Diabetic Foot Ulcer Treatment Diabetic Foot Ulcer Treatment and Amputation Prevention in and Amputation Prevention in Non-Tertiary VA Care FacilitiesNon-Tertiary VA Care Facilities

Gregory J. Raugi, MD, PhDGregory J. Raugi, MD, PhDGayle E. Reiber, MPH, PhDGayle E. Reiber, MPH, PhD

VA Puget Sound Health Care SystemVA Puget Sound Health Care System

Funding Support from VA HSR&D, RR&D – VISN Funding Support from VA HSR&D, RR&D – VISN 2020

The VA Situation for Veterans with The VA Situation for Veterans with DiabetesDiabetes

5,000,000+ patients in the VA 5,000,000+ patients in the VA systemsystem

1,000,000+ have diabetes1,000,000+ have diabetes

150,000+ will develop a foot ulcer 150,000+ will develop a foot ulcer some time during their livessome time during their lives

Unique VA Diabetic Foot Ulcer Unique VA Diabetic Foot Ulcer and Amputation Patients by and Amputation Patients by

SettingSetting

Tertiary Care Tertiary Care Centers (66)Centers (66)

Primary and Primary and Secondary Secondary

Care Centers Care Centers (91)(91)

Community- Community- Based Based

Outreach Outreach Clinics (862)Clinics (862)

Total number Total number of unique ulcer of unique ulcer

patientspatients21,81721,817 15,82615,826 7,7877,787

AmputationsAmputations 3,4263,426 1,6121,612

FY 2003-2004

Standards for Diabetic Foot Standards for Diabetic Foot Ulcer CareUlcer Care

““Good Wound Care”Good Wound Care” Set of principles should be applied to Set of principles should be applied to everyevery

patient at patient at eacheach encounter: encounter:Debride callus, devitalized tissueDebride callus, devitalized tissue

Measure the woundMeasure the wound

Treat Treat invasiveinvasive bacterial infection bacterial infection

Offload weightOffload weight

Provide moist healing environmentProvide moist healing environment

Provide a global assessmentProvide a global assessment

Schedule regular follow-up – continuity of careSchedule regular follow-up – continuity of care

Walla Walla ProjectWalla Walla Project

Diabetic Foot Ulcer Treatment and Diabetic Foot Ulcer Treatment and Amputation Prevention in a Rural VA Amputation Prevention in a Rural VA FacilityFacility Retrospective analysis of data abstracted Retrospective analysis of data abstracted

from veterans with diabetic foot ulcersfrom veterans with diabetic foot ulcers Prospective study of patient and ulcer Prospective study of patient and ulcer

outcomes; patient, provider, and outcomes; patient, provider, and institutional acceptance. institutional acceptance.

Specific QuestionsSpecific Questions

1.1. Will good wound care be delivered and documented Will good wound care be delivered and documented more frequently in diabetic foot ulcer patients during more frequently in diabetic foot ulcer patients during the intervention period versus the comparison period?the intervention period versus the comparison period?

2.2. Will delivering a package of good would care be Will delivering a package of good would care be associated with decreases in time to healing and associated with decreases in time to healing and increases in ulcer-free survival?increases in ulcer-free survival?

3.3. Will delivering a package of good wound care improve Will delivering a package of good wound care improve patient, provider and institutional acceptance for patient, provider and institutional acceptance for organized wound care?organized wound care?

4.4. Will a package of good wound care be safe and Will a package of good wound care be safe and transportable for a subsequent VA clinical trial of transportable for a subsequent VA clinical trial of diabetic foot ulcer treatment in non-tertiary care diabetic foot ulcer treatment in non-tertiary care facilities?facilities?

Walla Walla VAWalla Walla VA

Primary Care VA Medical CenterPrimary Care VA Medical Center

Serves ~70,000 veterans; catchment area of Serves ~70,000 veterans; catchment area of 42,000 square miles42,000 square miles 3 CBOCs3 CBOCs

10 primary care providers10 primary care providers No full-time specialistsNo full-time specialists Community podiatrists – contract careCommunity podiatrists – contract care

26-bed Skilled Nursing Home26-bed Skilled Nursing Home

Assessing the Foot Ulcer Assessing the Foot Ulcer ProblemProblem

at Walla Walla VAat Walla Walla VAReview of administrative data on foot Review of administrative data on foot ulcers and amputations:ulcers and amputations:

180 foot-ulcer-coded patients in 2003-180 foot-ulcer-coded patients in 2003-44

• 125 unique patient records125 unique patient records• 46 had diabetic foot ulcer (diabetes, at least one 46 had diabetic foot ulcer (diabetes, at least one

foot, and an ulcer at or below the malleoli) - 37%foot, and an ulcer at or below the malleoli) - 37%• 79 did not have a diabetic foot ulcer – 63%79 did not have a diabetic foot ulcer – 63%

• 8 veterans were dead before FY 20048 veterans were dead before FY 2004• 5 had no documented history of diabetes5 had no documented history of diabetes• 47 had no documented ulcer during FY 200447 had no documented ulcer during FY 2004• 19 had lower limb ulcers but did not meet criteria 19 had lower limb ulcers but did not meet criteria

for the diagnosis of diabetic foot ulcerfor the diagnosis of diabetic foot ulcer

Assessed Interest Level of Assessed Interest Level of Administrators and Administrators and

ProvidersProviders

• Interviews with key Walla Walla VA and Interviews with key Walla Walla VA and community providerscommunity providers

• Surveyed providers, 77% respondedSurveyed providers, 77% responded

• Identified a need for organized wound Identified a need for organized wound carecare

Implementing the ProjectImplementing the Project

Stipulated:Stipulated: Purpose, time framePurpose, time frame Walla Walla leadership selects teamWalla Walla leadership selects team Seattle trains and monitors teamSeattle trains and monitors team Seattle provides clinical back-upSeattle provides clinical back-up Seattle provides Foot Ulcer CPRS templateSeattle provides Foot Ulcer CPRS template Both provide resourcesBoth provide resources

We wrote, negotiated, and signed a cooperative We wrote, negotiated, and signed a cooperative agreement with the site PI (CMO)agreement with the site PI (CMO)

Intervention Components:Intervention Components:Team Education and TrainingTeam Education and Training

• University of Washington Nursing and University of Washington Nursing and Medical School coursesMedical School courses

• Practicums, Seattle VA and HarborviewPracticums, Seattle VA and Harborview

• Study protocol and procedure manualStudy protocol and procedure manual

• On-site supervised experienceOn-site supervised experience

• Certification ExamsCertification Exams

Intervention ComponentsIntervention ComponentsTeam BuildingTeam Building

Bimonthly visits to Walla WallaBimonthly visits to Walla Walla

3-hour Derm/Wound clinics3-hour Derm/Wound clinics

Patient roundsPatient rounds

Journal Club, M&M conferences, CNEJournal Club, M&M conferences, CNE

Team meetings, activitiesTeam meetings, activities

Open Medical Center meetingsOpen Medical Center meetings

Intervention Components:Intervention Components:Team Communication and Team Communication and

CoordinationCoordination

• Weekly V-tel conference – progress and problems

• Tele-wound consultationTele-wound consultation

• 24/7 back-up24/7 back-up

• Assist with patient transfersAssist with patient transfers

Intervention Components:Intervention Components:PatientsPatients

• Usually same day care Usually same day care

• Very high satisfaction

• Consultation as neededConsultation as needed

Intervention Components:Intervention Components:LogisticsLogistics

• Space and schedulingSpace and scheduling

• Clinic equipmentClinic equipment

• Same day Rx and dressing supply Same day Rx and dressing supply formulariesformularies

• Same day off-loading devicesSame day off-loading devices

Intervention Components:Intervention Components:Medical Center StaffMedical Center Staff

• Co-locate wound clinic in primary careCo-locate wound clinic in primary care

• Within medical center, recognition of Within medical center, recognition of service potentialservice potential

• Consults (drive by, scheduled)Consults (drive by, scheduled)

• Bimonthly clinics, educationBimonthly clinics, education

• Involved in problem solvingInvolved in problem solving

Chart Note TemplateChart Note Template

Intervention Components:Intervention Components:Clinical Information SystemClinical Information System

• Notebook computers with stylusNotebook computers with stylus• Foot ulcer data collection template built into CPRSFoot ulcer data collection template built into CPRS• Automatically gathers information from prior Automatically gathers information from prior

encounters and “feed forward” to today’s visit encounters and “feed forward” to today’s visit • Based on principles of “good wound care” thus Based on principles of “good wound care” thus

collects and integrates the proper datacollects and integrates the proper data• Prevents important omissionsPrevents important omissions• Allows oversight by off-site experts/case Allows oversight by off-site experts/case

managers; pictures, x-rays, images sharedmanagers; pictures, x-rays, images shared• Streamlines ordering, justifies coding, & Streamlines ordering, justifies coding, &

documentationdocumentation• Facilitates communication with PCPsFacilitates communication with PCPs

Intervention Components:Intervention Components:Other MeasuresOther Measures

• Provider Assessment X2Provider Assessment X2

• Patient Baseline QuestionnairePatient Baseline Questionnaire

• Patient Healed Questionnaire Patient Healed Questionnaire

• Patient Satisfaction @ each visitPatient Satisfaction @ each visit

EnrollmentEnrollmentAll wound patients seen

10-1-06 – 9-30-07N=217

Patients with diabetesand foot ulcers

66

No diabetes,other ulcers

N = 151

Met Expert Panel definitions

Analysis Data50 patients84 ulcers

Did not meet criteria

16 patients

Findings Findings

No patients with a diabetic foot ulcer No patients with a diabetic foot ulcer declined to participate in the study.declined to participate in the study.

No patients were lost to follow-up.No patients were lost to follow-up. One patient withdrew (in anticipation One patient withdrew (in anticipation

of death).of death).

Patient CharacteristicsPatient Characteristics

Age (years)Age (years) Mean = 66 ± 11 Mean = 66 ± 11

Range = 46 - 89Range = 46 - 89

BMIBMI Mean = 34 ± 7.4 Mean = 34 ± 7.4

Range = 19 - 51Range = 19 - 51

Level of Diabetes Level of Diabetes Control HbA1c Control HbA1c ≥ ≥ 8.0%8.0%

32%32%

Renal DiseaseRenal Disease

Cr Cr ≥ 2.0 mg/dl≥ 2.0 mg/dl6%6%

Pre-existing Pre-existing amputation at amputation at baselinebaseline

10 patients10 patients

20 amputations20 amputations

Clinician versus Patient Clinician versus Patient ReportReport

Clinician ReportClinician Report Patient ReportPatient Report

Neuropathy Neuropathy present at present at baselinebaseline

81%81% 58%58%

Foot Deformity Foot Deformity present at present at baselinebaseline

30%30% 30%30%

Depression Depression present at present at baselinebaseline

2%2% 34%34%

FindingsFindings

Accounting for competing risks, the Accounting for competing risks, the intervention group had significantly intervention group had significantly shorter times to healing and a greater shorter times to healing and a greater percentage of healed ulcers (p=0.002) percentage of healed ulcers (p=0.002) comparing the 2003 to the 2007 period. comparing the 2003 to the 2007 period. The amputation rate was 23.4% in 2003 The amputation rate was 23.4% in 2003 and 12.5% in 2007.and 12.5% in 2007.

Time to Healing, Amputation Time to Healing, Amputation and Death in FY 04 and Death in FY 04

Comparison Group and FY 07 Comparison Group and FY 07 Intervention GroupIntervention Group

0 50 100 150

0.0

0.2

0.4

0.6

0.8

1.0

Weeks

Pro

ba

bili

ty

Control 1Intervention 1Control 2Intervention 2Control 3Intervention 3

Weeks

Pro

babili

ty

Patient SatisfactionPatient Satisfaction

At the end of each encounter, At the end of each encounter, study patients were given a patient study patients were given a patient satisfaction form to fill out satisfaction form to fill out anonymously and mail to the study anonymously and mail to the study coordinator. coordinator.

The average number of satisfaction The average number of satisfaction reports per patient was 6.3; SD reports per patient was 6.3; SD 3.5. The range was 1-18. 3.5. The range was 1-18.

Patient Satisfaction ResultsPatient Satisfaction Results

25.4 % of study ulcer patients 25.4 % of study ulcer patients reported their health as fair or poorreported their health as fair or poor

96% of patients reported their 96% of patients reported their satisfaction with foot care at excellent, satisfaction with foot care at excellent, very good or goodvery good or good

6.6% identified there were VA foot 6.6% identified there were VA foot care services not receivedcare services not received

2% identified they were not involved 2% identified they were not involved enough in their foot care enough in their foot care

Specific QuestionsSpecific Questions

1.1. Will good wound care be delivered and documented Will good wound care be delivered and documented more frequently in diabetic foot ulcer patients during more frequently in diabetic foot ulcer patients during the intervention period versus the comparison period?the intervention period versus the comparison period?

2.2. Will delivering a package of good would care be Will delivering a package of good would care be associated with decreases in time to healing and associated with decreases in time to healing and increases in ulcer-free survival?increases in ulcer-free survival?

3.3. Will delivering a package of good wound care improve Will delivering a package of good wound care improve patient, provider and institutional acceptance for patient, provider and institutional acceptance for organized wound care?organized wound care?

4.4. Will a package of good wound care be safe and Will a package of good wound care be safe and transportable for a subsequent VA clinical trial of transportable for a subsequent VA clinical trial of diabetic foot ulcer treatment in non-tertiary care diabetic foot ulcer treatment in non-tertiary care facilities?facilities?

SummarySummary

The wound care program is continuing, The wound care program is continuing, now with a screening and surveillance now with a screening and surveillance component component

Leadership is critical in implementing a Leadership is critical in implementing a wound care programwound care program

Training, educational updates, clinical Training, educational updates, clinical back-up, regular review and discussion are back-up, regular review and discussion are all important staff considerations all important staff considerations

Patients have been well servedPatients have been well served

Implementation AnalysisImplementation Analysis

We asked colleagues at the Ann Arbor VA We asked colleagues at the Ann Arbor VA

to independently evaluate the programto independently evaluate the program

at Walla Walla. at Walla Walla.

Their findings follow.Their findings follow.

The “Perfect Storm”The “Perfect Storm” The PCP who ultimately became the team The PCP who ultimately became the team

leader was already aware that the facility leader was already aware that the facility was unable to properly treat wounds.was unable to properly treat wounds. The COS was also aware.The COS was also aware.

Tension for change was high.Tension for change was high. The PCP had already started trying to care for The PCP had already started trying to care for

patients with wounds.patients with wounds. She recognized the need for more training, She recognized the need for more training,

access to clinical expertise.access to clinical expertise. ““Good Wound Care” had a relative Good Wound Care” had a relative

advantage over other potentially advantage over other potentially competing programs because of built-in competing programs because of built-in access to Seattle experts.access to Seattle experts.

Ann Arbor Findings

Two Key FactorsTwo Key Factors

1.1. Intentional enrollment of team members Intentional enrollment of team members and related team-building processes.and related team-building processes.

Active involvement of the COS in recruitment.Active involvement of the COS in recruitment. Widespread respect for the Team Leader Widespread respect for the Team Leader

among her peers.among her peers. Exceptionally enthusiastic and professional Exceptionally enthusiastic and professional

nurse.nurse. Intuitive and proactive health technician.Intuitive and proactive health technician. Enthusiastic OT who gracefully balanced Enthusiastic OT who gracefully balanced

pressures from several fronts.pressures from several fronts. Multi-tasking scheduler managed patient and Multi-tasking scheduler managed patient and

staff issues.staff issues.

Ann Arbor Findings

Two Key FactorsTwo Key Factors

2.2. Research facilitators struck a good Research facilitators struck a good balance between accomplishing the balance between accomplishing the research goals and giving research goals and giving ownership of the program to the on-ownership of the program to the on-site stakeholders.site stakeholders. Tension between how much the research Tension between how much the research

facilitators should do and how much the facilitators should do and how much the local practitioners should do.local practitioners should do.

Ann Arbor Findings

Team BuildingTeam Building

Significant amount of time was Significant amount of time was invested in education and training in invested in education and training in Seattle.Seattle.

Research facilitators were available Research facilitators were available throughout the implementation and throughout the implementation and study.study.

Mutual trust and respect evolved into Mutual trust and respect evolved into genuine friendships.genuine friendships.

Ann Arbor Findings

Ripple EffectsRipple Effects Team leader willingly consulted for other PCP’s Team leader willingly consulted for other PCP’s

patients without a formal consult.patients without a formal consult.■ Garnered awareness and trust.Garnered awareness and trust.■ PCP identified problems earlier.PCP identified problems earlier.■ Rapid referral to Wound Clinic.Rapid referral to Wound Clinic.

Team members were energized by success – Team members were energized by success – expansion of the wound clinics.expansion of the wound clinics.

Positive experiences of the team creates a fertile Positive experiences of the team creates a fertile context for future innovations.context for future innovations.

New working relationships across 4 major services at New working relationships across 4 major services at WW benefits collaborative work in other areas.WW benefits collaborative work in other areas.

COS involvement in problem-solving increased staff COS involvement in problem-solving increased staff confidence in his leadership.confidence in his leadership.

Ann Arbor Findings