care

associated pressure ulcers as a patient

safety goal.4

• Over a boney prominence.5

1. Whittington KT, Briones R, “National Prevalence and Incidence Study: 6-Year Sequential Acute Care Data,” Adv Skin Wound Care. 2004 Nov/Dec;17(9):490-4. 2. Amlung SR, Miller WL, Bosley LM, Adv. Skin Wound Care. 2001 Nov/Dec; 14(6): 297-301. 3. Robinson, C; Gioekner, M; Bush, S; Copas, J; et al. Determining the efficacy of a pressure ulcer prevention program by collecting prevalence and incidence data: a unit-based effort. Ostomy Wound Manage. 2003. May: 49(5):44-6. 48-51. 4. http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/07_ltc_npsgs.htm . 5. Joan Junkin, MSN, RN, CWOCN, BryanLGH Medical Center

Searching for an Appropriate Name: Incontinence Associated Dermatitis

• Acknowledges that condition extends

beyond perineal skin.

• Clearly identifies UI or FI as primary

causative factor.

• Removes negative and unfair association

with diapers.

• Broad enough to encompass secondary infections such as candidiasis.

• Usually well beyond boney prominence

Gray M, Lerner-Selekof J, Junkin J, A Closer look at Perineal skin injury associated with incontinence in acute care facilities. A CE symposium in conjunction with the 2006 WOCN conference, Minnieapolis, MN June 2006

http://www.sageproducts.com/education/shArticles.asp

Multi-Site Prevalence Study- Bryan LGH;

University of Maryland1

• 608 patients surveyed• 120 patients incontinent

• 42.5% Perineal skin injury

• 20.0% had IAD• 21.7% had pressure

sores

May/June 2007

Lerner-Selekof J, Junkin J, Prevalence of Incontinence and Associated Skin Injury in the Acute Care Patient, JWOCN, May/June 2007

The Nix StudyHIGHLIGHTS

• The goal was to determine if facility has protocol in place for skin protectant application & the frequency of compliance to that protocol.

• 76 hospitals & LTC facilities were involved.• While 75% of protocols include the use

of a skin protectant, but the actual USAGE of those skin protectants is severely lacking.

• Only 10 cents per patient per day is being spent on skin protectants (barrier creams/ointments).

Nix, D., Ermer-Seltun, J, Ost/wound Mgmt. Dec 2004;50 (12):59-67

“Use of Skin Protectants is Lacking in Protocols and Application”

The Lyder StudyHIGHLIGHTS

• The goal was to put in place a 3-pronged prevention program to decrease pressure ulcers.

• The changes made were with pressure reduction, nutrition, and skin care protectants.

• Compliance to the changes was well managed & enforced.• They monitored 136 residents at 2 LTC facilities over a

5-month period.• Overall, they saw 87% and 76% reduction in their pressure

ulcer incidence rates.• The average cost for skin care products was about $5 per

patient per day.

Lyder CH, Shannon R, Empleo-Frazier O, McGeHee D, White C, Ostomy/Wound Management. Apr 2002;48(4):52-62.

“A review of Perineal Skin Care Protocols and Skin Barrier Product Use.”

“Evaluating the Efficacy of a Uniquely Delivered Skin Protectant and Its Effect on the Formation of Sacral/Buttock Pressure Ulcers”*

*Comfort Shield® was used on all incontinent patients and was the only variable changed from the control period.

Clever et al. - Pressure Ulcer Study

Average Monthly Incidence of Sacral/Buttock Pressure Ulcers

Old Standard of Care

7/00 – 3/01

New Standard of Care

5/01 – 7/01

2/02 – 4/02

Old standard of care vs. using Comfort Shield® as preventative in new

standard of careReduction in Incidence

Of sacral/buttock pressure ulcers0.5%

4.7%

Clever K, Smith G, Bowser C, Monroe KLong-Term Care Unit, Fulton County Medical Center, McConnellsburg, PA, Ostomy/Wound Management. Dec 2002;48(12):60-7.

Donna Driver MS, CWOCNPeer-reviewed clinical study published in Critical Care Nurse

August 2007

Two Phase Study

Phase 1 Multi-step process

Phase 2All in one product

Consistency is the Key for Treating Severe Perineal Dermatitis Due to Incontinence

Sluser S, Sturgeon Community Hospital and Health Centre.Poster presented at the Clinical Symposium on Advances in Skin and Wound Care, Las Vegas, NV. Oct 2005.

• Group A = Cleansing spray, washcloths, skin barrier (multi- step process and the current practice).• Group B = Shield Barrier Cloths.• Group C = Disposable washcloth without dimethicone.

“The Development of Cost-Effective Quality Care for the Patient with Incontinence”

Dieter L, Drolshagen C, Blum K, Cost-effective, quality care for the patient with incontinence. Research Poster Abstract presented at WOCN , Minneapolis, MN June 2006

http://www.sageproducts.com/education/shSymposiaPres.asp

Results: • Group A = $6.13 per patient per day; 10% skin breakdown. • Group B = $5.40 per patient per day; 8% skin breakdown.• Group C = Discontinued in week 4 due to 29% skin breakdown.• 2003 72 consults due to IAD and 2004 10 consults due to IAD.

“An Economic Evaluation of Four Skin Damage Prevention Regimens in Nursing Home Residents with Incontinence”

By Donna Bliss, Cindy Zehrer, Kay Savik, Graham Smith and Edwin Hedblom

Key Economic Findings:

Average Labor Costs (Per episode – when barrier and cleanser applied every time): $.64

Barrier Average (Per episode – applied every time): $0.23

Skin Care Product Costs Average (Per episode – applied every time): $.30

Total Average Costs

(Per episode – when barrier and cleanser applied every time): $1.17*

Average Cost for Shield Per episode – (all in one barrier and cleanser applied every time): $.90***Excludes average per episode supply cost of $.53 for gloves, 2 disposable wipes, 2 cloth washcloths, 1 absorbent pad, 1 brief, 1 underpad

**Based on 3 cloths per episode, $.30 per cloth - Nix

Journal of Wound, Ostomy & Continence Nursing. 34(2):143-152, March/April 2007.Bliss, Donna Z.; Zehrer, Cindy; Savik, Kay; Smith, Graham; Hedblom, Edwin

Getting Started Kit:Prevent Pressure Ulcers

How-to-Guide

IHI Protecting5 Million Lives From Harm

http://www.ihi.org/ihi

Six Essential Elements of Pressure Ulcer Prevention

1. Admission Assessment

2. Reassess Daily3. Inspect Skin Daily

4. Manage Moisture

5. Optimize Nutrition and Hydration

6. Minimize Pressure

http://www.ihi.org/IHI/Programs/Campaign/

“By combining routine activities in a protocol such as a “pressure ulcer prevention protocol,” staff can complete multiple tasks while in the room every two hours and document them all at once.”

• Provide supplies at the bedside of each at-risk patient who is incontinent. This provides the staff with the supplies that they need to immediately clean, dry, and protect the patient’s skin after each episode of incontinence.

• Provide under-pads that pull the moisture away from the skin, and limit the use of disposable briefs or containment garments if at all possible.

• Provide pre-moistened, disposable barrier wipes to help cleanse, moisturize, deodorize, and protect patients from perineal dermatitis due to incontinence.

4. Manage Moisture: Keep the Patient Dry and Moisturize Skin

http://www.ihi.org/IHI/Programs/Campaign/

“Location, location, location: Getting your incontinence care process bedside Yields reduction in skin injury”- Tory Schmitz, RN,MSN CCRN,

CNAA-BC The Methodist Hospital, Houston TX

• Used both Comfort Bath® and Shield Barrier Cloths

• Placed product at patient bedside

• Compliance to appropriate incontinence care increased from 76% to 97%

• IAD prevalence dropped from 15% to 0

“Location, location, location: Getting your incontinence care process bedside Yields reduction in skin injury”- Tory Schmitz, RN,MSN CCRN, CNAA-BC The Methodist Hospital, Houston TX

• OSF St Francis – 710 beds, Level 1 Trauma, Magnet, 25,000 admits.

• SOS Program: OR Skin Assessment; new skin prevention protocol-Shield Barrier Cloths.

• 9/2001 9.4% baseline incidence rate of PS’s.

• 12/2005 1.8% incidence rate.

• “Premoistened, disposable barrier wipes…..”

“Save our skin: Initiative cuts pressure ulcer incidence in half”

Courtney BA, Ruppman JB, Cooper HM, Save our skin: Initiative cuts pressure ulcer incidence in half. Nursing Management. Apr 2006;37(4):36-45

http://www.sageproducts.com/education/shArticles.asp

New CMS Guidelines: If It’s Not POA, We Won’t Pay

Conditions No Longer Covered:

1. Pressure Ulcers2. Vascular and Urinary Tract

Infections from Catheters3. Mediastinitis (a SSI from

heart surgery)4. Falls5. “Never Events”

– Objects left in body during surgery

– Air embolisms– Blood incompatibility

Federal Register, Vol 72, No.162, August 8, 2007

• MANDATORY POA Tracking: 10/1/07

• Non-Payment: 10/1/2008

• What’s “POA?” 48 Hours

• According to CMS, what percent of Pressure Ulcers are avoidable?

If POA, Stage III and IV pressure ulcers receive payment

Stage I or II pressure ulcers will not receive payment even if they progress to a Stage III or IV

100%!

What you NEED to Know:

Federal Register, Vol 72, No.162, August 8, 2007

“An Economic Evaluation of Four Skin Damage Prevention Regimens in Nursing Home Residents with

Incontinence”

By Donna Bliss, Cindy Zehrer, Kay Savik, Graham Smith and Edwin Hedblom

Key Economic Findings:

Barrier Average (Per episode – applied every time): $0.23

Skin Care Product Costs Average (Per episode – applied every time): $.30

Average Labor Costs (Per episode – when barrier and cleanser applied every time): $.64

Total Average Costs (Per episode – when barrier and cleanser applied every time):

$1.17*

Average Cost for Shield Per episode – when barrier and cleanser applied every time):

$.90***Excludes average per episode supply cost of $.53 for gloves, 2 disposable wipes, 2 cloth washcloths, 1 absorbent pad, 1 brief, 1 underpad

**Based on 3 cloths per episode, $.30 per cloth - Nix

http://www.ncbi.nlm.nih.gov/sites/entrez

Provide the Supplies at the Bedside

Why Comfort Shield Barrier Cloths?

1. One-step process.

2. Eliminates process variation between caregivers.

3. Reduces the impact of one of the major risk factors associated with pressure ulcer development which is incontinence.

4. Evidence-based clinical outcomes.

5. Less IAD consults

6. Cost effective: Comfort Shield average cost per day per patient = .29 per cloth x 9 washcloths = $2.64 / vs. traditional incontinence care products at $5.19 per day.

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

* others include: Healthpoint, 3M, Fougera, Derma Sciences, etc.

INCONTINENT

OINTMENTS & BARRIERSINCONTINENT

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42.4%42.4%42.4%42.4% 17.6%17.6%17.6%17.6% 8.6%8.6%8.6%8.6%15.8%15.8%15.8%15.8% 5.3%5.3%5.3%5.3% 3.3%3.3%3.3%3.3% <2% <2% eacheach<2% <2% eacheach

Annual 2011 MarketAnnual 2011 Market

Source: GHX Trend Report (Dollars) 2nd Quarter, 2011 Hospital; Annual market represents last 4 quarters of data

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

ALL-IN-ONE PREPACKAGED INCONTINENCE

OINTMENTS & BARRIERSALL-IN-ONE PREPACKAGED INCONTINENCE

OINTMENTS & BARRIERS

Medlin

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Medlin

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Shield

Barrie

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Shield

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92.6%92.6%92.6%92.6% 7.4%7.4%7.4%7.4%

Annual 2011 MarketAnnual 2011 Market

Source: GHX Trend Report (Dollars) 2nd Quarter, 2011 Hospital; Annual market represents last 4 quarters of data

Market Review - Shield

*Source: Inpatient admissions and LOS for US and Canada per 2006 HCUP Nationwide Inpatient Sample (NIS) and 2006 Canadian Institute for Health Information (CIHI). Rates calculated on assumption of 20% of inpatient incontinence (Junkin) with 3 episodes per day, 3 cloths @ $.31 per cloth. Shield sales figures: Sage Sales from September 2007 – August 2008

Potential Shield Market

$113 M

Market Available: 75%

Shield Sales*

$28.5 M

Current Market Capture: 25%

“At least daily, staff should remain alert to potential changes in the skin condition and should evaluate and document

identified changes. For example, a resident’s complaint about pain or burning at a site where there has been pressure or a nursing assistant’s observation during the resident’s bath that there is a change in skin condition should be reported so that

the resident may be evaluated further.”

Who is Focused on Skin Breakdown?CMS State Operations Manual, F314

Centers for Medicare & Medicaid Svcs, CMS Manual System, Pub. 100-07 State Operations, Provider Certification, Appendix PP Guidance to Surveyors for LTC Facilities, F314 §483.25(c) Pressure Sores, Monitoring (Rev. 4, Issued/Effective 11-12-2004). Dept of Health & Human Svcs, Transmittal 12, 14 Oct 2005:145 (available at new.cms.hhs.gov/transmittals/downloads/R12SOM.pdf).

“One key to preventing skin breakdown is to keep the perineal skin clean and dry. Research has shown that a soap and water regimen alone may be less effective in

preventing skin breakdown compared with moisture barriers and no-rinse incontinence cleansers.”

Who is Focused on Skin Breakdown? CMS State Operations Manual, F315

Centers for Medicare & Medicaid Svcs, CMS Manual System, Pub. 100-07 State Operations, Provider Certification, Appendix PP Guidance to Surveyors for LTC Facilities, F314 §483.25(c) Pressure Sores (Rev. 4, Issued/Effective 11-12-04) and F315 483.25(d) Urinary Incontinence, Skin-Related Complications (Rev.8, Issued/Effective 06-28-05). Dept of Health & Human Svcs, Transmittal 12, 14 Oct 2005:131,180 (available at new.cms.hhs.gov/transmittals/downloads/R12SOM.pdf).

Comfort Shield® Barrier Cloths Replace

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