Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study

Conditions
-----------------
Telemedicine, Primary Health Care, Developing Countries, Diagnosis, Therapeutics

Intervention / Treatment
-----------------
* Other: Telemedicine
* Other: In-person physician interaction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to give informed consent Non-emergent medical complaints At least 18 yrs in age Exclusion Criteria: Pregnancy Mental Disability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine First<br>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. | Other: Telemedicine<br>* 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.<br>* Other names: Skype;Other: In-person physician interaction<br>* Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.<br>* Other names: in-person consultation;|
| Experimental: Telemedicine Second<br>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. | Other: Telemedicine<br>* 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.<br>* Other names: Skype;Other: In-person physician interaction<br>* Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.<br>* Other names: in-person consultation;|
| Active Comparator: Two physician visits<br>Patients who had two sequential visits with different in-person physicians. | Other: In-person physician interaction<br>* Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.<br>* Other names: in-person consultation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Diagnoses | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient opinions of physician interactions | 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 | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic concordance, Treatment concordance, patient satisfaction, physician satisfaction, Medical Outreach Clinics, Medical Brigades, Medical Missions, Telemedicine, Videoconference, diagnoses, treatments, Satellite Internet, VSAT, cross cultural telemedicine