Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study
8. mai 2014 oppdatert av: Bart M. Demaerschalk, Mayo Clinic
Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers.
These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which stem, in part, from understaffing with volunteer physicians.
This study is designed to assess if it is feasible, safe, and acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US physicians connected with patients by videoconference.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
144
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Francisco Morazan
-
Tegucigalpa, Francisco Morazan, Honduras
- Global Brigades
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Able to give informed consent
- Non-emergent medical complaints
- At least 18 yrs in age
Exclusion Criteria:
- Pregnancy
- Mental Disability
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Telemedicine First
Patients whose first physician visit during the clinic was using videoconference, a form of telemedicine, and whose second physician visit during the clinic was with a physician in-person.
|
Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope.
A clinic volunteer aids with examination, translation and documentation.
Andre navn:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Andre navn:
|
|
Eksperimentell: Telemedicine Second
Patients whose first physician visit during the clinic was with a physician in-person, and whose second physician visit during the clinic was using videoconference, a form of telemedicine.
This is the reverse order of visits of the "Telemedicine fist" arm.
|
Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope.
A clinic volunteer aids with examination, translation and documentation.
Andre navn:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Andre navn:
|
|
Aktiv komparator: Two physician visits
Patients who had two sequential visits with different in-person physicians.
|
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Diagnoses
Tidsramme: Same Day as clinic visit (less than 6 hours)
|
The diagnoses resulting from the two physician visits will be compared and a cohen's kappa statistic will be calculated for diagnoses between the visits.
|
Same Day as clinic visit (less than 6 hours)
|
|
Recommended clinical treatments
Tidsramme: Same Day as clinic visit (less than 6 hours)
|
After each of a patient's two physician visits, the physician's resulting recommended treatments will be gathered for comparison between the two visits.
|
Same Day as clinic visit (less than 6 hours)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient opinions of physician interactions
Tidsramme: Immediately following physician interactions (less than 6 hours)
|
Patients will receive a survey following each interaction with a doctor.
These surveys cover communication, comfort and satisfaction.
|
Immediately following physician interactions (less than 6 hours)
|
|
Physician opinions of patient interactions
Tidsramme: immediately following volunteer activities with the clinic (less than 48 hours)
|
doctors will fill out a survey about their patient interactions after they complete their experience volunteering with the clinic.
|
immediately following volunteer activities with the clinic (less than 48 hours)
|
|
Volunteer opinions of physician-patient interactions
Tidsramme: immediately following experience with the clinic (Less than 48 hours)
|
Volunteers who helped with physician interactions will receive a survey about their experience concerning physician patient communication, volunteer educational value and perceived value of the experience.
|
immediately following experience with the clinic (Less than 48 hours)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cost
Tidsramme: One year (from pilot to completion of study)
|
The costs of materials and services required to conduct the patient examinations will be collected to build an economic model and projected cost of scaling up the videoconference interventions.
|
One year (from pilot to completion of study)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Bart Demaerschalk, MD/MSc, Mayo Clinic
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
1. juni 2013
Studiet fullført (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først innsendt
20. mars 2013
Først innsendt som oppfylte QC-kriteriene
26. mars 2013
Først lagt ut (Anslag)
29. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. mai 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. mai 2014
Sist bekreftet
1. mai 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13-000132
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .