Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 1 of 234572 for:    ALL
Previous Study | Return to List | Next Study

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by University Hospitals Cleveland Medical Center
Sponsor:
Collaborators:
Pfizer
Ohio Dermatological Association
Information provided by (Responsible Party):
Susan Nedorost, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT03022786
First received: December 29, 2016
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Stasis Dermatitis
Other: Order set
Other: Motivational Interviewing training for home health aides
Other: Tools & Education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Improving Value of Care for Patients With Severe Stasis Dermatitis

Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Length of stay for patients with stasis dermatitis [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Feb-Sept in both years


Secondary Outcome Measures:
  • Readmission rate for patients with stasis dermatitis [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Feb through Sept both years

  • Patch testing for stasis dermatitis [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Absolute number of patients referred for evaluation of secondary allergic contact dermatitis in the setting of stasis dermatitis


Estimated Enrollment: 150
Study Start Date: January 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Understanding patient perspective
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
No Intervention: Refining tool kit

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
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
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
Other: Motivational Interviewing training for home health aides

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.

Other: Tools & Education
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'

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients under the age of 18
  • Illiterate patients
  • Non-English speaking patients
  • Outpatients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03022786

Contacts
Contact: Erich M Zirzow, BS 216-844-7164 Erich.zirzow@UHhospitals.org
Contact: Mary Consolo, BS 216-844-7834 Mary.Consolo@UHhospitals.org

Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Pfizer
Ohio Dermatological Association
Investigators
Principal Investigator: Susan Nedorost, MD University Hospitals Cleveland Medical Center
  More Information

Responsible Party: Susan Nedorost, Professor of Dermatology, Case Western Reserve University, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03022786     History of Changes
Other Study ID Numbers: 12-15-10 
Study First Received: December 29, 2016
Last Updated: January 12, 2017
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University Hospitals Cleveland Medical Center:
Dermatitis

Additional relevant MeSH terms:
Dermatitis
Skin Diseases

ClinicalTrials.gov processed this record on January 17, 2017