Improving Value of Care for Patients With Severe Stasis Dermatitis

NCT03022786 | Completed DMC

• 1 other identifier: 12-15-10
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Stasis Dermatitis

Keywords

Dermatitis

Outcome Measures

Primary Outcomes (1)

• Length of stay for patients with stasis dermatitis

  Feb-Sept in both years

  Up to 2 years

Secondary Outcomes (2)

• Readmission rate for patients with stasis dermatitis

  Up to 2 years

• Patch testing for stasis dermatitis

  Up to 2 years

Study Arms (3)

Understanding patient perspective

NO 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

Refining tool kit

NO 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.

Implementation

OTHER

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.

Other: Order set; Other: Motivational Interviewing training for home health aides; Other: Tools & Education

Interventions

Order set OTHER

Inpatient order set and ambulatory care guide offer guidance on initial compression to decrease edema, obtaining gradient compression stockings, how to access evaluation by vascular medicine for pain or dermatology for evaluation of allergic contact dermatitis if itch persists, etc

Implementation

Motivational Interviewing training for home health aides OTHER

Home Care aides trained about use of compression stockings and use of motivational interviewing as a tool to help patients make behavior changes to reduce leg swelling. This is part of our 'tool kit'. 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.

Implementation

Tools & Education OTHER

Engaged physical therapists to evaluate patients for ability to don stockings, to assess need for strengthening exercises or leg exercises to improve venous return. This is part of our 'tool kit'

Implementation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18
• Inpatient admission to the hospital for inflamed skin of the lower legs, bilateral cellulitis, and contact dermatitis
• Fluent in English

You may not qualify if:

• Patients under the age of 18
• Illiterate patients
• Non-English speaking patients
• Outpatients

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Pfizer: collaborator
• Ohio Dermatological Association: collaborator

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Dermatitis

Interventions

Home Health Aides; Educational Status

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Susan Nedorost, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, Case Western Reserve University

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 16, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)