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

Primary Purpose

Stasis Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Order set
Motivational Interviewing training for home health aides
Tools & Education
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stasis Dermatitis focused on measuring Dermatitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Other

Arm Label

Understanding patient perspective

Refining tool kit

Implementation

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Length of stay for patients with stasis dermatitis
Feb-Sept in both years

Secondary Outcome Measures

Readmission rate for patients with stasis dermatitis
Feb through Sept both years
Patch testing for stasis dermatitis
Absolute number of patients referred for evaluation of secondary allergic contact dermatitis in the setting of stasis dermatitis

Full Information

First Posted
December 29, 2016
Last Updated
April 24, 2020
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Pfizer, Ohio Dermatological Association
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1. Study Identification

Unique Protocol Identification Number
NCT03022786
Brief Title
Improving Value of Care for Patients With Severe Stasis Dermatitis
Acronym
Dermatitis
Official Title
Improving Value of Care for Patients With Severe Stasis Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Pfizer, Ohio Dermatological Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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 effective means to achieve relief, but long-term management with this form of treatment requires a breadth of knowledge on behalf of providers and patients. For providers for example, multi-layer bandages must be used during the acute phase to reshape and reduce the size of the limb, appropriate stocking compression grade and length must be chosen, and patients and potential caregivers should be educated on donning and doffing stockings, application aids, appropriate hosiery care, skin care, use of emollients, limb massage, and exercise. Additionally, this requires stockings not covered by many insurance plans. Many patients are non-adherent because the patients do not have a family member or home health aide to assist, or the patients do not understand the importance of stockings as a treatment for the patients disease. Providers may not have knowledge of who to contact to get patients assistance in these situations. As a result, the edema gets worse, and patients are admitted and readmitted to the hospital with relapsing "bilateral cellulitis" of the lower extremities. Phase 1 of this study was approved by the University Hospitals Institutional Review Board in January 2016 and under this protocol investigators have interviewed 27 inpatients (28 admissions) using a structured survey. The results of these interviews informed the development of a tool kit to improve care for these patients. The tool kits consists of a patient brochure, a list of stockings and services available at local medical supply houses, and an order set that includes patient education including an Expectation Management and Medical Information (EMMI) module on compression stockings, a video patient story, and training of University Hospitals Home care aides in motivational interviewing to support adherence to regular use of gradient compression. PHASE 2: Focus Groups Using in-depth interviews for our inpatients selected using the same criteria as in Phase 1 and independent focus groups of providers, the Principal Investigator will obtain feedback to refine the items in our toolkit before implementing them in January 2017. The focus groups will be conducted with assistance from the Clinical and Translational Science Collaborative (CTSC) Behavioral Measurement and Resource Center. The in-depth interviews will be conducted either at patient homes or as inpatients. The interviews may be recorded as in Part 1. The recordings and data will be downloaded into REDCap. 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. With this information, investigators will design educational materials to help align resources in a timely fashion and avoid admission when possible. The order set will include guidance on when to obtain consultations as well as specific orders for reduction of lower extremity edema and monitoring for side effects of compression. 2.1.2 Design education for patients and providers to cue them when additional care is needed. PHASE 3: Tools & Education Access problem : Patients are often admitted to the hospital for "bilateral cellulitis" despite the fact that most of these patients do not have true skin infections. A research study published in 2015 demonstrated that 75% of inpatient dermatology consultations for 'cellulitis" resulted in a diagnosis of "pseudocellulitis" . Our data from phase 1 confirms that 75% of patients admitted for lower extremity cellulitis at University Hospitals do not in fact have cellulitis, although 90% receive antibiotics during a mean length of stay of 8.3 days. Patients and providers may not even be aware of this misdiagnosis, as stasis dermatitis will improve with leg elevation alone during a hospital stay. As a result, care givers erroneously give intravenous antibiotics all of the credit for the condition's resolution. When it recurs, a history of "recurrent cellulitis" is added to the patient's chart, and the cycle is repeated. Providers may also struggle with a lack of objective measures that can be used in the diagnosis of cellulitis and its severity, depending primarily on clinical appearance. Unnecessary admission and testing is expensive in many ways. For patients admitted to the hospital, standard treatment for cellulitis is IV antibiotics for a week or more. Prolonged bed rest in the hospital with potent antibiotics is problematic, especially for older patients. It puts them at risk for impaired mobility, deep venous thrombosis, nosocomial infections, particularly with Clostridium difficile, and is monetarily costly for all parties involved. Alternative diagnoses need to be considered. Allergic contact dermatitis, which is known to complicate stasis dermatitis, is one possibility. Patients can easily develop contact allergies to components of topical steroids and topical antibiotics prescribed in an attempt to treat dry, cracked, or fissured skin on an outpatient basis. However, many inpatient facilities do not have access to regular dermatological consultation, and local dermatologists may not have the appropriate patch tests or experience with patch testing to identify contact allergen in the setting of stasis dermatitis. Patient education materials and toolkit will help patients know who to contact when the edema progresses, what patients 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 chronic condition. Provider education materials will assist providers with making the correct diagnosis, ordering appropriate testing, understanding when to consider admission, especially in cases of "bilateral cellulitis", involving specialty providers, and aligning assistance for patients. The goal is to help providers when the patients feel stuck in attempting to help patients manage this chronic condition, especially after the patient has already had multiple admissions. Measure the value of services identified in steps 1 and 2. Investigators will track the number of patient admissions for antibiotics for "bilateral cellulitis" and length of stay at two different time points: (1) before and (2) after provider education ( e.g. clinical decision support in the electronic health record, an contact information guides for trained home health aides). Investigators will also track the number of readmissions and length of stay for patients at two time points: (1) before and (2) after patient education materials are implemented (e.g. educational brochure, information guides for community medical supply houses, and improved access e.g to increase use of patch testing for inpatients). Investigators will stratify patients who have been seen in wound care centers and those who have had patch testing and compare them to patients who have not, to help better understand the value of these services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stasis Dermatitis
Keywords
Dermatitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Understanding patient perspective
Arm Type
No Intervention
Arm Description
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
Arm Title
Refining tool kit
Arm Type
No Intervention
Arm Description
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.
Arm Title
Implementation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Order set
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Motivational Interviewing training for home health aides
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tools & Education
Intervention Description
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'
Primary Outcome Measure Information:
Title
Length of stay for patients with stasis dermatitis
Description
Feb-Sept in both years
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Readmission rate for patients with stasis dermatitis
Description
Feb through Sept both years
Time Frame
Up to 2 years
Title
Patch testing for stasis dermatitis
Description
Absolute number of patients referred for evaluation of secondary allergic contact dermatitis in the setting of stasis dermatitis
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Nedorost, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Value of Care for Patients With Severe Stasis Dermatitis

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