Study Assessing Impact of Dermatology Consultation for Patients Admitted With Cellulitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Dermatology Foundation
Information provided by (Responsible Party):
Daniela Kroshinsky, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01706913
First received: September 25, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

This is a randomized, controlled study to compare patients evaluated and managed by internal medicine hospitalists alone versus patients who are additionally evaluated by a dermatologist when they are admitted to the hospital, aiming to demonstrate that hospital admissions for cellulitis that involve early dermatology consultation will reduce hospital length of stay, readmission rates, prevalence of pseudocellulitis, cost, and antibiotic usage. The hypothesis of this study is that obtaining inpatient dermatology consultations, within 24 hours of a patient being admitted to the hospital for cellulitis, will reduce the length of stay, readmission rate, cost, and antibiotic usage of the patient‟s admission as well as properly evaluate and diagnose patients with pseudocellulitis. The primary objective will be to measure the difference in the length of stay for patients who are randomized to a dermatology consultation within 24 hours of hospital admission (active arm) versus being managed by an internal medicine hospitalist alone, as is the standard of care (control arm). The length of stay for each arm will be assessed once the study has been completed. The secondary endpoint will be to measure readmission rates for cellulitis after patients are discharged from the hospital. An additional endpoint will be to determine if antibiotic usage differs between patients randomized to a dermatology consultation and those not. Exploratory analyses will assess the percentage of patients with a concomitant known predisposing factor for recurrent cellulitis such as lymphedema, leg ulceration, tinea pedis, or onychomycosis, as well as the association of fever >100.5 F and a history of a prior episode of cellulitis.


Condition Intervention
Cellulitis
Other: Dermatology consult

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Controlled Study to Assess the Impact of Dermatology Consultations on the Hospital Course of Patients Admitted for Cellulitis

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Antibiotic usage [ Time Frame: 2 weeks after discharge from hospital stay ] [ Designated as safety issue: No ]
    We will be measuring the difference between antibiotic usage in patients in the control group as compared with the treatment group


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Will be measured at day of patient discharge ] [ Designated as safety issue: No ]
    We will be comparing the length of admission between the control group and the treatment group to assess whether a dermatology consult has any impact on the length of a patient's hospital stay.


Other Outcome Measures:
  • Readmission rate [ Time Frame: 2 weeks after patient discharge ] [ Designated as safety issue: No ]
    We will be measuring the readmission rate among patients in both groups in order to discover whether a dermatology consult has an impact on readmission rates among patients with cellultis.


Estimated Enrollment: 248
Study Start Date: October 2012
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No consult
Those who are in the control group will follow internal medicine hospitalist recommendations alone which will include when and what type of post-discharge follow-up appointments the patient will have. We would like to emphasize that as part of the standard of care, patients in the control arm may still receive a dermatology consult if it is deemed necessary and/or requested. We will not prevent patients or the patient's team of caregivers from requesting a dermatology consultation during the course of hospitalization. A follow-up phone call will be performed two weeks after discharge for patients in the control group in order to confirm the patient's outcome. There will also be a medical record review one month after the patient's initial discharge from the hospital to assess for readmission
Active Comparator: Dermatology Consult
The patients randomized to the treatment group will obtain a dermatology evaluation within 24 hours of being admitted to MGH for their cellulitis. The skin and lymph node exam performed by the dermatologist on patients in the treatment group will be documented in the LMR for the subjects' medical records. Patients who are readmitted for cellulitis within one month of being discharged from the hospital will be considered treatment failures. Patients in the treatment group will have a follow-up visit in dermatology clinic within two weeks after being discharged. There will also be a medical record review performed one month after the patient's initial discharge from the hospital to assess for readmission.
Other: Dermatology consult

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to understand and sign informed consent
  • Able to complete study and comply with study procedures
  • Presumed clinical diagnosis of cellulitis by medicine team

Exclusion Criteria:

  • Have a known postoperative site infection or abscess
  • Have a human/animal bite
  • Have known osteomyelitis
  • Have a hardware/line infection
  • Are under the age of 18
  • Have a history of transplantation less than six months after initial transplant and/or if they have had an episode of acute rejection in the last 90 days
  • Known use of antithymocyte globulin or campath in the last 6 months or more than 20 mg/day of prednisone for more than 30 days -
  • Are a known prisoner.
  • Are decisionally-impaired.
  • Have abnormal vital signs defined as systolic blood pressure <90 mmHg, diastolic blood pressure <80 mmHg, heart rate greater than 90 beats per minute or less than 50 beats per minute, respiratory rate greater than 20, or temperature > 100.5 F.
  • Are known to be pregnant.
  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: NCT01706913

Contacts
Contact: Daniela Kroshinsky, MD 617-643-3884 dkroshinsky@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniela Kroshinsky, MD    617-726-5066      
Principal Investigator: Daniela Kroshinsky, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Dermatology Foundation
Investigators
Principal Investigator: Daniela Kroshinsky, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Daniela Kroshinsky, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01706913     History of Changes
Other Study ID Numbers: DermFound-2008A058574
Study First Received: September 25, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014