Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study

May 8, 2014 updated by: 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Mental Disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other Names:
  • 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.
Other Names:
  • in-person visit
  • in-person examination
  • in-person consultation
Experimental: 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.
Other Names:
  • 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.
Other Names:
  • in-person visit
  • in-person examination
  • in-person consultation
Active Comparator: 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.
Other Names:
  • in-person visit
  • in-person examination
  • in-person consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Diagnoses
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient opinions of physician interactions
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Bart Demaerschalk, MD/MSc, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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