# Presentation: 155416

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

- Gregory J. Raugi, MD, PhD
- Gayle E. Reiber, MPH, PhD
- VA Puget Sound Health Care System
- Funding Support from VA HSR&D, RR&D – VISN 20

## The VA Situation for Veterans with Diabetes

- 5,000,000+ patients in the VA system
- 1,000,000+ have diabetes
- 150,000+ will develop a foot ulcer some time during their lives

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

|  | Tertiary Care Centers (66) | Primary and Secondary Care Centers (91) | Community- Based Outreach Clinics (862) |
| --- | --- | --- | --- |
| Total number of unique ulcer patients | 
21,817 | 
15,826 | 
7,787 |
| 
Amputations | 
3,426
 | 
1,612 |  |

**FY 2003-2004**

## Standards for Diabetic Foot Ulcer Care

- “Good Wound Care”
- Set of principles should be applied to *every* patient at *each* encounter:
- Debride callus, devitalized tissue
- Measure the wound
- Treat *invasive* bacterial infection
- Offload weight
- Provide moist healing environment
- Provide a global assessment
- Schedule regular follow-up – continuity of care

## Walla Walla Project

- Diabetic Foot Ulcer Treatment and Amputation Prevention in a Rural VA Facility
- Retrospective analysis of data abstracted from veterans with diabetic foot ulcers
- Prospective study of patient and ulcer outcomes; patient, provider, and institutional acceptance.

## Specific  Questions

- Will good wound care be delivered and documented more frequently in diabetic foot ulcer patients during the intervention period versus the comparison period?
- Will delivering a package of good would care be associated with decreases in time to healing and increases in ulcer-free survival?
- Will delivering a package of good wound care improve patient, provider and institutional acceptance for organized wound care?
- Will a package of good wound care be safe and transportable for a subsequent VA clinical trial of diabetic foot ulcer treatment in non-tertiary care facilities?

## Walla Walla VA

**Primary Care VA Medical Center**
- Serves ~70,000 veterans; catchment area of 42,000 square miles
- 3 CBOCs
- 10 primary care providers
- No full-time specialists
- Community podiatrists – contract care
- 26-bed Skilled Nursing Home

## Assessing the Foot Ulcer Problemat Walla Walla VA

**Review of administrative data on foot ulcers and amputations:****  **
**180 foot-ulcer-coded patients in 2003-4**
- 125 unique patient records
- 46 had diabetic foot ulcer (diabetes, at least one foot, and an ulcer at or below the malleoli) - 37%
- 79 did not have a diabetic foot ulcer – 63%
- 8 veterans were dead before FY 2004
- 5 had no documented history of diabetes
- 47 had no documented ulcer during FY 2004
- 19 had lower limb ulcers but did not meet criteria for the diagnosis of diabetic foot ulcer

## Assessed Interest Level of Administrators and Providers

- Interviews with key Walla Walla VA and community providers
- Surveyed providers, 77% responded
- Identified a need for organized wound care

## Implementing the Project

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

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

## Intervention Components:Team Education and Training

- University of Washington Nursing and Medical School  courses
- Practicums, Seattle VA and Harborview
- Study protocol and procedure manual
- On-site supervised experience
- Certification Exams

## Intervention ComponentsTeam Building

- Bimonthly visits to Walla Walla
- 	3-hour Derm/Wound clinics
- 	Patient rounds
- 	Journal Club, M&M conferences, CNE
- 	Team meetings, activities
- 	Open Medical Center meetings

## Intervention Components:Team Communication and Coordination

- Weekly V-tel conference – progress and problems
- Tele-wound consultation
- 24/7 back-up
- Assist with patient transfers

## Intervention Components:Patients 

- Usually same day care
- Very high satisfaction
- Consultation as needed

## Intervention Components:Logistics

- Space and scheduling
- Clinic equipment
- Same day Rx and dressing supply formularies
- Same day off-loading devices

## Intervention Components:Medical Center Staff

- Co-locate wound clinic in primary care
- Within medical center, recognition of   service potential
- Consults (drive by, scheduled)
- Bimonthly clinics, education
- Involved in problem solving

## Chart Note Template

## Intervention Components:Clinical Information System

- Notebook computers with stylus
- Foot ulcer data collection template built into CPRS
- Automatically gathers information from prior encounters and “feed forward” to today’s visit
- Based on principles of “good wound care” thus collects and integrates the proper data
- Prevents important omissions
- Allows oversight by off-site experts/case managers; pictures, x-rays, images shared
- Streamlines ordering, justifies coding, & documentation
- Facilitates communication with PCPs

## Intervention Components:Other Measures

- Provider Assessment X2
- Patient Baseline Questionnaire
- Patient Healed Questionnaire
- Patient Satisfaction @ each visit

## Enrollment

**All wound patients seen**
** ****10-1-06 – 9-30-07**
**N=217**

**Patients with diabetes**
**and foot ulcers**
**66**

**No diabetes,**
**other ulcers**
**N = 151**

**Met Expert Panel**
** ****definitions**

**Analysis Data**
**50 patients**
**84 ulcers**

**Did not meet**
** ****criteria**
**16 patients**

## Findings 

- No patients with a diabetic foot ulcer declined to participate in the study.
- No patients were lost to follow-up.
- One patient withdrew (in anticipation of death).

## Patient Characteristics

| Age (years) | Mean = 66 ± 11    
Range = 46 - 89 |
| --- | --- |
| BMI | Mean = 34 ± 7.4   
Range = 19 - 51 |
| Level of Diabetes Control HbA1c ≥ 8.0% | 32% |
| Renal Disease
Cr ≥ 2.0 mg/dl | 6% |
| Pre-existing amputation at baseline | 10 patients
20 amputations |

## Clinician versus Patient Report

|  | Clinician Report | Patient Report |
| --- | --- | --- |
| Neuropathy present at baseline | 81% | 58% |
| Foot Deformity present at baseline | 30% | 30% |
| Depression present at baseline | 2% | 34% |

## Findings

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

## Time to Healing, Amputation and Death in FY 04 Comparison Group and FY 07 Intervention Group

- Weeks

- Probability

## Patient Satisfaction

- At the end of each encounter, study patients were given a patient satisfaction form to fill out anonymously and mail to the study coordinator.
- The average number of satisfaction reports per patient was 6.3; SD 3.5. The range was 1-18.

## Patient Satisfaction Results

- 25.4 % of study ulcer patients reported their health as fair or poor
- 96% of patients reported their satisfaction with foot care at excellent, very good or good
- 6.6% identified there were VA foot care services not received
- 2% identified they were not involved enough in their foot care

## Specific  Questions

- Will good wound care be delivered and documented more frequently in diabetic foot ulcer patients during the intervention period versus the comparison period?
- Will delivering a package of good would care be associated with decreases in time to healing and increases in ulcer-free survival?
- Will delivering a package of good wound care improve patient, provider and institutional acceptance for organized wound care?
- Will a package of good wound care be safe and transportable for a subsequent VA clinical trial of diabetic foot ulcer treatment in non-tertiary care facilities?

## Summary

- The wound care program is continuing, now with a screening and surveillance component
- Leadership is critical in implementing a wound care program
- Training, educational updates, clinical back-up, regular review and discussion are all important staff considerations
- Patients have been well served

## Implementation Analysis

- We asked colleagues at the Ann Arbor VA
- to independently evaluate the program
- at Walla Walla.
- Their findings follow.

## The “Perfect Storm”

- The PCP who ultimately became the team leader was already aware that the facility was unable to properly treat wounds.
- The COS was also aware.
- Tension for change was high.
- The PCP had already started trying to care for patients with wounds.
- She recognized the need for more training, access to clinical expertise.
- “Good Wound Care” had a relative advantage over other potentially competing programs because of built-in access to Seattle experts.

**Ann Arbor Findings**

## Two Key Factors

- Intentional enrollment of team members and related team-building processes.
- Active involvement of the COS in recruitment.
- Widespread respect for the Team Leader among her peers.
- Exceptionally enthusiastic and professional nurse.
- Intuitive and proactive health technician.
- Enthusiastic OT who gracefully balanced pressures from several fronts.
- Multi-tasking scheduler managed patient and staff issues.

**Ann Arbor Findings**

## Two Key Factors

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

**Ann Arbor Findings**

## Team Building

- Significant amount of time was invested in education and training in Seattle.
- Research facilitators were available throughout the implementation and study.
- Mutual trust and respect evolved into genuine friendships.

**Ann Arbor Findings**

## Ripple Effects

- Team leader willingly consulted for other PCP’s patients without a formal consult.
- Garnered awareness and trust.
- PCP identified problems earlier.
- Rapid referral to Wound Clinic.
- Team members were energized by success – expansion of the wound clinics.
- Positive experiences of the team creates a fertile context for future innovations.
- New working relationships across 4 major services at WW benefits collaborative work in other areas.
- COS involvement in problem-solving increased staff confidence in his leadership.

**Ann Arbor Findings**