Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03022786 |
| Other study ID # |
12-15-10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2017 |
| Est. completion date |
December 2018 |
Study information
| Verified date |
April 2020 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
