A Study Assessing the Impact of Dermatology Consultation in Patients Presenting With Possible Cellulitis

NCT01795092 | Completed

• 1 other identifier: 2008A058574
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled study to compare patients evaluated by primary care physicians alone versus patients who are additionally evaluated by a dermatologist at the primary care physician"s office, aiming to demonstrate that visits to the primary care physician"s (PCP) office that involve both the PCP and an on-site dermatology consultation will reduce hospital admission rates. The hypothesis of this study is that obtaining outpatient dermatology consultations during a patient"s initial presentation to a primary care office will reduce admissions for cellulitis with accuracy. The primary objective will be to measure the difference in the proportion of patients requiring hospital admission utilizing a dermatology consultation at the PCP"s office (active arm) versus primary care evaluation alone (control arm) by calculating risk ratios and risk differences. The risk of admission for each arm will be assessed once the study has been completed. The secondary endpoint will be admission versus discharge home at a dermatology follow-up visit to assess accuracy of initial assessment. An additional endpoint will be to determine if any differences in frequencies of cellulitis and admission exist based on age and immunosuppression. 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.

Conditions

Cellulitis

Keywords

Cellulitis; Outpatient Medicine

Outcome Measures

Primary Outcomes (1)

• Rate of Hospital admission

  1 year

Secondary Outcomes (1)

• Number of patients antibiotic was prescribed, type, dose, and duration of antibiotic prescribed and adverse events related to antibiotic usage.

  3 months

Study Arms (2)

Control

NO INTERVENTION

Those in the control group do not obtain a dermatology evaluation and will be assessed and treated by their primary care provider. We will perform a chart review two weeks after presentation to assess for admission versus discharge home from clinic and outcome.

Dermatology consultation

EXPERIMENTAL

Patients randomized to the treatment group will obtain a dermatology evaluation at the primary care physician's office and will be sent to the Emergency Department (ED) or discharged home with outpatient dermatology follow-up in 2-3 days to assess their condition. Patients who are evaluated by a dermatologist and require hospitalization will have their transition to the ED managed by the dermatologist. Patients who are admitted after the initial outpatient discharge or at the follow-up visit will be considered treatment failures. A medical record review will be performed for patients in the treatment group two weeks after initial evaluation at the internal medicine clinic.

Other: Dermatology Consultation

Interventions

Dermatology Consultation OTHER

A dermatology consultation will be conducted on patients randomized to this group.

Dermatology consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and sign informed consent.
• Able to complete study and comply with study procedures.
• Presumed clinical diagnosis of cellulitis by primary care physician

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Arakaki RY, Strazzula L, Woo E, Kroshinsky D. The impact of dermatology consultation on diagnostic accuracy and antibiotic use among patients with suspected cellulitis seen at outpatient internal medicine offices: a randomized clinical trial. JAMA Dermatol. 2014 Oct;150(10):1056-61. doi: 10.1001/jamadermatol.2014.1085.

  PMID: 25143179 DERIVED

MeSH Terms

Conditions

Cellulitis

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniela Kroshinsky, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

US (1)