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Improving Value of Care for Patients With Severe Stasis Dermatitis (Dermatitis Trial)

N/A

Waitlist Available

Led By Susan Nedorost, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

Explore the unmet needs of patients admitted to the hospital for severely inflamed skin of the lower legs, often described as 'bilateral cellulitis". These patients usually have intractable lower extremity edema, stasis dermatitis and sometimes allergic contact dermatitis rather than an infectious process; readmission is common. Investigators will create patient and provider education materials to align dermatological, home health, and other resources and measure reduction in hospital re-admission rate and length of stay.

Eligible Conditions

Venous Dermatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of stay for patients with stasis dermatitis

Secondary study objectives

Patch testing for stasis dermatitis

Readmission rate for patients with stasis dermatitis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ImplementationExperimental Treatment3 Interventions

Our patient education materials and toolkit include an order set to help providers guide patients to adhere to compression, the gold standard of care for this condition. This will also direct patients to know who to contact if itching or pain persists, what the patient can do at home, when to go to the hospital, as well as information on financial and home care assistance as it relates to managing their chronic condition.

Group II: Understanding patient perspectiveActive Control1 Intervention

Patients will be interviewed who have been diagnosed with stasis dermatitis. The Principal Investigator will learn their perspective on their leg swelling, impact on quality of life, and obstacles to wearing compression stockings

Group III: Refining tool kitActive Control1 Intervention

Using in-depth interviews for our inpatients selected using the same criteria as in Phase 1 and independent focus groups of providers, The study staff will obtain feedback to refine the items in our toolkit before implementing them in January 2017. There will be a focus group comprised of providers. This focus group will explore the perceptions of the providers and what unmet needs remain for the patients.

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