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

19 februari 2013 bijgewerkt door: Daniela Kroshinsky, Massachusetts General Hospital

A Randomized-controlled Study to Assess the Impact of Dermatology Consultations on Reducing Admissions for Patients Presenting to Internal Medicine Clinics for Possible Cellulitis

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Patients to be enrolled in the study will be those that present to outpatient internal medicine clinic and are identified by primary care physicians as having pain, redness, and swelling of the skin that the physician believes may represent cellulitis. Patient recruitment will occur at five Massachusetts General Hospital (MGH) outpatient internal medicine clinical sites: Medical Walk-In, Internal Medicine Associates, Bulfinch Medical Group, Senior Health, and Women's health. Patients with abnormal vital signs will be excluded, specifically 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. In addition, any patients with a history of transplantation must be more than six months after initial transplant with no treated episodes of acute rejection in the last 90 days, no use of antithymocyte globulin or campath to treat rejection in the last 6 months, or more than 20 mg/day of prednisone for more than 30 days.

Once a patient is identified with potential cellulitis who is a candidate for outpatient treatment, the primary care physician will then approach them regarding their interest in entering our study. Patients will be randomized during this initial presentation to their primary care physician. The 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 or discharged home with outpatient dermatology follow-up in two to three days to assess for improvement in their condition versus no change or worsening that requires transfer to the Emergency Department. Patients who are evaluated by a dermatologist and who require hospitalization will have their transition to the Emergency Department managed by the dermatologist with notification of the patient"s PCP. These patients who have follow-up in dermatology clinic will not require a follow-up visit with their primary care physician. The skin and lymph node exam performed by the dermatologist on patients in the treatment group will be documented in the electronic medical record for the subjects" medical records. 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. A medical record review will be performed for patients who are randomized to the treatment group two weeks after initial evaluation at the internal medicine clinic.

Those in the control group who do not obtain a dermatology evaluation will follow primary care recommendations alone and will also have chart review two weeks later to assess for admission versus discharge home from clinic and outcome. In the control group, the need for additional clinical follow-up will be at the primary care physician"s discretion. These patients will receive a followup telephone call to confirm the final outcome of their condition two weeks after their visit to internal medicine clinic. The data sets generated from the treatment and control groups will then be compared to look for differences in hospital admission rates. For the treatment arm of the study, this data will be obtained during the follow-up visit and the medical record review. For the control arm, this will be obtained during both the medical record review and the follow-up phone call. The goal of this data collection is to determine what the final outcome is for patients in both groups in terms of need for hospital admission.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

29

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Massachusetts General Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control
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.
Experimenteel: Dermatology consultation
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.
A dermatology consultation will be conducted on patients randomized to this group.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Rate of Hospital admission
Tijdsspanne: 1 year
1 year

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of patients antibiotic was prescribed, type, dose, and duration of antibiotic prescribed and adverse events related to antibiotic usage.
Tijdsspanne: 3 months
We will be recording whether an antibiotic was prescribed, which antibiotic was used, the duration of treatment, the dosage of antibiotic, the cost of the antibiotic, and any adverse events related to antibiotic usage.
3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Daniela Kroshinsky, MD, MPH, Massachusetts General Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2012

Primaire voltooiing (Werkelijk)

1 december 2012

Studie voltooiing (Werkelijk)

1 december 2012

Studieregistratiedata

Eerst ingediend

18 februari 2013

Eerst ingediend dat voldeed aan de QC-criteria

19 februari 2013

Eerst geplaatst (Schatting)

20 februari 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

20 februari 2013

Laatste update ingediend die voldeed aan QC-criteria

19 februari 2013

Laatst geverifieerd

1 februari 2013

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2008A058574 (Ander subsidie-/financieringsnummer: Dermatology Foundation)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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