Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study

Telemedicine Clinical Trial

Official title:

Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821014
• Other study ID #: 13-000132
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: May 8, 2014
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardHonduras: Investigation Committee of Biomedical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to give informed consent

• Non-emergent medical complaints

• At least 18 yrs in age

Exclusion Criteria:

• Pregnancy

• Mental Disability

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Developing Countries
• Diagnosis
• Primary Health Care
• Telemedicine
• Therapeutics

Intervention

Other:
• Telemedicine
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.
• In-person physician interaction
Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.

Locations

Country	Name	City	State
Honduras	Global Brigades	Tegucigalpa	Francisco Morazan

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost	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)	No
Primary	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)	Yes
Primary	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)	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No