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Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study

8 maj 2014 uppdaterad 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

144

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Francisco Morazan
      • Tegucigalpa, Francisco Morazan, Honduras
        • Global Brigades

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Able to give informed consent
  • Non-emergent medical complaints
  • At least 18 yrs in age

Exclusion Criteria:

  • Pregnancy
  • Mental Disability

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • Skype
  • Videoconference
Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.
Andra namn:
  • personligt besök
  • in-person examination
  • in-person consultation
Experimentell: 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.
Andra namn:
  • Skype
  • Videoconference
Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.
Andra namn:
  • personligt besök
  • in-person examination
  • in-person consultation
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.
Andra namn:
  • personligt besök
  • in-person examination
  • in-person consultation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical Diagnoses
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient opinions of physician interactions
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cost
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Bart Demaerschalk, MD/MSc, Mayo Clinic

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2013

Primärt slutförande (Faktisk)

1 juni 2013

Avslutad studie (Faktisk)

1 juni 2013

Studieregistreringsdatum

Först inskickad

20 mars 2013

Först inskickad som uppfyllde QC-kriterierna

26 mars 2013

Första postat (Uppskatta)

29 mars 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 maj 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 maj 2014

Senast verifierad

1 maj 2014

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Telemedicin

Kliniska prövningar på Telemedicine

3
Prenumerera