Clinical Trial: Improving Value of Care for Patients With Severe Stasis Dermatitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Improving Value of Care for Patients With Severe Stasis Dermatitis

Brief 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.

Detailed Summary:

SPECIFIC AIMS 2.1.1 Understand the unmet needs for stasis dermatitis care from the patient and provider perspective.

PHASE 1: Patients Access problem: Severe stasis dermatitis is a multifactorial condition that can mimic "bilateral cellulitis". However, true bilateral cellulitis is exceedingly rare and in most cases, is a misdiagnosis. The diagnosis of cellulitis is based primarily on clinical appearance, sharing many features with severe stasis dermatitis. Objective measures for the diagnosis of cellulitis are rarely helpful, with low sensitivity and specificity rates for fever, leukocytosis, tachycardia, blood cultures, and imaging studies. Admissions for cellulitis and "bilateral cellulitis" in the United States are frequent, representing nearly 4% of all emergency admissions in 2010, with hospital stays averaging 5-7 days. Among the factors most highly associated with increased length of hospital stay in these patients, the top four include chronic edema, use of diuretics, elderly age, and living alone2. These patients are likely to have severe lower extremity swelling, complicating stasis dermatitis, and the most difficulty managing chronic health conditions. In a recent study of 145 patients admitted for cellulitis, it was found that 28% were incorrectly diagnosed with lower limb cellulitis, with venous stasis dermatitis being the most common diagnosis mistaken for cellulitis in 37% of cases. This is costly to patients, providers, hospitals, and the healthcare system.

In outpatient and inpatient settings, internists frequently prescribe diuretics to reduce lower extremity edema without awarding the problem a comprehensive evaluation for underlying causes. This chronic condition requires ongoing treatment, in many forms, which must address the primary cause. Gradient compression is the most effecti
Sponsor: University Hospitals Cleveland Medical Center

Current Primary Outcome: Length of stay for patients with stasis dermatitis [ Time Frame: Up to 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Readmission rate for patients with stasis dermatitis [ Time Frame: Up to 2 years ]
  Feb through Sept both years
• Patch testing for stasis dermatitis [ Time Frame: Up to 2 years ]
  Absolute number of patients referred for evaluation of secondary allergic contact dermatitis in the setting of stasis dermatitis

Original Secondary Outcome: Same as current

Information By: University Hospitals Cleveland Medical Center

Dates:
Date Received: December 29, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: January 12, 2017
Last Verified: January 2017