Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study
8 mai 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
144
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Francisco Morazan
-
Tegucigalpa, Francisco Morazan, Honduras
- Global Brigades
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Able to give informed consent
- Non-emergent medical complaints
- At least 18 yrs in age
Exclusion Criteria:
- Pregnancy
- Mental Disability
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Autres noms:
|
|
Comparateur actif: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Diagnoses
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient opinions of physician interactions
Délai: 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
Délai: 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.
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immediately following volunteer activities with the clinic (less than 48 hours)
|
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Volunteer opinions of physician-patient interactions
Délai: 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)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cost
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Bart Demaerschalk, MD/MSc, Mayo Clinic
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2013
Achèvement primaire (Réel)
1 juin 2013
Achèvement de l'étude (Réel)
1 juin 2013
Dates d'inscription aux études
Première soumission
20 mars 2013
Première soumission répondant aux critères de contrôle qualité
26 mars 2013
Première publication (Estimation)
29 mars 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
12 mai 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2014
Dernière vérification
1 mai 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13-000132
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .