- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01795092
A Study Assessing the Impact of Dermatology Consultation in Patients Presenting With Possible Cellulitis
A Randomized-controlled Study to Assess the Impact of Dermatology Consultations on Reducing Admissions for Patients Presenting to Internal Medicine Clinics for Possible Cellulitis
Studieoversikt
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: 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.
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Eksperimentell: 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.
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A dermatology consultation will be conducted on patients randomized to this group.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Rate of Hospital admission
Tidsramme: 1 year
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1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of patients antibiotic was prescribed, type, dose, and duration of antibiotic prescribed and adverse events related to antibiotic usage.
Tidsramme: 3 months
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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.
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3 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Daniela Kroshinsky, MD, MPH, Massachusetts General Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2008A058574 (Annet stipend/finansieringsnummer: Dermatology Foundation)
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